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saxagliptin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| dipeptidyl aminopeptidase-IV inhibitors | 4114 | 361442-04-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
inhibits Dipeptidyl Peptidase-4
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 5 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 0.23 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Hosey CM, Chan R, Benet LZ |
| S (Water solubility) | 63 mg/mL | Bocci G, Oprea TI, Benet LZ |
| EoM (Fraction excreted unchanged in urine) | 24 % | Hosey CM, Chan R, Benet LZ |
| fu (Fraction unbound in plasma) | 1 % | Lombardo F, Berellini G, Obach RS |
| Vd (Volume of distribution) | 1.80 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 7.10 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 7.50 hours | Lombardo F, Berellini G, Obach RS |
| BA (Bioavailability) | 0.87 % | Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | -0.002 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 3.873 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 3.357 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 1.581 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 80.940 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 80.650 | % | High | 1 |
| herg | hERG pIC50 | 4.230 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 1.119 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 3.155 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 87.190 | % | High | 1 |
| kinase-safety-class | CDK5,EIF2AK3,GRK2,PDK1,PDK2,PDK4 | 6 | |||
| kinase-selectivity-class | PDK1 | 1 | |||
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 2.328 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 5.702 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 87.750 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 7.345 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 91.060 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 2.692 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 91.660 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 85.310 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 928.966 | uM | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| July 31, 2009 | FDA | ASTRAZENECA AB | |
| Sept. 30, 2009 | EMA | 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 |
|---|---|---|---|---|---|---|
| Lactic acidosis | 63.31 | 20.15 | 34 | 3690 | 50429 | 90574294 |
| Hypoglobulinaemia | 62.17 | 20.15 | 10 | 3714 | 169 | 90624554 |
| Diabetic ketoacidosis | 50.12 | 20.15 | 23 | 3701 | 24384 | 90600339 |
| Ketoacidosis | 47.93 | 20.15 | 15 | 3709 | 5580 | 90619143 |
| Acute kidney injury | 44.47 | 20.15 | 60 | 3664 | 320327 | 90304396 |
| Urinary tract obstruction | 41.68 | 20.15 | 11 | 3713 | 2238 | 90622485 |
| Blood glucose increased | 33.08 | 20.15 | 29 | 3695 | 95217 | 90529506 |
| Subacute cutaneous lupus erythematosus | 32.35 | 20.15 | 10 | 3714 | 3572 | 90621151 |
| Drug interaction | 29.86 | 20.15 | 46 | 3678 | 276407 | 90348316 |
| Febrile bone marrow aplasia | 29.23 | 20.15 | 12 | 3712 | 9726 | 90614997 |
| Inappropriate antidiuretic hormone secretion | 26.87 | 20.15 | 14 | 3710 | 19491 | 90605232 |
| Arrhythmia | 25.84 | 20.15 | 18 | 3706 | 42314 | 90582409 |
| Pancreatitis | 25.73 | 20.15 | 22 | 3702 | 69804 | 90554919 |
| Hypoglycaemia | 23.71 | 20.15 | 21 | 3703 | 69827 | 90554896 |
| Cardiac failure | 22.43 | 20.15 | 25 | 3699 | 109471 | 90515252 |
| Dehydration | 21.88 | 20.15 | 33 | 3691 | 194414 | 90430309 |
| Hypogammaglobulinaemia | 21.72 | 20.15 | 10 | 3714 | 10664 | 90614059 |
| Hypoglycaemic coma | 21.43 | 20.15 | 7 | 3717 | 2983 | 90621740 |
| Small intestinal obstruction | 20.34 | 20.15 | 12 | 3712 | 21222 | 90603501 |
