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Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
peptides and glycopeptides	1123	141758-74-9

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: exenatide byetta exenatide synthetic bydureon exendin-4 AC002993 AC2993A	A synthetic form of exendin-4, a 39-amino acid peptide isolated from the venom of the Gila monster lizard (Heloderma suspectum). Exenatide increases CYCLIC AMP levels in pancreatic acinar cells and acts as a GLUCAGON-LIKE PEPTIDE-1 RECEPTOR (GLP-1) agonist and incretin mimetic, enhancing insulin secretion in response to increased glucose levels; it also suppresses inappropriate glucagon secretion and slows gastric emptying. It is used an anti-diabetic and anti-obesity agent. Molecular weight: 4186.63 Formula: C184H282N50O60S CLOGP: LIPINSKI: None HAC: 110 HDO: 58 TPSA: 1749.75 ALOGS: ROTB: 134

Molecule

Description

Molfile Inchi Smiles

Synonyms:

exenatide
byetta
exenatide synthetic
bydureon
exendin-4
AC002993
AC2993A

A synthetic form of exendin-4, a 39-amino acid peptide isolated from the venom of the Gila monster lizard (Heloderma suspectum). Exenatide increases CYCLIC AMP levels in pancreatic acinar cells and acts as a GLUCAGON-LIKE PEPTIDE-1 RECEPTOR (GLP-1) agonist and incretin mimetic, enhancing insulin secretion in response to increased glucose levels; it also suppresses inappropriate glucagon secretion and slows gastric emptying. It is used an anti-diabetic and anti-obesity agent.

Molecular weight: 4186.63
Formula: C184H282N50O60S
CLOGP:
LIPINSKI: None
HAC: 110
HDO: 58
TPSA: 1749.75
ALOGS:
ROTB: 134

Drug dosage:

Dose	Unit	Route
0.29	mg	P
15	mcg	P

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	25 mg/mL	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.00 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

