Drugs / Semaglutide

Semaglutide

Drug FDA approved

Marketed as Ozempic, Rybelsus, Wegovy

Glucagon-like peptide-1 (GLP-1) receptor agonist·First approved·2017·3 brands

Registered trials
376
Ongoing
127/ 34%
Completed
229
Indications
9

Approved indications by brand

Indications below are grouped by brand, since each brand carries its own label.

Brand Indication
Ozempic Type 2 diabetes mellitus (glycemic control adjunct to diet and exercise)
Reduction of major adverse cardiovascular events in adults with type 2 diabetes and established CVD
"Reduction of sustained eGFR decline
end-stage kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease"
Rybelsus Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Reduce risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus at high cardiovascular risk
Wegovy Reduce risk of major adverse cardiovascular events in adults with established cardiovascular disease and either obesity or overweight
Reduce excess body weight and maintain long-term weight reduction in adults/pediatric patients >=12 years with obesity and adults with overweight plus at least one weight-related comorbidity
Treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis with moderate to advanced fibrosis in adults (accelerated approval)

Added under accelerated approval. The indication may be withdrawn if confirmatory trials fail to verify clinical benefit.

Clinical trial landscape

376 registered studies reference this molecule or one of its brands. The split below shows how many are ongoing versus completed per phase.

Phase Total Ongoing Completed Split
Phase 3 113 35 73
Phase 1 78 9 67
Phase 2 61 31 26
Unknown 61 11 47
Phase 4 43 27 12
Not applicable 16 11 3
Phase 2/3 3 2 1
Phase 1/2 1 1 0
All phases 376 127 229

Ongoing Completed Balance withdrawn, terminated, or status unreported.

Study records: ClinicalTrials.gov →

Mechanism of action

GLP-1 receptor agonist that stimulates insulin secretion and lowers glucagon secretion in a glucose-dependent manner, with minor delay in early postprandial gastric emptying.

Recent developments