Retatrutide regulatory status
Current status of Retatrutide in the United States: Not eligible for compounding. In sport: WADA prohibited. Details, sources, and the dated timeline follow.
By the PeptideAgent Editorial Team. Draft, pending editorial review. Last verified
What is the current status of Retatrutide?
- FDA and compounding
- Not FDA approved and not approved by any other regulator as of the last verification date. Because retatrutide is not a component of an approved drug, has no USP monograph, and is not on the 503A bulks list, it cannot lawfully be compounded by 503A pharmacies or 503B outsourcing facilities. FDA has warned that unapproved GLP-1 class products sold online, including investigational molecules, are not evaluated for safety, quality, or dose. Any product sold as retatrutide outside a clinical trial is unlawful for human use.
- WADA
- WADA prohibited
- Access path
- No lawful United States access path identified on the last verified date outside a registered clinical trial.
- Not available as an FDA approved product and not eligible for compounding under section 503A or 503B while investigational.
- Products labeled research use only are not lawful for human use and are not verified for identity or purity.
Full Retatrutide page: evidence, dosing in the literature, and sources
How has the status of Retatrutide changed over time?
No dated regulatory event has been recorded for Retatrutide. That usually means no FDA, PCAC, Federal Register, or WADA action has named it specifically. Category-wide actions are listed on the tracker hub.
Sources
Numbered citations in the answers above point here, followed by the regulatory sources on record for Retatrutide and the source of each dated event.
- [1]FDA: concerns with unapproved GLP-1 drugs used for weight lossFDA, 2025
- [2]FDA: Bulk drug substances used in compounding under section 503A of the FD&C Act (links to the Category 1, 2, and 3 lists and the bulks list)FDA, 2026
- [3]WADA Prohibited List, section S0 non-approved substancesWADA, 2026
- [4]FDA prescribing information for Wegovy (semaglutide) injection and tablets, via DailyMedFDA
From the blog
- How to get retatrutide: clinical trials, expanded access, and the law
Retatrutide is not approved, so a clinical trial is the only lawful way to get it. How to search ClinicalTrials.gov, how expanded access works, and why online and compounded sources are unlawful.
- Retatrutide before and after: weight loss by dose and week in the trials
What retatrutide trials measured: 24.2% mean weight loss at 48 weeks in phase 2, up to 28.3% at 80 weeks in phase 3, and what happened to fat, waist size, and blood sugar.
- Retatrutide benefits beyond weight loss: liver fat, blood sugar, and blood pressure
What retatrutide trials measured besides weight: liver fat, HbA1c, blood pressure, lipids, fat mass, and knee pain. What is proven, what is post hoc, and what is still unknown.
- Retatrutide side effects: what the trials reported, dose by dose
Nausea, diarrhea, dysesthesia, heart rate, and dropouts in the retatrutide trials, with placebo rates. What the data say about safety, and what is still unknown.
- Retatrutide: where the phase 3 program stands
Five phase 3 readouts, one peer-reviewed paper, and no approval yet. What the retatrutide trials have shown, what is still pending, and why no one can lawfully sell it today.
- Peptides for weight loss, ranked by human evidence
Tirzepatide, semaglutide, and liraglutide lead on human trials. Retatrutide is trial-only, and AOD-9604 and 5-amino-1MQ are animal-only. Ranking, legal status, and dated prices.