Retatrutide approval tracker

Status today: Retatrutide is an investigational drug. The FDA has not approved it for any use, and Lilly says it "cannot be legally sold or marketed for human use" (Lilly, Jul 23 2026).

At a glance

Phase 3 results (80 weeks)

Lilly's press releases report the efficacy estimand (the effect if everyone stayed on treatment). Peer-reviewed papers also report the treatment-regimen estimand (everyone randomized, adherent or not), which usually gives a smaller number. We show both where both are public.

TRIUMPH-1: adults with obesity or overweight, without diabetes (2,339 participants)

Sources: Lilly May 21 2026; PubMed 42814954. The trial also met endpoints for knee osteoarthritis pain and obstructive sleep apnea.

TRIUMPH-2: obesity or overweight with type 2 diabetes (1,152 participants): −12.7% / −19.1% / −20.8% (4 / 9 / 12 mg) vs −4.0% placebo. A1C fell by up to 1.6 points. (Lilly)

TRIUMPH-3: severe obesity (BMI ≥35) with established cardiovascular disease (1,949 participants): −21.6% / −22.6% (9 / 12 mg) vs −3.2% placebo. This was not a cardiovascular outcomes trial. Cardiovascular events were few, and the hazard ratios were not statistically significant. (same source)

Side effects reported: mostly gastrointestinal (nausea, diarrhea, constipation, vomiting). Dysesthesia (abnormal skin sensations) was more common than on placebo. For dose-by-dose rates and discontinuation rates, see the Lilly releases above. PeptideX does not give dosing instructions.

Can anyone get retatrutide now?

• Only through clinical trials or a physician-initiated expanded access program (ClinicalTrials.gov NCT07629401; search all retatrutide trials).
• Products sold online as "retatrutide", including "research use only" vials, are not FDA-approved. The FDA has issued warning letters to sellers (FDA: concerns with unapproved GLP-1 drugs), and Lilly has filed lawsuits against sellers (example complaint).

Approval status and timeline

Retatrutide is investigational and not FDA approved. Lilly says it can't legally be sold or marketed for human use. Lilly plans to submit to FDA in the first quarter of 2027 and says there is no guarantee that timeline will be met (Lilly Medical, Lilly, checked Nov 2, 2026).

Phase 3 TRIUMPH trials on ClinicalTrials.gov (separate trials, not head to head, except TRIUMPH-5, which compares retatrutide with tirzepatide):

• TRIUMPH-1: NCT05929066
• TRIUMPH-2: NCT05929079
• TRIUMPH-3: NCT05882045
• TRIUMPH-4: NCT05931367
• TRIUMPH-5: NCT06662383
• TRIUMPH-6: NCT06859268
• TRIUMPH-7: NCT07035093
• TRIUMPH-8: NCT07232719
• TRIUMPH-9: NCT07357415
• TRIUMPH-Outcomes: NCT06383390

See also the comparison with approved medicines, the GLP-1 cost guide, and whether "research" retatrutide is legal or safe to buy.

Changelog

• 2026-11-02: Added approval status and TRIUMPH trial registry links; removed projected decision date.
• 2026-10-21: Page created.

This tracker is updated within 24 hours of any Lilly or FDA announcement. Get alerts on legal status changes.