Is retatrutide FDA-approved?

No. Retatrutide is investigational: it's being studied in clinical trials and isn't FDA-approved for any use.

Checked 23 Oct 2026. The sources are below.

Retatrutide

Also: LY3437943

Status label in the Peptimes Library
Phase 3 Trials
Routes in Peptimes
Subcutaneous
Updated
25 Oct 2026

US regulatory status

  • FDA status

    Not FDA-approved for any use. Drugs@FDA lists no application for retatrutide, and FDA refers to "unapproved drugs such as retatrutide."

    Source: FDA, checked 23 Oct 2026

  • Investigational

    Yes.

    Source: ClinicalTrials.gov, checked 23 Oct 2026

How to track it in Peptimes

Add retatrutide in My Protocols and set the schedule you already follow: days of the week, times of day and a start date. Peptimes never suggests an amount when you log or schedule a dose. Its Library entry shows the status label “Phase 3 Trials”, which describes its investigational status. It isn’t an approval.

  • Logging: the amount you took and how you feel.
  • Injection sites: each dose records the site, and Insights shows where you’ve injected and how recently. It never suggests where to inject next.
  • Reminders and history: reminders at your times, Dose History, the Calendar and CSV or JSON export work as described on the peptide tracker app page.

Peptimes is a tracking app, not medical advice. Talk to a licensed clinician about your treatment. Peptimes doesn’t sell retatrutide or any other compound.

More sources

  • NIH, ClinicalTrials.gov, TRIUMPH-5 (NCT06662383), checked 23 Oct 2026: a Phase 3 study of retatrutide sponsored by Eli Lilly and Company, active, not recruiting.
  • NIH, ClinicalTrials.gov, studies of retatrutide, checked 23 Oct 2026: registered studies, including active Phase 3 studies.
  • FDA, Drugs@FDA, searched 23 Oct 2026: no application lists retatrutide as an active ingredient.
  • FDA, Global Substance Registration System, Retatrutide, checked 23 Oct 2026: the code name LY3437943.

Coming soon to the App Store

See planned pricing