Eli Lilly has not yet submitted a Biologics License Application for retatrutide, the investigational triple agonist targeting GLP-1, GIP, and glucagon receptors, and company statements confirm plans to file only in the first quarter of 2027 after completing manufacturing and controls data. All pivotal Phase 3 TRIUMPH and TRANSCEND trials have delivered strong efficacy signals, including mean weight reductions of 20–28% at 80 weeks on the 12 mg dose alongside glycemic improvements, yet these results support a future application rather than an active FDA review. With the submission clock not started, standard or priority review timelines of six to twelve months make any 2026 approval decision impossible under current conditions. A realistic shift could occur only through an unexpected early filing combined with breakthrough therapy designation and accelerated review, though Lilly’s public timelines and ongoing classification dispute with the FDA over biologic versus drug status render such acceleration improbable before year-end.