Date	Agency	Company	Orphan
April 28, 2005	FDA	ASTRAZENECA AB

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
Blood glucose increased	1999.42	17.32	789	22174	94457	90511027
Pancreatitis	1973.23	17.32	719	22244	69107	90536377
Weight decreased	1134.68	17.32	861	22102	379049	90226435
Injection site nodule	734.03	17.32	180	22783	4293	90601191
Nausea	596.56	17.32	1027	21936	1109289	89496195
Blood glucose decreased	596.22	17.32	224	22739	23205	90582279
Pancreatitis acute	404.88	17.32	186	22777	31929	90573555
Injection site haemorrhage	360.05	17.32	165	22798	28153	90577331
Glycosylated haemoglobin increased	332.22	17.32	131	22832	15431	90590053
Injection site pruritus	303.82	17.32	182	22781	53652	90551832
Injection site mass	300.67	17.32	135	22828	21955	90583529
Incorrect dose administered by device	270.61	17.32	87	22876	5650	90599834
Device leakage	270.38	17.32	100	22863	9891	90595593
Injection site extravasation	261.58	17.32	95	22868	8924	90596560
Hypoglycaemia	226.03	17.32	167	22796	69681	90535803
Injection site pain	225.71	17.32	248	22715	173451	90432033
Injection site urticaria	213.47	17.32	100	22863	17911	90587573
Wrong technique in device usage process	205.47	17.32	71	22892	5764	90599720
Vomiting	202.40	17.32	543	22420	787750	89817734
Blood glucose abnormal	178.66	17.32	73	22890	9419	90596065
Pancreatic carcinoma	176.94	17.32	70	22893	8307	90597177
Device malfunction	172.94	17.32	91	22872	20886	90584598
Injection site erythema	168.25	17.32	163	22800	98339	90507145
Injection site bruising	166.79	17.32	124	22839	52183	90553301
Injection site rash	163.55	17.32	92	22871	24081	90581403
Decreased appetite	162.55	17.32	319	22644	376221	90229263
Device delivery system issue	158.08	17.32	44	22919	1734	90603750
Lipase increased	135.70	17.32	63	22900	11048	90594436
Incorrect dose administered	128.01	17.32	127	22836	78803	90526681
Blood glucose fluctuation	127.01	17.32	48	22915	5035	90600449
Injection site irritation	119.16	17.32	48	22915	5967	90599517
Diabetic ketoacidosis	118.45	17.32	75	22888	24332	90581152
Pancreatitis chronic	113.44	17.32	38	22925	2805	90602679
Diabetes mellitus inadequate control	112.72	17.32	66	22897	18618	90586866
Cholelithiasis	111.16	17.32	98	22865	52408	90553076
Device use issue	107.23	17.32	39	22924	3674	90601810
Early satiety	103.35	17.32	30	22933	1377	90604107
Intentional device misuse	98.26	17.32	26	22937	844	90604640
Hyperglycaemia	91.99	17.32	87	22876	50883	90554601
Pancreatic carcinoma metastatic	87.73	17.32	30	22933	2358	90603126
Device issue	80.91	17.32	64	22899	29473	90576011
Needle issue	80.84	17.32	48	22915	13886	90591598
Injury associated with device	79.47	17.32	33	22930	4431	90601053
Acute kidney injury	78.94	17.32	218	22745	320169	90285315
Systemic lupus erythematosus	75.34	17.32	4	22959	361892	90243592
Lactic acidosis	74.13	17.32	77	22886	50386	90555098
Joint swelling	70.73	17.32	20	22943	503280	90102204
Dehydration	68.74	17.32	152	22811	194295	90411189
Impaired gastric emptying	66.27	17.32	41	22922	12768	90592716
Amylase increased	64.95	17.32	33	22930	7039	90598445
Adenocarcinoma pancreas	64.44	17.32	20	22943	1156	90604328
Eructation	61.86	17.32	37	22926	10845	90594639
Treatment failure	61.29	17.32	4	22959	303924	90301560
Wound	61.07	17.32	4	22959	302976	90302508
Nodule	60.89	17.32	52	22911	26634	90578850
Blood triglycerides increased	58.68	17.32	39	22924	13722	90591762
Drug intolerance	57.18	17.32	21	22942	447570	90157914
Pericarditis	56.16	17.32	3	22960	270148	90335336
Pain	54.94	17.32	106	22857	996235	89609249
Musculoskeletal stiffness	54.07	17.32	6	22957	296526	90308958
Device defective	52.87	17.32	23	22940	3463	90602021
Arthropathy	52.45	17.32	14	22949	366228	90239256
Injection site haematoma	51.34	17.32	28	22935	6894	90598590
Product quality issue	50.69	17.32	80	22883	79245	90526239
Rheumatoid arthritis	49.82	17.32	15	22948	362599	90242885
Drug ineffective	48.66	17.32	184	22779	1384114	89221370
Increased appetite	46.95	17.32	32	22931	11733	90593751
General physical health deterioration	46.47	17.32	16	22947	355099	90250385
Product dose omission issue	45.72	17.32	170	22793	291517	90313967
Infection	44.55	17.32	18	22945	362076	90243408
Arthralgia	44.46	17.32	81	22882	778441	89827043
Stomatitis	44.38	17.32	8	22955	274690	90330794
Product use in unapproved indication	44.25	17.32	15	22948	336221	90269263
Pancreatitis necrotising	43.73	17.32	18	22945	2363	90603121
Abdominal pain	43.57	17.32	207	22756	395514	90209970
Hepatic steatosis	43.17	17.32	50	22913	36895	90568589
Helicobacter infection	42.88	17.32	4	22959	226846	90378638
Circumstance or information capable of leading to medication error	42.21	17.32	22	22941	4945	90600539
