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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.
4
Points tracked
4
Points current
1h
Since last verification
0
Points expired
Point statusCurrent — confirmed within its check windowChanged — the underlying fact movedPending — re-check queuedExpired — past its window, treat as unverified
Inside a tracker
Not approved — Phase 3 · 4 points| Tracked statement | Status | Source | Last confirmed |
|---|---|---|---|
| FDA approval status — Not approved (investigational) — Retatrutide is still in clinical development as of October 2026.Retatrutide is still in clinical development as of July 2026. | Current | — | Oct 1, 2026 |
| Trial phase — Phase 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.The Phase 3 program showed ~24–29% mean weight loss in earlier readouts; Eli Lilly has several Phase 3 readouts expected across 2026. | Current | — | Oct 1, 2026 |
| Earliest possible approval — 2026–2027 (projected) — No updates on approval status as of October 2026. | Current | — | Oct 1, 2026 |
| Compounding legality — Not permitted — Retatrutide is not a component of an FDA-approved drug and cannot be legally compounded.Retatrutide is not a component of an FDA-approved drug and cannot be legally compounded. | Current | — | Oct 1, 2026 |
Expired does not mean false — it means nobody has confirmed it recently enough for us to stand behind it. Nothing on this tracker is past its window right now.
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.