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Reproductive & sexual health

Degarelix

A GnRH antagonist approved for advanced prostate cancer — hormone suppression without the initial flare.

L5Practice-changingApproved — narrow indicationApprovedHigh confidenceLast reviewed 2026-08-23
SC injection

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

Human evidence82/100
Preclinical evidence78/100
Human safety evidence80/100

Clinical maturity: Approved oncology medicine

Routes & formulations

Studied / approved routes

SC injection

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

  1. Discovery

  2. Preclinical

  3. Phase I

  4. Phase II

  5. Phase III

  6. Approved

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

Used to treat prostate cancer by suppressing androgen signalling — a therapeutic context, not a cancer-risk concern.

Regulatory status

FDA-approved (Firmagon) for treatment of advanced prostate cancer. Approval is specific to that oncology indication.

Evidence grade

L5Practice-changingHigh confidence

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

Sources fully curated

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.