linagliptin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
dipeptidyl aminopeptidase-IV inhibitors 4175 668270-12-0

Description:

MoleculeDescription

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:

DoseUnitRoute
5 mg O

ADMET properties:

PropertyValueReference
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

Approvals:

DateAgencyCompanyOrphan
May 2, 2011 FDA BOEHRINGER INGELHEIM
July 1, 2011 PMDA Nippon Boehringer Ingelheim Co., Ltd

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Pemphigoid 202.25 14.89 69 11797 5838 50587420
Hypoglycaemia 201.14 14.89 136 11730 53445 50539813
Pancreatitis 166.68 14.89 111 11755 42503 50550755
Blood glucose increased 143.65 14.89 125 11741 71199 50522059
Glycosylated haemoglobin increased 90.78 14.89 46 11820 10560 50582698
Acute kidney injury 87.78 14.89 176 11690 227882 50365376
Renal impairment 87.50 14.89 98 11768 75563 50517695
Hyperglycaemia 79.73 14.89 67 11799 36338 50556920
Dermatitis bullous 69.94 14.89 34 11832 7139 50586119
Hyperlactacidaemia 66.34 14.89 24 11842 2409 50590849
Hyperkalaemia 56.78 14.89 63 11803 48026 50545232
Pancreatic carcinoma 56.25 14.89 28 11838 6186 50587072
Diabetic ketoacidosis 54.49 14.89 40 11826 17832 50575426
Diabetes mellitus inadequate control 53.16 14.89 35 11831 13110 50580148
Metabolic acidosis 53.12 14.89 55 11811 38770 50554488
Euglycaemic diabetic ketoacidosis 48.87 14.89 20 11846 2799 50590459
Blood glucose abnormal 48.66 14.89 26 11840 6646 50586612
Pain 47.26 14.89 40 11826 578863 50014395
Pancreatitis acute 46.38 14.89 41 11825 23771 50569487
Cardiac failure 45.06 14.89 71 11795 75969 50517289
Chronic kidney disease 45.05 14.89 51 11815 39720 50553538
Glomerular filtration rate decreased 44.65 14.89 30 11836 11622 50581636
Diabetic metabolic decompensation 41.85 14.89 15 11851 1465 50591793
Lactic acidosis 41.62 14.89 45 11821 33310 50559948
Subarachnoid haemorrhage 39.51 14.89 27 11839 10749 50582509
Renal failure 39.35 14.89 81 11785 106552 50486706
Dizziness 38.63 14.89 172 11694 346197 50247061
Drug ineffective 32.07 14.89 93 11773 819240 49774018
Blood glucose decreased 30.85 14.89 29 11837 18182 50575076
Lethargy 29.05 14.89 46 11820 49386 50543872
Urine calcium/creatinine ratio increased 26.20 14.89 6 11860 114 50593144
Hypoglycaemic encephalopathy 25.80 14.89 7 11859 271 50592987
Mucosal membrane hyperplasia 25.49 14.89 5 11861 43 50593215
Rheumatoid arthritis 25.31 14.89 8 11858 202542 50390716
Ketoacidosis 25.14 14.89 14 11852 3881 50589377
Shock 24.26 14.89 27 11839 20623 50572635
Insulin-like growth factor decreased 23.75 14.89 7 11859 367 50592891
Bite 23.62 14.89 7 11859 374 50592884
Albuminuria 23.19 14.89 6 11860 193 50593065
Systemic lupus erythematosus 22.82 14.89 3 11863 140619 50452639
Blood creatinine increased 22.57 14.89 53 11813 76107 50517151
Decreased appetite 22.49 14.89 100 11766 200823 50392435
Urethral caruncle 22.42 14.89 5 11861 84 50593174
Contraindicated product administered 22.30 14.89 4 11862 148954 50444304
Altered state of consciousness 21.32 14.89 26 11840 21884 50571374
Parathyroid hyperplasia 19.96 14.89 5 11861 141 50593117
Urinary tract infection 19.68 14.89 104 11762 223916 50369342
Lipase increased 19.26 14.89 16 11850 8525 50584733
Hypomagnesaemia 18.62 14.89 25 11841 23131 50570127
Blood potassium increased 18.51 14.89 21 11845 16377 50576881
Arthropathy 18.40 14.89 7 11859 157899 50435359
Drug intolerance 17.97 14.89 15 11851 219089 50374169
Mesenteric vein thrombosis 17.76 14.89 7 11859 889 50592369
Therapeutic product effect decreased 17.67 14.89 5 11861 136045 50457213
Rhabdomyolysis 17.23 14.89 32 11834 38995 50554263
Pyelonephritis 16.59 14.89 19 11847 14970 50578288
Pemphigus 16.39 14.89 4 11862 120162 50473096
Food refusal 16.04 14.89 5 11861 317 50592941
Pancreatic enzymes increased 16.03 14.89 6 11860 662 50592596
Hypophagia 15.19 14.89 25 11841 27703 50565555
Pruritus 15.15 14.89 116 11750 283452 50309806

