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
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nutritional and metabolic diseases | D009750 |
| endocrine system diseases | D004700 |
Trade Name
FDA
EMA
Brynovin, Januvia, Zituvio
CombinationsJanumet, Steglujan, Zituvimet (discontinued: Juvisync, Sitagliptin 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
+
Sitagliptin phosphate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| JANUMET | Merck & Co | N-022044 RX | 2007-03-30 | 2 products, RLD, RS |
| JANUMET XR | Merck & Co | N-202270 RX | 2012-02-02 | 3 products, RLD, RS |
Sitagliptin phosphate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| JANUVIA | Merck & Co | N-021995 RX | 2006-10-16 | 3 products, RLD, RS |
Simvastatin
+
Sitagliptin phosphate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| JUVISYNC | Merck & Co | N-202343 DISCN | 2011-10-07 | 6 products, RLD |
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Ertugliflozin
+
Sitagliptin phosphate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| STEGLUJAN | Merck & Co | N-209805 RX | 2017-12-19 | 2 products, RLD, RS |
Sitagliptin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ZITUVIO | Zydus Therapeutics | N-211566 RX | 2023-10-18 | 3 products, RLD, RS |
Metformin hydrochloride
+
Sitagliptin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ZITUVIMET | Zydus Therapeutics | N-216743 RX | 2023-11-03 | 2 products, RLD, RS |
| ZITUVIMET XR | Zydus Therapeutics | N-216778 RX | 2024-07-18 | 3 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| brynovin | New Drug Application | 2025-01-02 |
| janumet | New Drug Application | 2025-03-25 |
| januvia | New Drug Application | 2024-11-14 |
| sitagliptin | NDA authorized generic | 2025-01-31 |
| sitagliptin - metformin | Export only | 2023-04-14 |
| sitagliptin and metformin hydrochloride | NDA authorized generic | 2025-06-09 |
| steglujan | New Drug Application | 2024-12-20 |
| zituvimet | New Drug Application | 2025-06-09 |
| zituvimet xr | New Drug Application | 2024-07-23 |
| zituvio | New Drug Application | 2025-01-31 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ERTUGLIFLOZIN / SITAGLIPTIN PHOSPHATE, STEGLUJAN, MSD SUB MERCK | |||
| 2024-09-17 | M-275 | ||
METFORMIN HYDROCHLORIDE / SITAGLIPTIN PHOSPHATE, JANUMET, MSD SUB MERCK | |||
| 2024-06-04 | PED | ||
| 2023-12-04 | M-187 | ||
| 2023-02-12 | PED | ||
METFORMIN HYDROCHLORIDE / SITAGLIPTIN PHOSPHATE, JANUMET XR, MERCK SHARP DOHME | |||
| 2024-06-04 | PED | ||
| 2023-12-04 | M-187 | ||
| 2023-02-12 | PED | ||
SITAGLIPTIN PHOSPHATE, JANUVIA, MERCK SHARP DOHME | |||
| 2024-06-04 | PED | ||
| 2023-12-04 | M-187 | ||
| 2023-02-12 | PED | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Ertugliflozin / Sitagliptin Phosphate, Steglujan, Msd Sub Merck | |||
| 9308204 | 2030-10-21 | DP | |
| 9439901 | 2030-10-21 | U-2214 | |
| 8080580 | 2030-07-13 | DS, DP | U-2214 |
| 7326708 | 2026-11-24 | DS, DP | U-802, U-1188, U-1227, U-2214 |
| Metformin Hydrochloride / Sitagliptin Phosphate, Janumet, Msd Sub Merck | |||
| 8414921 | 2028-07-21 | DP | U-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
545 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 | 16 | 8 | 65 | 14 | 15 | 118 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 7 | 7 | 63 | 13 | 5 | 95 |
| Hypoglycemia | D007003 | — | E16.2 | — | 1 | — | 1 | 1 | 3 |
| Hospitalization | D006760 | — | — | — | — | — | 1 | — | 1 |
| Hyperglycemia | D006943 | — | R73.9 | — | — | — | 1 | — | 1 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | — | — | 1 | — | 1 |
| Adipose tissue neoplasms | D018205 | — | — | — | — | — | 1 | — | 1 |
| Diabetic foot | D017719 | EFO_1001459 | — | — | — | — | 1 | — | 1 |
| Foot ulcer | D016523 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal insufficiency | D051437 | — | N19 | 1 | — | 2 | — | — | 3 |
| Chronic renal insufficiency | D051436 | — | N18 | — | — | 2 | — | — | 2 |
| Islets of langerhans transplantation | D016381 | — | — | — | — | 1 | — | — | 1 |
| Hyperlipidemias | D006949 | EFO_0003774 | E78.5 | — | — | 1 | — | — | 1 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | 1 | — | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | — | 1 | — | — | 1 | 2 |
| Gestational diabetes | D016640 | — | O24.4 | — | 1 | — | — | — | 1 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Liver failure | D017093 | — | K72.9 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Heart failure | D006333 | EFO_0003144 | I50 | 1 | — | — | — | — | 1 |
| Gastroparesis | D018589 | EFO_1000948 | K31.84 | 1 | — | — | — | — | 1 |
| Renal dialysis | D006435 | EFO_0010690 | Z99.2 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | — | — | — | 1 | 1 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Sitagliptin |
| INN | sitagliptin |
| 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 class | dipeptidyl 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
| PDB | — |
| CAS-ID | 486460-32-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1422 |
| ChEBI ID | 40237 |
| PubChem CID | 4369359 |
| DrugBank | DB01261 |
| UNII ID | QFP0P1DV7Z (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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Januvia – Merck & Co
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Janumet – Merck & Co
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Estimated US medical usage
Sitagliptin
+
Metformin
Total medical expenditures per year (USD, in millions)
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Sitagliptin
Total medical expenditures per year (USD, in millions)
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Number of purchases
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Trends
PubMed Central
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Additional graphs summarizing 14,593 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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46,040 adverse events reported
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