FDA approves Retatrutide this year?
As of September 4, 2026, the market gives “FDA approves Retatrutide this year?” a 97% chance of NO.
| YES odds | 4% |
|---|---|
| NO odds | 97% |
| Volume | $580,022 |
| Closes | December 31, 2026 |
Updated September 4, 2026 · Live data from Polymarket
About this market
Eli Lilly’s planned Biologics License Application submission for retatrutide in Q1 2027, following positive Phase 3 TRIUMPH trial results showing mean weight reductions of 20.8–28.3% at 80 weeks with the 12 mg dose of this triple GIP/GLP-1/glucagon receptor agonist, drives the 97.1% market-implied probability against 2026 FDA approval. The company is still finalizing chemistry, manufacturing, and controls data required for filing, and standard FDA review timelines of 10–12 months place any potential approval in late 2027 or 2028. Ongoing trials in cardiovascular outcomes and other indications further extend the data package. A realistic shift could occur only if Lilly accelerates submission with priority review designation or if regulators accept a rolling filing, though current manufacturing validation needs make such acceleration improbable before year-end.