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, Sitagliptin metformin, 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 | 2025-11-05 |
| 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
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| type 2 diabetes mellitus | EFO_0001360 | D003924 | E11 |
| hypercholesterolemia | — | D006937 | — |
| coronary artery disease | — | D003324 | I25.1 |
| hypertriglyceridemia | EFO_0004211 | D015228 | — |
| hyperlipoproteinemias | — | D006951 | — |
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
549 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 | 45 | 37 | 135 | 102 | 81 | 396 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 19 | 30 | 93 | 62 | 42 | 240 |
| Healthy volunteers/patients | — | — | — | 16 | — | 1 | 3 | 2 | 22 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 3 | 7 | 2 | 7 | 2 | 18 |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | — | 1 | 1 | 3 | 5 | 10 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 2 | 1 | — | 4 | 3 | 10 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | 1 | 1 | 3 | 3 | 3 | 10 |
| Heart failure | D006333 | EFO_0003144 | I50 | 1 | — | — | 4 | 4 | 9 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 2 | 2 | 5 | 9 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | 2 | — | 4 | 3 | 9 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fibrosis | D005355 | — | — | 1 | 1 | 1 | — | 2 | 5 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | 4 | — | — | 5 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 1 | 1 | 1 | — | 1 | 4 |
| Inflammation | D007249 | MP_0001845 | — | — | 2 | 1 | — | 1 | 4 |
| Hyperlipidemias | D006949 | EFO_0003774 | E78.5 | — | 1 | 3 | — | — | 3 |
| Graft vs host disease | D006086 | — | D89.81 | — | 2 | 1 | — | — | 3 |
| Chronic renal insufficiency | D051436 | — | N18 | — | — | 2 | — | 1 | 3 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | 1 | — | 2 | 3 |
| Inferior wall myocardial infarction | D056989 | EFO_1000983 | — | — | 1 | 2 | — | — | 2 |
| Covid-19 | D000086382 | — | U07.1 | — | — | 1 | — | 1 | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 1 | 3 | — | — | — | 3 |
| Myelodysplastic syndromes | D009190 | — | D46 | 1 | 3 | — | — | — | 3 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 1 | 3 | — | — | — | 3 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 1 | 3 | — | — | — | 3 |
| Psoriasis | D011565 | EFO_0000676 | L40 | — | 2 | — | — | — | 2 |
| Gastroparesis | D018589 | EFO_1000948 | K31.84 | 1 | 1 | — | — | — | 2 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | — | 2 | — | — | — | 2 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | — | 2 | — | — | — | 2 |
| Myeloid leukemia | D007951 | — | C92 | — | 2 | — | — | — | 2 |
| Infertility | D007246 | EFO_0000545 | — | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Therapeutic equivalency | D013810 | — | — | 6 | — | — | — | — | 6 |
| Overweight | D050177 | — | E66.3 | 1 | — | — | — | 1 | 2 |
| Hepatitis c | D006526 | — | B19.2 | 1 | — | — | — | — | 1 |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | 1 | — | — | — | — | 1 |
| Hepatitis | D006505 | — | K75.9 | 1 | — | — | — | — | 1 |
| Chronic hepatitis | D006521 | — | K73.9 | 1 | — | — | — | — | 1 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | 1 | — | — | — | — | 1 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | 1 | — | — | — | — | 1 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 1 | — | — | — | — | 1 |
| Anorexia | D000855 | — | R63.0 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sepsis | D018805 | EFO_0001420 | A41.9 | — | — | — | — | 1 | 1 |
| Ischemic stroke | D000083242 | — | — | — | — | — | — | 1 | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | — | — | — | 1 | 1 |
| Vascular stiffness | D059289 | — | — | — | — | — | — | 1 | 1 |
| Physiological phenomena | D010829 | — | — | — | — | — | — | 1 | 1 |
| Morbid obesity | D009767 | EFO_0001074 | — | — | — | — | — | 1 | 1 |
| Angioedema | D000799 | EFO_0005532 | T78.3 | — | — | — | — | 1 | 1 |
| Randomized controlled trials as topic | D016032 | — | — | — | — | — | — | 1 | 1 |
| Endoplasmic reticulum stress | D059865 | EFO_1001886 | — | — | — | — | — | 1 | 1 |
| Exocrine pancreatic insufficiency | D010188 | — | K86.81 | — | — | — | — | 1 | 1 |
Show 8 more
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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Janumet – Merck & Co
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Januvia – Merck & Co
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Tabular view
Estimated US medical usage
Sitagliptin
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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 purchases
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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 15,209 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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46,637 adverse events reported
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