Eli Lilly has completed multiple Phase 3 TRIUMPH and TRANSCEND trials showing substantial weight loss and A1C reductions with retatrutide, a triple GIP/GLP-1/glucagon receptor agonist, yet the company has not submitted a Biologics License Application or New Drug Application to the FDA. Lilly’s stated plan targets filing only in Q1 2027 after finalizing the chemistry, manufacturing, and controls package, placing any potential approval well into late 2027 or 2028 under standard review timelines. With November 2026 already past the window for a 2026 decision, trader consensus reflects the absence of a filed application and the FDA’s typical review duration. An unexpectedly accelerated submission and priority review could theoretically compress timelines, though current data and regulatory statements indicate this remains improbable before year-end.