U.S. Food and Drug Administration (FDA)
Is Maridebart cafraglutide (MariTide) legal in United States?
Not approvedInvestigational; Amgen is running Phase 3 trials (MARITIME programme) and no FDA approval or filing has been reported
Not approved as a medicine here.
Maridebart cafraglutide (MariTide, Amgen) is an antibody-peptide conjugate that blocks the GIP receptor and activates the GLP-1 receptor. Amgen has US Phase 3 trials registered, including one on cardiovascular outcomes in adults with atherosclerotic disease and overweight or obesity, which is recruiting. No marketing application is public, so it is not approved and can be obtained lawfully only through trials.
Last verified 2026-09-29 · how we verify
Maridebart cafraglutide (MariTide) elsewhere
Sources (2)
- 01Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity, NCT07037433U.S. National Library of Medicine (ClinicalTrials.gov) · 2026-09 · accessed 2026-09-29
- 02Development & Approval Process | DrugsU.S. Food and Drug Administration · 2022-08-08 · accessed 2026-09-29