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Drug ReportsSitagliptin
Januvia(sitagliptin)
Brynovin, Efficib, Janumet, Januvia, Juvisync, Ristaben, Ristfor, Sitagliptin, Sitagliptin / Metformin, Steglujan, Tesavel, Velmetia, Xelevia, Zituvimet, Zituvio (sitagliptin) is a small molecule pharmaceutical. Sitagliptin was first approved as Januvia on 2006-10-16. It is used to treat type 2 diabetes mellitus in the USA. It has been approved in Europe to treat 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
Brynovin, Januvia, Zituvio
Combinations
Janumet, Steglujan, Zituvimet (discontinued: Juvisync)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Metformin hydrochloride
+
Sitagliptin phosphate
Tradename
Company
Number
Date
Products
JANUMETMerck & CoN-022044 RX2007-03-30
2 products, RLD, RS
JANUMET XRMerck & CoN-202270 RX2012-02-02
3 products, RLD, RS
Sitagliptin phosphate
Tradename
Company
Number
Date
Products
JANUVIAMerck & CoN-021995 RX2006-10-16
3 products, RLD, RS
Simvastatin
+
Sitagliptin phosphate
Tradename
Company
Number
Date
Products
JUVISYNCMerck & CoN-202343 DISCN2011-10-07
6 products, RLD
Hide discontinued
Ertugliflozin
+
Sitagliptin phosphate
Tradename
Company
Number
Date
Products
STEGLUJANMerck & CoN-209805 RX2017-12-19
2 products, RLD, RS
Sitagliptin
Tradename
Company
Number
Date
Products
ZITUVIOZydus TherapeuticsN-211566 RX2023-10-18
3 products, RLD, RS
Metformin hydrochloride
+
Sitagliptin
Tradename
Company
Number
Date
Products
ZITUVIMETZydus TherapeuticsN-216743 RX2023-11-03
2 products, RLD, RS
ZITUVIMET XRZydus TherapeuticsN-216778 RX2024-07-18
3 products, RLD, RS
Sitagliptin hydrochloride
Tradename
Company
Number
Date
Products
BRYNOVINAzurityN-219122 RX2025-01-16
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
janumetNew Drug Application2025-01-07
januviaNew Drug Application2024-11-14
sitagliptinNDA authorized generic2025-01-31
sitagliptin - metforminExport only2023-04-14
sitagliptin and metformin hydrochlorideNDA authorized generic2024-08-31
steglujanNew Drug Application2024-12-20
zituvimetNew Drug Application2024-08-09
zituvimet xrNew Drug Application2024-07-23
zituvioNew Drug Application2025-01-31
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
type 2 diabetes mellitusEFO_0001360D003924E11
hypercholesterolemia—D006937—
coronary artery disease—D003324I25.1
hypertriglyceridemiaEFO_0004211D015228—
hyperlipoproteinemias—D006951—
Agency Specific
FDA
EMA
Expiration
Code
ERTUGLIFLOZIN / SITAGLIPTIN PHOSPHATE, STEGLUJAN, MSD SUB MERCK
2024-09-17M-275
METFORMIN HYDROCHLORIDE / SITAGLIPTIN PHOSPHATE, JANUMET, MSD SUB MERCK
2024-06-04PED
2023-12-04M-187
2023-02-12PED
METFORMIN HYDROCHLORIDE / SITAGLIPTIN PHOSPHATE, JANUMET XR, MERCK SHARP DOHME
2024-06-04PED
2023-12-04M-187
2023-02-12PED
SITAGLIPTIN PHOSPHATE, JANUVIA, MERCK SHARP DOHME
2024-06-04PED
2023-12-04M-187
2023-02-12PED
Patent Expiration
Patent
Expires
Flag
FDA Information
Ertugliflozin / Sitagliptin Phosphate, Steglujan, Msd Sub Merck
93082042030-10-21DP
94399012030-10-21U-2214
80805802030-07-13DS, DPU-2214
73267082026-11-24DS, DPU-802, U-1188, U-1227, U-2214
Metformin Hydrochloride / Sitagliptin Phosphate, Janumet, Msd Sub Merck
84149212028-07-21DPU-1036
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
— A10BD07: Metformin and sitagliptin
— A10BD12: Pioglitazone and sitagliptin
— A10BD24: Sitagliptin and ertugliflozin
— A10BH: Dipeptidyl peptidase 4 (dpp-4) inhibitors for blood glucose lowering
— A10BH01: Sitagliptin
— A10BH51: Sitagliptin and simvastatin
HCPCS
No data
Clinical
Clinical Trials
535 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Type 2 diabetes mellitusD003924EFO_0001360E11——1——1
Diabetes mellitusD003920EFO_0000400E08-E13——1——1
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSitagliptin
INNsitagliptin
Description
Sitagliptin is a triazolopyrazine that exhibits hypoglycemic activity. It has a role as a serine proteinase inhibitor, a hypoglycemic agent, an EC 3.4.14.5 (dipeptidyl-peptidase IV) inhibitor, an environmental contaminant and a xenobiotic. It is a triazolopyrazine and a trifluorobenzene.
Classification
Small molecule
Drug classdipeptidyl aminopeptidase-IV inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
N[C@@H](CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F
Identifiers
PDB—
CAS-ID486460-32-6
RxCUI—
ChEMBL IDCHEMBL1422
ChEBI ID40237
PubChem CID4369359
DrugBankDB01261
UNII IDQFP0P1DV7Z (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‚£
Janumet – Merck & Co
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Januvia – Merck & Co
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Tabular view
Estimated US medical usage
Sitagliptin
+
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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Sitagliptin
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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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 13,924 documents
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Safety
Black-box Warning
Black-box warning for: Janumet, Sitagliptin and metformin hydrochloride, Zituvimet, Zituvimet xr
Adverse Events
Top Adverse Reactions
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48,948 adverse events reported
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