Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
dipeptidyl aminopeptidase-IV inhibitors	4175	668270-12-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: linagliptin tradjenta BI 1356 BI-1356	Linagliptin is an inhibitor of DPP-4, an enzyme that degrades the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). Thus, linagliptin increases the concentrations of active incretin hormones, stimulating the release of insulin in a glucose-dependent manner and decreasing the levels of glucagon in the circulation. Both incretin hormones are involved in the physiological regulation of glucose homeostasis. Incretin hormones are secreted at a low basal level throughout the day and levels rise immediately after meal intake. GLP-1 and GIP increase insulin biosynthesis and secretion from pancreatic beta cells in the presence of normal and elevated blood glucose levels. Furthermore, GLP-1 also reduces glucagon secretion from pancreatic alpha cells, resulting in a reduction in hepatic glucose output. Molecular weight: 472.55 Formula: C25H28N8O2 CLOGP: 2.19 LIPINSKI: 0 HAC: 10 HDO: 1 TPSA: 113.48 ALOGS: -3.97 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

linagliptin
tradjenta
BI 1356
BI-1356

Linagliptin is an inhibitor of DPP-4, an enzyme that degrades the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). Thus, linagliptin increases the concentrations of active incretin hormones, stimulating the release of insulin in a glucose-dependent manner and decreasing the levels of glucagon in the circulation. Both incretin hormones are involved in the physiological regulation of glucose homeostasis. Incretin hormones are secreted at a low basal level throughout the day and levels rise immediately after meal intake. GLP-1 and GIP increase insulin biosynthesis and secretion from pancreatic beta cells in the presence of normal and elevated blood glucose levels. Furthermore, GLP-1 also reduces glucagon secretion from pancreatic alpha cells, resulting in a reduction in hepatic glucose output.

Molecular weight: 472.55
Formula: C25H28N8O2
CLOGP: 2.19
LIPINSKI: 0
HAC: 10
HDO: 1
TPSA: 113.48
ALOGS: -3.97
ROTB: 5

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
5	mg	O

ADMET properties:

Property	Value	Reference
Vd (Volume of distribution)	16 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	1.90 mL/min/kg	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	129 hours	Lombardo F, Berellini G, Obach RS
S (Water solubility)	0.90 mg/mL	Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Bocci G, Oprea TI, Benet LZ

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value	Unit	Confidence	Similarity
kinase-safety-class	ACVR2B,AXL,BRAF,CAMK2D,CDK5,CDK9,EIF2AK3,ERBB2,GRK2,ITK,MAPK7,MET,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PIK3CD,PRKDC,TEK	20
pfas-class	PFAS structural alert (1 = True, 0 = False)	0

Approvals:

Date	Agency	Company	Orphan
May 2, 2011	FDA	BOEHRINGER INGELHEIM
July 1, 2011	PMDA	Nippon Boehringer Ingelheim Co., Ltd

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Pemphigoid	360.38	15.77	123	24691	8903	90594730
Subarachnoid haemorrhage	337.91	15.77	141	24673	17763	90585870
Cardiospasm	330.47	15.77	92	24722	3354	90600279
Palmoplantar keratoderma	328.87	15.77	92	24722	3415	90600218
Hypoglycaemia	320.29	15.77	213	24601	69635	90533998
Pruritus genital	318.00	15.77	95	24719	4463	90599170
Sleep terror	306.93	15.77	92	24722	4372	90599261
Dermatitis bullous	303.24	15.77	112	24702	10204	90593429
Blood glucose increased	288.92	15.77	226	24588	95020	90508613
Atrial tachycardia	284.33	15.77	93	24721	5897	90597736
Carotid artery occlusion	279.12	15.77	93	24721	6249	90597384
Tension headache	263.73	15.77	93	24721	7416	90596217
Anosmia	239.15	15.77	93	24721	9755	90593878
Immunisation	234.92	15.77	64	24750	2149	90601484
Facial pain	206.45	15.77	91	24723	13091	90590542
Vasculitis	195.45	15.77	104	24710	22589	90581044
Pain of skin	195.24	15.77	93	24721	15989	90587644
Ventricular tachycardia	189.89	15.77	105	24709	24603	90579030
Blindness	172.16	15.77	101	24713	26467	90577166
Transient ischaemic attack	170.17	15.77	120	24694	43056	90560577
Lip swelling	167.89	15.77	114	24700	38496	90565137
Eye pruritus	163.89	15.77	101	24713	28926	90574707
Muscle twitching	162.09	15.77	94	24720	24108	90579525
Diplopia	147.25	15.77	94	24720	28620	90575013
Angioedema	140.82	15.77	127	24687	64749	90538884
Tinnitus	125.65	15.77	100	24714	43002	90560631
Hallucination	125.53	15.77	120	24694	65839	90537794
Pancreatitis	114.26	15.77	117	24697	69709	90533924
Glycosylated haemoglobin increased	105.67	15.77	61	24753	15501	90588132
Disturbance in attention	103.75	15.77	93	24721	47016	90556617
Hyperglycaemia	101.30	15.77	95	24719	50875	90552758
Renal impairment	94.71	15.77	130	24684	105291	90498342
Metabolic acidosis	92.37	15.77	94	24720	55582	90548051
Intentional product misuse	92.05	15.77	118	24696	89486	90514147
Acute kidney injury	91.78	15.77	242	24572	320145	90283488
Dehydration	91.61	15.77	179	24635	194268	90409365
Euglycaemic diabetic ketoacidosis	91.28	15.77	41	24773	6160	90597473
Palpitations	90.38	15.77	146	24668	136582	90467051
Pancreatitis haemorrhagic	89.04	15.77	23	24791	626	90603007
Cognitive disorder	88.54	15.77	102	24712	69305	90534328
Rash papular	88.22	15.77	60	24754	20295	90583338
Dry skin	87.36	15.77	114	24700	87959	90515674
Systemic lupus erythematosus	85.78	15.77	3	24811	361893	90241740
Diabetic ketoacidosis	82.86	15.77	62	24752	24345	90579288
Myocardial infarction	80.97	15.77	121	24693	105851	90497782
Lactic acidosis	76.16	15.77	81	24733	50382	90553251
Heart rate increased	73.83	15.77	120	24694	112782	90490851
Diabetes mellitus inadequate control	73.75	15.77	52	24762	18632	90585001
Arthropathy	72.22	15.77	8	24806	366234	90237399
Infusion related reaction	70.94	15.77	14	24800	416766	90186867
Hyperhidrosis	69.73	15.77	130	24684	136175	90467458
Drug ineffective	69.63	15.77	175	24639	1384123	89219510
Hyperkalaemia	68.99	15.77	87	24727	64877	90538756
Rheumatoid arthritis	68.84	15.77	9	24805	362605	90241028
Cardiac failure	67.05	15.77	113	24701	109383	90494250
Wound	66.95	15.77	4	24810	302976	90300657
Glossodynia	66.12	15.77	6	24808	321773	90281860
Drug intolerance	64.72	15.77	21	24793	447570	90156063
Pemphigus	59.95	15.77	9	24805	326855	90276778
Glomerular filtration rate decreased	59.68	15.77	44	24770	16888	90586745
Chronic kidney disease	57.77	15.77	70	24744	50121	90553512
Therapeutic product effect decreased	57.49	15.77	5	24809	277566	90326067
Renal failure	57.33	15.77	117	24697	130890	90472743
COVID-19	57.14	15.77	136	24678	168707	90434926
Drug hypersensitivity	56.81	15.77	28	24786	463581	90140052
Contraindicated product administered	56.07	15.77	10	24804	320129	90283504
Visual impairment	55.32	15.77	116	24698	132249	90471384
Joint swelling	53.69	15.77	36	24778	503264	90100369
Hyperlactacidaemia	53.51	15.77	25	24789	4111	90599522
Feeling abnormal	52.64	15.77	131	24683	167104	90436529
Pancreatic carcinoma	52.03	15.77	31	24783	8346	90595287
Impaired healing	52.01	15.77	3	24811	234196	90369437
Dizziness	51.62	15.77	306	24508	588978	90014655
Helicobacter infection	50.09	15.77	3	24811	226847	90376786
Tachycardia	48.04	15.77	122	24692	157551	90446082
Amnesia	47.58	15.77	97	24717	108408	90495225
Discomfort	47.11	15.77	9	24805	274326	90329307
Cystostomy	45.89	15.77	9	24805	65	90603568
Blood glucose abnormal	43.57	15.77	29	24785	9463	90594170
Muscular weakness	43.55	15.77	140	24674	206526	90397107
Pancreatitis acute	42.29	15.77	48	24766	32067	90571566
Hepatic enzyme increased	40.93	15.77	24	24790	360712	90242921
Diabetic metabolic decompensation	38.89	15.77	16	24798	1941	90601692
Irritable bowel syndrome	37.37	15.77	6	24808	207442	90396191
Psoriatic arthropathy	36.13	15.77	9	24805	228326	90375307
Chest pain	36.05	15.77	178	24636	319467	90284166
Condition aggravated	35.77	15.77	68	24746	595477	90008156
Swelling	33.77	15.77	39	24775	419019	90184614
Vomiting	32.99	15.77	345	24469	787948	89815685
Back pain	32.53	15.77	172	24642	317003	90286630
Blood creatinine increased	32.49	15.77	80	24734	101306	90502327
Hypoglycaemic encephalopathy	32.21	15.77	9	24805	332	90603301
Sinusitis	32.13	15.77	28	24786	343060	90260573
Neoplasm skin	31.63	15.77	16	24798	3126	90600507
Pain	31.03	15.77	154	24660	996187	89607446
Musculoskeletal stiffness	30.53	15.77	22	24792	296510	90307123
Ketoacidosis	30.38	15.77	19	24795	5576	90598057
Memory impairment	29.90	15.77	120	24694	197124	90406509
Abdominal pain upper	29.85	15.77	174	24640	332500	90271133
Ill-defined disorder	29.81	15.77	7	24807	184884	90418749
Hypersensitivity	28.99	15.77	50	24764	454627	90149006
Lower respiratory tract infection	27.96	15.77	17	24797	250642	90352991
Breast cancer metastatic	27.76	15.77	27	24787	15105	90588528
Injury	27.20	15.77	10	24804	197339	90406294
Contusion	26.70	15.77	18	24796	251198	90352435
Haemorrhoidal haemorrhage	26.22	15.77	17	24797	5306	90598327
Urinary tract infection	26.21	15.77	158	24656	305474	90298159
Azotaemia	26.15	15.77	17	24797	5331	90598302
Tubulointerstitial nephritis	25.41	15.77	33	24781	25310	90578323
Urine calcium/creatinine ratio increased	25.13	15.77	6	24808	117	90603516
Stomatitis	25.02	15.77	23	24791	274675	90328958
Pyelonephritis	24.96	15.77	30	24784	21286	90582347
Infection	24.78	15.77	38	24776	362056	90241577
Mucosal membrane hyperplasia	24.72	15.77	5	24809	43	90603590
Therapy non-responder	24.51	15.77	4	24810	136700	90466933
Wheezing	24.07	15.77	18	24796	238062	90365571
Pruritus	24.03	15.77	240	24574	541285	90062348
Nasopharyngitis	23.96	15.77	47	24767	407057	90196576
Shock	23.61	15.77	34	24780	28744	90574889
Vulvovaginal mycotic infection	23.59	15.77	17	24797	6297	90597336
Malaise	23.31	15.77	254	24560	585732	90017901
Product use in unapproved indication	23.28	15.77	35	24779	336201	90267432
Albuminuria	22.92	15.77	7	24807	354	90603279
Blood glucose decreased	22.70	15.77	30	24784	23399	90580234
Sleep disorder	22.69	15.77	13	24801	198017	90405616
Rhabdomyolysis	22.66	15.77	46	24768	51210	90552423
Insulin-like growth factor decreased	22.01	15.77	7	24807	405	90603228
Blood cholesterol increased	21.98	15.77	15	24799	207997	90395636
Urethral caruncle	21.53	15.77	5	24809	86	90603547
Altered state of consciousness	21.25	15.77	34	24780	31498	90572135
Cyclothymic disorder	21.01	15.77	6	24808	240	90603393
Toxic encephalopathy	20.79	15.77	18	24796	8681	90594952
Dementia	20.77	15.77	29	24785	23832	90579801
Incorrect product administration duration	20.70	15.77	26	24788	19296	90584337
Bite	20.36	15.77	7	24807	517	90603116
Adverse event	19.83	15.77	4	24810	117414	90486219
Hypomagnesaemia	19.51	15.77	35	24779	35553	90568080
Blood urea increased	19.42	15.77	32	24782	30381	90573252
Lethargy	19.36	15.77	49	24765	63090	90540543
Wound infection	19.33	15.77	3	24811	106399	90497234
Parathyroid hyperplasia	19.29	15.77	5	24809	138	90603495
Blood potassium increased	19.23	15.77	26	24788	20723	90582910
Asthma	18.99	15.77	23	24791	242137	90361496
Clostridium test positive	18.95	15.77	14	24800	5387	90598246
Autoimmune myositis	18.87	15.77	6	24808	347	90603286
Liver injury	18.42	15.77	12	24802	170555	90433078
Hypoglycaemic coma	18.40	15.77	11	24803	2979	90600654
Hypophagia	18.01	15.77	34	24780	35903	90567730
Haematuria	17.44	15.77	33	24781	34904	90568729
Facet joint syndrome	17.37	15.77	3	24811	98386	90505247
Lung disorder	16.94	15.77	10	24804	149873	90453760
Intentional product use issue	16.63	15.77	109	24705	216783	90386850
Diarrhoea	16.49	15.77	354	24460	938836	89664797
Arthritis	16.46	15.77	13	24801	167302	90436331
Migraine	16.03	15.77	98	24716	190294	90413339
Musculoskeletal pain	15.99	15.77	14	24800	171237	90432396
Injection site reaction	15.84	15.77	3	24811	92077	90511556
Blood creatine increased	15.82	15.77	14	24800	6953	90596680

