FDA tracker
Retatrutide: FDA regulatory status
InvestigationalUpdated Apr 23, 2026
Phase 3 (Eli Lilly, 2025–)
Editorially reviewedThe Peptide Examiner editorial team, Editorial review · Reviewed Apr 23, 2026
Regulatory timeline
Dec 10, 2024 · Warning letter
FDA warning letters re: retatrutide sales
Research peptide vendors received warning letters specifically flagging retatrutide, an investigational drug not approved for human use, as being sold under research-use-only labeling paired with human-use framing.
What this means for patients
Retatrutide is investigational. Access is through clinical trial enrollment only. Research-peptide vendors selling it face FDA enforcement risk.