Ozempic®

Drug

Drug Profile

Ozempic is a semaglutide GLP-1 analog used for type 2 diabetes and cardio-renal risk reduction in appropriate adults. It is administered as a once-weekly injection, and tablet formulations are also listed under the Ozempic brand. The FDA first approved Ozempic on December 5, 2017.

Drug Class
GLP-1 analog / GLP-1 receptor agonist
Approval Status
FDA approved; first approved December 5, 2017.
Mechanism of Action
Semaglutide selectively binds and activates GLP-1 receptor, stimulating insulin secretion and lowering glucagon when glucose is high.
Brand Names
  • Ozempic
Indications
  • \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\

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.

Related Clinical Trials

NCT ID Title Status Phase
NCT07046273

Phase III Clinical Study on the Efficacy and Safety of Semaglutide and Ozempic® in Patients With Type 2 Diabetes

NOT_YET_RECRUITING PHASE3
NCT06967389

Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity

RECRUITING
NCT06739044

Efficacy and Safety of Semaglutide Injection vs Ozempic® in Patients With Type 2 Diabetes

COMPLETED PHASE3
NCT06634927

Pharmacokinetic Similarity, Safety, and Immunogenicity of Semaglutide Injection and Ozempic ® Injection in Healthy Subjects.

COMPLETED PHASE1
NCT06161844

Efficacy and Safety of Semaglutide Injection (HD1916) in Patients With Type 2 Diabetes Mellitus

COMPLETED PHASE3
NCT04572165

Epidemiological Assessment of the Risk for Pancreatic Cancer Associated With the Use of Semaglutide in Patients With Type 2 Diabetes - A Cohort Study Based on Nordic Registry Data

ENROLLING_BY_INVITATION