Reproductive & sexual health
Degarelix
A GnRH antagonist approved for advanced prostate cancer — hormone suppression without the initial flare.
Also known as: Firmagon
Evidence passport
Last reviewed 2026-08-23
- Evidence level
- L5Practice-changing
- Confidence
- High confidence
- Human efficacy
- 82/100
- Human safety
- 80/100
- Regulatory status
- Approved — narrow indication
- Development
- Approved
- Routes
- SC injection
- Evidence base
- Includes human data
- Furthest stage
- Approved
- Source curation
- Sources fully curated
- Clinical maturity
- Approved oncology medicine
Overview
Clinical maturity: Approved oncology medicine
Routes & formulations
Studied / approved routes
Approved as a subcutaneous depot-style injection administered by healthcare professionals.
Route availability is not evidence of efficacy, and evidence from one route does not transfer to another. The Registry never provides dosing or sourcing information.
Peptide lifecycle
Discovery
Preclinical
Phase I
Phase II
Phase III
Approved
What it is
A synthetic GnRH antagonist that rapidly lowers testosterone for androgen-deprivation therapy in advanced prostate cancer.
What people claim
- Testosterone suppression in advanced prostate cancer without an initial surge
What the evidence actually says
Controlled trials supported approval, including the mechanistic advantage of avoiding the testosterone flare seen with GnRH agonists. This is a treatment for a cancer, not a 'cancer-risk' compound — the distinction matters in this registry.
Human evidence
- Pivotal randomised trials in advanced prostate cancer supporting approval.
Preclinical evidence
- GnRH antagonist pharmacology and prostate-cancer models.
Animal and cell findings are Level 1–2 evidence.
Mechanism and pathways
- Immediate GnRH-receptor blockade suppresses LH/FSH and, downstream, testosterone.
Safety and unknowns
- Labelled effects include injection-site reactions and the consequences of intended androgen suppression.
- Cardiovascular and metabolic monitoring considerations are defined in the label.
Cancer relevance
No concern identified
Regulatory status
FDA-approved (Firmagon) for treatment of advanced prostate cancer. Approval is specific to that oncology indication.
Evidence grade
Replicated large randomised trials, pivotal Phase 3 programmes, or a major regulatory decision.
What would change our rating?
- Not applicable at this evidence tier.
References and sources
- Regulatory / labelFDA label — Firmagon (degarelix) prescribing information
Source hierarchy: regulatory documents and trial registries first, peer-reviewed work next, sponsor material flagged as non-independent. We never use supplier or clinic marketing as evidence, and where a verified source has not yet been curated we say so rather than inventing one.
Evidence change history
No recorded changes yet. Baseline position set on 2026-08-23.