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Onglyza(saxagliptin)
Kombiglyze, Komboglyze, Onglyza, Qtern, Qternmet, Qtrilmet (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 diseasesD009750
endocrine system diseasesD004700
Trade Name
FDA
EMA
Onglyza
Combinations
Kombiglyze, Qtern (discontinued: Qternmet)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dapagliflozin
+
Metformin hydrochloride
+
Saxagliptin hydrochloride
Tradename
Company
Number
Date
Products
QTERNMET XRAstraZenecaN-210874 DISCN2019-05-02
4 products, RLD
Hide discontinued
Dapagliflozin
+
Saxagliptin hydrochloride
Tradename
Company
Number
Date
Products
QTERNAstraZenecaN-209091 RX2017-02-27
2 products, RLD, RS
Metformin hydrochloride
+
Saxagliptin hydrochloride
Tradename
Company
Number
Date
Products
KOMBIGLYZE XRAstraZenecaN-200678 RX2010-11-05
3 products, RLD
Saxagliptin hydrochloride
Tradename
Company
Number
Date
Products
ONGLYZAAstraZenecaN-022350 RX2009-07-31
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
kombiglyzeNew Drug Application2019-10-24
onglyzaNew Drug Application2022-12-15
qternNew Drug Application2020-01-24
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
type 2 diabetes mellitusEFO_0001360D003924E11
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Dapagliflozin / Metformin Hydrochloride / Saxagliptin Hydrochloride, Qternmet Xr, Astrazeneca Ab
96160282030-11-12DP
79195982029-12-16DP
87162512028-03-21DP
85016982027-06-20DPU-493, U-1976, U-1977
65151172025-10-04DS, DPU-493
86287992025-07-13DP
RE441862023-07-31DS, DPU-493, U-995, U-1097, U-1837, U-1838
Saxagliptin Hydrochloride, Onglyza, Astrazeneca Ab
79514002028-11-30DP
Dapagliflozin / Saxagliptin Hydrochloride, Qtern, Astrazeneca Ab
82217862028-03-21DP
83619722028-03-21U-493, U-1976, U-1977
Metformin Hydrochloride / Saxagliptin Hydrochloride, Kombiglyze Xr, Astrazeneca Ab
93394722025-07-13DP
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
114 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 mellitusD003924EFO_0001360E111653129989
Type 1 diabetes mellitusD003922EFO_0001359E10—112—4
Cardiovascular diseasesD002318EFO_0000319I98———213
Glucose intoleranceD018149HP_0000833R73.03—1—113
Diabetes mellitusD003920EFO_0000400E08-E132——1—3
ObesityD009765EFO_0001073E66.9———2—2
Prediabetic stateD011236EFO_1001121R73.03———2—2
Heart failureD006333EFO_0003144I50———2—2
Coronary artery diseaseD003324I25.1———1—1
HypertriglyceridemiaD015228EFO_0004211———1—1
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Inferior wall myocardial infarctionD056989EFO_1000983——1——1
Polycystic ovary syndromeD011085EFO_0000660E28.2——1——1
HypoglycemiaD007003HP_0001943E16.2——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Insulin resistanceD007333EFO_0002614—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ExerciseD015444EFO_00004831————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cystic fibrosisD003550EFO_0000390E84————22
Urinary tract infectionsD014552EFO_0003103N39.0————11
Erectile dysfunctionD007172EFO_0004234F52.21————11
Drug interactionsD004347————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSAXAGLIPTIN
INNsaxagliptin
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 classdipeptidyl 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-ID945667-22-1
RxCUI—
ChEMBL IDCHEMBL2103745
ChEBI ID71271
PubChem CID11243969
DrugBankDB06335
UNII ID8I7IO46IVQ (ChemIDplus, GSRS)
Target
Agency Approved
DPP4
DPP4
Organism
Homo sapiens
Gene name
DPP4
Gene synonyms
ADCP2, CD26
NCBI Gene ID
1803
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
Q53TN1
Mouse ortholog
Dpp4 (13482)
dipeptidyl peptidase 4 (P28843)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Onglyza - AstraZeneca
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Onglyza - Bristol Myers Squibb
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Qtern - AstraZeneca
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,043 documents
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Safety
Black-box Warning
Black-box warning for: Kombiglyze
Adverse Events
Top Adverse Reactions
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113 adverse events reported
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