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Pemphigoid 473.21 14.60 169 15003 7412 29551943
Pancreatitis 180.27 14.60 146 15026 34368 29524987
Hypoglycaemia 163.69 14.60 160 15012 48186 29511169
Glycosylated haemoglobin increased 127.43 14.60 72 15100 9354 29550001
Dermatitis bullous 116.34 14.60 58 15114 5848 29553507
Blood glucose increased 108.21 14.60 142 15030 58842 29500513
Cardiac failure 76.55 14.60 142 15030 79145 29480210
Blood mercury abnormal 74.51 14.60 18 15154 189 29559166
5-hydroxyindolacetic acid in urine increased 72.47 14.60 18 15154 214 29559141
Pericardial disease 63.57 14.60 18 15154 364 29558991
Left ventricular dysfunction 62.57 14.60 45 15127 8857 29550498
Pulmonary valve disease 58.57 14.60 16 15156 282 29559073
Euglycaemic diabetic ketoacidosis 58.29 14.60 28 15144 2602 29556753
Diastolic dysfunction 50.98 14.60 32 15140 5032 29554323
Cerebral infarction 47.66 14.60 61 15111 24614 29534741
Low density lipoprotein decreased 46.22 14.60 18 15154 1002 29558353
Ventricular hyperkinesia 44.39 14.60 12 15160 203 29559152
Mean platelet volume increased 43.99 14.60 14 15158 427 29558928
Pancreatic carcinoma 43.19 14.60 33 15139 7117 29552238
Right atrial enlargement 43.13 14.60 12 15160 227 29559128
Hyperglycaemia 42.99 14.60 69 15103 34218 29525137
Renal impairment 42.48 14.60 114 15058 81219 29478136
Stenosis 42.37 14.60 17 15155 1024 29558331
Rales 41.76 14.60 33 15139 7477 29551878
Physical examination abnormal 41.47 14.60 12 15160 263 29559092
Diabetic nephropathy 41.46 14.60 20 15152 1875 29557480
Diabetic ketoacidosis 41.37 14.60 46 15126 16027 29543328
Acute kidney injury 41.06 14.60 254 14918 265013 29294342
Hypochromasia 40.09 14.60 12 15160 297 29559058
Hepatic neoplasm 39.04 14.60 19 15153 1817 29557538
Pancreatitis acute 39.02 14.60 55 15117 24330 29535025
Mitral valve thickening 37.86 14.60 12 15160 361 29558994
Tricuspid valve incompetence 36.51 14.60 32 15140 8362 29550993
Cardiac discomfort 34.99 14.60 12 15160 464 29558891
Blood glucose abnormal 31.89 14.60 24 15148 5059 29554296
Left ventricular enlargement 31.30 14.60 12 15160 640 29558715
Chronic kidney disease 31.12 14.60 62 15110 36354 29523001
Drug abuse 30.19 14.60 3 15169 79880 29479475
Necrotising oesophagitis 30.14 14.60 11 15161 511 29558844
Left atrial enlargement 29.62 14.60 12 15160 741 29558614
Mucosal dryness 29.18 14.60 13 15159 1016 29558339
Neoplasm 29.16 14.60 21 15151 4140 29555215
Mitral valve incompetence 29.09 14.60 35 15137 13258 29546097
Bundle branch block left 28.93 14.60 23 15149 5254 29554101
Expired product administered 28.89 14.60 18 15154 2793 29556562
Haematocrit increased 28.49 14.60 15 15157 1693 29557662
Pericardial haemorrhage 28.20 14.60 18 15154 2913 29556442
Completed suicide 28.09 14.60 6 15166 90240 29469115
Mitral valve disease 27.17 14.60 13 15159 1197 29558158
Aortic valve incompetence 25.68 14.60 21 15151 4992 29554363
Ventricular arrhythmia 25.10 14.60 20 15152 4584 29554771
Echocardiogram abnormal 24.69 14.60 11 15161 860 29558495
Interstitial lung disease 24.38 14.60 75 15097 57643 29501712