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Pemphigoid	653.10	14.45	252	26419	11215	42583449
Dermatitis bullous	425.65	14.45	170	26501	8286	42586378
Cardiospasm	232.71	14.45	74	26597	1833	42592831
Palmoplantar keratoderma	216.60	14.45	73	26598	2181	42592483
Pruritus genital	205.33	14.45	73	26598	2566	42592098
Sleep terror	197.98	14.45	73	26598	2853	42591811
Tension headache	194.12	14.45	75	26596	3339	42591325
Blood glucose increased	191.20	14.45	233	26438	73466	42521198
Atrial tachycardia	180.11	14.45	75	26596	4065	42590599
Carotid artery occlusion	179.17	14.45	75	26596	4119	42590545
Facial pain	178.04	14.45	75	26596	4185	42590479
Hypoglycaemia	169.64	14.45	198	26473	59656	42535008
Anosmia	160.87	14.45	74	26597	5102	42589562
Immunisation	154.25	14.45	49	26622	1209	42593455
Glycosylated haemoglobin increased	144.81	14.45	94	26577	12830	42581834
Pancreatitis	137.61	14.45	152	26519	43116	42551548
Pain of skin	127.04	14.45	73	26598	8007	42586657
Subarachnoid haemorrhage	107.83	14.45	82	26589	14390	42580274
Muscle twitching	106.45	14.45	75	26596	11705	42582959
Lip swelling	103.96	14.45	90	26581	18963	42575701
Eye pruritus	103.92	14.45	73	26598	11339	42583325
Pericarditis	101.98	14.45	77	26594	13367	42581297
Drug ineffective	101.48	14.45	149	26522	630048	41964616
Blood mercury abnormal	94.09	14.45	24	26647	258	42594406
Ventricular tachycardia	87.42	14.45	101	26570	30059	42564605
Pericardial disease	83.78	14.45	25	26646	497	42594167
Blindness	78.61	14.45	75	26596	17903	42576761
Rash papular	77.31	14.45	62	26609	11749	42582915
Vasculitis	77.15	14.45	75	26596	18319	42576345
Cardiac failure	76.63	14.45	191	26480	106665	42487999
Pulmonary valve disease	75.62	14.45	22	26649	399	42594265
Diplopia	70.90	14.45	75	26596	20241	42574423
Alopecia	66.95	14.45	87	26584	29189	42565475
Left ventricular dysfunction	64.09	14.45	55	26616	11446	42583218
Physical examination abnormal	60.86	14.45	19	26652	442	42594222
Migraine	60.42	14.45	77	26594	25337	42569327
Palpitations	59.71	14.45	111	26560	50686	42543978
Product use in unapproved indication	58.81	14.45	21	26650	184435	42410229
Hyperglycaemia	58.71	14.45	104	26567	45755	42548909
Electrocardiogram Q wave abnormal	58.11	14.45	19	26652	515	42594149
Low density lipoprotein decreased	57.98	14.45	24	26647	1280	42593384
5-hydroxyindolacetic acid in urine increased	57.07	14.45	15	26656	183	42594481
Diabetic ketoacidosis	55.13	14.45	69	26602	22298	42572366
Cognitive disorder	53.76	14.45	85	26586	34087	42560577
Amnesia	53.66	14.45	77	26594	28360	42566304
Hepatojugular reflux	53.64	14.45	19	26652	660	42594004
Visual impairment	52.92	14.45	96	26575	43017	42551647
Tinnitus	51.18	14.45	76	26595	28862	42565802
Euglycaemic diabetic ketoacidosis	51.04	14.45	36	26635	5624	42589040
Disturbance in attention	50.77	14.45	77	26594	29789	42564875
Transient ischaemic attack	49.09	14.45	81	26590	33658	42561006
Hepatic neoplasm	48.96	14.45	25	26646	2166	42592498
Diastolic dysfunction	48.58	14.45	38	26633	6945	42587719
Cardiac discomfort	48.43	14.45	18	26653	719	42593945
Cerebral infarction	48.30	14.45	77	26594	31092	42563572
Abdominal discomfort	48.21	14.45	129	26542	75126	42519538
Helicobacter gastritis	47.23	14.45	21	26650	1336	42593328
Occult blood	46.74	14.45	19	26652	967	42593697
Hypoglycaemic coma	46.38	14.45	26	26645	2718	42591946
Echocardiogram abnormal	45.31	14.45	20	26651	1250	42593414
Dry skin	45.20	14.45	96	26575	48242	42546422
Dehydration	45.16	14.45	192	26479	141575	42453089
Renal impairment	44.61	14.45	161	26510	110067	42484597
Angioedema	42.81	14.45	87	26584	42390	42552274
Diabetic nephropathy	41.81	14.45	23	26648	2318	42592346
Stenosis	41.31	14.45	22	26649	2079	42592585
Carotid artery stenosis	40.92	14.45	31	26640	5405	42589259
Ventricular hyperkinesia	40.82	14.45	12	26659	226	42594438
Aortic valve incompetence	39.96	14.45	33	26638	6515	42588149
Mitral valve disease	38.97	14.45	19	26652	1491	42593173
Right atrial enlargement	38.57	14.45	12	26659	276	42594388
Hyperkalaemia	38.21	14.45	124	26547	80334	42514330
Off label use	37.15	14.45	241	26430	638094	41956570
Tricuspid valve incompetence	36.96	14.45	40	26631	11073	42583591
Hypochromasia	36.92	14.45	12	26659	319	42594345
Acute kidney injury	36.84	14.45	371	26300	366966	42227698
Pancreatic carcinoma	36.59	14.45	37	26634	9469	42585195
Chronic kidney disease	36.53	14.45	87	26584	47154	42547510
Rales	36.12	14.45	40	26631	11360	42583304
Mean platelet volume increased	36.08	14.45	14	26657	630	42594034
Dyspnoea at rest	35.95	14.45	26	26645	4223	42590441
Drug abuse	34.98	14.45	11	26660	104760	42489904
5-hydroxyindolacetic acid increased	34.38	14.45	9	26662	108	42594556
Mucosal dryness	34.20	14.45	18	26653	1660	42593004
Hypovolaemia	34.17	14.45	39	26632	11446	42583218
Carotid arteriosclerosis	33.82	14.45	20	26651	2312	42592352
Disease progression	32.98	14.45	25	26646	143631	42451033
Mitral valve thickening	32.56	14.45	12	26659	468	42594196
Ureteric haemorrhage	32.47	14.45	10	26661	222	42594442
Bundle branch block left	32.14	14.45	29	26642	6447	42588217
Memory impairment	32.06	14.45	86	26585	50136	42544528
Haematocrit increased	32.05	14.45	20	26651	2547	42592117
Expired product administered	31.91	14.45	24	26647	4139	42590525
Death	30.98	14.45	171	26500	471014	42123650
Mitral valve incompetence	30.15	14.45	44	26627	16445	42578219
Heart rate increased	29.86	14.45	87	26584	53168	42541496
Hallucination	29.47	14.45	91	26580	57416	42537248
Lactic acidosis	29.39	14.45	78	26593	45183	42549481
Ventricular arrhythmia	28.98	14.45	27	26644	6252	42588412
Neoplasm	28.88	14.45	27	26644	6278	42588386
Abdominal pain upper	28.72	14.45	115	26556	82494	42512170
Anaemia macrocytic	28.38	14.45	21	26650	3534	42591130
Left atrial dilatation	28.20	14.45	18	26653	2384	42592280
Blood glucose abnormal	28.16	14.45	28	26643	7025	42587639
Haemoglobin increased	27.19	14.45	24	26647	5182	42589482
Blood iron decreased	26.93	14.45	26	26645	6292	42588372
Systolic dysfunction	26.70	14.45	19	26652	3009	42591655
Left atrial enlargement	26.64	14.45	13	26658	1022	42593642
Left ventricular hypertrophy	26.64	14.45	31	26640	9288	42585376
Left ventricular enlargement	26.17	14.45	12	26659	820	42593844
Depression	26.04	14.45	19	26652	111344	42483320
General physical health deterioration	25.91	14.45	34	26637	151212	42443452
Neutropenia	25.66	14.45	54	26617	199377	42395287
Diabetes mellitus inadequate control	25.19	14.45	39	26632	15351	42579313
Pruritus	24.63	14.45	202	26469	188569	42406095
Completed suicide	24.52	14.45	15	26656	96450	42498214
Blood follicle stimulating hormone increased	24.50	14.45	8	26663	216	42594448
Necrotising oesophagitis	24.41	14.45	12	26659	959	42593705
Hypohidrosis	24.19	14.45	8	26663	225	42594439
Pancreatitis acute	24.01	14.45	60	26611	33504	42561160
Peak expiratory flow rate decreased	23.96	14.45	7	26664	129	42594535
Bronchitis viral	22.86	14.45	8	26663	268	42594396
Febrile neutropenia	22.47	14.45	52	26619	185651	42409013
Product dose omission issue	22.29	14.45	39	26632	154326	42440338
Metabolic acidosis	22.02	14.45	77	26594	51781	42542883
Pericardial haemorrhage	21.80	14.45	18	26653	3551	42591113
Pancytopenia	21.70	14.45	25	26646	117718	42476946
Ventricular hypokinesia	21.54	14.45	24	26647	6860	42587804
Acute lung injury	21.42	14.45	13	26658	1576	42593088
Muscular weakness	21.29	14.45	106	26565	83392	42511272
Poikilocytosis	21.09	14.45	7	26664	199	42594465
Pemphigus	21.02	14.45	14	26657	1992	42592672
Fibrous histiocytoma	20.87	14.45	8	26663	348	42594316
Angiopathy	20.83	14.45	21	26650	5356	42589308
Malaise	20.58	14.45	213	26458	211943	42382721
Feeling abnormal	20.27	14.45	92	26579	69694	42524970
Supraventricular tachycardia	19.69	14.45	31	26640	12377	42582287
Chills	19.57	14.45	18	26653	94048	42500616
Renal tubular acidosis	19.20	14.45	15	26656	2735	42591929
Chest pain	19.10	14.45	151	26520	139379	42455285
Tachycardia	18.88	14.45	118	26553	100969	42493695
Seizure	18.76	14.45	29	26642	120532	42474132
Mucosal inflammation	18.73	14.45	4	26667	49370	42545294
Skin disorder	18.62	14.45	36	26635	16908	42577756
Pulmonary embolism	18.39	14.45	29	26642	119583	42475081
Acute myocardial infarction	17.88	14.45	78	26593	58087	42536577
Hypertensive heart disease	17.86	14.45	14	26657	2566	42592098
Diabetic ketoacidotic hyperglycaemic coma	17.71	14.45	6	26665	182	42594482
Infusion related reaction	17.59	14.45	8	26663	60798	42533866
Drug hypersensitivity	17.36	14.45	22	26649	99367	42495297
Peripheral swelling	17.25	14.45	106	26565	90164	42504500
Coma	17.21	14.45	6	26665	53548	42541116
Glomerular filtration rate decreased	17.07	14.45	34	26637	16317	42578347
Red blood cell count decreased	16.96	14.45	52	26619	32663	42562001
Thrombosis	16.93	14.45	11	26660	68500	42526164
Electrocardiogram T wave inversion	16.88	14.45	13	26658	2321	42592343
Vitamin B12 deficiency	16.86	14.45	18	26653	4904	42589760
Hyperaesthesia teeth	16.70	14.45	8	26663	604	42594060
Marasmus	16.52	14.45	9	26662	890	42593774
Psoriasis	16.40	14.45	5	26666	48599	42546065
Gangrene	16.26	14.45	18	26653	5108	42589556
Toxicity to various agents	16.20	14.45	81	26590	229055	42365609
COVID-19	16.15	14.45	126	26545	115822	42478842
Syncope	16.12	14.45	112	26559	99294	42495370
Intentional product misuse	16.07	14.45	79	26592	61821	42532843
Coeliac disease	16.00	14.45	9	26662	947	42593717
Myocardial infarction	15.78	14.45	132	26539	123877	42470787
Diabetic foot	15.72	14.45	14	26657	3059	42591605
Irregular sleep phase	15.56	14.45	5	26666	128	42594536
Interstitial lung disease	15.54	14.45	93	26578	78369	42516295
Therapy non-responder	15.47	14.45	7	26664	53352	42541312
Multiple organ dysfunction syndrome	15.42	14.45	23	26648	97012	42497652
Neuropsychiatric syndrome	15.38	14.45	5	26666	133	42594531
Amylase increased	15.38	14.45	20	26651	6709	42587955
Cardiomegaly	15.32	14.45	33	26638	16733	42577931
Urine ketone body present	15.27	14.45	10	26661	1384	42593280
Therapeutic product effect decreased	15.21	14.45	3	26668	39147	42555517
Incontinence	15.14	14.45	20	26651	6810	42587854
Multifocal motor neuropathy	15.10	14.45	5	26666	141	42594523
Hepatic function abnormal	14.98	14.45	68	26603	51499	42543165
Blindness transient	14.85	14.45	13	26658	2776	42591888
Blister	14.54	14.45	44	26627	27446	42567218
Bronchial hyperreactivity	14.52	14.45	11	26660	1918	42592746

