Peptide reference
Degarelix
Firmagon ·FE200486 ·Degarelix acetate
What cited sources report about Degarelix
Degarelix is a synthetic decapeptide GnRH receptor antagonist developed by Ferring Pharmaceuticals and marketed as Firmagon. Unlike GnRH agonists (leuprolide, goserelin), degarelix produces immediate suppression of LH, FSH, and testosterone without an initial flare, which is the key clinical differentiator. It was approved by the FDA in December 2008 and by the EMA in 2009. The summaries below report what individual cited sources state; this page does not assert claims beyond what those sources report.
FDA DailyMed — Firmagon prescribing information
The current US prescribing information describes degarelix as a GnRH receptor antagonist indicated for treatment of patients with advanced prostate cancer. The recommended starting dose is 240 mg administered as two 120 mg subcutaneous injections, followed by an 80 mg maintenance dose every 28 days. The label highlights the absence of testosterone surge as the principal mechanistic differentiator from GnRH agonists.
FIRMAGON is a gonadotropin releasing hormone (GnRH) receptor antagonist indicated for treatment of patients with advanced prostate cancer.
Klotz et al. (2008) — BJU International (CS21 pivotal trial)
The pivotal CS21 trial was a 12-month open-label, randomized, parallel-group phase 3 study in 610 men with prostate cancer randomized to degarelix 240/80 mg, degarelix 240/160 mg, or leuprolide 7.5 mg monthly. Both degarelix regimens met the primary endpoint of testosterone suppression to ≤0.5 ng/mL across 12 months and were non-inferior to leuprolide. The authors observed faster testosterone suppression and no testosterone surge with degarelix.
Both degarelix dosing regimens were not inferior to leuprolide at maintaining low testosterone levels over a 12-month treatment period.
European Medicines Agency — Firmagon EPAR
The EMA European Public Assessment Report summarizes the centralized authorization for Firmagon for treatment of adult male patients with advanced hormone-dependent prostate cancer. The dossier describes the GnRH antagonist mechanism, a 240 mg starting dose with 80 mg monthly maintenance, and the pharmacovigilance commitments.
ClinicalTrials.gov NCT00295750 — CS21 registration trial
The CS21 registry record describes the pivotal phase 3 study sponsored by Ferring Pharmaceuticals that randomized 610 men with prostate cancer to two degarelix dosing regimens or monthly leuprolide. Primary endpoint was the cumulative probability of testosterone ≤0.5 ng/mL from day 28 through day 364.
PubChem CID 16136245 — National Center for Biotechnology Information
The PubChem record for degarelix lists the decapeptide structure with several non-natural amino acid substitutions, molecular formula C82H103ClN18O16, molecular weight 1632.3 g/mol, and aggregated synonyms (Firmagon, FE200486).
Coverage notes
Degarelix is the most established GnRH receptor antagonist for prostate cancer and the principal alternative to GnRH agonists when avoidance of the testosterone surge is clinically important. The CS21 trial (Klotz 2008) is the pivotal randomized evidence that supported FDA and EMA approval. This page reflects FDA labeling current as of the cited sources.