Hypovolaemia 24.17 14.60 25 15147 8020 29551335
Haemoglobin increased 23.57 14.60 16 15156 2870 29556485
Blood iron decreased 23.56 14.60 19 15153 4429 29554926
Poikilocytosis 23.55 14.60 7 15165 169 29559186
Diabetes mellitus inadequate control 23.42 14.60 30 15142 12104 29547251
Hyperkalaemia 23.40 14.60 77 15095 61315 29498040
Acute lung injury 23.07 14.60 12 15160 1321 29558034
Left atrial dilatation 23.05 14.60 13 15159 1680 29557675
Amylase increased 22.70 14.60 20 15152 5260 29554095
Hypohidrosis 22.70 14.60 7 15165 192 29559163
Hypoglycaemic coma 22.61 14.60 14 15158 2149 29557206
Glomerular filtration rate decreased 21.98 14.60 28 15144 11238 29548117
Bronchitis viral 21.95 14.60 7 15165 215 29559140
Eosinophilic pneumonia 21.41 14.60 15 15157 2831 29556524
Peak expiratory flow rate decreased 21.25 14.60 6 15166 120 29559235
Electrocardiogram T wave inversion 21.06 14.60 13 15159 1984 29557371
Hypertensive heart disease 20.42 14.60 13 15159 2094 29557261
Hepatojugular reflux 20.13 14.60 8 15164 470 29558885
Red blood cell count decreased 19.99 14.60 42 15130 25560 29533795
Diabetic ketoacidotic hyperglycaemic coma 19.98 14.60 6 15166 150 29559205
Supraventricular tachycardia 19.97 14.60 25 15147 9859 29549496
Dyspnoea at rest 19.78 14.60 15 15157 3199 29556156
Electrocardiogram Q wave abnormal 19.54 14.60 7 15165 308 29559047
Blindness transient 18.99 14.60 12 15160 1908 29557447
Occult blood 18.77 14.60 8 15164 562 29558793
Drug ineffective 18.54 14.60 110 15062 363060 29196295
Hepatic function abnormal 18.46 14.60 53 15119 39206 29520149
Lipase increased 18.32 14.60 22 15150 8315 29551040
Rhinalgia 18.26 14.60 7 15165 373 29558982
Respiratory symptom 17.77 14.60 9 15163 937 29558418
Hyperlactacidaemia 17.59 14.60 13 15159 2665 29556690
Blood chloride increased 17.46 14.60 13 15159 2696 29556659
Haemodynamic instability 17.24 14.60 21 15151 8052 29551303
Bronchial hyperreactivity 17.02 14.60 10 15162 1396 29557959
Blood phosphorus increased 16.93 14.60 13 15159 2824 29556531
Left ventricular hypertrophy 16.92 14.60 19 15153 6684 29552671
Helicobacter gastritis 16.79 14.60 9 15163 1053 29558302
Epidermolysis 16.71 14.60 6 15166 266 29559089
Intestinal obstruction 16.67 14.60 33 15139 19244 29540111
Hyperaesthesia teeth 16.65 14.60 7 15165 475 29558880
General physical health deterioration 16.55 14.60 17 15155 102840 29456515
Dust allergy 16.55 14.60 7 15165 482 29558873
Syncope 16.54 14.60 84 15088 81287 29478068
Marasmus 16.47 14.60 7 15165 488 29558867
Gastric cancer 16.43 14.60 16 15156 4778 29554577
Erythema multiforme 16.36 14.60 20 15152 7697 29551658
High density lipoprotein decreased 16.36 14.60 13 15159 2966 29556389
Off label use 15.93 14.60 90 15082 300710 29258645
Blood uric acid increased 15.69 14.60 17 15155 5751 29553604
Product use in unapproved indication 15.58 14.60 13 15159 86862 29472493
Carotid artery stenosis 15.47 14.60 15 15157 4454 29554901
Eosinophil count increased 15.47 14.60 19 15153 7350 29552005
Skin disorder 15.40 14.60 24 15148 11594 29547761
Lactic acidosis 15.36 14.60 42 15130 30205 29529150
Pain 14.98 14.60 42 15130 171390 29387965

