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Oncology · FDA Approved

Degarelix (Firmagon)

FDA-approved

How to ask your doctor
Written by Peptide Association Editorial TeamLast reviewed Editorial policy

01 · Overview

Degarelix is a synthetic decapeptide gonadotropin-releasing hormone (GnRH) receptor antagonist used for advanced prostate cancer, marketed as Firmagon. Unlike GnRH agonists it blocks pituitary GnRH receptors directly, suppressing luteinizing hormone and testosterone without the initial testosterone surge, so antiandrogen cover for flare is not needed (PMID 19035858).

The peptide contains unnatural amino acids that resist enzymatic breakdown.

02 · Research summary & key findings

Degarelix received FDA approval in December 2008 under NDA 022201. In the pivotal 12-month phase 3 CS21 trial of 610 patients, testosterone suppression to 0.5 ng/mL or below from day 28 through day 364 was achieved in 97.2 and 98.3 percent of degarelix patients versus 96.4 percent with leuprolide, meeting non-inferiority, and testosterone fell below that threshold within 3 days in over 95 percent of degarelix patients compared with none on leuprolide; injection-site reactions were much more common with degarelix (PMID 19035858). The randomized PRONOUNCE trial in men with prostate cancer and existing cardiovascular disease found no difference in major adverse cardiovascular events between degarelix and leuprolide at 1 year, though it was stopped early and underpowered (PMID 34459214).

03 · Regulatory status

Degarelix (Firmagon) has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.

Degarelix (Firmagon) is an FDA-approved medicine prescribed for the conditions on its label. It is not part of our intake, so we do not propose protocols for it. If you think it may be relevant to you, talk to your own doctor. How to ask your doctor.

04 · Administration routes

  • Subcutaneous injection

References

  1. [1]The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer BJU Int, 2008. PMID 19035858
  2. [2]Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Prostate Cancer: The Primary Results of the PRONOUNCE Randomized Trial Circulation, 2021. PMID 34459214

Primary literature

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Disclaimer: This information is provided for educational and research purposes only. It is not intended as medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before starting any peptide therapy. The Peptide Association does not endorse or recommend any specific treatment protocol. See our editorial policy for how this content is produced and reviewed. Clinicians: join the network.