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)
CombinationsQtern, 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 | 2024-11-13 |
| saxagliptin | ANDA | 2024-12-18 |
| saxagliptin and metformin | ANDA | 2023-04-22 |
| saxagliptin and metformin hydrochloride | ANDA | 2024-10-30 |
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 | 15 | 3 | 30 | 11 | 16 | 74 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 5 | 2 | 24 | 10 | 10 | 50 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Albuminuria | D000419 | EFO_0004285 | R80.9 | — | 1 | 1 | — | — | 1 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | — | — | 1 | — | — | 1 |
| Renal insufficiency | D051437 | — | N19 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | — | — | — | — | 1 | 1 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | — | — | — | 1 | 1 |
| Acute kidney injury | D058186 | — | N17 | — | — | — | — | 1 | 1 |
| Lymphopenia | D008231 | — | D72.810 | — | — | — | — | 1 | 1 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | — | — | — | — | 1 | 1 |
| Liver failure | D017093 | — | K72.9 | — | — | — | — | 1 | 1 |
| Acute liver failure | D017114 | — | — | — | — | — | — | 1 | 1 |
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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Qtern – AstraZeneca
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Onglyza – AstraZeneca
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Onglyza – Bristol Myers Squibb
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Tabular view
Estimated US medical usage
Saxagliptin
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Metformin
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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Price per prescription (USD)
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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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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,837 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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7,840 adverse events reported
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