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Pemphigoid	981.07	13.62	356	47660	19351	110521932
Dermatitis bullous	592.98	13.62	239	47777	17290	110523993
Cardiospasm	522.87	13.62	158	47858	4809	110536474
Palmoplantar keratoderma	506.02	13.62	157	47859	5230	110536053
Pruritus genital	488.57	13.62	160	47856	6362	110534921
Sleep terror	474.42	13.62	157	47859	6453	110534830
Atrial tachycardia	435.06	13.62	160	47856	9018	110532265
Carotid artery occlusion	428.62	13.62	160	47856	9405	110531878
Tension headache	427.76	13.62	160	47856	9458	110531825
Hypoglycaemia	421.00	13.62	371	47645	115733	110425550
Subarachnoid haemorrhage	397.64	13.62	213	47803	29489	110511794
Blood glucose increased	396.02	13.62	380	47636	132116	110409167
Anosmia	384.03	13.62	159	47857	12313	110528970
Facial pain	355.56	13.62	160	47856	15179	110526104
Immunisation	355.53	13.62	106	47910	3077	110538206
Pain of skin	314.90	13.62	160	47856	19869	110521414
Muscle twitching	259.93	13.62	162	47854	29773	110511510
Ventricular tachycardia	257.27	13.62	196	47820	49813	110491470
Eye pruritus	251.36	13.62	164	47852	32611	110508672
Vasculitis	247.37	13.62	168	47848	35705	110505578
Blindness	245.32	13.62	168	47848	36191	110505092
Lip swelling	229.08	13.62	184	47832	50483	110490800
Glycosylated haemoglobin increased	210.58	13.62	130	47886	23489	110517794
Diplopia	204.12	13.62	159	47857	41735	110499548
Transient ischaemic attack	201.45	13.62	189	47827	63793	110477490
Tinnitus	168.27	13.62	167	47849	60373	110480910
Drug ineffective	160.54	13.62	259	47757	1520281	109021002
Rash papular	159.28	13.62	116	47900	27523	110513760
Disturbance in attention	154.08	13.62	161	47855	61834	110479449
Pancreatitis	151.81	13.62	195	47821	93338	110447945
Angioedema	151.54	13.62	200	47816	98300	110442983
Cardiac failure	151.30	13.62	283	47733	187343	110353940
Acute kidney injury	147.09	13.62	605	47411	634825	109906458
Hallucination	143.92	13.62	198	47818	101234	110440049
Hyperglycaemia	142.20	13.62	180	47836	84910	110456373
Diabetic ketoacidosis	141.59	13.62	129	47887	41929	110499354
Dehydration	140.50	13.62	348	47668	279163	110262120
Euglycaemic diabetic ketoacidosis	137.93	13.62	77	47939	11546	110529737
Cognitive disorder	135.09	13.62	178	47838	87333	110453950
Dry skin	134.82	13.62	198	47818	107455	110433828
Palpitations	128.16	13.62	240	47776	158972	110382311
Renal impairment	122.75	13.62	260	47756	188185	110353098
Hyperkalaemia	110.89	13.62	206	47810	135590	110405693
Chronic kidney disease	106.81	13.62	148	47868	76143	110465140
Metabolic acidosis	105.95	13.62	170	47846	99574	110441709
Blood mercury abnormal	102.81	13.62	24	47992	258	110541025
Synovitis	101.57	13.62	4	48012	274088	110267195
Infusion related reaction	99.32	13.62	22	47994	381140	110160143
Visual impairment	98.78	13.62	195	47821	134233	110407050
Lactic acidosis	96.95	13.62	157	47859	92654	110448629
Arthropathy	92.31	13.62	9	48007	287513	110253770
Heart rate increased	91.96	13.62	197	47819	143637	110397646
Intentional product misuse	90.75	13.62	187	47829	132717	110408566
Drug hypersensitivity	88.93	13.62	43	47973	454047	110087236
Amnesia	88.68	13.62	162	47854	105246	110436037
Diabetes mellitus inadequate control	88.06	13.62	85	47931	29690	110511593
Systemic lupus erythematosus	87.07	13.62	6	48010	254332	110286951
Pulmonary valve disease	87.06	13.62	22	47994	337	110540946
Myocardial infarction	86.95	13.62	230	47786	191853	110349430
Pericardial disease	84.76	13.62	25	47991	698	110540585
Treatment failure	83.18	13.62	11	48005	277223	110264060
Therapeutic product effect decreased	82.95	13.62	6	48010	244310	110296973
Product use in unapproved indication	82.21	13.62	46	47970	447331	110093952
Rheumatoid arthritis	78.63	13.62	17	47999	299596	110241687
Drug intolerance	75.84	13.62	41	47975	406471	110134812
Pancreatic carcinoma	73.62	13.62	57	47959	14815	110526468
Impaired healing	72.44	13.62	3	48013	196714	110344569
Hyperhidrosis	71.67	13.62	211	47805	187087	110354196
Glossodynia	71.12	13.62	7	48009	221997	110319286
COVID-19	69.32	13.62	249	47767	244811	110296472
Cerebral infarction	68.74	13.62	98	47918	51740	110489543
Pancreatitis haemorrhagic	68.39	13.62	23	47993	993	110540290
Glomerular filtration rate decreased	68.02	13.62	73	47943	28883	110512400
Hypoglycaemic coma	66.59	13.62	37	47979	5496	110535787
Hepatic enzyme increased	66.53	13.62	28	47988	320864	110220419
Wound	66.40	13.62	11	48005	234426	110306857
Physical examination abnormal	64.88	13.62	19	47997	517	110540766
Low density lipoprotein decreased	64.47	13.62	24	47992	1398	110539885
Duodenal ulcer perforation	64.47	13.62	3	48013	177697	110363586
5-hydroxyindolacetic acid in urine increased	62.37	13.62	15	48001	185	110541098
Feeling abnormal	62.05	13.62	196	47820	180515	110360768
Helicobacter infection	60.23	13.62	5	48011	181872	110359411
Renal failure	59.69	13.62	225	47791	226349	110314934
Hepatojugular reflux	58.97	13.62	19	47997	716	110540567
Tachycardia	58.82	13.62	224	47792	226421	110314862
Electrocardiogram Q wave abnormal	58.74	13.62	19	47997	725	110540558
Folliculitis	57.24	13.62	4	48012	167649	110373634
Swelling	55.13	13.62	43	47973	350998	110190285
Muscular weakness	52.92	13.62	231	47785	248237	110293046
Psoriatic arthropathy	51.94	13.62	11	48005	196750	110344533
Left ventricular dysfunction	51.30	13.62	57	47959	23436	110517847
Hyperlactacidaemia	50.53	13.62	36	47980	8250	110533033
Diabetic nephropathy	49.30	13.62	26	47990	3482	110537801
Sinusitis	48.30	13.62	35	47981	296653	110244630
Irritable bowel syndrome	48.10	13.62	7	48009	164208	110377075
Chest pain	47.70	13.62	303	47713	376072	110165211
Memory impairment	47.32	13.62	190	47826	196754	110344529
Cardiac discomfort	46.65	13.62	19	47997	1409	110539874
Ureteric haemorrhage	45.27	13.62	11	48005	142	110541141
Hepatic neoplasm	44.20	13.62	25	47991	3842	110537441
Discomfort	44.06	13.62	19	47997	214688	110326595
Hypersensitivity	44.05	13.62	67	47949	403931	110137352
Joint swelling	44.04	13.62	78	47938	442767	110098516
Depression	43.65	13.62	44	47972	317291	110223992
Diastolic dysfunction	43.61	13.62	39	47977	12365	110528918
Hypovolaemia	42.94	13.62	50	47966	21624	110519659
Contusion	42.82	13.62	24	47992	233337	110307946
Pancreatitis acute	42.53	13.62	86	47930	60188	110481095
Blood glucose abnormal	42.26	13.62	39	47977	12877	110528406
Occult blood	41.86	13.62	19	47997	1837	110539446
Ventricular hyperkinesia	41.61	13.62	12	48004	309	110540974
Aortic valve incompetence	41.56	13.62	36	47980	10945	110530338
Migraine	41.55	13.62	166	47850	171486	110369797
Helicobacter gastritis	41.40	13.62	21	47995	2595	110538688
Stomatitis	41.29	13.62	34	47982	270208	110271075
Contraindicated product administered	40.78	13.62	29	47987	248238	110293045
Cystostomy	40.40	13.62	9	48007	77	110541206
Condition aggravated	40.39	13.62	173	47843	734663	109806620
Ketoacidosis	40.07	13.62	34	47982	10053	110531230
Stenosis	39.21	13.62	22	47994	3329	110537954
Blood iron decreased	39.20	13.62	45	47971	19169	110522114
General physical health deterioration	38.70	13.62	79	47937	425216	110116067
Carotid arteriosclerosis	38.32	13.62	21	47995	3036	110538247
Pruritus	38.15	13.62	403	47613	581157	109960126
Echocardiogram abnormal	38.09	13.62	20	47996	2654	110538629
Pemphigus	38.04	13.62	23	47993	214547	110326736
Left ventricular hypertrophy	37.64	13.62	37	47979	13207	110528076
Therapy non-responder	37.25	13.62	11	48005	157296	110383987
Cardiomegaly	37.05	13.62	54	47962	29076	110512207
Haemoglobin increased	36.68	13.62	31	47985	9116	110532167
Dizziness	36.50	13.62	463	47553	697730	109843553
Hepatic function abnormal	36.45	13.62	103	47913	89192	110452091
Carotid artery stenosis	36.34	13.62	31	47985	9232	110532051
5-hydroxyindolacetic acid increased	36.30	13.62	9	48007	127	110541156
Diabetic metabolic decompensation	36.17	13.62	22	47994	3867	110537416
Back pain	36.04	13.62	280	47736	370716	110170567
Right atrial enlargement	36.00	13.62	12	48004	504	110540779
Psoriasis	34.62	13.62	9	48007	139984	110401299
Haematocrit increased	33.64	13.62	23	47993	4936	110536347
Nasopharyngitis	33.59	13.62	76	47940	394285	110146998
Pain	33.54	13.62	260	47756	954695	109586588
Injury	32.85	13.62	18	47998	177247	110364036
Acute myocardial infarction	32.61	13.62	95	47921	83682	110457601
Hypochromasia	32.22	13.62	12	48004	700	110540583
End stage renal disease	32.07	13.62	43	47973	21430	110519853
