Retatrutide release date & FDA approval status

Research purposes only (investigational) Not FDA-approved

Retatrutide has now won phase 3 trial after phase 3 trial, with average weight loss up to −25.0% in its published TRIUMPH-1 results. So when can people actually get it? Here's exactly where it stands, with every date sourced.

The TRIUMPH timeline

2023Phase 2 published
Retatrutide 12 mg averaged −24.2% at 48 weeks vs −2.1% on placebo in 338 adults (NEJM 2023, PMID 37366315).
May–Aug 2023TRIUMPH phase 3 trials start
ClinicalTrials.gov start dates: TRIUMPH-3 May 30, TRIUMPH-1 July 10, TRIUMPH-2 July 11, TRIUMPH-4 Aug 1, 2023 (NCT05882045, NCT05929066, NCT05929079, NCT05931367). Lilly says the initial program enrolled more than 5,800 people.
Dec 11, 2025TRIUMPH-4: first phase 3 win
Obesity plus knee osteoarthritis, 68 weeks. 12 mg: −28.7% average weight (efficacy estimand; −23.7% treatment-regimen) and knee pain down 4.5 points on WOMAC at 9 mg (Lilly).
May 21, 2026TRIUMPH-1 topline
Obesity without diabetes, 80 weeks. 12 mg: −28.3% (efficacy estimand; −25.0% treatment-regimen), and 45.3% lost at least 30% of body weight (Lilly).
July 23, 2026TRIUMPH-2 & TRIUMPH-3 topline, filing plan
Type 2 diabetes: up to −20.8%. Severe obesity with heart disease: up to −22.6% (efficacy estimand, 80 weeks). Lilly said it plans to submit a BLA to FDA in Q1 2027 (Lilly).
Sept 29, 2026Full results published
TRIUMPH-1 in NEJM: −17.6%, −23.7% and −25.0% vs −3.9% on placebo (PMID 42814954). TRIUMPH-2 in The Lancet: −11.9%, −16.8% and −18.8% vs −5.1% (PMID 42810372). Both treatment-regimen estimand, online Sept 29.
Oct 2, 2026FDA: not a biologic
On remand from a federal court, FDA again concluded retatrutide is not a biological product, so an application would need to be submitted under section 505 of the FD&C Act rather than as a BLA (FDA letter, filed in the Seventh Circuit Oct 8, 2026).

"Efficacy estimand" estimates the effect if everyone stayed on treatment; "treatment-regimen estimand" counts everyone randomized, including people who stopped. That's why Lilly's press-release numbers run higher than the published ones.

What happens next

Submission: Lilly says it is finishing the chemistry, manufacturing and controls (CMC) package and then plans to submit in Q1 2027.
Pathway fight: Lilly wants retatrutide reviewed as a biologic (BLA). FDA's October 2 letter says it's a drug that needs a section 505 application. Lilly's legal challenge is ongoing in the U.S. Court of Appeals for the Seventh Circuit.
More trials: Lilly is also studying retatrutide in type 2 diabetes, chronic low back pain, cardiovascular and kidney outcomes, and fatty liver disease (MASLD).

Can you get it now?

Not legitimately. The only real retatrutide is Lilly's product in clinical trials. Products sold online are labeled for research purposes only, and their content isn't checked. If you're reading about people using it anyway, see what 13,589 users reported online and how to tell if a source is legit.

On semaglutide or tirzepatide? Our units calculator is the converter for semaglutide and tirzepatide vials.

Full trial results, myths and FAQs: our retatrutide guide. Comparing options: all four GLP-1s side by side.

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Retatrutide release date FAQ

When will retatrutide be released?

There's no release date yet. Lilly has said it plans to submit retatrutide to the FDA for U.S. approval in the first quarter of 2027. Lilly hasn't announced an approval or launch date, and we don't guess one.

Is retatrutide FDA-approved?

No. Retatrutide is investigational. Lilly says it cannot be legally sold or marketed for human use.

Has Lilly filed retatrutide with the FDA?

Not as of Lilly's latest update we found (July 23, 2026). Lilly said it was completing the manufacturing and quality (CMC) data package and planned to submit in Q1 2027.

Will retatrutide be reviewed as a drug or a biologic?

That's in dispute. Lilly plans a Biologics License Application (BLA). In an October 2, 2026 letter, FDA again concluded retatrutide is not a biological product and that an application would need to go under section 505 of the Federal Food, Drug, and Cosmetic Act. Lilly's legal challenge is ongoing.

How much weight did people lose in the retatrutide trials?

In TRIUMPH-1, published in NEJM, average weight change at 80 weeks was −17.6% (4 mg), −23.7% (9 mg) and −25.0% (12 mg) vs −3.9% on placebo.

Research purposes only. Not FDA-approved for human use, and products vary in quality. Findings above are from the studies cited.

Not medical advice. Education only. We don't sell anything or tell you what to take. Label doses are there so you can follow along with your prescriber. Talk to a licensed clinician about your health.