Sitagliptin hydrochloride
Approved · EMAAlso known as Brynovin, Sitagliptin, sitagliptin (as hydrochloride), sitagliptin HCl.
Recent clinical, regulatory, research and industry developments relating to this drug.
Approval: Sitagliptin Accord (EMA)
Profile
Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.
Regulatory timeline
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.
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… Show full indicationShow less
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.
Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.
- RxNorm (U.S. National Library of Medicine) — drug identity
- Regulatory event sources are credited in the Regulatory Timeline above.