Dry mouth	32.00	13.62	24	47992	199924	110341359
Lower respiratory tract infection	31.97	13.62	35	47981	243071	110298212
Completed suicide	31.76	13.62	35	47981	242346	110298937
Infection	31.50	13.62	69	47947	362131	110179152
Abdominal pain upper	31.45	13.62	259	47757	348852	110192431
Tricuspid valve incompetence	31.45	13.62	45	47971	23828	110517455
Mitral valve thickening	31.32	13.62	12	48004	757	110540526
Wheezing	31.14	13.62	39	47977	255191	110286092
Facet joint syndrome	31.14	13.62	3	48013	96825	110444458
Expired product administered	30.93	13.62	27	47989	8293	110532990
Mitral valve disease	30.90	13.62	19	47997	3406	110537877
Left atrial enlargement	30.66	13.62	15	48001	1716	110539567
Neutropenia	30.46	13.62	74	47942	374546	110166737
Sleep disorder	30.33	13.62	25	47991	198619	110342664
Ventricular arrhythmia	30.21	13.62	29	47987	10058	110531225
Left ventricular enlargement	29.87	13.62	12	48004	859	110540424
Dyspnoea at rest	28.87	13.62	26	47990	8320	110532963
Systolic dysfunction	28.82	13.62	20	47996	4395	110536888
Blood creatinine increased	28.81	13.62	156	47860	182733	110358550
Mean platelet volume increased	28.71	13.62	14	48002	1590	110539693
Arthritis	28.28	13.62	19	47997	167567	110373716
Injection site reaction	28.02	13.62	3	48013	89067	110452216
Musculoskeletal pain	27.98	13.62	23	47993	183000	110358283
Left atrial dilatation	27.74	13.62	18	47998	3542	110537741
Interstitial lung disease	27.73	13.62	127	47889	139207	110402076
Bundle branch block left	27.67	13.62	31	47985	12857	110528426
Paraesthesia	27.20	13.62	49	47967	276472	110264811
Mucosal dryness	27.10	13.62	19	47997	4244	110537039
Adverse event	26.89	13.62	7	48009	108802	110432481
Liver injury	26.83	13.62	16	48000	150397	110390886
Drug ineffective for unapproved indication	26.62	13.62	6	48010	102832	110438451
Product dose omission issue	26.60	13.62	63	47953	321719	110219564
Gastrointestinal disorder	26.47	13.62	40	47976	241912	110299371
Inflammation	26.32	13.62	27	47989	193211	110348072
Weight increased	26.07	13.62	94	47922	419550	110121733
Off label use	25.76	13.62	478	47538	1499707	109041576
Chills	25.54	13.62	27	47989	190553	110350730
Diabetic foot	25.45	13.62	18	47998	4077	110537206
Hypoglycaemic encephalopathy	25.06	13.62	10	48006	703	110540580
Gait inability	25.04	13.62	14	48002	136362	110404921
Syncope	24.97	13.62	162	47854	202374	110338909
Rales	24.67	13.62	41	47975	24698	110516585
Musculoskeletal stiffness	24.58	13.62	53	47963	279769	110261514
Neoplasm skin	24.47	13.62	16	48000	3188	110538095
Hypohidrosis	24.42	13.62	8	48008	318	110540965
Neoplasm	24.38	13.62	27	47989	11060	110530223
Malaise	24.25	13.62	418	47598	671401	109869882
Wound infection	24.24	13.62	6	48010	96459	110444824
Injection site erythema	23.39	13.62	6	48010	94170	110447113
Obesity	23.30	13.62	10	48006	113341	110427942
Hypoaesthesia	23.29	13.62	65	47951	314158	110227125
Clostridium test positive	23.05	13.62	26	47990	10867	110530416
Pain in extremity	23.01	13.62	121	47895	486997	110054286
Azotaemia	22.94	13.62	25	47991	10060	110531223
Necrotising oesophagitis	22.89	13.62	12	48004	1588	110539695
Mitral valve incompetence	22.85	13.62	47	47969	33282	110508001
Loss of personal independence in daily activities	22.75	13.62	19	47997	150001	110391282
Blood follicle stimulating hormone increased	22.60	13.62	8	48008	403	110540880
Vomiting	22.37	13.62	535	47481	910140	109631143
Altered state of consciousness	22.09	13.62	65	47951	57561	110483722
Anaemia macrocytic	21.88	13.62	21	47995	7282	110534001
Mobility decreased	21.66	13.62	44	47972	237378	110303905
Peripheral venous disease	21.59	13.62	5	48011	84112	110457171
Pericardial haemorrhage	21.58	13.62	18	47998	5199	110536084
Diabetic ketoacidotic hyperglycaemic coma	21.52	13.62	7	48009	272	110541011
Lipase increased	21.44	13.62	33	47983	18639	110522644
Mucosal membrane hyperplasia	21.40	13.62	5	48011	54	110541229
Renal disorder	21.10	13.62	58	47958	49421	110491862
Urine calcium/creatinine ratio increased	21.01	13.62	6	48010	149	110541134
Pulmonary fibrosis	20.97	13.62	9	48007	102033	110439250
Mucosal inflammation	20.54	13.62	8	48008	96133	110445150
Penile oedema	20.53	13.62	7	48009	315	110540968
Angiopathy	20.48	13.62	22	47994	8708	110532575
Haemodynamic instability	20.28	13.62	36	47980	22852	110518431
Urethral caruncle	20.14	13.62	5	48011	71	110541212
Diabetes mellitus	20.08	13.62	91	47925	99290	110441993
Suicidal ideation	19.77	13.62	8	48008	93929	110447354
Road traffic accident	19.76	13.62	11	48005	107387	110433896
Coronary artery stenosis	19.71	13.62	27	47989	13731	110527552
Urine ketone body present	19.60	13.62	15	48001	3831	110537452
Marasmus	19.51	13.62	11	48005	1680	110539603
Peripheral arterial occlusive disease	19.38	13.62	22	47994	9258	110532025
Ventricular hypokinesia	19.16	13.62	24	47992	11190	110530093
Vulvovaginal mycotic infection	19.09	13.62	17	47999	5360	110535923
Poikilocytosis	19.02	13.62	7	48009	395	110540888
Pyelonephritis	18.98	13.62	37	47979	25213	110516070
Respiratory disorder	18.81	13.62	4	48012	71378	110469905
Autoimmune disorder	18.69	13.62	3	48013	65480	110475803
Melaena	18.68	13.62	69	47947	68688	110472595
Supraventricular tachycardia	18.61	13.62	36	47980	24386	110516897
Amylase increased	18.59	13.62	25	47991	12494	110528789
Peak expiratory flow rate decreased	18.47	13.62	8	48008	692	110540591
Erythema multiforme	18.46	13.62	33	47983	21064	110520219
Asthma	18.38	13.62	52	47964	250239	110291044
Pericarditis	18.36	13.62	160	47856	218954	110322329
Cardiac failure chronic	18.14	13.62	26	47990	13785	110527498
Glomerulonephritis membranous	17.78	13.62	11	48005	1992	110539291
Acute lung injury	17.64	13.62	13	48003	3138	110538145
Dementia	17.55	13.62	41	47975	31632	110509651
Fibrous histiocytoma	17.08	13.62	8	48008	831	110540452
Multifocal motor neuropathy	17.08	13.62	5	48011	136	110541147
Injection site pain	17.07	13.62	32	47984	177890	110363393
Blood cholesterol increased	17.06	13.62	34	47982	184751	110356532
Renal tubular acidosis	16.92	13.62	15	48001	4700	110536583
Intentional product use issue	16.78	13.62	173	47843	247733	110293550
Coma	16.59	13.62	16	48000	117853	110423430
Sputum discoloured	16.39	13.62	37	47979	27908	110513375
Electrocardiogram T wave inversion	16.39	13.62	16	48000	5664	110535619
Vitamin B12 deficiency	16.35	13.62	21	47995	10034	110531249
Irregular sleep phase	16.27	13.62	5	48011	161	110541122
Flushing	16.21	13.62	13	48003	104723	110436560
Insulin-like growth factor decreased	16.15	13.62	7	48009	606	110540677
Therapeutic product effect incomplete	16.06	13.62	47	47969	223758	110317525
Bite	16.02	13.62	7	48009	618	110540665
Nail disorder	15.78	13.62	3	48013	57932	110483351
Parathyroid hyperplasia	15.76	13.62	5	48011	179	110541104
Confusional state	15.75	13.62	129	47887	468551	110072732
Hypercholesterolaemia	15.73	13.62	10	48006	90827	110450456
Albuminuria	15.66	13.62	8	48008	1003	110540280
Haematuria	15.29	13.62	74	47942	82931	110458352
Hypertensive heart disease	15.27	13.62	14	48002	4582	110536701
Drug abuse	15.24	13.62	34	47982	177377	110363906
Type 2 diabetes mellitus	15.20	13.62	34	47982	177198	110364085
Lung disorder	15.07	13.62	35	47981	180012	110361271
Diarrhoea	15.06	13.62	621	47395	1138884	109402399
Haemorrhoidal haemorrhage	14.92	13.62	18	47998	8075	110533208
Jaundice	14.90	13.62	58	47958	59178	110482105
Neuropsychiatric syndrome	14.82	13.62	5	48011	218	110541065
Urinary tract infection	14.78	13.62	211	47805	326071	110215212
Shock	14.74	13.62	54	47962	53534	110487749
Epidermolysis	14.51	13.62	8	48008	1170	110540113
Ill-defined disorder	14.36	13.62	29	47987	156824	110384459
Insomnia	14.32	13.62	228	47788	360362	110180921
Disease progression	14.27	13.62	56	47960	243978	110297305
Cardiac failure acute	14.26	13.62	32	47984	24046	110517237
Femoral neck fracture	14.13	13.62	22	47994	12545	110528738
Throat irritation	14.11	13.62	3	48013	53549	110487734
Osteoarthritis	14.11	13.62	37	47979	182586	110358697
Rhabdomyolysis	14.04	13.62	95	47921	120306	110420977
Aplasia pure red cell	14.03	13.62	19	47997	9559	110531724
Pharyngeal perforation	14.00	13.62	3	48013	21	110541262
Intraductal papillary mucinous neoplasm	13.90	13.62	7	48009	852	110540431
Red blood cell count decreased	13.79	13.62	61	47955	65862	110475421
Joint stiffness	13.71	13.62	6	48010	67237	110474046