Pyrexia	42.07	17.32	64	22899	660421	89945063
Nasopharyngitis	41.45	17.32	26	22937	407078	90198406
Injection site swelling	40.53	17.32	62	22901	59777	90545707
Pneumonia	39.51	17.32	63	22900	637996	89967488
Underdose	39.48	17.32	58	22905	53959	90551525
Toxicity to various agents	39.36	17.32	12	22951	287834	90317650
Feeling jittery	39.31	17.32	32	22931	15339	90590145
Peripheral swelling	38.57	17.32	29	22934	413077	90192407
Renal failure	38.17	17.32	95	22868	130912	90474572
Intentional product use issue	38.02	17.32	5	22958	216887	90388597
Neutropenia	37.54	17.32	6	22957	224898	90380586
Impaired healing	37.44	17.32	7	22956	234192	90371292
Hunger	36.49	17.32	22	22941	6541	90598943
Irritable bowel syndrome	35.85	17.32	5	22958	207443	90398041
Alopecia	35.49	17.32	44	22919	495027	90110457
Hepatic enzyme increased	35.41	17.32	24	22939	360712	90244772
Discomfort	34.79	17.32	13	22950	274322	90331162
Drug dose omission by device	34.26	17.32	25	22938	10206	90595278
Injection site abscess	33.70	17.32	13	22950	1441	90604043
Muscle injury	33.69	17.32	3	22960	176651	90428833
Injection site indentation	33.39	17.32	9	22954	314	90605170
Mobility decreased	33.30	17.32	11	22952	250723	90354761
Wheezing	32.41	17.32	10	22953	238070	90367414
Sinusitis	32.13	17.32	24	22939	343064	90262420
Swelling	31.35	17.32	36	22927	419022	90186462
Pancreatitis relapsing	30.82	17.32	12	22951	1364	90604120
Feeling abnormal	30.05	17.32	102	22861	167133	90438351
Injection site inflammation	29.94	17.32	17	22946	4524	90600960
C-reactive protein increased	29.90	17.32	5	22958	181384	90424100
Thyroid cancer	29.71	17.32	19	22944	6265	90599219
Blister	29.26	17.32	14	22949	254984	90350500
Cholecystitis	28.68	17.32	28	22935	17012	90588472
Therapeutic product effect incomplete	28.53	17.32	7	22956	193889	90411595
Confusional state	28.00	17.32	34	22929	386171	90219313
Thrombocytopenia	27.99	17.32	9	22954	208716	90396768
Product quality control issue	27.80	17.32	5	22958	23	90605461
Abdominal distension	27.40	17.32	84	22879	130517	90474967
Injection site induration	27.20	17.32	22	22941	10446	90595038
Urticaria	27.03	17.32	153	22810	312581	90292903
Febrile neutropenia	26.93	17.32	4	22959	158345	90447139
Fatigue	26.84	17.32	177	22786	1153846	89451638
Ill-defined disorder	26.58	17.32	7	22956	184884	90420600
Sleep disorder	25.75	17.32	9	22954	198021	90407463
Medullary thyroid cancer	25.68	17.32	7	22956	255	90605229
Inflammation	25.22	17.32	7	22956	178585	90426899
Hypoglycaemic unconsciousness	25.19	17.32	9	22954	805	90604679
White blood cell count decreased	24.65	17.32	6	22957	167103	90438381
Diabetic neuropathy	24.57	17.32	15	22948	4559	90600925
Injection site warmth	24.41	17.32	26	22937	17489	90587995
Pancreatic duct stenosis	24.34	17.32	5	22958	51	90605433
Medication error	24.24	17.32	61	22902	84591	90520893
Loss of personal independence in daily activities	24.18	17.32	3	22960	136102	90469382
Product use issue	23.96	17.32	29	22934	329890	90275594
Bile duct stent insertion	23.52	17.32	5	22958	61	90605423
Pancreatitis haemorrhagic	23.24	17.32	8	22955	641	90604843
Glycosylated haemoglobin decreased	23.24	17.32	8	22955	641	90604843
Coronary artery disease	22.99	17.32	35	22928	33588	90571896
Product prescribing error	22.94	17.32	33	22930	30112	90575372
Metastases to liver	22.61	17.32	32	22931	28775	90576709
Product dispensing error	22.23	17.32	21	22942	12252	90593232
Intestinal malrotation	22.00	17.32	7	22956	439	90605045
Joint range of motion decreased	21.79	17.32	4	22959	135639	90469845
Injection site infection	21.76	17.32	11	22952	2321	90603163
Therapeutic response unexpected	21.30	17.32	27	22936	21853	90583631
Vomiting projectile	21.29	17.32	10	22953	1799	90603685
Bursitis	20.89	17.32	4	22959	131650	90473834
Glycosylated haemoglobin abnormal	20.89	17.32	6	22957	265	90605219
Type 2 diabetes mellitus	20.63	17.32	13	22950	203231	90402253
Disease progression	20.56	17.32	7	22956	156608	90448876
Nail growth abnormal	19.94	17.32	7	22956	595	90604889
Fibromyalgia	19.85	17.32	14	22949	206255	90399229
Pancreatic neoplasm	19.83	17.32	8	22955	998	90604486
Goitre	19.25	17.32	15	22948	6752	90598732
Lung disorder	19.16	17.32	7	22956	149876	90455608
Drug delivery system issue	19.15	17.32	5	22958	154	90605330
Device failure	19.00	17.32	15	22948	6882	90598602
Dry mouth	18.37	17.32	12	22951	184047	90421437
Night sweats	18.26	17.32	5	22958	128761	90476723
Mass	18.06	17.32	21	22942	15556	90589928
Death	17.71	17.32	58	22905	456493	90148991
Flatulence	17.70	17.32	35	22928	41332	90564152
Myocardial infarction	17.61	17.32	63	22900	105909	90499575
Hypoaesthesia	17.60	17.32	33	22930	314177	90291307

