Is zenagamtide FDA-approved?

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

Checked 1 Nov 2026. The sources are below.

Zenagamtide

Also: amycretin, NNC0487-0111

Status label in the Peptimes Library
Phase 3 Trials
Routes in Peptimes
SubcutaneousOral
Updated
1 Nov 2026

US regulatory status

  • FDA status

    Not FDA-approved for any use. Drugs@FDA lists no application with zenagamtide or amycretin as an active ingredient.

    Source: Drugs@FDA, checked 1 Nov 2026

  • Investigational

    Yes.

    Source: ClinicalTrials.gov, checked 1 Nov 2026

How to track it in Peptimes

Add zenagamtide in My Protocols and set the schedule you already follow: days of the week, times of day and a start date. Its Library entry is called “Zenagamtide (amycretin)”. 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.

  • Routes: subcutaneous or oral. Choose the one that matches each dose.
  • Logging: the amount you took, the route and how you feel.
  • Injection sites: subcutaneous doses record the site, and Insights shows where you’ve injected and how recently. It never suggests where to inject next. Oral doses skip this step.
  • 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 zenagamtide or any other compound.

More sources

  • NIH, ClinicalTrials.gov, AMAZE 9 (NCT07720271), checked 1 Nov 2026: a Phase 3 study of zenagamtide sponsored by Novo Nordisk, recruiting.
  • NIH, ClinicalTrials.gov, studies of NNC0487-0111, checked 1 Nov 2026: Novo Nordisk studies under its code name, including AMAZE 1 (NCT07339423), a Phase 3 study, and NCT06049329, titled with the name amycretin.
  • FDA, Drugs@FDA, checked 1 Nov 2026: no application lists zenagamtide or amycretin as an active ingredient.
  • FDA, Global Substance Registration System, Zenagamtide, checked 1 Nov 2026: a modified fusion peptide, under its nonproprietary (INN) name.

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