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Pemphigoid 649.97 13.51 228 24493 12758 64461253
Hypoglycaemia 323.53 13.51 271 24450 89621 64384390
Pancreatitis 227.42 13.51 186 24535 59421 64414590
Glycosylated haemoglobin increased 174.26 13.51 96 24625 15923 64458088
Blood glucose increased 169.10 13.51 198 24523 97875 64376136
Dermatitis bullous 133.20 13.51 73 24648 11981 64462030
Acute kidney injury 129.76 13.51 422 24299 448818 64025193
Cardiac failure 125.53 13.51 200 24521 132173 64341838
Renal impairment 105.36 13.51 187 24534 134830 64339181
Euglycaemic diabetic ketoacidosis 104.93 13.51 48 24673 5362 64468649
Diabetic ketoacidosis 99.04 13.51 86 24635 29759 64444252
Hyperglycaemia 98.26 13.51 119 24602 60849 64413162
Pancreatic carcinoma 90.90 13.51 54 24667 10319 64463692
Chronic kidney disease 82.06 13.51 106 24615 57813 64416198
Blood mercury abnormal 79.73 13.51 18 24703 189 64473822
5-hydroxyindolacetic acid in urine increased 77.53 13.51 18 24703 216 64473795
Diabetes mellitus inadequate control 71.87 13.51 62 24659 21259 64452752
Hyperkalaemia 69.92 13.51 133 24588 100996 64373015
Hyperlactacidaemia 69.66 13.51 35 24686 4809 64469202
Pain 67.20 13.51 68 24653 553443 63920568
Pulmonary valve disease 65.18 13.51 16 24705 247 64473764
Completed suicide 64.17 13.51 6 24715 224408 64249603
Pericardial disease 63.82 13.51 18 24703 486 64473525
Glomerular filtration rate decreased 60.14 13.51 54 24667 19518 64454493
Drug ineffective 56.52 13.51 152 24569 840095 63633916
Pancreatitis acute 55.39 13.51 75 24646 42780 64431231
Metabolic acidosis 53.64 13.51 97 24624 70861 64403150
Left ventricular dysfunction 52.53 13.51 47 24674 16907 64457104
Cerebral infarction 51.79 13.51 71 24650 40973 64433038
Low density lipoprotein decreased 50.16 13.51 18 24703 1072 64472939
Lactic acidosis 49.05 13.51 86 24635 61324 64412687
Diabetic nephropathy 46.65 13.51 22 24699 2632 64471379
Physical examination abnormal 45.73 13.51 12 24709 245 64473766
Diastolic dysfunction 45.40 13.51 33 24688 8842 64465169
Blood glucose abnormal 45.28 13.51 33 24688 8880 64465131
Ventricular hyperkinesia 45.01 13.51 12 24709 261 64473750
Renal failure 42.90 13.51 160 24561 181528 64292483
Right atrial enlargement 42.58 13.51 12 24709 323 64473688
Mitral valve thickening 40.45 13.51 12 24709 389 64473622
Drug abuse 39.30 13.51 3 24718 132371 64341640
Stenosis 38.04 13.51 17 24704 1798 64472213
Interstitial lung disease 37.72 13.51 102 24619 97630 64376381
Mean platelet volume increased 37.06 13.51 14 24707 964 64473047
Hepatic neoplasm 35.00 13.51 19 24702 3058 64470953
Hypochromasia 34.57 13.51 12 24709 648 64473363
Blood iron decreased 34.37 13.51 32 24689 12110 64461901
Diabetic metabolic decompensation 34.28 13.51 18 24703 2710 64471301
Left ventricular enlargement 34.15 13.51 12 24709 672 64473339
Ketoacidosis 33.93 13.51 25 24696 6838 64467173
Cardiac discomfort 32.12 13.51 13 24708 1076 64472935
Rales 31.77 13.51 34 24687 15195 64458816
Product use in unapproved indication 31.69 13.51 14 24707 176604 64297407
Haemodynamic instability 30.59 13.51 33 24688 14879 64459132
Necrotising oesophagitis 30.27 13.51 11 24710 679 64473332
Left atrial enlargement 29.35 13.51 12 24709 1020 64472991
Altered state of consciousness 28.87 13.51 52 24669 37850 64436161
Tricuspid valve incompetence 28.70 13.51 34 24687 16969 64457042
Therapeutic product effect decreased 28.35 13.51 5 24716 115346 64358665
Haematocrit increased 28.23 13.51 17 24704 3328 64470683
Expired product administered 27.79 13.51 21 24700 5966 64468045
Pericardial haemorrhage 27.32 13.51 18 24703 4118 64469893
Left ventricular hypertrophy 26.80 13.51 25 24696 9481 64464530
Hypoglycaemic coma 26.79 13.51 18 24703 4256 64469755
Treatment failure 26.74 13.51 6 24715 116810 64357201
Blood phosphorus increased 26.69 13.51 19 24702 4927 64469084
End stage renal disease 26.60 13.51 26 24695 10449 64463562
Lipase increased 26.32 13.51 30 24691 14372 64459639
Arthropathy 26.16 13.51 7 24714 120960 64353051
Hepatic function abnormal 25.69 13.51 68 24653 64245 64409766
Rheumatoid arthritis 25.09 13.51 16 24705 164278 64309733
Synovitis 25 13.51 4 24717 99086 64374925
Subarachnoid haemorrhage 24.94 13.51 33 24688 18405 64455606
Neoplasm 24.82 13.51 21 24700 7010 64467001
Drug hypersensitivity 24.69 13.51 33 24688 237782 64236229
Amylase increased 24.52 13.51 24 24697 9661 64464350
