empagliflozin Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
sodium glucose co-transporter inhibitors, phlorizin derivatives 4830 864070-44-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • empagliflozin
  • BI 10773
  • jardiance
Empagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.
  • Molecular weight: 450.91
  • Formula: C23H27ClO7
  • CLOGP: 2.59
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 4
  • TPSA: 108.61
  • ALOGS: -3.61
  • ROTB: 6

  • Status: ONP

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

Drug dosage:

DoseUnitRoute
17.50 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Hosey CM, Chan R, Benet LZ

Approvals:

DateAgencyCompanyOrphan
March 20, 2014 EMA
Aug. 1, 2014 FDA BOEHRINGER INGELHEIM

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
Diabetic ketoacidosis 4238.68 60.56 693 2362 2871 2352159
Ketoacidosis 1708.48 60.56 266 2789 665 2354365
Fungal infection 988.54 60.56 217 2838 4672 2350358
Euglycaemic diabetic ketoacidosis 684.48 60.56 97 2958 78 2354952
Vomiting 349.04 60.56 193 2862 71409 2283621
Dehydration 267.61 60.56 112 2943 22183 2332847
Urinary tract infection 267.13 60.56 122 2933 29820 2325210
Blood ketone body increased 228.08 60.56 34 3021 52 2354978
Blood glucose increased 225.44 60.56 84 2971 12206 2342824
Nausea 195.71 60.56 160 2895 112029 2243001
Metabolic acidosis 195.37 60.56 63 2992 5935 2349095
Urine ketone body present 155.84 60.56 30 3025 315 2354715
Fournier's gangrene 147.31 60.56 21 3034 18 2355012
Pancreatitis 129.09 60.56 50 3005 8029 2347001
Weight decreased 124.88 60.56 72 2983 28299 2326731
Glycosylated haemoglobin increased 124.35 60.56 34 3021 1800 2353230
Dizziness 115.06 60.56 90 2965 58575 2296455
Altered state of consciousness 107.28 60.56 36 3019 3824 2351206
Ketosis 105.50 60.56 18 3037 88 2354942
Pollakiuria 104.27 60.56 35 3020 3721 2351309
Glomerular filtration rate decreased 93.45 60.56 26 3029 1467 2353563
Off label use 93.38 60.56 88 2967 73510 2281520
Vulvovaginal mycotic infection 92.23 60.56 23 3032 845 2354185
Acute kidney injury 89.37 60.56 58 2997 28064 2326966
Blood glucose abnormal 87.68 60.56 24 3031 1274 2353756
Necrotising fasciitis 87.60 60.56 20 3035 500 2354530
Diarrhoea 87.56 60.56 90 2965 83474 2271556
Hypoglycaemia 83.27 60.56 37 3018 8370 2346660
Urosepsis 81.90 60.56 25 3030 1956 2353074
Abdominal pain 81.10 60.56 59 2996 34315 2320715
Hyperglycaemia 77.14 60.56 30 3025 4855 2350175
Toe amputation 72.60 60.56 16 3039 339 2354691
Malaise 71.38 60.56 67 2988 55518 2299512
Polyuria 71.29 60.56 20 3035 1162 2353868
Ketonuria 69.51 60.56 13 3042 115 2354915
Rash 69.32 60.56 68 2987 59490 2295540
Pyelonephritis 63.57 60.56 21 3034 2120 2352910
Sepsis 63.29 60.56 40 3015 18448 2336582
Acidosis 60.97 60.56 19 3036 1591 2353439

