Is petrelintide FDA-approved?

No. Petrelintide 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.

Petrelintide

Also: ZP8396, ZP-8396, RO7895515

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 petrelintide as an active ingredient.

    Source: Drugs@FDA, checked 1 Nov 2026

  • Investigational

    Yes.

    Source: ClinicalTrials.gov, checked 1 Nov 2026

What studies have looked at

Each point says who or what was studied and what the study reported, with its source and the date we checked it. These are findings from the sources cited, not advice or a promise of any result.

  • In animals or the lab

    Its developers at Zealand Pharma describe petrelintide as a long-acting analogue of human amylin, designed to stay chemically stable at about neutral pH while keeping its potency in lab and animal tests.

    Source: PMID 41217931, checked 1 Nov 2026

How to track it in Peptimes

Add petrelintide 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 petrelintide or any other compound.

More sources

  • NIH, ClinicalTrials.gov, NCT07843498, checked 1 Nov 2026: a Phase 3 study of petrelintide sponsored by Hoffmann-La Roche, recruiting, with the other names RO7895515 and ZP8396.
  • NIH, ClinicalTrials.gov, studies of petrelintide, checked 1 Nov 2026: registered studies, including Phase 1, 2 and 3 studies.
  • FDA, Drugs@FDA, checked 1 Nov 2026: no application lists petrelintide as an active ingredient.
  • FDA, Global Substance Registration System, Petrelintide, checked 1 Nov 2026: a modified peptide, and the code name ZP-8396.

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