Is mazdutide FDA-approved?

Not in the US. Drugs@FDA lists no application with mazdutide as an active ingredient. China has approved it, but that doesn't apply in the US.

Checked 1 Nov 2026. The sources are below.

Mazdutide

Also: IBI362, LY3305677

Status label in the Peptimes Library
Approved outside the US
Routes in Peptimes
Subcutaneous
Updated
1 Nov 2026

US regulatory status

  • FDA status

    Not FDA-approved in the US. Drugs@FDA lists no application with mazdutide as an active ingredient.

    Source: Drugs@FDA, checked 1 Nov 2026

How to track it in Peptimes

Add mazdutide 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 “Approved outside the US”. In the US it is not FDA-approved. Innovent Biologics reports that China’s National Medical Products Administration (NMPA) approved its mazdutide injection in June 2025, with a second approval in September 2025. That approval doesn’t apply in the US, and other mazdutide products don’t share it.

  • 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 mazdutide or any other compound.

More sources

  • Innovent Biologics, press release, 27 Jun 2025 and press release, 19 Sep 2025 (copies on BioSpace), checked 1 Nov 2026: NMPA approvals of mazdutide in China (company-reported).
  • FDA, Drugs@FDA, searched 1 Nov 2026: no application lists mazdutide as an active ingredient.
  • FDA, Global Substance Registration System, Mazdutide, checked 1 Nov 2026: its sequence of 34 amino acids, the attached fatty-acid chain and the codes IBI362 and LY3305677.

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