Diabetic ketoacidotic hyperglycaemic coma 23.86 13.51 7 24714 218 64473793
Ventricular arrhythmia 23.85 13.51 21 24700 7394 64466617
Infusion related reaction 23.80 13.51 17 24704 164450 64309561
Bundle branch block left 23.80 13.51 24 24697 10010 64464001
Renal disorder 23.78 13.51 46 24675 35319 64438692
Aortic valve incompetence 23.73 13.51 22 24699 8279 64465732
Haemoglobin increased 23.61 13.51 18 24703 5183 64468828
Hypohidrosis 23.59 13.51 7 24714 227 64473784
Headache 23.35 13.51 114 24607 529353 63944658
Mitral valve incompetence 23.35 13.51 38 24683 25500 64448511
Diabetes mellitus 23.29 13.51 67 24654 66407 64407604
Mucosal membrane hyperplasia 22.94 13.51 5 24716 44 64473967
Blood creatinine increased 22.23 13.51 107 24614 135675 64338336
Poikilocytosis 22.14 13.51 7 24714 282 64473729
Gastric cancer 22.12 13.51 19 24702 6474 64467537
Arthralgia 22.03 13.51 91 24630 442169 64031842
Urine calcium/creatinine ratio increased 22.03 13.51 6 24715 142 64473869
Hepatojugular reflux 21.64 13.51 8 24713 519 64473492
Mitral valve disease 21.22 13.51 13 24708 2625 64471386
Erythema multiforme 21.08 13.51 28 24693 15673 64458338
Marasmus 21.01 13.51 9 24712 859 64473152
Decreased appetite 20.70 13.51 181 24540 281108 64192903
Left atrial dilatation 20.65 13.51 13 24708 2753 64471258
Urethral caruncle 20.56 13.51 5 24716 74 64473937
Hypoglycaemic encephalopathy 20.47 13.51 8 24713 604 64473407
Blood uric acid increased 20.24 13.51 20 24701 8143 64465868
Echocardiogram abnormal 20.22 13.51 11 24710 1778 64472233
Red blood cell count decreased 20.18 13.51 52 24669 48334 64425677
Electrocardiogram T wave inversion 20.18 13.51 16 24705 4878 64469133
Electrocardiogram Q wave abnormal 19.73 13.51 7 24714 403 64473608
Sputum discoloured 19.73 13.51 29 24692 17827 64456184
Mucosal dryness 19.68 13.51 13 24708 2988 64471023
Syncope 19.50 13.51 115 24606 157520 64316491
Bite 19.44 13.51 7 24714 421 64473590
Supraventricular tachycardia 18.47 13.51 29 24692 18878 64455133
Depression 18.45 13.51 26 24695 183265 64290746
Hypovolaemia 18.35 13.51 26 24695 15460 64458551
Acute lung injury 18.32 13.51 12 24709 2719 64471292
Neutropenia 17.83 13.51 41 24680 239583 64234428
Insulin-like growth factor decreased 17.63 13.51 7 24714 551 64473460
Diabetic foot 17.28 13.51 12 24709 2993 64471018
Antibiotic level above therapeutic 17.00 13.51 7 24714 606 64473405
Acute myocardial infarction 16.93 13.51 62 24659 69656 64404355
Hypertensive heart disease 16.90 13.51 13 24708 3791 64470220
Peak expiratory flow rate decreased 16.83 13.51 7 24714 621 64473390
Parathyroid hyperplasia 16.77 13.51 5 24716 165 64473846
Albuminuria 16.58 13.51 7 24714 645 64473366
High density lipoprotein decreased 16.48 13.51 13 24708 3933 64470078
Nephrogenic anaemia 16.19 13.51 12 24709 3313 64470698
Cardiomegaly 16.16 13.51 31 24690 23653 64450358
Toxicity to various agents 16.15 13.51 78 24643 363435 64110576
Carotid arteriosclerosis 16.10 13.51 10 24711 2069 64471942
Pruritus 15.75 13.51 186 24535 312214 64161797
Eosinophil count increased 15.71 13.51 23 24698 14089 64459922
Femoral neck fracture 15.65 13.51 18 24703 8706 64465305
Arteriosclerosis coronary artery 15.42 13.51 24 24697 15505 64458506
Rhinalgia 15.39 13.51 8 24713 1180 64472831
Drug eruption 15.24 13.51 39 24682 36097 64437914
Alopecia 15.23 13.51 25 24696 165665 64308346
Hypersensitivity 15.11 13.51 33 24688 196419 64277592
Epidermolysis 15.09 13.51 6 24715 474 64473537
Hyperuricaemia 14.97 13.51 19 24702 10172 64463839
Drug intolerance 14.94 13.51 31 24690 187961 64286050
Dyspnoea at rest 14.76 13.51 15 24706 6314 64467697
Contraindicated product administered 14.51 13.51 12 24709 107817 64366194
Haematocrit decreased 14.46 13.51 50 24671 54605 64419406
Serum ferritin increased 14.40 13.51 17 24704 8451 64465560
Sinusitis 14.38 13.51 21 24700 145907 64328104
Bronchial hyperreactivity 14.37 13.51 10 24711 2502 64471509
Chills 14.28 13.51 19 24702 137245 64336766
Blood chloride increased 14.26 13.51 13 24708 4790 64469221
Blood glucose decreased 14.25 13.51 29 24692 23094 64450917
Systemic lupus erythematosus 14.15 13.51 6 24715 77606 64396405
Occult blood 14.14 13.51 8 24713 1394 64472617
Anxiety 14.02 13.51 36 24685 202613 64271398
Blindness transient 13.91 13.51 12 24709 4110 64469901
Intraductal papillary mucinous neoplasm 13.83 13.51 6 24715 591 64473420
Pneumonia 13.65 13.51 295 24426 559281 63914730
Pyelonephritis 13.54 13.51 24 24697 17242 64456769

