Eli Lilly has not yet submitted a biologics license application for retatrutide, its investigational triple agonist targeting GLP-1, GIP, and glucagon receptors, with the company explicitly targeting a Q1 2027 filing after completing the chemistry, manufacturing, and controls package. As of early October 2026, five pivotal Phase 3 TRIUMPH trials have delivered positive topline results on weight loss and related endpoints in obesity, type 2 diabetes, osteoarthritis, and sleep apnea, but the regulatory clock has not started. FDA standard review typically spans 10–12 months after filing, placing any approval decision well into 2027 or later under normal timelines. While accelerated review or an unexpectedly early submission could theoretically shift this, the current data package and manufacturing readiness make 2026 approval improbable.