Is buserelin FDA-approved?

Not in the US. Drugs@FDA lists no application with buserelin as an active ingredient. Canada lists Suprefact as a marketed prescription medicine, but that doesn't apply in the US.

Checked 1 Nov 2026. The sources are below, with the non-US regulator in More sources.

Buserelin

Also: Suprefact, Suprecur, buserelin acetate, HOE 766

Status label in the Peptimes Library
Approved outside the US
Routes in Peptimes
Subcutaneous
Updated
1 Nov 2026

US regulatory status

  • FDA status

    Not FDA-approved in the US. Drugs@FDA lists no application with buserelin as an active ingredient.

    Source: Drugs@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 1-year randomised trial in 140 men with painful metastatic prostate cancer, buserelin, estrogens and orchiectomy showed no significant differences in testosterone suppression or survival.

    Source: PMID 8908651, checked 1 Nov 2026

How to track it in Peptimes

Add buserelin 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 “Approved outside the US”. In the US it is not FDA-approved.

  • 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 buserelin or any other compound.

More sources

  • Health Canada, Drug Product Database, SUPREFACT, DIN 02225166, checked 1 Nov 2026: buserelin (as buserelin acetate) subcutaneous solution, prescription, status “Marketed”.
  • FDA, Drugs@FDA, checked 1 Nov 2026: no application lists buserelin as an active ingredient.
  • FDA, Global Substance Registration System, Buserelin, checked 1 Nov 2026: its formula and its description as an LHRH analog.

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