FDA Tracker
Retatrutide FDA approval status
Updated as new data and regulatory milestones are released. FDA filing expected late 2026. Approval decision expected late 2027.
Phase 3 status
Complete
FDA filing
Late 2026
Approval expected
Late 2027
2023
CompletePhase 2 results published
NEJM publication of Phase 2b data. 24% weight loss at 48 weeks. NAFLD sub-study: 86% liver fat clearance.
2024
CompletePhase 3 trials initiated
TRIUMPH program launched. Multiple Phase 3 trials across obesity, NAFLD, and cardiovascular indications.
2025
CompletePhase 3 results released
2,339 patients. 80 weeks. 25% mean weight loss. No plateau at 2 years. FDA filing preparation begins.
Late 2026
UpcomingFDA filing (NDA/BLA) expected
Eli Lilly expected to submit New Drug Application to FDA. Standard review process begins (10–12 months).
Late 2027
UpcomingFDA approval decision expected
Priority review possible given unmet need. If approved, retatrutide enters US market as Eli Lilly branded product.
Research access before approval
Until FDA approval, retatrutide is available only through research-use suppliers operating under the research chemicals framework. The pre-approval window — typically the highest-demand period — runs from now through approximately 2027. Pricing is expected to increase significantly post-approval as the branded product enters the market.
This page is updated as regulatory milestones are confirmed. All timeline projections are estimates based on standard FDA review timelines. For research use only. Not medical advice.