U.S. Food and Drug Administration (FDA)
Is Mazdutide legal in United States?
Not approvedNot approved by FDA; Eli Lilly has run US Phase 2 studies of the medicine (LY3305677) but no application has been reported
Not approved as a medicine here.
Mazdutide (Eli Lilly code LY3305677, developed with Innovent in China) has no FDA approval and no reported US application. Lilly has registered US Phase 2 trials, for example in adults with obesity or overweight. Mazdutide's regulatory status elsewhere, including China, does not change its status here: in the US it is an investigational drug that can lawfully be supplied only in trials. FDA says it has warned companies that illegally sold mazdutide falsely labelled 'for research purposes' or 'not for human consumption'.
Last verified 2026-09-29 · how we verify
Mazdutide elsewhere
Sources (3)
- 01A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight, NCT06124807U.S. National Library of Medicine (ClinicalTrials.gov) · 2026-04 · accessed 2026-09-29
- 02Development & Approval Process | DrugsU.S. Food and Drug Administration · 2022-08-08 · accessed 2026-09-29
- 03FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight LossU.S. Food and Drug Administration · 2026-09-01 · accessed 2026-09-29