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	A10BD11	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BD19	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BD27	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BH05	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Dipeptidyl peptidase 4 (DPP-4) inhibitors
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D006728	Hormones
MeSH PA	D007004	Hypoglycemic Agents
MeSH PA	D011480	Protease Inhibitors
MeSH PA	D054795	Incretins
MeSH PA	D054873	Dipeptidyl-Peptidase IV Inhibitors
FDA MoA	N0000175912	Dipeptidyl Peptidase 4 Inhibitors
FDA EPC	N0000175913	Dipeptidyl Peptidase 4 Inhibitor
CHEBI has role	CHEBI:22587	antiviral agent
CHEBI has role	CHEBI:35476	antipsychotic agent
CHEBI has role	CHEBI:35526	hypoglycemic agent
CHEBI has role	CHEBI:35610	antineoplastic agent
CHEBI has role	CHEBI:35674	antihypertensive agent
CHEBI has role	CHEBI:68612	EC 3.4.14.5 (dipeptidyl-peptidase IV) inhibitor

Related Drugs by ATC class:

A10BD Combinations of oral blood glucose lowering drugs 19 drugs

acarbose alogliptin canagliflozin dapagliflozin empagliflozin ertugliflozin evogliptin gemigliptin glimepiride lobeglitazone metformin phenformin show all 19 →

A10BH Dipeptidyl peptidase 4 (DPP-4) inhibitors 9 drugs

alogliptin evogliptin gemigliptin rosuvastatin saxagliptin simvastatin sitagliptin teneligliptin vildagliptin

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Diabetes mellitus type 2	indication	44054006	DOID:9352
Pancreatitis	contraindication	75694006	DOID:4989
Hypoglycemic disorder	contraindication	237630007

