Is Retatrutide FDA Approved? Status & Timeline
No — Retatrutide is not yet FDA approved. Here's the current trial status, what the data shows, and the projected approval timeline.
Current Legal Status
Investigational (not yet FDA approved). Not legally available for human use outside of clinical trials in the US.
Clinical Trial Results
Retatrutide has been studied in multiple clinical trials. Here's a summary of the key findings:
24mg dose achieved mean body weight reduction of 24.2% at 48 weeks — the highest ever recorded for any injectable weight-loss drug in a clinical trial at the time.
Phase 3 trials ongoing. Expected to seek FDA approval in 2026–2027.
Projected Approval Timeline
What FDA Approval Will Mean
Phase 3 Trial Details
The Phase 3 program is evaluating Retatrutide across multiple trials:
| Trial | Population | Primary Endpoint | Status |
|---|---|---|---|
| Phase 2 (TRIUMPH-1) | Adults with obesity/overweight | Body weight reduction at 48 weeks | Published |
| Phase 3 (TRIUMPH-3, ongoing) | Adults with obesity/overweight | Weight loss + cardiovascular outcomes | Published |
Frequently Asked Questions
Is Retatrutide FDA approved?
No. As of 2026, Retatrutide is not FDA approved. It is currently in Phase 3 clinical trials. FDA filing is anticipated in 2026–2027.
What phase are Retatrutide clinical trials in?
Phase 2 (TRIUMPH-1): 24mg dose achieved mean body weight reduction of 24.2% at 48 weeks — the highest ever recorded for any injectable weight-loss drug in a clinical trial at the time. Phase 3 (TRIUMPH-3, ongoing): Phase 3 trials ongoing. Expected to seek FDA approval in 2026–2027.
When will Retatrutide be FDA approved?
Based on Phase 3 trial timelines and typical FDA review periods (6–12 months from filing), approval is projected for 2027–2028 if all goes on schedule.
What happens to Retatrutide access after FDA approval?
FDA approval means Retatrutide can be legally prescribed by physicians, dispensed by licensed pharmacies, and eventually covered by insurance. It also unlocks the possibility of compounding pharmacy versions if supply shortages occur.
Can I use Retatrutide before it's approved?
The main legal pathway is enrolling in an active clinical trial. Research-grade versions exist but are sold strictly for laboratory use, not human consumption.
References & Sources
- [1]Jastreboff AM, et al. Triple-Hormone-Receptor Agonist Retatrutide for Obesity — A Phase 2 Trial. N Engl J Med. 2023;389:514–526.
- [2]ClinicalTrials.gov NCT04867785 — TRIUMPH-1 (Phase 2, completed)
- [3]ClinicalTrials.gov NCT05703841 — TRIUMPH-3 (Phase 3, enrolling)
- [4]ClinicalTrials.gov NCT05882045 — TRIUMPH-CVOT (Phase 3 cardiovascular outcomes)
Exploring Retatrutide Access?
See how patients are accessing retatrutide through physician-supervised telehealth and compounding pharmacies.
Not FDA approved. Access requires physician oversight.
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