Is ipamorelin FDA-approved?

No. Ipamorelin isn't FDA-approved: Drugs@FDA lists no application with it, and FDA puts ipamorelin acetate on its Category 2 list of bulk substances for compounding that may present significant safety risks.

Checked 1 Nov 2026. The sources are below.

Ipamorelin

Also: NNC 26-0161, ipamorelin acetate

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

US regulatory status

  • FDA status

    Not FDA-Approved. Drugs@FDA lists no application with ipamorelin as an active ingredient.

    Source: Drugs@FDA, checked 1 Nov 2026

  • FDA status

    On FDA's Category 2 list: FDA lists ipamorelin acetate among bulk drug substances for compounding that may present significant safety risks, under its interim policy for outsourcing facilities (503B), added 29 Sep 2023.

    Source: FDA, 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 humans

    In a placebo-controlled study in healthy men, ipamorelin caused a single burst of growth hormone release that peaked within an hour and then fell to negligible levels, in every group studied.

    Source: PMID 10496658, checked 1 Nov 2026

How to track it in Peptimes

Add ipamorelin 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 “Compounding Restricted”, the app’s label for compounds on FDA’s Category 2 list. Category 2 is FDA’s list of bulk drug substances for compounding that may present significant safety risks; it is not 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 ipamorelin or any other compound.

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