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.16	Basic
pKa2	6.13	Basic
pKa3	3.79	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
5MG	TRADJENTA	BOEHRINGER INGELHEIM	N201280	May 2, 2011	RX	TABLET	ORAL	8673927	May 4, 2027	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
2.5MG;1GM	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	8673927	May 4, 2027	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
2.5MG;500MG	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	8673927	May 4, 2027	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
2.5MG;850MG	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	8673927	May 4, 2027	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
10MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	8673927	May 4, 2027	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
10MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	9173859	May 4, 2027	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
25MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	8673927	May 4, 2027	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
25MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	9173859	May 4, 2027	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
2.5MG;1GM	JENTADUETO XR	BOEHRINGER INGELHEIM	N208026	May 27, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	8673927	May 4, 2027	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
2.5MG;1GM	JENTADUETO XR	BOEHRINGER INGELHEIM	N208026	May 27, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	9173859	May 4, 2027	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
5MG;1GM	JENTADUETO XR	BOEHRINGER INGELHEIM	N208026	May 27, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	8673927	May 4, 2027	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
5MG;1GM	JENTADUETO XR	BOEHRINGER INGELHEIM	N208026	May 27, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	9173859	May 4, 2027	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
2.5MG;1GM	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	10022379	April 2, 2029	USE OF A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN AND A BASIC AMINO ACID TO TREAT TYPE 2 DIABETES MELLITUS
2.5MG;500MG	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	10022379	April 2, 2029	USE OF A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN AND A BASIC AMINO ACID TO TREAT TYPE 2 DIABETES MELLITUS
2.5MG;850MG	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	10022379	April 2, 2029	USE OF A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN AND A BASIC AMINO ACID TO TREAT TYPE 2 DIABETES MELLITUS
2.5MG;1GM	JENTADUETO XR	BOEHRINGER INGELHEIM	N208026	May 27, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	10022379	April 2, 2029	USE OF A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN AND A BASIC AMINO ACID TO TREAT TYPE 2 DIABETES MELLITUS
5MG;1GM	JENTADUETO XR	BOEHRINGER INGELHEIM	N208026	May 27, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	10022379	April 2, 2029	USE OF A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN AND A BASIC AMINO ACID TO TREAT TYPE 2 DIABETES MELLITUS
10MG;5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	10022379	April 2, 2029	METHOD OF TREATING TYPE 2 DIABETES USING A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN, EMPAGLIFLOZIN AND A BASIC AMINO ACID
12.5MG;2.5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	10022379	April 2, 2029	METHOD OF TREATING TYPE 2 DIABETES USING A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN, EMPAGLIFLOZIN AND A BASIC AMINO ACID
25MG;5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	10022379	April 2, 2029	METHOD OF TREATING TYPE 2 DIABETES USING A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN, EMPAGLIFLOZIN AND A BASIC AMINO ACID
5MG;2.5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	10022379	April 2, 2029	METHOD OF TREATING TYPE 2 DIABETES USING A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN, EMPAGLIFLOZIN AND A BASIC AMINO ACID
5MG	TRADJENTA	BOEHRINGER INGELHEIM	N201280	May 2, 2011	RX	TABLET	ORAL	10034877	Aug. 5, 2029	TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT AND FOR WHOM METFORMIN THERAPY IS INAPPROPRIATE BY ADMINISTERING LINAGLIPTIN WITHOUT DOSE ADJUSTMENT
5MG	TRADJENTA	BOEHRINGER INGELHEIM	N201280	May 2, 2011	RX	TABLET	ORAL	9486526	Aug. 5, 2029	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS WITH SEVERE CHRONIC RENAL IMPAIRMENT AND WHO ARE INELIGIBLE FOR METFORMIN THERAPY BY ADMINISTERING LINAGLIPTIN
10MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	8551957	Oct. 14, 2029	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
25MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	8551957	Oct. 14, 2029	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
10MG;5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	8551957	Oct. 14, 2029	METHOD OF TREATING TYPE 2 DIABETES MELLITUS USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
12.5MG;2.5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	8551957	Oct. 14, 2029	METHOD OF TREATING TYPE 2 DIABETES MELLITUS USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
25MG;5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	8551957	Oct. 14, 2029	METHOD OF TREATING TYPE 2 DIABETES MELLITUS USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
5MG;2.5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	8551957	Oct. 14, 2029	METHOD OF TREATING TYPE 2 DIABETES MELLITUS USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
10MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	12115179	Feb. 11, 2030	TREATMENT OF TYPE 2 DIABETES MELLITUS BY ADMINISTRATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
25MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	12115179	Feb. 11, 2030	TREATMENT OF TYPE 2 DIABETES MELLITUS BY ADMINISTRATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
10MG;5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	12115179	Feb. 11, 2030	TREATMENT OF TYPE 2 DIABETES MELLITUS BY ADMINISTRATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
12.5MG;2.5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	12115179	Feb. 11, 2030	TREATMENT OF TYPE 2 DIABETES MELLITUS BY ADMINISTRATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
25MG;5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	12115179	Feb. 11, 2030	TREATMENT OF TYPE 2 DIABETES MELLITUS BY ADMINISTRATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
5MG;2.5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	12115179	Feb. 11, 2030	TREATMENT OF TYPE 2 DIABETES MELLITUS BY ADMINISTRATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
5MG	TRADJENTA	BOEHRINGER INGELHEIM	N201280	May 2, 2011	RX	TABLET	ORAL	11911388	April 10, 2030	LINAGLIPTIN (5 MG DAILY DOSE) AND METFORMIN (WITH OR WITHOUT INSULIN) FOR TREATING TYPE 2 DIABETES PATIENTS WITH RENAL IMPAIRMENT AND INSUFFICIENT GLYCEMIC CONTROL DESPITE PREVIOUS TREATMENT WITH METFORMIN ALONE OR IN COMBINATION WITH INSULIN
2.5MG;1GM	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	11911388	April 10, 2030	LINAGLIPTIN (5 MG DAILY DOSE) AND METFORMIN (WITH OR WITHOUT INSULIN) FOR TREATING TYPE 2 DIABETES PATIENTS WITH RENAL IMPAIRMENT AND INSUFFICIENT GLYCEMIC CONTROL DESPITE PREVIOUS TREATMENT WITH METFORMIN ALONE OR IN COMBINATION WITH INSULIN
2.5MG;500MG	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	11911388	April 10, 2030	LINAGLIPTIN (5 MG DAILY DOSE) AND METFORMIN (WITH OR WITHOUT INSULIN) FOR TREATING TYPE 2 DIABETES PATIENTS WITH RENAL IMPAIRMENT AND INSUFFICIENT GLYCEMIC CONTROL DESPITE PREVIOUS TREATMENT WITH METFORMIN ALONE OR IN COMBINATION WITH INSULIN
2.5MG;850MG	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	11911388	April 10, 2030	LINAGLIPTIN (5 MG DAILY DOSE) AND METFORMIN (WITH OR WITHOUT INSULIN) FOR TREATING TYPE 2 DIABETES PATIENTS WITH RENAL IMPAIRMENT AND INSUFFICIENT GLYCEMIC CONTROL DESPITE PREVIOUS TREATMENT WITH METFORMIN ALONE OR IN COMBINATION WITH INSULIN
2.5MG;1GM	JENTADUETO XR	BOEHRINGER INGELHEIM	N208026	May 27, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	11911388	April 10, 2030	LINAGLIPTIN (5 MG DAILY DOSE) AND METFORMIN (WITH OR WITHOUT INSULIN) FOR TREATING TYPE 2 DIABETES PATIENTS WITH RENAL IMPAIRMENT AND INSUFFICIENT GLYCEMIC CONTROL DESPITE PREVIOUS TREATMENT WITH METFORMIN ALONE OR IN COMBINATION WITH INSULIN
5MG;1GM	JENTADUETO XR	BOEHRINGER INGELHEIM	N208026	May 27, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	11911388	April 10, 2030	LINAGLIPTIN (5 MG DAILY DOSE) AND METFORMIN (WITH OR WITHOUT INSULIN) FOR TREATING TYPE 2 DIABETES PATIENTS WITH RENAL IMPAIRMENT AND INSUFFICIENT GLYCEMIC CONTROL DESPITE PREVIOUS TREATMENT WITH METFORMIN ALONE OR IN COMBINATION WITH INSULIN
5MG	TRADJENTA	BOEHRINGER INGELHEIM	N201280	May 2, 2011	RX	TABLET	ORAL	8846695	June 4, 2030	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
2.5MG;1GM	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	8846695	June 4, 2030	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
2.5MG;500MG	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	8846695	June 4, 2030	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
2.5MG;850MG	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	8846695	June 4, 2030	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
10MG;5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	10406172	June 15, 2030	METHOD OF TREATING A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE THERAPY WITH METFORMIN USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
12.5MG;2.5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	10406172	June 15, 2030	METHOD OF TREATING A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE THERAPY WITH METFORMIN USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
25MG;5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	10406172	June 15, 2030	METHOD OF TREATING A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE THERAPY WITH METFORMIN USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
5MG;2.5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	10406172	June 15, 2030	METHOD OF TREATING A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE THERAPY WITH METFORMIN USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
5MG	TRADJENTA	BOEHRINGER INGELHEIM	N201280	May 2, 2011	RX	TABLET	ORAL	8853156	March 5, 2031	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS WITH SEVERE CHRONIC RENAL IMPAIRMENT AND FOR WHOM METFORMIN THERAPY IS INAPPROPRIATE BY ADMINISTERING LINAGLIPTIN
10MG;5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	10596120	March 7, 2032	TREATMENT OF A TREATMENT-NAIVE PATIENT WITH INADEQUATELY CONTROLLED TYPE 2 DIABETES USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN
10MG;5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	10596120	March 7, 2032	TREATMENT OF A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN
10MG;5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	11564886	March 7, 2032	TREATMENT OF A TYPE 2 DIABETES PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN
12.5MG;2.5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	10596120	March 7, 2032	TREATMENT OF A TREATMENT-NAIVE PATIENT WITH INADEQUATELY CONTROLLED TYPE 2 DIABETES USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN
12.5MG;2.5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	10596120	March 7, 2032	TREATMENT OF A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN
12.5MG;2.5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	11564886	March 7, 2032	TREATMENT OF A TYPE 2 DIABETES PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN
25MG;5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	10596120	March 7, 2032	TREATMENT OF A TREATMENT-NAIVE PATIENT WITH INADEQUATELY CONTROLLED TYPE 2 DIABETES USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN
25MG;5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	10596120	March 7, 2032	TREATMENT OF A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN
5MG;2.5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	10596120	March 7, 2032	TREATMENT OF A TREATMENT-NAIVE PATIENT WITH INADEQUATELY CONTROLLED TYPE 2 DIABETES USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN
5MG;2.5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	10596120	March 7, 2032	TREATMENT OF A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN
5MG;2.5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	11564886	March 7, 2032	TREATMENT OF A TYPE 2 DIABETES PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN
2.5MG;1GM	JENTADUETO XR	BOEHRINGER INGELHEIM	N208026	May 27, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	9555001	March 6, 2033	METHOD OF TREATING TYPE 2 DIABETES IN PATIENTS WHO HAVE NOT BEEN PREVIOUSLY TREATED WITH AN ANTIHYPERGLYCEMIC AGENT BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
2.5MG;1GM	JENTADUETO XR	BOEHRINGER INGELHEIM	N208026	May 27, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	9555001	March 6, 2033	METHOD OF TREATING TYPE 2 DIABETES IN PATIENTS WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE THERAPY WITH ONE OR MORE CONVENTIONAL ANTIHYPERGLYCEMIC AGENTS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
5MG;1GM	JENTADUETO XR	BOEHRINGER INGELHEIM	N208026	May 27, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	9555001	March 6, 2033	METHOD OF TREATING TYPE 2 DIABETES IN PATIENTS WHO HAVE NOT BEEN PREVIOUSLY TREATED WITH AN ANTIHYPERGLYCEMIC AGENT BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
5MG;1GM	JENTADUETO XR	BOEHRINGER INGELHEIM	N208026	May 27, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	9555001	March 6, 2033	METHOD OF TREATING TYPE 2 DIABETES IN PATIENTS WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE THERAPY WITH ONE OR MORE CONVENTIONAL ANTIHYPERGLYCEMIC AGENTS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
10MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	10258637	April 3, 2034	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
10MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	11090323	April 3, 2034	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (30 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
10MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	11833166	April 3, 2034	TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR>=45 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL
10MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	11833166	April 3, 2034	TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL
10MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	12433906	April 3, 2034	TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION, ADMINISTERING 10 EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2, AND ADMINISTERING 25 MG EMPAGLIFLOZIN IF REQUIRED FOR ADDITIONAL GLYCEMIC CONTROL AND THE EGER IS >=30 ML/MIN/1.73 M2
10MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	12433906	April 3, 2034	TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION IN A PATIENT AND ADMINISTERING EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2
10MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	12433906	April 3, 2034	TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION IN A PATIENT AND ADMINISTERING EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2
10MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	12433906	April 3, 2034	TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH MODERATE RENAL IMPAIRMENT (30 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ADMINISTRATION OF EMPAGLIFLOZIN
10MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	12433906	April 3, 2034	TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH STAGE 3 CHRONIC KIDNEY DISEASE BY ADMINISTRATION OF EMPAGLIFLOZIN
25MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	10258637	April 3, 2034	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
25MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	11090323	April 3, 2034	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (30 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
25MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	11833166	April 3, 2034	TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR>=45 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL
25MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	11833166	April 3, 2034	TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL
25MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	12433906	April 3, 2034	TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION, ADMINISTERING 10 EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2, AND ADMINISTERING 25 MG EMPAGLIFLOZIN IF REQUIRED FOR ADDITIONAL GLYCEMIC CONTROL AND THE EGER IS >=30 ML/MIN/1.73 M2
25MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	12433906	April 3, 2034	TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION IN A PATIENT AND ADMINISTERING EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2
25MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	12433906	April 3, 2034	TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION IN A PATIENT AND ADMINISTERING EMPAGLIFLOZIN IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2
25MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	12433906	April 3, 2034	TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH MODERATE RENAL IMPAIRMENT (30 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ADMINISTRATION OF EMPAGLIFLOZIN
25MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	12433906	April 3, 2034	TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH STAGE 3 CHRONIC KIDNEY DISEASE BY ADMINISTRATION OF EMPAGLIFLOZIN
10MG;5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	10258637	April 3, 2034	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN
10MG;5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	11090323	April 3, 2034	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR <30 ML/MIN/1.73 M2
10MG;5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	11833166	April 3, 2034	TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR>=45 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL
10MG;5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	11833166	April 3, 2034	TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL
12.5MG;2.5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	10258637	April 3, 2034	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN
12.5MG;2.5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	11090323	April 3, 2034	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR <30 ML/MIN/1.73 M2
12.5MG;2.5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	11833166	April 3, 2034	TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR>=45 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL
12.5MG;2.5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	11833166	April 3, 2034	TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL
25MG;5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	10258637	April 3, 2034	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN
25MG;5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	11090323	April 3, 2034	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR <30 ML/MIN/1.73 M2
25MG;5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	11833166	April 3, 2034	TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR>=45 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL
25MG;5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	11833166	April 3, 2034	TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL
5MG;2.5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	10258637	April 3, 2034	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN
5MG;2.5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	11090323	April 3, 2034	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR <30 ML/MIN/1.73 M2
5MG;2.5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	11833166	April 3, 2034	TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR>=45 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL
5MG;2.5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	11833166	April 3, 2034	TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND <60 ML/MIN/1.73 M2, WHEREIN THE TREATMENT IMPROVES GLYCEMIC CONTROL
10MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	9949998	June 11, 2034	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
25MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	9949998	June 11, 2034	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
10MG;5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	9949998	June 11, 2034	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN
12.5MG;2.5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	9949998	June 11, 2034	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN
25MG;5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	9949998	June 11, 2034	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN
5MG;2.5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	9949998	June 11, 2034	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN
5MG	TRADJENTA	BOEHRINGER INGELHEIM	N201280	May 2, 2011	RX	TABLET	ORAL	12364700	June 8, 2037	TREATMENT OF TYPE 2 DIABETES IN A PATIENT HAVING ESTIMATED GLOMERULAR FILTRATION RATE LEVELS DOWN TO 30 ML/MINUTE/1.73 M2, ALBUMINURIA AND PREVIOUS MACROVASCULAR DISEASE BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
2.5MG;1GM	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	12364700	June 8, 2037	TREATMENT OF TYPE 2 DIABETES IN A PATIENT HAVING ESTIMATED GLOMERULAR FILTRATION RATE LEVELS DOWN TO 30 ML/MINUTE/1.73 M2, ALBUMINURIA AND PREVIOUS MACROVASCULAR DISEASE BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
2.5MG;500MG	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	12364700	June 8, 2037	TREATMENT OF TYPE 2 DIABETES IN A PATIENT HAVING ESTIMATED GLOMERULAR FILTRATION RATE LEVELS DOWN TO 30 ML/MINUTE/1.73 M2, ALBUMINURIA AND PREVIOUS MACROVASCULAR DISEASE BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
2.5MG;850MG	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	12364700	June 8, 2037	TREATMENT OF TYPE 2 DIABETES IN A PATIENT HAVING ESTIMATED GLOMERULAR FILTRATION RATE LEVELS DOWN TO 30 ML/MINUTE/1.73 M2, ALBUMINURIA AND PREVIOUS MACROVASCULAR DISEASE BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
10MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	12364700	June 8, 2037	TREATMENT OF TYPE 2 DIABETES IN A PATIENT HAVING ESTIMATED GLOMERULAR FILTRATION RATE LEVELS DOWN TO 30 ML/MINUTE/1.73 M2, ALBUMINURIA AND PREVIOUS MACROVASCULAR DISEASE BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
25MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	12364700	June 8, 2037	TREATMENT OF TYPE 2 DIABETES IN A PATIENT HAVING ESTIMATED GLOMERULAR FILTRATION RATE LEVELS DOWN TO 30 ML/MINUTE/1.73 M2, ALBUMINURIA AND PREVIOUS MACROVASCULAR DISEASE BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
2.5MG;1GM	JENTADUETO XR	BOEHRINGER INGELHEIM	N208026	May 27, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	12364700	June 8, 2037	TREATMENT OF TYPE 2 DIABETES IN A PATIENT HAVING ESTIMATED GLOMERULAR FILTRATION RATE LEVELS DOWN TO 30 ML/MINUTE/1.73 M2, ALBUMINURIA AND PREVIOUS MACROVASCULAR DISEASE BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
5MG;1GM	JENTADUETO XR	BOEHRINGER INGELHEIM	N208026	May 27, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	12364700	June 8, 2037	TREATMENT OF TYPE 2 DIABETES IN A PATIENT HAVING ESTIMATED GLOMERULAR FILTRATION RATE LEVELS DOWN TO 30 ML/MINUTE/1.73 M2, ALBUMINURIA AND PREVIOUS MACROVASCULAR DISEASE BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
10MG;5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	12364700	June 8, 2037	TREATMENT OF TYPE 2 DIABETES IN A PATIENT HAVING ESTIMATED GLOMERULAR FILTRATION RATE LEVELS DOWN TO 30 ML/MINUTE/1.73 M2, ALBUMINURIA AND PREVIOUS MACROVASCULAR DISEASE BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
12.5MG;2.5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	12364700	June 8, 2037	TREATMENT OF TYPE 2 DIABETES IN A PATIENT HAVING ESTIMATED GLOMERULAR FILTRATION RATE LEVELS DOWN TO 30 ML/MINUTE/1.73 M2, ALBUMINURIA AND PREVIOUS MACROVASCULAR DISEASE BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
25MG;5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	12364700	June 8, 2037	TREATMENT OF TYPE 2 DIABETES IN A PATIENT HAVING ESTIMATED GLOMERULAR FILTRATION RATE LEVELS DOWN TO 30 ML/MINUTE/1.73 M2, ALBUMINURIA AND PREVIOUS MACROVASCULAR DISEASE BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
5MG;2.5MG;1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	12364700	June 8, 2037	TREATMENT OF TYPE 2 DIABETES IN A PATIENT HAVING ESTIMATED GLOMERULAR FILTRATION RATE LEVELS DOWN TO 30 ML/MINUTE/1.73 M2, ALBUMINURIA AND PREVIOUS MACROVASCULAR DISEASE BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
5MG	TRADJENTA	BOEHRINGER INGELHEIM	N201280	May 2, 2011	RX	TABLET	ORAL	June 20, 2026	REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY 1218-0091, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST
2.5MG;1GM	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	June 20, 2026	REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY 1218-0091, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST
2.5MG;500MG	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	June 20, 2026	REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY 1218-0091, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST
2.5MG;850MG	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	June 20, 2026	REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY 1218-0091, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST
2.5MG;1GM	JENTADUETO XR	BOEHRINGER INGELHEIM	N208026	May 27, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	June 20, 2026	REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY 1218-0091, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST
5MG;1GM	JENTADUETO XR	BOEHRINGER INGELHEIM	N208026	May 27, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	June 20, 2026	REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY 1218-0091, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST
5MG	TRADJENTA	BOEHRINGER INGELHEIM	N201280	May 2, 2011	RX	TABLET	ORAL	Dec. 20, 2026	PEDIATRIC EXCLUSIVITY
2.5MG;1GM	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	Dec. 20, 2026	PEDIATRIC EXCLUSIVITY
2.5MG;500MG	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	Dec. 20, 2026	PEDIATRIC EXCLUSIVITY
2.5MG;850MG	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	Dec. 20, 2026	PEDIATRIC EXCLUSIVITY
2.5MG;1GM	JENTADUETO XR	BOEHRINGER INGELHEIM	N208026	May 27, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	Dec. 20, 2026	PEDIATRIC EXCLUSIVITY
5MG;1GM	JENTADUETO XR	BOEHRINGER INGELHEIM	N208026	May 27, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	Dec. 20, 2026	PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Dipeptidyl peptidase 4	Enzyme	P27487	DPP4_HUMAN	INHIBITOR	IC50	10	CHEMBL	CHEMBL
Prolyl endopeptidase FAP	Enzyme	Q12884	SEPR_HUMAN		IC50	7.05	CHEMBL
Dipeptidyl peptidase 8	Enzyme	Q6V1X1	DPP8_HUMAN		IC50	4.40	CHEMBL
Dipeptidyl peptidase 9	Enzyme	Q86TI2	DPP9_HUMAN		IC50	4	CHEMBL
Muscarinic acetylcholine receptor M1	GPCR	P11229	ACM1_HUMAN		IC50	6.53	CHEMBL
Dipeptidyl peptidase 4	Enzyme		DPP4_MOUSE		IC50	9.92	CHEMBL
Prolyl endopeptidase FAP	Enzyme		SEPR_MOUSE		IC50	6.43	CHEMBL
Dipeptidyl peptidase IV	Enzyme		O31048_PORGN		IC50	5	CHEMBL

