Is pegapamodutide FDA-approved?

No. Pegapamodutide 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.

Pegapamodutide

Also: OPK-88006, OPK88006, OPK-88003, OPK88003, TT401, LY2944876, LY-2944876

Status label in the Peptimes Library
Phase 1 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 pegapamodutide 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 pegapamodutide 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 1 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 pegapamodutide or any other compound.

More sources

  • NIH, ClinicalTrials.gov, NCT07512427, checked 1 Nov 2026: a Phase 1/2 study of OPK-88006 sponsored by OPKO Health, recruiting.
  • NIH, ClinicalTrials.gov, NCT02119819 and NCT02188303 (LY2944876), and NCT03406377 (OPK-88003), checked 1 Nov 2026: earlier Phase 2 and Phase 1 studies, completed or terminated.
  • FDA, Drugs@FDA, checked 1 Nov 2026: no application lists pegapamodutide as an active ingredient.
  • FDA, Global Substance Registration System, Pegapamodutide, checked 1 Nov 2026: its 39-amino-acid sequence and the code name LY2944876.

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