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Drug ReportsSaxagliptin
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
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nutritional and metabolic diseasesD009750
endocrine system diseasesD004700
Trade Name
FDA
EMA
Saxagliptin (discontinued: Onglyza, Saxagliptin)
Combinations
Dapagliflozin saxagliptin, Saxagliptin metformin (discontinued: Kombiglyze, Qtern, Qternmet, Saxagliptin metformin)
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 XRAstraZenecaN-200678 DISCN2010-11-05
3 products, RLD
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Saxagliptin hydrochloride
Tradename
Company
Number
Date
Products
ONGLYZAAstraZenecaN-022350 DISCN2009-07-31
2 products, RLD
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Dapagliflozin
+
Saxagliptin hydrochloride
Tradename
Company
Number
Date
Products
QTERNAstraZenecaN-209091 DISCN2017-02-27
2 products, RLD
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Dapagliflozin
+
Metformin hydrochloride
+
Saxagliptin hydrochloride
Tradename
Company
Number
Date
Products
QTERNMET XRAstraZenecaN-210874 DISCN2019-05-02
4 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
dapagliflozin and saxagliptinANDA2026-04-08
onglyzaNew Drug Application2012-01-09
saxagliptinANDA2026-01-27
saxagliptin and metforminANDA2026-06-08
saxagliptin and metformin hydrochlorideANDA2024-10-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
type 2 diabetes mellitusEFO_0001360D003924E11
Agency Specific
FDA
EMA
Expiration
Code
SAXAGLIPTIN HYDROCHLORIDE, SAXAGLIPTIN, AMNEAL
2024-01-27PC
SAXAGLIPTIN HYDROCHLORIDE, SAXAGLIPTIN, AUROBINDO PHARMA
2024-01-27PC
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
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
157 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_0001360E11166353535125
Diabetes mellitusD003920EFO_0000400E08-E134423191664
Cardiovascular diseasesD002318EFO_0000319I98———358
Type 1 diabetes mellitusD003922EFO_0001359E10—123—6
Heart failureD006333EFO_0003144I50———325
Glucose intoleranceD018149HP_0000833R73.03—1—315
ObesityD009765EFO_0001073E66.9———4—4
InflammationD007249MP_0001845————213
Prediabetic stateD011236EFO_1001121R73.03———213
Diabetes complicationsD048909—————112
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myocardial infarctionD009203EFO_0000612I21——1—12
Insulin resistanceD007333EFO_0002614E88.819—11——2
InfarctionD007238EFO_0009463———1——1
Inferior wall myocardial infarctionD056989EFO_1000983———1——1
Polycystic ovary syndromeD011085EFO_0000660E28.2——1——1
HypoglycemiaD007003—E16.2——1——1
Renal insufficiencyD051437—N19——1——1
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ExerciseD015444EFO_0000483—1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
FibrosisD005355——————22
Cystic fibrosisD003550EFO_0000390E84————22
InfectionsD007239EFO_0000544—————11
Urinary tract infectionsD014552EFO_0003103N39.0————11
Communicable diseasesD003141——————11
SepsisD018805EFO_0001420A41.9————11
Diabetic ketoacidosisD016883EFO_1000897—————11
Ischemic strokeD000083242——————11
PancreatitisD010195EFO_0000278K85————11
Pancreatic neoplasmsD010190EFO_0003860C25————11
Show 13 more
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)Loading
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 (Q3U514)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
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
+
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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Refill frequency
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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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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,836 documents
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Safety
Black-box Warning
Black-box warning for: Saxagliptin and metformin, Saxagliptin and metformin hydrochloride
Adverse Events
Top Adverse Reactions
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4,340 adverse events reported
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