Retatrutide FDA Approval Tracker
Tracking retatrutide — Eli Lilly's investigational triple GLP-1/GIP/glucagon receptor agonist — on its path to FDA approval. As of mid-2026 it remains in Phase 3 development and is not approved for any use.
- CurrentFDA approval statusNot approved (investigational)
Retatrutide is still in clinical development as of July 2026.
- CurrentTrial phasePhase 3 (multiple readouts through 2026)
The Phase 3 program showed ~24–29% mean weight loss in earlier readouts; Eli Lilly has several Phase 3 readouts expected across 2026.
- PendingEarliest possible approval2026–2027 (projected)
- CurrentCompounding legalityNot permitted
Retatrutide is not a component of an FDA-approved drug and cannot be legally compounded.
How we keep this current
Our AI Librarian periodically re-checks each line against primary sources — FDA notices, manufacturer announcements, and clinical-trial registries — and re-stamps the "last verified" date above. Fast-moving regulatory facts can still change between checks; always confirm against the linked primary source before relying on any single line.