Onglyza(saxagliptin)
Komboglyze, Onglyza, Qtern, Qternmet, Qtrilmet, Saxagliptin (saxagliptin) is a small molecule pharmaceutical. Saxagliptin was first approved as Onglyza on 2009-07-31. It is used to treat type 2 diabetes mellitus in the USA. It has been approved in Europe to treat diabetes mellitus, glucose metabolism disorders, metabolic diseases, nutritional and metabolic diseases, and type 2 diabetes mellitus. The pharmaceutical is active against dipeptidyl peptidase 4.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nutritional and metabolic diseases | D009750 |
| endocrine system diseases | D004700 |
Trade Name
FDA
EMA
Saxagliptin (discontinued: Onglyza, Saxagliptin)
CombinationsMetformin hydrochloride; saxagliptin, Qtern, Saxagliptin metformin (discontinued: Kombiglyze, Qternmet)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Metformin hydrochloride
+
Saxagliptin hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| KOMBIGLYZE XR | AstraZeneca | N-200678 DISCN | 2010-11-05 | 3 products, RLD |
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Saxagliptin hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ONGLYZA | AstraZeneca | N-022350 DISCN | 2009-07-31 | 2 products, RLD |
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Dapagliflozin
+
Saxagliptin hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| QTERN | AstraZeneca | N-209091 RX | 2017-02-27 | 2 products, RLD, RS |
Dapagliflozin
+
Metformin hydrochloride
+
Saxagliptin hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| QTERNMET XR | AstraZeneca | N-210874 DISCN | 2019-05-02 | 4 products, RLD |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| kombiglyze | New Drug Application | 2024-10-11 |
| onglyza | New Drug Application | 2024-10-11 |
| qtern | New Drug Application | 2023-09-29 |
| saxagliptin | ANDA | 2024-01-09 |
| saxagliptin and metformin | ANDA | 2023-04-22 |
| saxagliptin and metformin hydrochloride | ANDA | 2023-07-28 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| type 2 diabetes mellitus | EFO_0001360 | D003924 | E11 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
SAXAGLIPTIN HYDROCHLORIDE, SAXAGLIPTIN, AMNEAL | |||
| 2024-01-27 | PC | ||
SAXAGLIPTIN HYDROCHLORIDE, SAXAGLIPTIN, AUROBINDO PHARMA | |||
| 2024-01-27 | PC | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Dapagliflozin / Metformin Hydrochloride / Saxagliptin Hydrochloride, Qternmet Xr, Astrazeneca Ab | |||
| 9616028 | 2030-11-12 | DP | |
| 7919598 | 2029-12-16 | DP | |
| 8716251 | 2028-03-21 | DP | |
| 8501698 | 2027-06-20 | DP | U-493, U-1976, U-1977 |
| 6515117 | 2025-10-04 | DS, DP | U-493 |
| 8628799 | 2025-07-13 | DP | |
| Saxagliptin Hydrochloride, Onglyza, Astrazeneca Ab | |||
| 7951400 | 2028-11-30 | DP | |
| Dapagliflozin / Saxagliptin Hydrochloride, Qtern, Astrazeneca Ab | |||
| 8221786 | 2028-03-21 | DP | |
| 8361972 | 2028-03-21 | U-493, U-1976, U-1977 | |
| Metformin Hydrochloride / Saxagliptin Hydrochloride, Kombiglyze Xr, Astrazeneca Ab | |||
| 9339472 | 2025-07-13 | DP | |
ATC Codes
A: Alimentary tract and metabolism drugs
— A10: Drugs used in diabetes
— A10B: Blood glucose lowering drugs, excl. insulins
— A10BD: Combinations of oral blood glucose lowering drugs
— A10BD10: Metformin and saxagliptin
— A10BD21: Saxagliptin and dapagliflozin
— A10BD25: Metformin, saxagliptin and dapagliflozin
— A10BH: Dipeptidyl peptidase 4 (dpp-4) inhibitors for blood glucose lowering
— A10BH03: Saxagliptin
HCPCS
No data
Clinical
Clinical Trials
154 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 16 | 5 | 34 | 35 | 36 | 125 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | 6 | 3 | 28 | 24 | 24 | 84 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | — | 3 | 4 | 7 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | — | 3 | 3 | 6 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | 1 | 1 | 3 | 1 | 6 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | 1 | — | 3 | 1 | 5 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | 4 | — | 4 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | 2 | 1 | 3 |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | — | — | — | 2 | 1 | 3 |