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
Pancreatitis	1769.32	18.39	655	16006	42613	42562061
Blood glucose increased	1172.14	18.39	571	16090	73128	42531546
Weight decreased	738.07	18.39	624	16037	207324	42397350
Injection site nodule	712.26	18.39	166	16495	1995	42602679
Pancreatitis acute	466.39	18.39	238	16423	33326	42571348
Device leakage	386.69	18.39	147	16514	10138	42594536
Injection site haemorrhage	360.92	18.39	145	16516	11591	42593083
Incorrect dose administered by device	331.88	18.39	95	16566	2661	42602013
Pancreatic carcinoma	311.59	18.39	123	16538	9383	42595291
Injection site mass	274.20	18.39	109	16552	8466	42596208
Nausea	273.15	18.39	524	16137	396275	42208399
Blood glucose decreased	260.79	18.39	122	16539	14097	42590577
Glycosylated haemoglobin increased	249.81	18.39	115	16546	12809	42591865
Wrong technique in device usage process	219.20	18.39	69	16592	2688	42601986
Injection site extravasation	218.88	18.39	71	16590	3051	42601623
Device delivery system issue	205.77	18.39	53	16608	984	42603690
Injection site pain	186.27	18.39	165	16496	57633	42547041
Blood glucose abnormal	165.80	18.39	72	16589	6981	42597693
Cholelithiasis	148.78	18.39	100	16561	23246	42581428
Device malfunction	146.94	18.39	79	16582	12248	42592426
Intentional device misuse	133.57	18.39	29	16632	245	42604429
Pancreatic carcinoma metastatic	132.56	18.39	49	16612	3117	42601557
Lipase increased	110.18	18.39	62	16599	10504	42594170
Hypoglycaemia	108.17	18.39	125	16536	59729	42544945
Device use issue	105.52	18.39	31	16630	952	42603722
Needle issue	95.87	18.39	53	16608	8674	42596000
Drug dose omission by device	94.14	18.39	46	16615	5840	42598834
Product quality issue	93.80	18.39	68	16593	17814	42586860
Injection site pruritus	92.17	18.39	53	16608	9352	42595322
Diabetes mellitus inadequate control	91.08	18.39	63	16598	15327	42589347
Vomiting	79.45	18.39	271	16390	289452	42315222
Adenocarcinoma pancreas	77.11	18.39	27	16634	1467	42603207
Drug delivery system issue	76.90	18.39	15	16646	69	42604605
Device issue	76.90	18.39	54	16607	13455	42591219
Injection site erythema	73.76	18.39	62	16599	20133	42584541
Decreased appetite	71.79	18.39	201	16460	192936	42411738
Blood glucose fluctuation	70.83	18.39	35	16626	4552	42600122
Incorrect dose administered	70.59	18.39	95	16566	52879	42551795
Pancreatitis chronic	69.18	18.39	28	16633	2274	42602400
Underdose	66.79	18.39	54	16607	16612	42588062
Toxicity to various agents	64.93	18.39	7	16654	229129	42375545
Injection site urticaria	58.82	18.39	28	16633	3355	42601319
Injection site bruising	58.56	18.39	43	16618	11482	42593192
Product use in unapproved indication	56.68	18.39	4	16657	184452	42420222
Pancreaticoduodenectomy	55.31	18.39	11	16650	57	42604617
Neutropenia	54.24	18.39	7	16654	199424	42405250
Pancreatitis necrotising	53.84	18.39	27	16634	3622	42601052
Diabetic ketoacidosis	53.12	18.39	54	16607	22313	42582361
Pyrexia	51.59	18.39	47	16614	393995	42210679
Cholecystectomy	49.89	18.39	25	16636	3349	42601325
Metastases to liver	49.32	18.39	45	16616	16281	42588393
Death	46.86	18.39	70	16591	471115	42133559
Injection site irritation	45.78	18.39	19	16642	1645	42603029
Thrombocytopenia	44.44	18.39	10	16651	190269	42414405
Hepatic steatosis	42.45	18.39	47	16614	21401	42583273
Hyperglycaemia	42.01	18.39	69	16592	45790	42558884
Disease progression	41.67	18.39	4	16657	143652	42461022
Renal failure	41.50	18.39	137	16524	143589	42461085
Injection site injury	40.92	18.39	12	16649	366	42604308
Amylase increased	40.87	18.39	28	16633	6701	42597973
Injection site rash	40.08	18.39	26	16635	5686	42598988
Blood triglycerides increased	38.88	18.39	39	16622	15857	42588817
Pneumonia	38.83	18.39	66	16595	422083	42182591
Injury associated with device	38.59	18.39	16	16645	1381	42603293
Anaemia	34.79	18.39	35	16626	280243	42324431
COVID-19	34.23	18.39	3	16658	115945	42488729
Impaired gastric emptying	33.43	18.39	21	16640	4345	42600329
Injection site reaction	32.06	18.39	35	16626	15686	42588988
Malignant neoplasm progression	31.48	18.39	3	16658	108397	42496277
Platelet count decreased	30.94	18.39	8	16653	138573	42466101
Abdominal pain upper	30.62	18.39	86	16575	82523	42522151
Pancytopenia	29.98	18.39	5	16656	117738	42486936
Pancreatic neoplasm	29.79	18.39	12	16649	962	42603712
Pancreatic neuroendocrine tumour	29.61	18.39	9	16652	311	42604363
Condition aggravated	28.59	18.39	36	16625	260718	42343956
Bile duct stent insertion	28.26	18.39	7	16654	110	42604564
Therapeutic product effect decreased	28.18	18.39	53	16608	39097	42565577
Pancreatic stent placement	28.12	18.39	5	16656	12	42604662
General physical health deterioration	28.05	18.39	12	16649	151234	42453440
Biliary dyskinesia	28.03	18.39	6	16655	47	42604627
Drug abuse	27.69	18.39	4	16657	104767	42499907
White blood cell count decreased	27.42	18.39	5	16656	110391	42494283
Pancreatitis haemorrhagic	27.42	18.39	9	16652	401	42604273
Injection site induration	27.27	18.39	17	16644	3470	42601204
Fatigue	27.16	18.39	84	16577	435557	42169117
Abdominal pain	26.25	18.39	145	16516	190326	42414348
Injection site abscess	25.77	18.39	11	16650	1021	42603653
Drug delivery system malfunction	25.65	18.39	9	16652	492	42604182
Drug interaction	25.18	18.39	41	16620	266958	42337716
Early satiety	24.14	18.39	10	16651	861	42603813
Nodule	24.00	18.39	27	16634	12507	42592167
Pancreatic pseudocyst	23.91	18.39	10	16651	882	42603792
Feeling jittery	23.34	18.39	17	16644	4481	42600193
Pancreatic cyst	23.24	18.39	10	16651	947	42603727
Diverticulum	23.19	18.39	21	16640	7520	42597154
Dehydration	23.03	18.39	113	16548	141654	42463020
Hepatic cancer	22.96	18.39	22	16639	8458	42596216
Drug ineffective	22.72	18.39	149	16512	630048	41974626
Eructation	22.45	18.39	18	16643	5468	42599206
Injection site haematoma	21.99	18.39	12	16649	1913	42602761
Hypoglycaemic unconsciousness	21.73	18.39	9	16652	775	42603899
Circumstance or information capable of leading to medication error	21.49	18.39	13	16648	2515	42602159
Diabetic neuropathy	21.08	18.39	16	16645	4486	42600188
Insulin-requiring type 2 diabetes mellitus	21.02	18.39	6	16655	166	42604508
Pancreatic enzymes increased	20.68	18.39	9	16652	876	42603798
Device defective	20.61	18.39	11	16650	1677	42602997
Cholecystitis chronic	20.11	18.39	9	16652	936	42603738
Injection site discomfort	19.78	18.39	12	16649	2334	42602340
Pancreatic duct dilatation	19.55	18.39	5	16656	90	42604584
Leukopenia	19.41	18.39	3	16658	74743	42529931
Therapeutic response unexpected	19.24	18.39	23	16638	11358	42593316
Glycosylated haemoglobin decreased	19.01	18.39	7	16654	440	42604234
Hunger	18.93	18.39	11	16650	1977	42602697
Weight increased	18.92	18.39	88	16573	107895	42496779
Injection site scar	18.92	18.39	7	16654	446	42604228
Pancreatectomy	18.73	18.39	4	16657	31	42604643
Interstitial lung disease	18.55	18.39	4	16657	78458	42526216