| Cerebral infarction | 20.30 | 20.15 | 13 | 3711 | 26583 | 90598140 |
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 |
|---|---|---|---|---|---|---|
| Pancreatic carcinoma | 71.91 | 19.74 | 29 | 4122 | 9477 | 42607707 |
| Vertigo | 50.64 | 19.74 | 35 | 4116 | 34312 | 42582872 |
| Infection parasitic | 45.12 | 19.74 | 10 | 4141 | 407 | 42616777 |
| Insulin C-peptide decreased | 44.80 | 19.74 | 7 | 4144 | 37 | 42617147 |
| Diabetic ketoacidotic hyperglycaemic coma | 40.66 | 19.74 | 8 | 4143 | 180 | 42617004 |
| Gastrointestinal bacterial infection | 40.09 | 19.74 | 10 | 4141 | 681 | 42616503 |
| Pancreatitis | 39.23 | 19.74 | 33 | 4118 | 43235 | 42573949 |
| Dizziness | 38.86 | 19.74 | 79 | 4072 | 249175 | 42368009 |
| Blood glucose increased | 34.31 | 19.74 | 39 | 4112 | 73660 | 42543524 |
| Hypoglycaemia | 31.88 | 19.74 | 34 | 4117 | 59820 | 42557364 |
| Diabetes mellitus inadequate control | 30.79 | 19.74 | 19 | 4132 | 15371 | 42601813 |
| Dyspepsia | 30.39 | 19.74 | 28 | 4123 | 41324 | 42575860 |
| Hypoglycaemic coma | 30.17 | 19.74 | 11 | 4140 | 2733 | 42614451 |
| Angina pectoris | 29.62 | 19.74 | 25 | 4126 | 32871 | 42584313 |
| Acute kidney injury | 28.23 | 19.74 | 89 | 4062 | 367248 | 42249936 |
| Pancreatitis acute | 27.17 | 19.74 | 24 | 4127 | 33540 | 42583644 |
| Faeces soft | 27.16 | 19.74 | 12 | 4139 | 4900 | 42612284 |
| Abdominal pain upper | 26.08 | 19.74 | 36 | 4115 | 82573 | 42534611 |
| Volvulus | 25.65 | 19.74 | 9 | 4142 | 2004 | 42615180 |
| Large intestine polyp | 25.31 | 19.74 | 14 | 4137 | 9251 | 42607933 |
| Spleen congestion | 24.94 | 19.74 | 6 | 4145 | 351 | 42616833 |
| Post procedural erythema | 24.71 | 19.74 | 3 | 4148 | 0 | 42617184 |
| B-cell lymphoma | 23.98 | 19.74 | 11 | 4140 | 4902 | 42612282 |
| Drug effect less than expected | 23.20 | 19.74 | 10 | 4141 | 3847 | 42613337 |
| Suprapubic pain | 23.11 | 19.74 | 6 | 4145 | 480 | 42616704 |
| Ketoacidosis | 23.08 | 19.74 | 11 | 4140 | 5341 | 42611843 |
| Anal fissure | 20.28 | 19.74 | 10 | 4141 | 5229 | 42611955 |
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 |
|---|---|---|---|---|---|---|
| Pancreatic carcinoma | 73.41 | 17.31 | 30 | 7325 | 14842 | 110567102 |
| Ketoacidosis | 69.80 | 17.31 | 26 | 7329 | 10061 | 110571883 |
| Hypoglobulinaemia | 68.06 | 17.31 | 12 | 7343 | 217 | 110581727 |
| Acute kidney injury | 67.01 | 17.31 | 137 | 7218 | 635293 | 109946651 |
| Lactic acidosis | 60.90 | 17.31 | 50 | 7305 | 92761 | 110489183 |
| Hypoglycaemia | 56.95 | 17.31 | 53 | 7302 | 116051 | 110465893 |
| Hypoglycaemic coma | 52.41 | 17.31 | 18 | 7337 | 5515 | 110576429 |
| Pancreatitis | 52.36 | 17.31 | 46 | 7309 | 93487 | 110488457 |
| Diabetic ketoacidosis | 51.30 | 17.31 | 33 | 7322 | 42025 | 110539919 |
| Blood glucose increased | 49.25 | 17.31 | 52 | 7303 | 132444 | 110449500 |
| Insulin C-peptide decreased | 41.72 | 17.31 | 7 | 7348 | 93 | 110581851 |
| Infection parasitic | 41.32 | 17.31 | 10 | 7345 | 884 | 110581060 |
| Diabetic ketoacidotic hyperglycaemic coma | 40.55 | 17.31 | 8 | 7347 | 271 | 110581673 |
| Diabetes mellitus inadequate control | 37.89 | 17.31 | 24 | 7331 | 29751 | 110552193 |
| Gastrointestinal bacterial infection | 36.74 | 17.31 | 10 | 7345 | 1408 | 110580536 |
| Cerebral infarction | 36.25 | 17.31 | 29 | 7326 | 51809 | 110530135 |
| Vertigo | 35.70 | 17.31 | 36 | 7319 | 86834 | 110495110 |
| Dehydration | 35.10 | 17.31 | 65 | 7290 | 279446 | 110302498 |
| Cardiac failure | 34.80 | 17.31 | 52 | 7303 | 187574 | 110394370 |
| Pancreatitis acute | 34.44 | 17.31 | 30 | 7325 | 60244 | 110521700 |
| Large intestine polyp | 32.10 | 17.31 | 17 | 7338 | 15100 | 110566844 |
| Pemphigoid | 30.49 | 17.31 | 18 | 7337 | 19689 | 110562255 |
| Hypogammaglobulinaemia | 30.18 | 17.31 | 18 | 7337 | 20058 | 110561886 |
| Angina pectoris | 29.68 | 17.31 | 28 | 7327 | 62267 | 110519677 |
| B-cell lymphoma | 27.22 | 17.31 | 12 | 7343 | 7142 | 110574802 |
| Spleen congestion | 25.22 | 17.31 | 6 | 7349 | 493 | 110581451 |
| Subacute cutaneous lupus erythematosus | 24.39 | 17.31 | 10 | 7345 | 4984 | 110576960 |
| Volvulus | 24.09 | 17.31 | 9 | 7346 | 3509 | 110578435 |
| Renal cancer | 23.08 | 17.31 | 13 | 7342 | 13021 | 110568923 |
| Faeces soft | 22.10 | 17.31 | 12 | 7343 | 11198 | 110570746 |
| Post procedural erythema | 21.70 | 17.31 | 3 | 7352 | 9 | 110581935 |
| Peripheral arterial occlusive disease | 21.31 | 17.31 | 11 | 7344 | 9269 | 110572675 |
| Hyperglycaemia | 20.88 | 17.31 | 27 | 7328 | 85063 | 110496881 |
| Urinary tract obstruction | 20.72 | 17.31 | 9 | 7346 | 5168 | 110576776 |
| Drug effect less than expected | 20.72 | 17.31 | 10 | 7345 | 7310 | 110574634 |
| Glycosylated haemoglobin increased | 20.43 | 17.31 | 15 | 7340 | 23604 | 110558340 |
| Suprapubic pain | 20.38 | 17.31 | 6 | 7349 | 1119 | 110580825 |
| Arrhythmia | 20.16 | 17.31 | 24 | 7331 | 69551 | 110512393 |
| Inappropriate antidiuretic hormone secretion | 19.64 | 17.31 | 17 | 7338 | 33834 | 110548110 |
| Urosepsis | 19.01 | 17.31 | 16 | 7339 | 30659 | 110551285 |
| Anal fissure | 17.89 | 17.31 | 10 | 7345 | 9871 | 110572073 |
| Scab | 17.67 | 17.31 | 11 | 7344 | 13225 | 110568719 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | A10BD10 | ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs |
| ATC | A10BD21 | ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs |
| ATC | A10BD25 | ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs |
| ATC | A10BH03 | ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Dipeptidyl peptidase 4 (DPP-4) inhibitors |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D006728 | Hormones |
| MeSH PA | D007004 | Hypoglycemic Agents |
| MeSH PA | D011480 | Protease Inhibitors |
| MeSH PA | D054795 | Incretins |
| MeSH PA | D054873 | Dipeptidyl-Peptidase IV Inhibitors |
| CHEBI has role | CHEBI:35526 | hypoglycemic agent |
| CHEBI has role | CHEBI:68612 | EC 3.4.14.5 (dipeptidyl-peptidase IV) inhibitor |
| CHEBI has role | CHEBI:35554 | cardiovascular drug |
Related Drugs by ATC class:
A10BD Combinations of oral blood glucose lowering drugs 19 drugs
A10BH Dipeptidyl peptidase 4 (DPP-4) inhibitors 9 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Diabetes mellitus type 2 | indication | 44054006 | DOID:9352 |
| Alcoholism | contraindication | 7200002 | |
| Asthenia | contraindication | 13791008 | |
| Myocardial infarction | contraindication | 22298006 | DOID:5844 |
| Acute vomiting | contraindication | 23971007 | |
| Alcohol intoxication | contraindication | 25702006 | |
| Shock | contraindication | 27942005 | |
| Dehydration | contraindication | 34095006 | |
| Infectious disease | contraindication | 40733004 | |
| End stage renal disease | contraindication | 46177005 | DOID:784 |
| Lymphocytopenia | contraindication | 48813009 | DOID:614 |
| Ketoacidosis | contraindication | 56051008 | |
| Acute nephropathy | contraindication | 58574008 | |
| Metabolic acidosis | contraindication | 59455009 | |
| Hypopituitarism | contraindication | 74728003 | DOID:9406 |
| Cardiogenic shock | contraindication | 89138009 | |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Lactic acidosis | contraindication | 91273001 | DOID:3650 |
| Cobalamin deficiency | contraindication | 190634004 | |
| Decompensated cardiac failure | contraindication | 195111005 | |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Hypoglycemic disorder | contraindication | 237630007 | |
| Sepsis syndrome | contraindication | 238150007 | |
| Adrenal cortical hypofunction | contraindication | 386584007 | DOID:10493 |
| Fever | contraindication | 386661006 | |
| Surgical procedure | contraindication | 387713003 | |
| Severe diarrhea | contraindication | 409587002 | |
| Traumatic injury | contraindication | 417746004 | |
| Radiography with IV Iodinated Contrast Agent | contraindication | ||
| Severe Hypoxemia | contraindication |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 5.77 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 10MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | QTERN | ASTRAZENECA AB | N209091 | Feb. 27, 2017 | DISCN | TABLET | ORAL | 6515117 | Oct. 4, 2025 | TREATMENT OF TYPE 2 DIABETES MELLITUS |
| 5MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | QTERN | ASTRAZENECA AB | N209091 | May 2, 2019 | DISCN | TABLET | ORAL | 6515117 | Oct. 4, 2025 | TREATMENT OF TYPE 2 DIABETES MELLITUS |
| 10MG;1GM;EQ 5MG BASE | QTERNMET XR | ASTRAZENECA AB | N210874 | May 2, 2019 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 6515117 | Oct. 4, 2025 | TREATMENT OF TYPE 2 DIABETES MELLITUS |
| 2.5MG;1GM;EQ 2.5MG BASE | QTERNMET XR | ASTRAZENECA AB | N210874 | May 2, 2019 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 6515117 | Oct. 4, 2025 | TREATMENT OF TYPE 2 DIABETES MELLITUS |
| 5MG;1GM;EQ 2.5MG BASE | QTERNMET XR | ASTRAZENECA AB | N210874 | May 2, 2019 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 6515117 | Oct. 4, 2025 | TREATMENT OF TYPE 2 DIABETES MELLITUS |
| 5MG;1GM;EQ 5MG BASE | QTERNMET XR | ASTRAZENECA AB | N210874 | May 2, 2019 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 6515117 | Oct. 4, 2025 | TREATMENT OF TYPE 2 DIABETES MELLITUS |
| 10MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | QTERN | ASTRAZENECA AB | N209091 | Feb. 27, 2017 | DISCN | TABLET | ORAL | 8501698 | June 20, 2027 | METHOD FOR TREATING TYPE 2 DIABETES MELLITUS (T2DM) IN PATIENTS WHO ARE ALREADY TREATED WITH DAPAGLIFLOZIN AND SAXAGLIPTIN |
| 10MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | QTERN | ASTRAZENECA AB | N209091 | Feb. 27, 2017 | DISCN | TABLET | ORAL | 8501698 | June 20, 2027 | METHOD FOR TREATING TYPE 2 DIABETES MELLITUS (T2DM) IN PATIENTS WHO HAVE INADEQUATE CONTROL WITH DAPAGLIFLOZIN |
| 10MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | QTERN | ASTRAZENECA AB | N209091 | Feb. 27, 2017 | DISCN | TABLET | ORAL | 8501698 | June 20, 2027 | TREATMENT OF TYPE 2 DIABETES MELLITUS |
| 5MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | QTERN | ASTRAZENECA AB | N209091 | May 2, 2019 | DISCN | TABLET | ORAL | 8501698 | June 20, 2027 | TREATMENT OF TYPE 2 DIABETES MELLITUS |
| 10MG;1GM;EQ 5MG BASE | QTERNMET XR | ASTRAZENECA AB | N210874 | May 2, 2019 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8501698 | June 20, 2027 | TREATMENT OF TYPE 2 DIABETES MELLITUS |
| 2.5MG;1GM;EQ 2.5MG BASE | QTERNMET XR | ASTRAZENECA AB | N210874 | May 2, 2019 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8501698 | June 20, 2027 | TREATMENT OF TYPE 2 DIABETES MELLITUS |
| 5MG;1GM;EQ 2.5MG BASE | QTERNMET XR | ASTRAZENECA AB | N210874 | May 2, 2019 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8501698 | June 20, 2027 | TREATMENT OF TYPE 2 DIABETES MELLITUS |
| 5MG;1GM;EQ 5MG BASE | QTERNMET XR | ASTRAZENECA AB | N210874 | May 2, 2019 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8501698 | June 20, 2027 | TREATMENT OF TYPE 2 DIABETES MELLITUS |
| 10MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | QTERN | ASTRAZENECA AB | N209091 | Feb. 27, 2017 | DISCN | TABLET | ORAL | 8361972 | March 21, 2028 | METHOD FOR TREATING TYPE 2 DIABETES MELLITUS (T2DM) IN PATIENTS WHO ARE ALREADY TREATED WITH DAPAGLIFLOZIN AND SAXAGLIPTIN |