External reference:

ID	Source
4030725	VUID
N0000182735	NUI
D09566	KEGG_DRUG
4030725	VANDF
C2746078	UMLSCUI
CHEBI:68610	CHEBI
356	PDB_CHEM_ID
CHEMBL237500	ChEMBL_ID
D000069476	MESH_DESCRIPTOR_UI
DB08882	DRUGBANK_ID
6318	IUPHAR_LIGAND_ID
9039	INN_ID
3X29ZEJ4R2	UNII
10096344	PUBCHEM_CID
1100699	RXNORM
181237	MMSL
27861	MMSL
d07767	MMSL
013732	NDDF
702798009	SNOMEDCT_US
703667006	SNOMEDCT_US
3X29ZEJ4R2	INXIGHT DRUGS

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Tradjenta	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0140	TABLET, FILM COATED	5 mg	ORAL	NDA	32 sections
Jentadueto	HUMAN PRESCRIPTION DRUG LABEL	2	0597-0146	TABLET, FILM COATED	2.50 mg	ORAL	NDA	33 sections
Jentadueto	HUMAN PRESCRIPTION DRUG LABEL	2	0597-0147	TABLET, FILM COATED	2.50 mg	ORAL	NDA	33 sections
Jentadueto	HUMAN PRESCRIPTION DRUG LABEL	2	0597-0148	TABLET, FILM COATED	2.50 mg	ORAL	NDA	33 sections
Glyxambi	HUMAN PRESCRIPTION DRUG LABEL	2	0597-0164	TABLET, FILM COATED	5 mg	ORAL	NDA	32 sections
Glyxambi	HUMAN PRESCRIPTION DRUG LABEL	2	0597-0164	TABLET, FILM COATED	5 mg	ORAL	NDA	32 sections
Glyxambi	HUMAN PRESCRIPTION DRUG LABEL	2	0597-0182	TABLET, FILM COATED	5 mg	ORAL	NDA	32 sections
Glyxambi	HUMAN PRESCRIPTION DRUG LABEL	2	0597-0182	TABLET, FILM COATED	5 mg	ORAL	NDA	32 sections
Jentadueto XR	HUMAN PRESCRIPTION DRUG LABEL	2	0597-0270	TABLET, FILM COATED, EXTENDED RELEASE	2.50 mg	ORAL	NDA	33 sections
Jentadueto XR	HUMAN PRESCRIPTION DRUG LABEL	2	0597-0275	TABLET, FILM COATED, EXTENDED RELEASE	5 mg	ORAL	NDA	33 sections
Trijardy XR	HUMAN PRESCRIPTION DRUG LABEL	3	0597-0380	TABLET, EXTENDED RELEASE	5 mg	ORAL	NDA	34 sections
Trijardy XR	HUMAN PRESCRIPTION DRUG LABEL	3	0597-0380	TABLET, EXTENDED RELEASE	5 mg	ORAL	NDA	34 sections
Trijardy XR	HUMAN PRESCRIPTION DRUG LABEL	3	0597-0385	TABLET, EXTENDED RELEASE	2.50 mg	ORAL	NDA	34 sections
Trijardy XR	HUMAN PRESCRIPTION DRUG LABEL	3	0597-0385	TABLET, EXTENDED RELEASE	2.50 mg	ORAL	NDA	34 sections
Trijardy XR	HUMAN PRESCRIPTION DRUG LABEL	3	0597-0390	TABLET, EXTENDED RELEASE	5 mg	ORAL	NDA	34 sections
Trijardy XR	HUMAN PRESCRIPTION DRUG LABEL	3	0597-0390	TABLET, EXTENDED RELEASE	5 mg	ORAL	NDA	34 sections
Trijardy XR	HUMAN PRESCRIPTION DRUG LABEL	3	0597-0395	TABLET, EXTENDED RELEASE	2.50 mg	ORAL	NDA	34 sections
Trijardy XR	HUMAN PRESCRIPTION DRUG LABEL	3	0597-0395	TABLET, EXTENDED RELEASE	2.50 mg	ORAL	NDA	34 sections
linagliptin	HUMAN PRESCRIPTION DRUG LABEL	1	48792-7865	TABLET, FILM COATED	5 mg	ORAL	ANDA	26 sections
Tradjenta	HUMAN PRESCRIPTION DRUG LABEL	1	50090-4383	TABLET, FILM COATED	5 mg	ORAL	NDA	32 sections
Jentadueto	HUMAN PRESCRIPTION DRUG LABEL	2	54868-6461	TABLET, FILM COATED	2.50 mg	ORAL	NDA	28 sections
Tradjenta	HUMAN PRESCRIPTION DRUG LABEL	1	55154-0410	TABLET, FILM COATED	5 mg	ORAL	NDA	32 sections
Linagliptin and metformin hydrochloride	Human Prescription Drug Label	2	72205-407	TABLET, FILM COATED	2.50 mg	ORAL	ANDA	26 sections
Linagliptin and metformin hydrochloride	Human Prescription Drug Label	2	72205-408	TABLET, FILM COATED	2.50 mg	ORAL	ANDA	26 sections
Linagliptin and metformin hydrochloride	Human Prescription Drug Label	2	72205-409	TABLET, FILM COATED	2.50 mg	ORAL	ANDA	26 sections

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linagliptin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Description:

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Predicted pharmacokinetic/toxicological properties (PK-AZ):

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FDA Adverse Event Reporting System (Female)

FDA Adverse Event Reporting System (Male)

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🐶 Veterinary Drug Use

🐶 Veterinary products

Acid dissociation constants calculated using MoKa v3.0.0

Orange Book patent data (new drug applications)

Orange Book exclusivity data (new drug applications)

Bioactivity Summary:

External reference:

Pharmaceutical products: