Retatrutide: Path to FDA Approval Tracker
Where things stand
As of 2026-10-24, retatrutide (Eli Lilly's GIP/GLP-1/glucagon triple agonist) is investigational and not approved anywhere. Lilly has reported five positive Phase 3 readouts (TRIUMPH-4, TRANSCEND-T2D-1, TRIUMPH-1, TRIUMPH-2, TRIUMPH-3) and said on 2026-07-23 that it plans to submit a Biologics License Application to FDA in Q1 2027; no submission or FDA acceptance has been announced and Lilly has not given an expected decision date. FDA states retatrutide cannot be used in compounding and has warned sellers of 'research use only' retatrutide.
Status by item
| name | nct id | status | primary completion | note | Source |
|---|---|---|---|---|---|
| TRIUMPH-1 (obesity/overweight) | NCT05929066 | Completed | 2026-04-06 | Topline reported 2026-05-21. | Source |
| TRIUMPH-2 (obesity with type 2 diabetes) | NCT05929079 | Completed | 2026-06-16 | Topline reported 2026-07-23. | Source |
| TRIUMPH-3 (obesity with cardiovascular disease) | NCT05882045 | Completed | 2026-04-16 | Topline reported 2026-07-23; MACE results not statistically significant. | Source |
| TRIUMPH-4 (obesity with knee osteoarthritis) | NCT05931367 | Completed | 2025-11-14 | Topline reported 2025-12-11. | Source |
| TRIUMPH-5 (vs. tirzepatide) | NCT06662383 | Active, not recruiting | 2026-11 | Results not yet reported. | Source |
| TRANSCEND-T2D-1 (type 2 diabetes vs. placebo) | NCT06354660 | Completed | 2026-01-22 | Topline reported 2026-03-19. | Source |
| Retatrutide vs. semaglutide in type 2 diabetes | NCT06260722 | Active, not recruiting | 2026-08-27 | Results not yet reported. | Source |
| Cardiovascular and kidney outcomes trial | NCT06383390 | Active, not recruiting | 2029-02 | Outcomes trial. | Source |
Timeline
- · Regulatory
FDA warns online sellers of 'research' retatrutide
FDA warning letters to five online peptide vendors cited retatrutide among unapproved new drugs and rejected 'for research use only' labeling as a defense.
FDA Warning Letter: Royal Peptides LLC (MARCS-CMS 734884) - · Legal
Lilly files six lawsuits against retatrutide sellers
Lilly announced suits in federal courts in California and Texas against med spas, a pharmacy and online peptide sellers, and said it had referred more than 200 individuals and entities to FDA, DOJ, state attorneys general and licensing boards.
Lilly news release (Aug 12, 2026) - · Trial
TRIUMPH-2 and TRIUMPH-3 positive; Q1 2027 BLA planned
At 80 weeks, weight fell up to 20.8% (TRIUMPH-2, type 2 diabetes) and 22.6% (TRIUMPH-3, established cardiovascular disease) vs. 4.0% and 3.2% with placebo. Lilly said it plans to submit a BLA to FDA in Q1 2027 after completing its CMC package.
Lilly news release (Jul 23, 2026) - · Trial
TRIUMPH-1 topline results
In 2,339 adults with obesity or overweight without diabetes, mean weight change at 80 weeks was -19.0%, -25.9% and -28.3% for 4, 9 and 12 mg vs. -2.2% with placebo (efficacy estimand).
Lilly news release (May 21, 2026) - · Trial
TRANSCEND-T2D-1 topline results
In 537 adults with type 2 diabetes, A1C fell up to 2.0% and weight up to 16.8% at 40 weeks vs. 0.8% and 2.5% with placebo.
Lilly news release (Mar 19, 2026) - · Trial
TRIUMPH-4: first Phase 3 readout
In 445 adults with obesity and knee osteoarthritis, weight fell 26.4% (9 mg) and 28.7% (12 mg) at 68 weeks vs. 2.1% with placebo, with reductions in WOMAC pain.
Lilly news release (Dec 11, 2025)
Questions
Is retatrutide FDA-approved?
No. As of 2026-10-24 it is investigational, and Lilly states no retatrutide medicine has been approved by any regulator worldwide.
When could FDA decide?
Lilly plans to submit in Q1 2027. Lilly has not announced an expected FDA action date, so any decision date is not confirmed.
Can retatrutide be compounded?
FDA states that 'Retatrutide and cagrilintide cannot be used in compounding under federal law' because they are not components of FDA-approved drugs.
Is 'research use only' retatrutide sold online legal?
FDA's August 2026 warning letters treated such products as unapproved new drugs intended for human use, and Lilly has sued several sellers.
Regulatory status changes; check the linked primary source before relying on any entry. This tracker is information, not legal advice. Report an error.