Is Retatrutide FDA-Approved? Status and What Is Missing

What happened / Why it matters

Short answer. Retatrutide is an investigational drug. It is not FDA-approved for any use as of Nov. 5, 2026. Eli Lilly, which makes it, says it plans to submit an application to FDA in the first quarter of 2027. That is a company plan, not an FDA decision.

This page answers one question: is retatrutide approved, and what is missing? We keep it current and log each change below. For what the phase 3 trials found, see our report on TRIUMPH-1 and TRIUMPH-2. For the full evidence guide, see Retatrutide: What Published Trials Show, and Its Status. For how it compares with an approved drug, see Tirzepatide vs Retatrutide.

Is retatrutide approved?

No. A search of FDA’s Drugs@FDA data on Nov. 5, 2026 found no product listed under the name retatrutide. Drugs@FDA lists approved products, not pending applications, so it cannot tell us whether an application has been filed. What we have is Lilly’s statement: in a Sept. 29, 2026 release, the company says it plans to submit an application to FDA in the first quarter of 2027.

Where do the trials stand?

What about TRIUMPH-4, the knee osteoarthritis trial?

Retatrutide is not FDA-approved. TRIUMPH-4 is the trial in people with knee osteoarthritis, and its results do not change that.

In TRIUMPH-4, a 68-week trial of 445 adults without diabetes who had painful knee osteoarthritis and a body-mass index of at least 27, scores on the WOMAC pain scale (0 to 10) fell by 3.96 and 3.74 points on the two retatrutide doses and by 2.12 points on placebo, according to the NEJM paper. That is a difference of about 1.6 to 1.8 points, in the journal’s main analysis. People on placebo also improved, by 2.12 points. Lilly’s earlier figures, a drop of about 4.4 to 4.5 points, came from a different analysis that assumes people stayed on treatment. Between 12% and 18% of people on retatrutide stopped because of side effects, compared with 4% on placebo, according to Lilly’s December 2025 release.

Lilly first reported these results in December 2025. The results of TRIUMPH-4 and TRIUMPH-1-OA were published in the New England Journal of Medicine on Nov. 8, 2026. The journal says they were presented in part at the American College of Rheumatology’s annual meeting.

What is still missing?

• An application and an FDA decision. Neither exists yet that we can see. An FDA decision requires an application first.
• Long-term safety. The cardiovascular and renal outcomes trial has not reported.
• A published head-to-head comparison with tirzepatide. The registered trial is active, and we found no published results.

Can it be compounded?

No, according to FDA. FDA says that retatrutide and cagrilintide “cannot be used in compounding under federal law.” The HHS interim policy published Oct. 30, 2026 covers six other peptides and does not include retatrutide.

What has FDA said about retatrutide sold online?

FDA has sent warning letters to sellers of products labeled retatrutide, saying the products are unapproved new drugs. In a Dec. 8, 2025 letter to an API distributor, FDA wrote that “Retatrutide is a GLP-1 API that is not identified as an active ingredient in any drug approved by FDA.” Later letters to sellers, dated March 31 and Aug. 24, 2026, also named products labeled as retatrutide. A warning letter is FDA’s position on specific facts, not a ruling. See our tracker of FDA warning letters on peptides. Products sold online are not the product used in the trials, and we do not link to or recommend sellers.

Change log

We add a row each time an application is filed, FDA acts, or a trial reports, and we update the date at the top.

What does this mean for a reader?

Retatrutide is not available as an FDA-approved medicine. People who want to treat obesity or type 2 diabetes can talk with a licensed clinician about approved options and the evidence for each. We give no dosing guidance.

U.S. regulatory status checked Nov. 5, 2026.