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
Diabetic ketoacidosis 3877.22 50.67 705 2999 2578 1740499
Ketoacidosis 1522.04 50.67 260 3444 535 1742542
Euglycaemic diabetic ketoacidosis 895.48 50.67 135 3569 51 1743026
Fournier's gangrene 582.21 50.67 93 3611 92 1742985
Fungal infection 369.26 50.67 97 3607 2165 1740912
Pollakiuria 312.30 50.67 90 3614 2856 1740221
Dehydration 293.04 50.67 137 3567 17521 1725556
Urinary tract infection 273.69 50.67 111 3593 10042 1733035
Vomiting 222.60 50.67 149 3555 38166 1704911
Acute kidney injury 210.37 50.67 139 3565 34805 1708272
Urine ketone body present 202.39 50.67 39 3665 186 1742891
Blood ketone body increased 178.53 50.67 31 3673 70 1743007
Ketonuria 171.62 50.67 32 3672 123 1742954
Weight decreased 170.25 50.67 104 3600 22649 1720428
Dizziness 162.60 50.67 118 3586 34243 1708834
Toe amputation 158.04 50.67 36 3668 427 1742650
Nausea 156.77 50.67 136 3568 51060 1692017
Metabolic acidosis 151.92 50.67 61 3643 5341 1737736
Balanoposthitis 145.79 50.67 31 3673 260 1742817
Polyuria 142.98 50.67 41 3663 1269 1741808
Ketosis 140.03 50.67 26 3678 97 1742980
Pancreatitis 131.96 50.67 60 3644 7127 1735950
Blood glucose increased 126.90 50.67 66 3638 10518 1732559
Glycosylated haemoglobin increased 115.91 50.67 38 3666 1853 1741224
Urosepsis 108.53 50.67 34 3670 1430 1741647
Urine ketone body 101.49 50.67 16 3688 13 1743064
Hyperglycaemia 100.73 50.67 45 3659 5120 1737957
Cerebral infarction 97.18 50.67 44 3660 5165 1737912
Dysuria 87.96 50.67 37 3667 3635 1739442
Gangrene 78.34 50.67 23 3681 773 1742304
Malaise 77.13 50.67 72 3632 29493 1713584
Hypovolaemia 76.29 50.67 25 3679 1215 1741862
Micturition urgency 74.94 50.67 22 3682 739 1742338
Necrotising fasciitis 69.39 50.67 20 3684 629 1742448
Blood glucose abnormal 65.23 50.67 21 3683 964 1742113
Balanitis candida 64.23 50.67 11 3693 22 1743055
Altered state of consciousness 63.48 50.67 29 3675 3468 1739609
Insulin C-peptide decreased 61.48 50.67 10 3694 12 1743065
Blood creatinine increased 61.36 50.67 46 3658 13900 1729177
Abdominal pain 59.20 50.67 54 3650 21436 1721641
Sepsis 57.79 50.67 51 3653 19387 1723690
Prostatitis 57.30 50.67 19 3685 958 1742119
Glomerular filtration rate decreased 57.18 50.67 21 3683 1436 1741641
Thirst 56.85 50.67 20 3684 1207 1741870
Blood ketone body present 53.99 50.67 9 3695 14 1743063
Hypoglycaemia 53.89 50.67 35 3669 8403 1734674
Leg amputation 52.11 50.67 15 3689 469 1742608

Pharmacologic Action:

SourceCodeDescription
ATC A10BD19 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BD20 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BK03 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Sodium-glucose co-transporter 2 (SGLT2) inhibitors
CHEBI has role CHEBI:35526 hypoglycemic agent
FDA EPC N0000187059 Sodium-Glucose Cotransporter 2 Inhibitor
MeSH PA D007004 Hypoglycemic Agents
MeSH PA D000077203 Sodium-Glucose Transporter 2 Inhibitors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Diabetes mellitus type 2 indication 44054006 DOID:9352
Cardiovascular event reduce risk 405617006

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.62 acidic
pKa2 13.26 acidic
pKa3 13.7 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10MG 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 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 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 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 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 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)
10MG 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 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 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 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 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 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 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 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
10MG 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 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 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 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
10MG TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8673927 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
10MG TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 9173859 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
10MG TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 9173859 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
12.5MG TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8673927 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
12.5MG TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 9173859 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
12.5MG TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 9173859 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
25MG TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8673927 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
25MG TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 9173859 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
25MG TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 9173859 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
5MG TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8673927 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
5MG TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 9173859 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
5MG TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 9173859 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
10MG 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 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 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 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
10MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL 8551957 Oct. 14, 2029 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
25MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL 8551957 Oct. 14, 2029 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
10MG 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 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 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 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 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 TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8551957 Oct. 14, 2029 METHOD OF TREATING TYPE 2 DIABETES MELLITUS USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
10MG 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 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 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 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
10MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 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 JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 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 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 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
12.5MG SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 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
5MG SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 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 SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 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
12.5MG SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 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
25MG SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 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
5MG SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 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
10MG 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 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 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 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 JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL 9949997 May 17, 2034 METHOD OF REDUCING THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND CARDIOVASCULAR DISEASE BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
25MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL 9949997 May 17, 2034 METHOD OF REDUCING THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND CARDIOVASCULAR DISEASE BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
10MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 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 JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 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 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 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 SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 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
12.5MG SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 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
25MG SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 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
5MG SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 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
10MG 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 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 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 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)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Sodium/glucose cotransporter 2 Transporter INHIBITOR Kd 7.24 SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE
Sodium/glucose cotransporter 1 Transporter IC50 5.08 SCIENTIFIC LITERATURE
Sodium/glucose cotransporter 4 Transporter IC50 4.96 SCIENTIFIC LITERATURE
Sodium/glucose cotransporter 5 Transporter IC50 5.96 SCIENTIFIC LITERATURE
Sodium/myo-inositol cotransporter 2 Transporter IC50 5.70 SCIENTIFIC LITERATURE

