Is Retatrutide FDA approved?

No. Retatrutide is not approved by the FDA for any indication.

Retatrutide has no FDA approval for any use. In practice it is sold as a compounded preparation or labelled "research use only".

Neither of those is an FDA approval. Compounded preparations do not undergo premarket review for safety, effectiveness, or manufacturing quality. "Research use only" is a labelling phrase that lets a seller ship an unapproved substance without formally stating it is for human use — it describes their legal position, not the product's quality.

Source
Checked against the public registry
This answer is generated from ClinicalTrials.gov records, counting interventional human studies only. It is automated aggregation, not medical advice, and no physician has reviewed it. See how we count or open the Retatrutide page to check every trial yourself.