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
Blood glucose increased	2159.35	18.35	865	22132	131631	110434671
Pancreatitis	1539.78	18.35	616	22381	92917	110473385
Weight decreased	982.74	18.35	795	22202	467262	110099040
Injection site nodule	804.66	18.35	188	22809	4458	110561844
Nausea	639.24	18.35	1008	21989	1234682	109331620
Blood glucose decreased	517.92	18.35	204	22793	29284	110537018
Incorrect dose administered by device	491.11	18.35	137	22860	6677	110559625
Device leakage	478.64	18.35	164	22833	15884	110550418
Injection site haemorrhage	448.42	18.35	190	22807	32838	110533464
Pancreatitis acute	372.84	18.35	202	22795	60072	110506230
Glycosylated haemoglobin increased	364.81	18.35	149	22848	23470	110542832
Device delivery system issue	341.38	18.35	81	22916	2052	110564250
Wrong technique in device usage process	334.56	18.35	102	22895	6799	110559503
Injection site mass	263.97	18.35	120	22877	24493	110541809
Hypoglycaemia	258.35	18.35	205	22792	115899	110450403
Injection site pruritus	257.72	18.35	150	22847	51108	110515194
Injection site pain	241.02	18.35	237	22760	177685	110388617
Device malfunction	219.79	18.35	107	22890	25451	110540851
Vomiting	210.52	18.35	533	22464	910142	109656160
Pancreatic carcinoma	206.56	18.35	87	22910	14785	110551517
Blood glucose abnormal	204.59	18.35	83	22914	12833	110553469
Injection site extravasation	198.45	18.35	76	22921	10093	110556209
Decreased appetite	195.04	18.35	352	22645	475494	110090808
Device use issue	192.27	18.35	58	22939	3726	110562576
Injection site urticaria	187.95	18.35	85	22912	17130	110549172
Incorrect dose administered	153.29	18.35	145	22852	103496	110462806
Needle issue	148.32	18.35	73	22924	17767	110548535
Injection site bruising	143.75	18.35	104	22893	51159	110515143
Injection site erythema	143.57	18.35	134	22863	94042	110472260
Lipase increased	142.23	18.35	72	22925	18600	110547702
Blood glucose fluctuation	137.66	18.35	54	22943	7644	110558658
Diabetic ketoacidosis	124.05	18.35	88	22909	41970	110524332
Drug dose omission by device	119.48	18.35	59	22938	14457	110551845
Injection site rash	116.23	18.35	68	22929	23351	110542951
Injection site irritation	115.05	18.35	42	22955	4882	110561420
Diabetes mellitus inadequate control	110.94	18.35	72	22925	29703	110536599
Acute kidney injury	94.17	18.35	318	22679	635112	109931190
Drug delivery system issue	80.76	18.35	17	22980	244	110566058
Intentional device misuse	78.93	18.35	21	22976	853	110565449
Cholelithiasis	77.50	18.35	80	22917	63342	110502960
Hyperglycaemia	77.48	18.35	92	22905	84998	110481304
Device issue	76.75	18.35	61	22936	34474	110531828
Product quality issue	76.10	18.35	87	22910	77212	110489090
Early satiety	74.20	18.35	24	22973	1939	110564363
Amylase increased	69.20	18.35	39	22958	12480	110553822
Lactic acidosis	67.98	18.35	90	22907	92721	110473581
Eructation	62.42	18.35	38	22959	14019	110552283
Pyrexia	61.32	18.35	58	22939	898207	109668095
Dehydration	59.35	18.35	159	22838	279352	110286950
Injury associated with device	58.68	18.35	25	22972	4364	110561938
Device defective	58.59	18.35	24	22973	3798	110562504
Toxicity to various agents	58.58	18.35	14	22983	480541	110085761
Product use in unapproved indication	56.60	18.35	12	22985	447365	110118937
Feeling jittery	50.94	18.35	34	22963	14688	110551614
Febrile neutropenia	50.75	18.35	4	22993	316763	110249539
Pancreatic carcinoma metastatic	50.05	18.35	22	22975	4142	110562160
Neutropenia	49.58	18.35	9	22988	374611	110191691
Product dose omission issue	49.24	18.35	163	22834	321619	110244683
Pneumonia	48.53	18.35	67	22930	876647	109689655
Injection site indentation	46.18	18.35	11	22986	283	110566019
Treatment failure	45.85	18.35	3	22994	277231	110289071
Impaired gastric emptying	44.35	18.35	30	22967	13245	110553057
Joint swelling	43.22	18.35	19	22978	442826	110123476
Underdose	42.53	18.35	59	22938	63495	110502807
Drug intolerance	42.00	18.35	16	22981	406496	110159806
