Is cagrilintide FDA-approved?

No. Cagrilintide 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.

Cagrilintide

Also: AM833

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

US regulatory status

  • FDA status

    Not FDA-approved for any use. Drugs@FDA lists no application with cagrilintide 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 cagrilintide 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 cagrilintide or any other compound.

More sources

  • NIH, ClinicalTrials.gov, RENEW 4 (NCT07745504), checked 1 Nov 2026: a Phase 3 study of cagrilintide compared with placebo, sponsored by Novo Nordisk, recruiting.
  • NIH, ClinicalTrials.gov, studies of cagrilintide, checked 1 Nov 2026: registered studies, all sponsored by Novo Nordisk, including Phase 3 studies.
  • FDA, Drugs@FDA, searched 1 Nov 2026: no application lists cagrilintide as an active ingredient.
  • FDA, Global Substance Registration System, Cagrilintide, checked 1 Nov 2026: its sequence of 37 amino acids and the attached fatty-acid chain.

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