Is sermorelin FDA-approved?

Not now. Geref (sermorelin acetate) injection was FDA-approved, but Drugs@FDA lists it as discontinued and lists no other sermorelin product. Compounded sermorelin isn't FDA-approved.

Checked 1 Nov 2026. The sources are below.

Sermorelin

Also: sermorelin acetate, GHRH 1-29, GRF 1-29, groliberin

Status label in the Peptimes Library
Compoundable
Routes in Peptimes
Subcutaneous
Updated
1 Nov 2026

US regulatory status

  • FDA status

    No longer marketed. Drugs@FDA lists Geref (sermorelin acetate) injection, NDA 019863, approved 28 Dec 1990, as discontinued.

    Source: Drugs@FDA, checked 1 Nov 2026

  • FDA status

    No longer marketed. Drugs@FDA lists Geref (sermorelin acetate) injection, NDA 020443, approved 26 Sep 1997, as discontinued. It lists no other application with sermorelin as an active ingredient.

    Source: Drugs@FDA, checked 1 Nov 2026

  • FDA status

    FDA: "Compounded drugs are not FDA-approved." Compounded sermorelin doesn't share Geref's approval.

    Source: FDA, checked 1 Nov 2026

How to track it in Peptimes

Add sermorelin 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 “Compoundable”, which is about compounding. It isn’t an FDA 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 sermorelin or any other compound.

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