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Drug

Sitagliptin hydrochloride

Approved · EMA

Also known as Brynovin, Sitagliptin, sitagliptin (as hydrochloride), sitagliptin HCl.

1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Approval: Sitagliptin Accord (EMA)

Regulatory2022-04-25EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Sitagliptin hydrochloride
Aliases & brands
BrynovinSitagliptinsitagliptin (as hydrochloride)sitagliptin HCl
RxNorm CUI
2716481
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2022-04-25
Latest approval
2022-04-25
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2022-04-25Approval
Approval: Sitagliptin Accord (EMA)
Indication: For adult patients with type 2 diabetes mellitus, Sitagliptin Accord is indicated to improve glycaemic control: as monotherapy:- in patients inadequately controlled by diet andShow full indication

For adult patients with type 2 diabetes mellitus, Sitagliptin Accord is indicated to improve glycaemic control: as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.- a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.- a peroxisome proliferator-activated receptor gamma (PPARy) agonist (i.e. a thiazolidinedione) when use of a PPARy agonist is appropriate and when diet and exercise plus the PPARy agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.- a PPARy agonist and metformin when use of a PPARy agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Sitagliptin Accord is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Regulatory event sources are credited in the Regulatory Timeline above.