General physical health deterioration	41.89	18.35	18	22979	425277	110141025
Feeling abnormal	41.60	18.35	106	22891	180605	110385697
Pancreatitis necrotising	41.26	18.35	21	22976	5480	110560822
Injection site induration	41.10	18.35	27	22970	11356	110554946
Thrombocytopenia	40.88	18.35	11	22986	348874	110217428
Blood triglycerides increased	38.27	18.35	35	22962	23891	110542411
Renal failure	36.64	18.35	117	22880	226457	110339845
Musculoskeletal stiffness	36.42	18.35	7	22990	279815	110286487
Device failure	35.95	18.35	21	22976	7186	110559116
Injection site injury	35.71	18.35	12	22985	1092	110565210
Stomatitis	34.67	18.35	7	22990	270235	110296067
Abdominal distension	34.53	18.35	97	22900	175006	110391296
Increased appetite	34.44	18.35	27	22970	14950	110551352
Lower respiratory tract infection	34.03	18.35	5	22992	243101	110323201
Circumstance or information capable of leading to medication error	33.60	18.35	18	22979	5215	110561087
Injection site swelling	33.58	18.35	52	22945	61738	110504564
Rheumatoid arthritis	32.29	18.35	11	22986	299602	110266700
Disease progression	31.98	18.35	6	22991	244028	110322274
Myocardial infarction	31.79	18.35	100	22897	191983	110374319
Glycosylated haemoglobin decreased	30.28	18.35	10	22987	862	110565440
White blood cell count decreased	29.30	18.35	6	22991	229384	110336918
Injection site infection	28.92	18.35	13	22984	2580	110563722
Pain	28.83	18.35	102	22895	954853	109611449
Injection site abscess	28.73	18.35	12	22985	1994	110564308
Intentional product use issue	28.69	18.35	8	22989	247898	110318404
Arthropathy	28.57	18.35	12	22985	287510	110278792
Injection site haematoma	28.35	18.35	16	22981	5130	110561172
Abdominal pain	28.27	18.35	193	22804	512796	110053506
Urticaria	28.11	18.35	136	22861	318721	110247581
Hyperhidrosis	27.83	18.35	94	22903	187204	110379098
Hepatic steatosis	27.81	18.35	42	22955	48789	110517513
Peripheral swelling	27.60	18.35	26	22971	404008	110162294
Adenocarcinoma pancreas	27.34	18.35	12	22985	2251	110564051
C-reactive protein increased	27.22	18.35	6	22991	217913	110348389
Ketoacidosis	27.20	18.35	20	22977	10067	110556235
Coronary artery occlusion	27.06	18.35	24	22973	15748	110550554
Mobility decreased	26.85	18.35	8	22989	237414	110328888
Injection site inflammation	26.74	18.35	15	22982	4756	110561546
Wheezing	26.42	18.35	10	22987	255220	110311082
Drug abuse	26.39	18.35	3	22994	177408	110388894
Therapeutic product effect incomplete	26.31	18.35	7	22990	223798	110342504
Malignant neoplasm progression	25.85	18.35	3	22994	174564	110391738
Therapeutic response unexpected	25.44	18.35	28	22969	23815	110542487
Psoriatic arthropathy	25.43	18.35	5	22992	196756	110369546
Infection	25.10	18.35	23	22974	362177	110204125
Pancreatitis chronic	24.92	18.35	14	22983	4451	110561851
Injection site discomfort	24.01	18.35	16	22981	6891	110559411
Platelet count decreased	23.90	18.35	9	22988	230434	110335868
Confusional state	23.75	18.35	38	22959	468642	110097660
COVID-19	23.13	18.35	11	22986	245049	110321253
Inflammation	22.80	18.35	6	22991	193232	110373070
Anaemia	21.93	18.35	51	22946	547035	110019267
Irritable bowel syndrome	21.59	18.35	4	22993	164211	110402091
Impaired healing	21.57	18.35	7	22990	196710	110369592
Nodule	21.39	18.35	30	22967	32601	110533701
Drug ineffective	21.34	18.35	208	22789	1520332	109045970
Nasopharyngitis	20.91	18.35	31	22966	394330	110171972
Non-cardiac chest pain	20.51	18.35	17	22980	10181	110556121
Sleep disorder	20.20	18.35	8	22989	198636	110367666
Hunger	19.88	18.35	14	22983	6590	110559712
Liver disorder	19.73	18.35	3	22994	142240	110424062
Diverticulum	19.71	18.35	20	22977	15506	110550796
Coronary artery disease	19.64	18.35	45	22952	71645	110494657
Medication error	19.43	18.35	57	22940	105309	110460993
Death	18.89	18.35	78	22919	698791	109867511
Blister	18.86	18.35	12	22985	227364	110338938
Product dispensing error	18.85	18.35	20	22977	16325	110549977
Arthralgia	18.68	18.35	91	22906	779541	109786761