External reference:

IDSource
D10459 KEGG_DRUG
4033569 VUID
N0000190927 NUI
C3490348 UMLSCUI
703895009 SNOMEDCT_US
015572 NDDF
1545653 RXNORM
30461 MMSL
d08275 MMSL
4033569 VANDF
703894008 SNOMEDCT_US
11949646 PUBCHEM_CID
CHEBI:82720 CHEBI
HDC1R2M35U UNII
9398 INN_ID
DB09038 DRUGBANK_ID
4754 IUPHAR_LIGAND_ID
CHEMBL2107830 ChEMBL_ID
C570240 MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Jardiance HUMAN PRESCRIPTION DRUG LABEL 1 0597-0152 TABLET, FILM COATED 10 mg ORAL NDA 19 sections
Jardiance HUMAN PRESCRIPTION DRUG LABEL 1 0597-0153 TABLET, FILM COATED 25 mg ORAL NDA 19 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0159 TABLET 5 mg ORAL NDA 20 sections
Glyxambi HUMAN PRESCRIPTION DRUG LABEL 2 0597-0164 TABLET, FILM COATED 25 mg ORAL NDA 19 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0168 TABLET 12.50 mg ORAL NDA 20 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0175 TABLET 5 mg ORAL NDA 20 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0180 TABLET 12.50 mg ORAL NDA 20 sections
Glyxambi HUMAN PRESCRIPTION DRUG LABEL 2 0597-0182 TABLET, FILM COATED 10 mg ORAL NDA 19 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0280 TABLET, EXTENDED RELEASE 10 mg ORAL NDA 20 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0290 TABLET, EXTENDED RELEASE 5 mg ORAL NDA 20 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0295 TABLET, EXTENDED RELEASE 25 mg ORAL NDA 20 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0300 TABLET, EXTENDED RELEASE 12.50 mg ORAL NDA 20 sections
Trijardy XR HUMAN PRESCRIPTION DRUG LABEL 3 0597-0380 TABLET, EXTENDED RELEASE 10 mg ORAL NDA 19 sections
Trijardy XR HUMAN PRESCRIPTION DRUG LABEL 3 0597-0385 TABLET, EXTENDED RELEASE 12.50 mg ORAL NDA 19 sections
Trijardy XR HUMAN PRESCRIPTION DRUG LABEL 3 0597-0390 TABLET, EXTENDED RELEASE 25 mg ORAL NDA 19 sections
Trijardy XR HUMAN PRESCRIPTION DRUG LABEL 3 0597-0395 TABLET, EXTENDED RELEASE 5 mg ORAL NDA 19 sections
Jardiance HUMAN PRESCRIPTION DRUG LABEL 1 50090-4384 TABLET, FILM COATED 25 mg ORAL NDA 20 sections
Jardiance HUMAN PRESCRIPTION DRUG LABEL 1 50090-4492 TABLET, FILM COATED 10 mg ORAL NDA 20 sections
Jardiance HUMAN PRESCRIPTION DRUG LABEL 1 55154-0411 TABLET, FILM COATED 10 mg ORAL NDA 19 sections
Jardiance HUMAN PRESCRIPTION DRUG LABEL 1 55154-0412 TABLET, FILM COATED 25 mg ORAL NDA 19 sections
Jardiance HUMAN PRESCRIPTION DRUG LABEL 1 70518-1986 TABLET, FILM COATED 10 mg ORAL NDA 19 sections
Glyxambi HUMAN PRESCRIPTION DRUG LABEL 2 70518-2046 TABLET, FILM COATED 10 mg ORAL NDA 19 sections
Jardiance HUMAN PRESCRIPTION DRUG LABEL 1 70518-2447 TABLET, FILM COATED 25 mg ORAL NDA 19 sections
Jardiance HUMAN PRESCRIPTION DRUG LABEL 1 71610-177 TABLET, FILM COATED 25 mg ORAL NDA 19 sections