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Degarelix regulatory status

Current status of Degarelix in the United States: FDA approved. In sport: Not WADA prohibited. Details, sources, and the dated timeline follow.

By the PeptideAgent Editorial Team. Draft, pending editorial review.  Last verified

What is the current status of Degarelix?

Regulatory: FDA approvedWADA: Not WADA prohibitedVerified: Verified Sep 23, 2026
FDA and compounding
FDA approved as Firmagon in December 2008 for advanced prostate cancer. No generic is available as of the last verified date. Because an approved product exists, compounding is not permitted beyond patient specific exceptions.
WADA
Not WADA prohibited
Access path
  1. Prescription from a urologist or oncologist, administered in clinic as a monthly subcutaneous injection.
  2. Not available through compounding or telehealth peptide clinics.

Full Degarelix page: evidence, dosing in the literature, and sources

How has the status of Degarelix changed over time?

  1. FDA

    FDA approves Firmagon (degarelix) for advanced prostate cancer

    FDA approved degarelix injection (Firmagon), a GnRH receptor antagonist peptide, for adults with advanced prostate cancer.

    Regulatory: FDA approvedSource: Drugs@FDA: Firmagon (degarelix) NDA 022201

Sources

Numbered citations in the answers above point here, followed by the regulatory sources on record for Degarelix and the source of each dated event.

  1. [1]FDA prescribing information for Firmagon (degarelix for injection), via DailyMedFDA, 2024
  2. [2]WADA Prohibited List, section S2 (GnRH and its analogs in males)WADA, 2026
  3. [3]Drugs@FDA: Firmagon (degarelix) NDA 022201FDA, 2008