Rybelsus

Drug

Drug Profile

Rybelsus is oral semaglutide, a GLP-1 receptor agonist indicated for adults with type 2 diabetes to improve glycemic control and to reduce major adverse cardiovascular events in high-risk patients. The label describes semaglutide as a GLP-1 analogue that stimulates insulin secretion and lowers glucagon in a glucose-dependent manner. U.S. labeling lists initial approval in 2017.

Drug Class
Glucagon-like peptide-1 (GLP-1) receptor agonist
Approval Status
FDA approved (Initial U.S. Approval: 2017)
Mechanism of Action
GLP-1 receptor agonist that stimulates insulin secretion and lowers glucagon in a glucose-dependent manner, with minor delay of early postprandial gastric emptying.
Brand Names
  • RYBELSUS
Indications
  • \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\

Related News

FDA crackdown puts focus on risks of compounded GLP-1 weight-loss drugs

The FDA has announced plans to crack down on active pharmaceutical ingredients used in compounded GLP-1 drugs and warned about the risks of these products. The agency has cited counterfeit products, non-FDA-approved ingredients and more than 1,000 adverse event reports tied to compounded semaglutide and tirzepatide.

Indian Generic Semaglutide Launches Follow Novo Nordisk Patent Expiry

Seven Indian pharmaceutical companies have launched generic semaglutide drugs at prices 70-80% lower than Novo Nordisk's Ozempic following patent expiration. Novo Nordisk has cut prices by 37% to maintain market share as competition intensifies in India's growing weight-loss drug market.

Related Clinical Trials

NCT ID Title Status Phase
NCT07487103

Efficacy and Safety of QLG1091 vs Rybelsus as add-on to Metformin in Subjects With Type 2 Diabetes

NOT_YET_RECRUITING PHASE3
NCT05579977

Trial to Learn About the Study Medicine (PF-07081532) and Rybelsus in People With Type 2 Diabetes and Separately PF-07081532 in People With Obesity

TERMINATED PHASE2