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
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 D054873 Dipeptidyl-Peptidase IV Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D006728 Hormones
MeSH PA D007004 Hypoglycemic Agents
MeSH PA D054795 Incretins
MeSH PA D011480 Protease Inhibitors
FDA MoA N0000175912 Dipeptidyl Peptidase 4 Inhibitors
FDA EPC N0000175913 Dipeptidyl Peptidase 4 Inhibitor
CHEBI has role CHEBI:35526 antidiabetic
CHEBI has role CHEBI:68612 dipeptidyl peptidase-4 inhibitors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
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 levelDissociation constantType (acidic/basic)
pKa1 9.16 Basic
pKa2 6.13 Basic
pKa3 3.79 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
5MG TRADJENTA BOEHRINGER INGELHEIM N201280 May 2, 2011 RX TABLET ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
5MG TRADJENTA BOEHRINGER INGELHEIM N201280 May 2, 2011 RX TABLET ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH INSULIN (WITH OR WITHOUT METFORMIN AND/OR PIOGLITAZONE)
5MG TRADJENTA BOEHRINGER INGELHEIM N201280 May 2, 2011 RX TABLET ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH PIOGLITAZONE
5MG TRADJENTA BOEHRINGER INGELHEIM N201280 May 2, 2011 RX TABLET ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH SULFONLYUREA
5MG TRADJENTA BOEHRINGER INGELHEIM N201280 May 2, 2011 RX TABLET ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN AND/OR A SULFONYLUREA
5MG TRADJENTA BOEHRINGER INGELHEIM N201280 May 2, 2011 RX TABLET ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH INSULIN (WITH OR WITHOUT METFORMIN AND/OR PIOGLITAZONE)
2.5MG;1GM JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
2.5MG;1GM JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN AND/OR A SULFONYLUREA
2.5MG;500MG JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
2.5MG;500MG JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN AND/OR A SULFONYLUREA
2.5MG;850MG JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
2.5MG;850MG JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN AND/OR A SULFONYLUREA
10MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
10MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN (WITH OR WITHOUT INSULIN OR A SULFONYLUREA)
10MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN (WITH OR WITHOUT METFORMIN)
25MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8119648 Aug. 12, 2023 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 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN (WITH OR WITHOUT INSULIN OR A SULFONYLUREA)
25MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN (WITH OR WITHOUT METFORMIN)
2.5MG;1GM JENTADUETO XR BOEHRINGER INGELHEIM N208026 May 27, 2016 RX TABLET, EXTENDED RELEASE ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
2.5MG;1GM JENTADUETO XR BOEHRINGER INGELHEIM N208026 May 27, 2016 RX TABLET, EXTENDED RELEASE ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN AND, OPTIONALLY, A SULFONYLUREA
5MG;1GM JENTADUETO XR BOEHRINGER INGELHEIM N208026 May 27, 2016 RX TABLET, EXTENDED RELEASE ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
5MG;1GM JENTADUETO XR BOEHRINGER INGELHEIM N208026 May 27, 2016 RX TABLET, EXTENDED RELEASE ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN AND, OPTIONALLY, A SULFONYLUREA
10MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
10MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
12.5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
12.5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
25MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
25MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
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
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 COMPRISINGMETFORMIN 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
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 COMPRISINGMETFORMIN 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
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 COMPRISINGMETFORMIN 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 COMPRISINGMETFORMIN 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
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
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
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
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
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
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
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

