When will retatrutide be available? Probably not before late 2027. Lilly says it plans to submit retatrutide to the FDA in the first quarter of 2027, and an FDA review of a new drug normally takes 8 to 12 months from submission.[1][4] Until then, the only legal routes are a Lilly clinical trial or a narrow expanded access program.[5]
This page tracks where retatrutide stands, what happens next and what to watch for. For the science, see the retatrutide profile.
Where retatrutide stands in October 2026
Retatrutide is an investigational triple agonist from Eli Lilly that acts on GIP, GLP-1 and glucagon receptors. It is not approved by the FDA or sold by prescription anywhere in the US.
Lilly has finished the core clinical work. In its second-quarter 2026 results, published August 5, 2026, the company said its clinical data package was complete to support global registrations for obesity, obstructive sleep apnea and knee osteoarthritis pain, with plans to submit a Biologics License Application (BLA) to the FDA in the first quarter of 2027.[1] In July it said it was still completing the Chemistry, Manufacturing and Controls (CMC) part of that application, which covers how the drug is made and tested.[2]
Retatrutide development timeline
| Date | Milestone |
|---|---|
| 2023 | Phase 2 obesity results published; the phase 3 TRIUMPH program begins |
| December 11, 2025 | First phase 3 results (TRIUMPH-4, knee osteoarthritis) |
| May 21, 2026 | TRIUMPH-1 topline results |
| June 2026 | Expanded access program posted on ClinicalTrials.gov |
| July 23, 2026 | TRIUMPH-2 and TRIUMPH-3 topline results |
| August 5, 2026 | Lilly confirms a planned FDA submission in Q1 2027 |
| September 29, 2026 | TRIUMPH-1 and TRIUMPH-2 published in full |
| November 2026 (estimated) | Head-to-head trial against tirzepatide finishes its main phase |
| Q1 2027 (planned) | BLA submitted to FDA |
Sources: phase 2,[12] TRIUMPH-4,[11] TRIUMPH-1 topline,[3] expanded access,[5] TRIUMPH-2 and -3,[2] Lilly’s Q2 report,[1] the TRIUMPH-1 and TRIUMPH-2 papers[9][10] and TRIUMPH-5.[7]
When could the FDA approve retatrutide?
No approval date exists yet, because nothing has been submitted. What we can say is how long FDA reviews usually take.
Under FDA’s current review commitments (PDUFA VII), the agency aims to act on 90% of new biologics within 10 months of a 60-day filing period for a standard review, or 6 months for a priority review.[4] Adding the filing period, that is about 12 months or 8 months from submission.
If Lilly files in the first quarter of 2027 as planned, those goals point to a decision roughly between late 2027 (priority review) and early 2028 (standard review). This is our arithmetic, not a Lilly or FDA forecast. Timelines can slip if FDA asks for more information, schedules an advisory committee, or does not approve the application on the first review.
Lilly has not said how soon after an approval retatrutide would reach pharmacies.
What a first approval would likely cover
Lilly has said its data package supports registrations for three uses: chronic weight management in obesity, obstructive sleep apnea, and knee osteoarthritis pain.[1] Those match what the TRIUMPH trials tested. TRIUMPH-1, for example, included separate groups of 574 people with knee osteoarthritis and 243 with sleep apnea, and retatrutide improved both conditions compared with placebo.[9]
The phase 3 trials used three maintenance doses, 4 mg, 9 mg and 12 mg once weekly, reached by starting at 2 mg and stepping up every four weeks.[3] The final doses, warnings and who the drug is for will be set by the FDA label if retatrutide is approved, and they may differ from the trials.
Lilly describes its plans as “global” submissions, but it has not published dates for regulators outside the US.[2] Availability in other countries will depend on each country’s own review.
What is still to come before and after filing
- TRIUMPH-5: a head-to-head trial against tirzepatide in about 800 adults with obesity, with primary completion estimated for November 2026.[7]
- TRIUMPH-Outcomes: a roughly 5-year trial in about 10,000 adults with heart or kidney disease, testing whether retatrutide reduces heart attacks, strokes, heart failure events and kidney decline. Primary completion is estimated for February 2029, well after any first approval.[8]
- Other indications: Lilly is also studying retatrutide for type 2 diabetes, chronic low back pain and fatty liver disease.[2] These would need their own data and approvals.
How much will retatrutide cost?
There is no price. Lilly has not announced one in the releases and filings we reviewed. Insurance coverage would depend on the approved uses and on each plan.
Any “retatrutide price” you see online refers to unapproved products, not Lilly’s medicine. FDA says those products are of unknown quality.[6] To estimate what an approved weight-loss drug might cost you, look at how current options are priced and covered: see GLP-1 cost without insurance.
Can you get retatrutide before approval?
There are two legal routes:
- Clinical trials. Lilly says retatrutide is legally available only to participants in its clinical trials.[3] You can search ClinicalTrials.gov for studies that are recruiting.
- Expanded access. Since mid-2026, Lilly has offered single-patient pre-approval access for adults with a BMI of 35 or more despite the highest available dose of an approved weight-management drug, with at least two serious or life-threatening obesity-related complications, who cannot join a trial. A doctor must request it.[5]
What is not a legal route: compounding pharmacies and “research use” sellers. FDA says retatrutide cannot be used in compounding under federal law. It has warned telehealth companies for marketing it, ingredient suppliers for selling it to compounders, and companies selling it labeled “for research purposes” with dosing instructions.[6] See is retatrutide legal? for details.
What to do while you wait
If you need treatment for obesity or type 2 diabetes now, approved options exist, including tirzepatide and semaglutide. Waiting for retatrutide is a choice to discuss with a clinician, not a reason to delay care. Our comparisons of retatrutide vs tirzepatide and retatrutide vs semaglutide show how the trial results line up, and the retatrutide dosage guide covers the doses tested.
Questions to ask a clinician
- Is an approved medicine a good fit for me today?
- Would I qualify for a retatrutide trial or the expanded access program?
- If retatrutide is approved, how would switching work?
We update this page when Lilly files, when FDA accepts or rejects the application for review, and when FDA makes a decision.
