Eli Lilly’s investigational triple hormone receptor agonist retatrutide remains unapproved as of late September 2026, with the company completing its Phase 3 TRIUMPH program but planning a Biologics License Application submission only in Q1 2027 after finalizing the chemistry, manufacturing, and controls package. Positive topline results across five trials showed weight reductions up to 22.6% at 80 weeks in high-risk populations, yet standard FDA review timelines of 10–12 months make a 2026 approval impossible. Trader consensus at 96.8% “No” reflects this clear regulatory calendar. A late-2026 filing or unexpected priority review could theoretically compress timelines, though manufacturing validation and data completeness currently preclude such acceleration.