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	A10BJ01	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Glucagon-like peptide-1 (GLP-1) analogues
FDA CS	M0160181	Glucagon-Like Peptide 1
FDA MoA	N0000020058	Glucagon-like Peptide-1 (GLP-1) Agonists
MeSH PA	D000097789	Glucagon-Like Peptide-1 Receptor Agonists
MeSH PA	D006728	Hormones
MeSH PA	D007004	Hypoglycemic Agents
MeSH PA	D019440	Anti-Obesity Agents
MeSH PA	D054795	Incretins
FDA EPC	N0000178480	GLP-1 Receptor Agonist
CHEBI has role	CHEBI:35526	hypoglycemic agent
CHEBI has role	CHEBI:64088	incretin mimetic
CHEBI has role	CHEBI:71196	glucagon-like peptide-1 receptor agonist
CHEBI has role	CHEBI:35554	cardiovascular drug
CHEBI has role	CHEBI:48407	antiparkinson drug
CHEBI has role	CHEBI:74518	anti-obesity agent

Related Drugs by ATC class:

A10BJ Glucagon-like peptide-1 (GLP-1) analogues 5 drugs

albiglutide dulaglutide liraglutide lixisenatide semaglutide

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

Disease	Relation	SNOMED_ID	DOID
Type 2 Diabetes Mellitus Treatment Adjunct	indication
Alcoholism	contraindication	7200002
Acute vomiting	contraindication	23971007
Dehydration	contraindication	34095006
Hypertensive disorder	contraindication	38341003	DOID:10763
Acute nephropathy	contraindication	58574008
Transplant of kidney	contraindication	70536003
Pancreatitis	contraindication	75694006	DOID:4989
Chronic renal failure syndrome	contraindication	90688005
Impaired renal function disorder	contraindication	197663003
Gastroparesis	contraindication	235675006
Hypoglycemic disorder	contraindication	237630007
Calculus in biliary tract	contraindication	266474003
Severe diarrhea	contraindication	409587002

