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Januvia(sitagliptin)
Efficib, Janumet, Januvia, Juvisync, Ristaben, Ristfor, Steglujan, Tesavel, Velmetia, Xelevia (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
Therapeutic Areas
Therapeutic Area
MeSH
nutritional and metabolic diseasesD009750
endocrine system diseasesD004700
Trade Name
FDA
EMA
Januvia
Combinations
Janumet, Steglujan (discontinued: Juvisync)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ertugliflozin
+
Sitagliptin phosphate
Tradename
Company
Number
Date
Products
STEGLUJANMerck Sharp & DohmeN-209805 RX2017-12-19
2 products, RLD, RS
Metformin hydrochloride
+
Sitagliptin phosphate
Tradename
Company
Number
Date
Products
JANUMET XRMerck Sharp & DohmeN-202270 RX2012-02-02
3 products, RLD, RS
JANUMETMerck Sharp & DohmeN-022044 RX2007-03-30
2 products, RLD, RS
Simvastatin
+
Sitagliptin phosphate
Tradename
Company
Number
Date
Products
JUVISYNCMerck Sharp & DohmeN-202343 DISCN2011-10-07
6 products, RLD
Hide discontinued
Sitagliptin phosphate
Tradename
Company
Number
Date
Products
JANUVIAMerck Sharp & DohmeN-021995 RX2006-10-16
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
janumetNew Drug Application2023-02-06
januviaNew Drug Application2023-04-26
steglujanNew Drug Application2021-11-19
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
type 2 diabetes mellitusEFO_0001360D003924E11
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
435 clinical trials
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Mock data
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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_0001360E1137341247938309
Diabetes mellitusD003920EFO_0000400E08-E132337418
Type 1 diabetes mellitusD003922EFO_0001359E103724215
Healthy volunteers/patients—10—13—14
ObesityD009765EFO_0001073E66.9—1—337
Non-alcoholic fatty liver diseaseD065626EFO_0003095K75.81—1—326
Glucose intoleranceD018149HP_0000833R73.03—2—215
HyperglycemiaD006943HP_0003074R73.9———5—5
HypertensionD006973EFO_0000537I10———224
Heart failureD006333EFO_0003144I501——3—4
Show 25 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cystic fibrosisD003550EFO_0000390E84111—14
HyperlipidemiasD006949EFO_0003774E78.5—13——3
Renal insufficiencyD051437HP_0000083N191—2——3
Graft vs host diseaseD006086D89.81—21——3
Chronic renal insufficiencyD051436N18——2—13
Inferior wall myocardial infarctionD056989EFO_1000983—12——2
InflammationD007249—11——2
Covid-19D000086382U07.1——1——1
Peptic ulcerD010437HP_0004398K27—11——1
Iron metabolism disordersD019189E83.1—11——1
Show 5 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PsoriasisD011565EFO_0000676L40—2———2
GastroparesisD018589EFO_1000948K31.8411———2
Myeloid leukemia acuteD015470C92.0—2———2
Non-hodgkin lymphomaD008228C85.9—2———2
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.0—2———2
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340—2———2
InfertilityD007246EFO_000054511———1
Hematopoietic stem cell transplantationD018380—1———1
Hiv infectionsD015658EFO_0000764B20—1———1
Myelodysplastic syndromesD009190D46—1———1
Show 3 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Therapeutic equivalencyD0138102————2
Hepatitis cD006526B19.21————1
Liver neoplasmsD008113EFO_1001513C22.01————1
Hepatic insufficiencyD0485501————1
Renal dialysisD006435EFO_0010690Z99.21————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Vascular stiffnessD059289————11
Exocrine pancreatic insufficiencyD010188K86.81————11
Systemic inflammatory response syndromeD018746EFO_1001478R65.10————11
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)
Structure (InChI/SMILES or Protein Sequence)
N[C@@H](CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F
Identifiers
PDB4FFW
CAS-ID486460-32-6
RxCUI593411
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 (P28843)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Januvia - Merck Sharp & Dohme
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£
₣
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Janumet - Merck Sharp & Dohme
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£
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 10,992 documents
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Safety
Black-box Warning
Black-box warning for: Janumet
Adverse Events
Top Adverse Reactions
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17,483 adverse events reported
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