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
5MG TRADJENTA BOEHRINGER INGELHEIM N201280 May 2, 2011 RX TABLET ORAL July 3, 2022 INFORMATION ADDED TO THE LABELING TO DESCRIBE CARMELINA TRIAL TO FULFILL POSTMARKETING COMMITMENT 1766-4
2.5MG;1GM JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL July 3, 2022 INFORMATION ADDED TO THE LABELING TO DESCRIBE CARMELINA TRIAL TO FULFILL POSTMARKETING COMMITMENT 1766-4
2.5MG;500MG JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL July 3, 2022 INFORMATION ADDED TO THE LABELING TO DESCRIBE CARMELINA TRIAL TO FULFILL POSTMARKETING COMMITMENT 1766-4
2.5MG;850MG JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL July 3, 2022 INFORMATION ADDED TO THE LABELING TO DESCRIBE CARMELINA TRIAL TO FULFILL POSTMARKETING COMMITMENT 1766-4
10MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL July 3, 2022 INFORMATION ADDED TO THE LABELING TO DESCRIBE CARMELINA TRIAL TO FULFILL POSTMARKETING COMMITMENT 1766-4
25MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL July 3, 2022 INFORMATION ADDED TO THE LABELING TO DESCRIBE CARMELINA TRIAL TO FULFILL POSTMARKETING COMMITMENT 1766-4
2.5MG;1GM JENTADUETO XR BOEHRINGER INGELHEIM N208026 May 27, 2016 RX TABLET, EXTENDED RELEASE ORAL July 3, 2022 INFORMATION ADDED TO THE LABELING TO DESCRIBE CARMELINA TRIAL TO FULFILL POSTMARKETING COMMITMENT 1766-4
5MG;1GM JENTADUETO XR BOEHRINGER INGELHEIM N208026 May 27, 2016 RX TABLET, EXTENDED RELEASE ORAL July 3, 2022 INFORMATION ADDED TO THE LABELING TO DESCRIBE CARMELINA TRIAL TO FULFILL POSTMARKETING COMMITMENT 1766-4
5MG TRADJENTA BOEHRINGER INGELHEIM N201280 May 2, 2011 RX TABLET ORAL March 30, 2023 ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
2.5MG;1GM JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL March 30, 2023 ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
2.5MG;500MG JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL March 30, 2023 ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
2.5MG;850MG JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL March 30, 2023 ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
10MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL March 30, 2023 ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
25MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL March 30, 2023 ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
2.5MG;1GM JENTADUETO XR BOEHRINGER INGELHEIM N208026 May 27, 2016 RX TABLET, EXTENDED RELEASE ORAL March 30, 2023 ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
5MG;1GM JENTADUETO XR BOEHRINGER INGELHEIM N208026 May 27, 2016 RX TABLET, EXTENDED RELEASE ORAL March 30, 2023 ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Dipeptidyl peptidase 4 Enzyme INHIBITOR IC50 10 CHEMBL CHEMBL
Muscarinic acetylcholine receptor M1 GPCR IC50 6.53 CHEMBL
Prolyl endopeptidase FAP Enzyme IC50 7.05 CHEMBL
Dipeptidyl peptidase 9 Enzyme IC50 4 CHEMBL
Prolyl endopeptidase FAP Enzyme IC50 6.43 CHEMBL
Dipeptidyl peptidase IV Unclassified IC50 5 CHEMBL

