https://retatrutidestatus.com Verified changes to the regulatory status of retatrutide. Current status: Not FDA approved. Independent tracker, not affiliated with Eli Lilly or the FDA. en-US Fri, 31 Jul 2026 02:56:00 GMT 360 Retatrutide Status https://retatrutidestatus.com/news/triumph-2-and-triumph-3-topline-results https://retatrutidestatus.com/news/triumph-2-and-triumph-3-topline-results Thu, 23 Jul 2026 12:00:00 GMT results Lilly reported that both trials met their primary endpoint. With these two readouts, the company describes five Phase 3 retatrutide studies as positive. The cardiovascular event data in TRIUMPH-3 did not establish a benefit. What changed: Two additional pivotal trials read out. TRIUMPH-2 studied adults with type 2 diabetes and obesity or overweight; TRIUMPH-3 studied adults with severe obesity and established cardiovascular disease. Both met their primary weight endpoint. What did not change: None of these results has been through peer review. None of them changes the regulatory status. A trial meeting its endpoint is evidence for an application, not a substitute for one. Status before: Three Phase 3 trials with disclosed positive topline results Status after: Five Phase 3 trials with disclosed positive topline results Primary source: Lilly's triple agonist retatrutide successful in two additional Phase 3 obesity trials (Eli Lilly and Company) — https://investor.lilly.com/news-releases/news-release-details/lillys-triple-agonist-retatrutide-successful-two-additional Retatrutide Status https://retatrutidestatus.com/news/lilly-states-q1-2027-bla-submission-plan https://retatrutidestatus.com/news/lilly-states-q1-2027-bla-submission-plan Thu, 23 Jul 2026 12:00:00 GMT regulatory Eli Lilly said it is completing the manufacturing data package for a Biologics License Application and plans to file with the FDA in the first quarter of 2027. Nothing has been submitted yet, and the FDA has not set any date. What changed: For the first time, Lilly named a specific quarter for a U.S. regulatory submission. Before this, the company had disclosed trial results without naming a filing window. What did not change: Retatrutide is still investigational. Nothing has been filed with the FDA, the FDA has not accepted anything, there is no PDUFA date, and there is no approval. The drug cannot be prescribed. Status before: Investigational — no submission timing stated publicly Status after: Investigational — company has stated a Q1 2027 filing plan Primary source: Lilly's triple agonist retatrutide successful in two additional Phase 3 obesity trials (Eli Lilly and Company) — https://investor.lilly.com/news-releases/news-release-details/lillys-triple-agonist-retatrutide-successful-two-additional Retatrutide Status https://retatrutidestatus.com/news/transcend-t2d-1-published-in-the-lancet https://retatrutidestatus.com/news/transcend-t2d-1-published-in-the-lancet Sat, 13 Jun 2026 12:00:00 GMT publication TRANSCEND-T2D-1 was published in The Lancet — the first and, so far, only Phase 3 retatrutide trial to be externally peer reviewed rather than reported only by the sponsor. What changed: The type 2 diabetes trial went through external peer review and full publication, which means the methods and the complete dataset were examined by people outside the company. What did not change: The four TRIUMPH readouts remain unpublished. The regulatory status is unaffected — journals do not approve drugs. Status before: All Phase 3 results were sponsor-reported topline figures only Status after: One Phase 3 trial peer reviewed; the rest remain sponsor-reported topline figures Primary source: Efficacy and safety of retatrutide in people with type 2 diabetes and inadequate glycaemic control with diet and exercise (TRANSCEND-T2D-1) (The Lancet) — https://pubmed.ncbi.nlm.nih.gov/42250575/ Retatrutide Status