Is gonadorelin FDA-approved?

Not as a product you can get today: Factrel and Lutrepulse were FDA-approved, but Drugs@FDA lists both as discontinued, and compounded gonadorelin isn't FDA-approved.

Checked 1 Nov 2026. The sources are below.

Gonadorelin

Also: GnRH, LHRH, gonadotropin-releasing hormone, Factrel, Lutrepulse

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

US regulatory status

  • FDA status

    Factrel (gonadorelin hydrochloride) was FDA-approved; Drugs@FDA lists it as Discontinued.

    Source: Drugs@FDA, checked 1 Nov 2026

  • FDA status

    Lutrepulse (gonadorelin acetate) was FDA-approved; Drugs@FDA lists it as Discontinued.

    Source: Drugs@FDA, checked 1 Nov 2026

  • FDA status

    Compounded drugs, compounded gonadorelin included, are not FDA-approved: FDA doesn't verify their safety, effectiveness or quality before they are marketed.

    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

    A multicentre trial of Lutrepulse in 109 women with primary or secondary hypothalamic amenorrhea reported ovulation in 91% and 96% of them, respectively. Multiple pregnancies occurred in 12%.

    Source: PMID 2122733, checked 1 Nov 2026

How to track it in Peptimes

Add gonadorelin 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”. No FDA-approved gonadorelin product is marketed today, and a compounded product isn’t FDA-approved.

  • Routes: subcutaneous or Other. Choose the one that matches each dose.
  • Logging: the amount you took, the route and how you feel.
  • Injection sites: subcutaneous doses record the site, and Insights shows where you’ve injected and how recently. It never suggests where to inject next. Other doses skip this step.
  • 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 gonadorelin or any other compound.

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