External reference:

IDSource
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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Tradjenta HUMAN PRESCRIPTION DRUG LABEL 1 0597-0140 TABLET, FILM COATED 5 mg ORAL NDA 33 sections
Tradjenta HUMAN PRESCRIPTION DRUG LABEL 1 0597-0140 TABLET, FILM COATED 5 mg ORAL NDA 33 sections
Jentadueto HUMAN PRESCRIPTION DRUG LABEL 2 0597-0146 TABLET, FILM COATED 2.50 mg ORAL NDA 34 sections
Jentadueto HUMAN PRESCRIPTION DRUG LABEL 2 0597-0146 TABLET, FILM COATED 2.50 mg ORAL NDA 34 sections
Jentadueto HUMAN PRESCRIPTION DRUG LABEL 2 0597-0147 TABLET, FILM COATED 2.50 mg ORAL NDA 34 sections
Jentadueto HUMAN PRESCRIPTION DRUG LABEL 2 0597-0147 TABLET, FILM COATED 2.50 mg ORAL NDA 34 sections
Jentadueto HUMAN PRESCRIPTION DRUG LABEL 2 0597-0148 TABLET, FILM COATED 2.50 mg ORAL NDA 34 sections
Jentadueto HUMAN PRESCRIPTION DRUG LABEL 2 0597-0148 TABLET, FILM COATED 2.50 mg ORAL NDA 34 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 34 sections
Jentadueto XR HUMAN PRESCRIPTION DRUG LABEL 2 0597-0275 TABLET, FILM COATED, 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 0597-0390 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
Tradjenta HUMAN PRESCRIPTION DRUG LABEL 1 50090-4383 TABLET, FILM COATED 5 mg ORAL NDA 29 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 29 sections
Tradjenta HUMAN PRESCRIPTION DRUG LABEL 1 55154-0410 TABLET, FILM COATED 5 mg ORAL NDA 29 sections
Jentadueto HUMAN PRESCRIPTION DRUG LABEL 2 63629-6524 TABLET, FILM COATED 2.50 mg ORAL NDA 31 sections