| 10MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | QTERN | ASTRAZENECA AB | N209091 | Feb. 27, 2017 | DISCN | TABLET | ORAL | 8361972 | March 21, 2028 | METHOD FOR TREATING TYPE 2 DIABETES MELLITUS (T2DM) IN PATIENTS WHO HAVE INADEQUATE CONTROL WITH DAPAGLIFLOZIN |
| 10MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | QTERN | ASTRAZENECA AB | N209091 | Feb. 27, 2017 | DISCN | TABLET | ORAL | 8361972 | March 21, 2028 | TREATMENT OF TYPE 2 DIABETES MELLITUS |
| 5MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | QTERN | ASTRAZENECA AB | N209091 | May 2, 2019 | DISCN | TABLET | ORAL | 8361972 | March 21, 2028 | TREATMENT OF TYPE 2 DIABETES MELLITUS |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | KOMBIGLYZE XR | ASTRAZENECA AB | N200678 | Nov. 5, 2010 | DISCN | TABLET, EXTENDED RELEASE | ORAL | Oct. 11, 2027 | ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION |
| 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | KOMBIGLYZE XR | ASTRAZENECA AB | N200678 | Nov. 5, 2010 | DISCN | TABLET, EXTENDED RELEASE | ORAL | Oct. 11, 2027 | ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION |
| 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | KOMBIGLYZE XR | ASTRAZENECA AB | N200678 | Nov. 5, 2010 | DISCN | TABLET, EXTENDED RELEASE | ORAL | Oct. 11, 2027 | ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Dipeptidyl peptidase 4 | Enzyme | INHIBITOR | Ki | 9.22 | CHEMBL | CHEMBL | |||
| Cytochrome P450 3A4 | Enzyme | WOMBAT-PK | |||||||
| Multidrug resistance protein 1 | Transporter | WOMBAT-PK | |||||||
| Dipeptidyl peptidase 8 | Enzyme | Ki | 6.89 | CHEMBL | |||||
| Dipeptidyl peptidase 9 | Enzyme | Ki | 7.15 | CHEMBL | |||||
| Dipeptidyl peptidase 4 | Enzyme | IC50 | 8.72 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4029055 | VUID |
| N0000179814 | NUI |
| D08996 | KEGG_DRUG |
| 709031-78-7 | SECONDARY_CAS_RN |
| 4029055 | VANDF |
| 4029067 | VANDF |
| C1611934 | UMLSCUI |
| CHEBI:71272 | CHEBI |
| CHEMBL2103745 | ChEMBL_ID |
| CHEMBL1201743 | ChEMBL_ID |
| DB06335 | DRUGBANK_ID |
| C502994 | MESH_SUPPLEMENTAL_RECORD_UI |
| 11243969 | PUBCHEM_CID |
| 6316 | IUPHAR_LIGAND_ID |
| 9GB927LAJW | UNII |
| 1043560 | RXNORM |
| 166611 | MMSL |
| 26648 | MMSL |
| 32427 | MMSL |
| 369212 | MMSL |
| d07467 | MMSL |
| 013204 | NDDF |
| 013205 | NDDF |
| 443066009 | SNOMEDCT_US |
| 443087004 | SNOMEDCT_US |
| 734452007 | SNOMEDCT_US |
| BJM | PDB_CHEM_ID |
| CHEMBL385517 | ChEMBL_ID |
| 945667-22-1 | SECONDARY_CAS_RN |
| 9GB927LAJW | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Saxagliptin and Metformin Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 2 | 43598-618 | TABLET, FILM COATED, EXTENDED RELEASE | 2.50 mg | ORAL | ANDA | 27 sections |
| Saxagliptin and Metformin Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 2 | 43598-619 | TABLET, FILM COATED, EXTENDED RELEASE | 5 mg | ORAL | ANDA | 27 sections |
| Saxagliptin and Metformin Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 2 | 43598-620 | TABLET, FILM COATED, EXTENDED RELEASE | 5 mg | ORAL | ANDA | 27 sections |
| ONGLYZA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-6309 | TABLET, FILM COATED | 5 mg | ORAL | NDA | 31 sections |
| Saxagliptin | Human Prescription Drug Label | 1 | 65862-825 | TABLET, FILM COATED | 2.50 mg | ORAL | ANDA | 27 sections |
| Saxagliptin | Human Prescription Drug Label | 1 | 65862-826 | TABLET, FILM COATED | 5 mg | ORAL | ANDA | 27 sections |
| SAXAGLIPTIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68462-726 | TABLET, FILM COATED | 2.50 mg | ORAL | ANDA | 28 sections |
| SAXAGLIPTIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68462-727 | TABLET, FILM COATED | 5 mg | ORAL | ANDA | 28 sections |