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	3.15	acidic
pKa2	3.62	acidic
pKa3	3.86	acidic
pKa4	4.07	acidic
pKa5	4.31	acidic
pKa6	4.6	acidic
pKa7	12.09	acidic
pKa8	12.31	acidic
pKa9	12.61	acidic
pKa10	12.68	acidic
pKa11	12.87	acidic
pKa12	12.92	acidic
pKa13	12.99	acidic
pKa14	13.18	acidic
pKa15	13.2	acidic
pKa16	13.29	acidic
pKa17	13.3	acidic
pKa18	13.4	acidic
pKa19	13.5	acidic
pKa20	13.51	acidic
pKa21	13.52	acidic
pKa22	13.64	acidic
pKa23	13.68	acidic
pKa24	13.77	acidic
pKa25	13.82	acidic
pKa26	13.86	acidic
pKa27	11.25	Basic
pKa28	10.81	Basic
pKa29	10.31	Basic
pKa30	7.86	Basic
pKa31	5.98	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
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	6515117	Oct. 4, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	6515117	Oct. 4, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	6515117	Oct. 4, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	REDUCING BODY WEIGHT IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	REDUCING FASTING PLASMA GLUCOSE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	REDUCING HBA1C IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	REDUCING BODY WEIGHT IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	REDUCING FASTING PLASMA GLUCOSE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	REDUCING HBA1C IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	REDUCING BODY WEIGHT IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	REDUCING FASTING PLASMA GLUCOSE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	REDUCING HBA1C IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	REDUCING BODY WEIGHT IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	REDUCING FASTING PLASMA GLUCOSE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	REDUCING HBA1C IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	REDUCING BODY WEIGHT IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	REDUCING FASTING PLASMA GLUCOSE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	REDUCING HBA1C IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AS ADD-ON TO METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AS ADD-ON TO METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	REDUCING BODY WEIGHT IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	REDUCING FASTING PLASMA GLUCOSE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	REDUCING HBA1C IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8501698	June 20, 2027	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8501698	June 20, 2027	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8501698	June 20, 2027	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8361972	March 21, 2028	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8361972	March 21, 2028	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8361972	March 21, 2028	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8895033	Oct. 4, 2030	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8895033	Oct. 4, 2030	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AS ADD-ON TO METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8895033	Oct. 4, 2030	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8895033	Oct. 4, 2030	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8895033	Oct. 4, 2030	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8895033	Oct. 4, 2030	DELAYING GASTRIC EMPTYING IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A PRE-MIXED EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8895033	Oct. 4, 2030	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	DISCN	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8895033	Oct. 4, 2030	STIMULATING INSULIN RELEASE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A PRE-MIXED EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Glucagon-like peptide 1 receptor	GPCR	P43220	GLP1R_HUMAN	AGONIST	IC50	9.18		CHEMBL	CHEMBL
Glucagon-like peptide 1 receptor	GPCR		GLP1R_RAT		IC50	9.85		CHEMBL

External reference:

ID	Source
4024921	VUID
N0000171592	NUI
D04121	KEGG_DRUG
4024921	VANDF
C0167117	UMLSCUI
CHEBI:64073	CHEBI
CHEMBL414357	ChEMBL_ID
D000077270	MESH_DESCRIPTOR_UI
DB01276	DRUGBANK_ID
8219	INN_ID
9P1872D4OL	UNII
45588096	PUBCHEM_CID
1242964	RXNORM
110131	MMSL
184698	MMSL
19812	MMSL
d05529	MMSL
010772	NDDF
416859008	SNOMEDCT_US
417734003	SNOMEDCT_US
1135	IUPHAR_LIGAND_ID
9P1872D4OL	INXIGHT DRUGS

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Byetta	HUMAN PRESCRIPTION DRUG LABEL	1	0310-6512	INJECTION	250 ug	SUBCUTANEOUS	NDA	29 sections
Byetta	HUMAN PRESCRIPTION DRUG LABEL	1	0310-6524	INJECTION	250 ug	SUBCUTANEOUS	NDA	29 sections
BYDUREON BCise	HUMAN PRESCRIPTION DRUG LABEL	1	0310-6540	INJECTION, SUSPENSION, EXTENDED RELEASE	2 mg	SUBCUTANEOUS	NDA	29 sections
BYETTA	HUMAN PRESCRIPTION DRUG LABEL	1	54868-5384	INJECTION	250 ug	SUBCUTANEOUS	NDA	30 sections
Exenatide	HUMAN PRESCRIPTION DRUG LABEL	1	70121-1685	INJECTION	250 ug	SUBCUTANEOUS	ANDA	27 sections
Exenatide	HUMAN PRESCRIPTION DRUG LABEL	1	70121-1685	INJECTION	250 ug	SUBCUTANEOUS	ANDA	27 sections
Exenatide	HUMAN PRESCRIPTION DRUG LABEL	1	70121-1686	INJECTION	250 ug	SUBCUTANEOUS	ANDA	27 sections
Exenatide	HUMAN PRESCRIPTION DRUG LABEL	1	70121-1686	INJECTION	250 ug	SUBCUTANEOUS	ANDA	27 sections

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General architecture

Using the assistant

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

Description:

Drug dosage:

ADMET properties:

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Approvals:

FDA Adverse Event Reporting System (Female)

FDA Adverse Event Reporting System (Male)

FDA Adverse Event Reporting System (Geriatric)

FDA Adverse Event Reporting System (Pediatric)

Pharmacologic Action:

Related Drugs by ATC class:

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

🐶 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: