Eli Lilly to File for Retatrutide Approval in 2027 After Two More Successful Late-Stage Trials
Eli Lilly announced it will file for regulatory approval of its next-generation obesity drug retatrutide in the first quarter of 2027, delaying earlier plans for a 2026 submission to gather additional manufacturing and quality-control data. The decision follows positive results from two new Phase 3 trials, bringing the total to five successful late-stage studies. In one trial, adults with obesity and Type 2 diabetes lost up to 20.8% of their weight (nearly 50 pounds) over 80 weeks. In another, patients with severe obesity and established cardiovascular disease lost up to 22.6% (55.8 pounds) and showed reduced cardiovascular risk factors. Retatrutide, a 'triple G' drug targeting GLP-1, GIP, and glucagon, is positioned as the next pillar of Lilly's obesity portfolio after Zepbound and the newly launched pill Foundayo. TD Cowen analysts estimate retatrutide could generate $3.8 billion in sales by 2030. Common side effects include diarrhea, nausea, and constipation.
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