| Diabetes complications | D048909 | — | — | — | — | — | 1 | 1 | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | 1 | — | 1 | 2 |
| Infarction | D007238 | EFO_0009463 | — | — | — | 1 | — | 1 | 2 |
| Inferior wall myocardial infarction | D056989 | EFO_1000983 | — | — | — | 1 | — | — | 1 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | — | — | 1 | — | — | 1 |
| Hypoglycemia | D007003 | HP_0001943 | E16.2 | — | — | 1 | — | — | 1 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fragile x syndrome | D005600 | — | Q99.2 | 1 | 1 | — | — | — | 1 |
| Syndrome | D013577 | — | — | 1 | 1 | — | — | — | 1 |
| Insulin resistance | D007333 | HP_0000855 | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Exercise | D015444 | EFO_0000483 | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fibrosis | D005355 | — | — | — | — | — | — | 2 | 2 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | — | — | 2 | 2 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 1 | 1 |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | — | — | — | 1 | 1 |
| Communicable diseases | D003141 | — | — | — | — | — | — | 1 | 1 |
| Sepsis | D018805 | HP_0100806 | A41.9 | — | — | — | — | 1 | 1 |
| Ketosis | D007662 | HP_0002919 | R82.4 | — | — | — | — | 1 | 1 |
| Diabetic ketoacidosis | D016883 | EFO_1000897 | — | — | — | — | — | 1 | 1 |
| Ischemic stroke | D000083242 | — | — | — | — | — | — | 1 | 1 |
| Pancreatitis | D010195 | HP_0001733 | K85 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Saxagliptin |
| INN | saxagliptin |
| Description | Saxagliptin is a monocarboxylic acid amide obtained by formal condensation of the carboxy group of (2S)-amino(3-hydroxyadamantan-1-yl)acetic acid with the amino group of (1S,3S,5S)-2-azabicyclo[3.1.0]hexane-3-carbonitrile. Used in its monohydrate form for the treatment of Type II diabetes. It has a role as a hypoglycemic agent and an EC 3.4.14.5 (dipeptidyl-peptidase IV) inhibitor. It is a member of adamantanes, a nitrile, an azabicycloalkane, a tertiary alcohol and a monocarboxylic acid amide. |
| Classification | Small molecule |
| Drug class | dipeptidyl aminopeptidase-IV inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | N#C[C@@H]1C[C@@H]2C[C@@H]2N1C(=O)[C@@H](N)C12CC3CC(CC(O)(C3)C1)C2.O |
Identifiers
| PDB | — |
| CAS-ID | 945667-22-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2103745 |
| ChEBI ID | 71271 |
| PubChem CID | 11243969 |
| DrugBank | DB06335 |
| UNII ID | 8I7IO46IVQ (ChemIDplus, GSRS) |
Target
Agency Approved
DPP4
DPP4
Organism
Homo sapiens
Gene name
DPP4
Gene synonyms
ADCP2, CD26
NCBI Gene ID
Protein name
dipeptidyl peptidase 4
Protein synonyms
ADABP, ADCP-2, Adenosine deaminase complexing protein 2, CD26, Dipeptidyl peptidase IV, dipeptidylpeptidase 4, dipeptidylpeptidase IV (CD26, adenosine deaminase complexing protein 2), DPP IV, Gly-Pro naphthylamidase, Post-proline dipeptidyl aminopeptidase IV, T-cell activation antigen CD26, TP103, Xaa-Pro-dipeptidylaminopeptidase
Uniprot ID
Mouse ortholog
Dpp4 (13482)
dipeptidyl peptidase 4 (Q3U514)
Alternate
No data
Variants
No data
Financial
Revenue by drug
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Onglyza – AstraZeneca
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Onglyza – Bristol Myers Squibb
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Qtern – AstraZeneca
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Estimated US medical usage
Saxagliptin
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Metformin
Total medical expenditures per year (USD, in millions)
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Saxagliptin
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,692 documents
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Safety
Black-box Warning
Black-box warning for: Kombiglyze, Saxagliptin and metformin, Saxagliptin and metformin hydrochloride
Adverse Events
Top Adverse Reactions
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7,772 adverse events reported
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