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Drug

Degarelix acetate

Approved · EMA
Emerging researchLate-stage development

Also known as Degarelix, Firmagon, degarelix (as acetate).

RxNorm835863
3
Research papers
24
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Phase I/II Trial of Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Blockade, in Patients With Newly Diagnosed, High-Risk Prostate Cancer

Clinical trial2026-07-02Results expected Q4 2026 · ClinicalTrials.gov

A Phase 2 Study Combining Ipilimumab, Degarelix, and Radical Prostatectomy in Men With Newly Diagnosed Metastatic Castration Sensitive Prostate Cancer or Ipilimumab and Degarelix in Men With Biochemically Recurrent Castration Sensitive Prostate Cancer After Radical Prostatectomy

Clinical trial2026-06-30Completed · ClinicalTrials.gov

Parallel Phase III Randomized Trials for High Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk With Radiation (PREDICT-RT*)

Clinical trial2026-06-25Results expected Q4 2033 · ClinicalTrials.gov

Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation (GUIDANCE)

Clinical trial2026-06-25Results expected Q4 2026 · ClinicalTrials.gov

Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients With Post-ProstaTEctomy Biochemical Recurrence (INDICATE)

Clinical trial2026-06-18Results expected Q4 2032 · ClinicalTrials.gov

Presurgical Phase II Study of Talazoparib in Combination With Enzalutamide in de Novo Metastatic to Lymph Nodes Prostate Cancer

Clinical trial2026-06-12Results expected Q4 2026 · ClinicalTrials.gov

A Phase 1/2 Study of Darolutamide and Abemaciclib in High-Risk Prostate Cancer

Clinical trial2026-06-01Completed · ClinicalTrials.gov

A Phase I/II Study of High-Dose-Rate Brachytherapy as Monotherapy for Prostate Cancer

Clinical trial2026-05-17Completed · ClinicalTrials.gov

Approval: Degarelix Accord (EMA)

Regulatory2023-09-29EMA

The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer.

Research2008-12-01BJU international

A 1-year, open label, randomized phase II dose finding study of degarelix for the treatment of prostate cancer in North America.

Research2008-09-17The Journal of urology

Degarelix: a novel gonadotropin-releasing hormone (GnRH) receptor blocker--results from a 1-yr, multicentre, randomised, phase 2 dosage-finding study in the treatment of prostate cancer.

Research2008-05-08European urology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Degarelix acetate
Aliases & brands
DegarelixFirmagondegarelix (as acetate)
RxNorm CUI
835863
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2023-09-29
Latest approval
2023-09-29
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2023-09-29Approval
Approval: Degarelix Accord (EMA)
Indication: Degarelix Accord is a gonadotrophin releasing hormone (GnRH) antagonist indicated: for treatment of adult male patients with advanced hormone-dependent prostate cancer. for… Show full indication

Degarelix Accord is a gonadotrophin releasing hormone (GnRH) antagonist indicated: for treatment of adult male patients with advanced hormone-dependent prostate cancer. for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

104 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
104
registered trials across all phases
LATEST COMPLETION 2026
24
Active studies
10
Recruiting
42
Late-stage (III+)
56
Completed
24
Discontinued
PHASE DISTRIBUTIONn = 104
Early Phase 12Phase 16Phase 1 / 24Phase 250Phase 2 / 34Phase 326Phase 46Phase N / A6

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Cardiometabolic Consequences of the Loss of Ovarian Function

RecruitingPH IVUniversity of Colorado, Denvern=1002028

The Impact of Continuous Versus Intermittent Androgen Deprivation Therapy on Bone Mineral Density Change in Prostate Cancer Patients: A Multicenter, Randomized Clinical Trial

Unknown statusPH IVWonju Severance Christian Hospitaln=1642022

An Open-label, Single-Arm, Multicenter, Phase IV Trial to Evaluate the Safety of Firmagon® in Androgen Deprivation Therapy in Indian Patients Diagnosed With Advanced Hormone-dependent Prostate Cancer

CompletedPH IVFerring Pharmaceuticalsn=2302020

A Pilot Phase IV Study to Evaluate Variation in Bone Mineral Density, Lean and Fat Body Mass Index Measured by Dual-energy X-ray Absorptiometry in Patients With Prostate Cancer Without Bone Metastasis Treated With Degarelix

Unknown statusPH IVAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescian=352020

A Pilot Study on Endothelial Function and Cardiovascular Biomarkers in Prostate Cancer (PCa) Patients, With Pre-existing Cardiovascular Disease, Treated With Degarelix vs. Luteinizing Hormone-Releasing Hormone (LHRH) Agonists

CompletedPH IVRabin Medical Centern=802019

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 2 Study Combining Ipilimumab, Degarelix, and Radical Prostatectomy in Men With Newly Diagnosed Metastatic Castration Sensitive Prostate Cancer or Ipilimumab and Degarelix in Men With Biochemically Recurrent Castration Sensitive Prostate Cancer After Radical Prostatectomy

CompletedPH IIMemorial Sloan Kettering Cancer Centern=162026

A Phase 1/2 Study of Darolutamide and Abemaciclib in High-Risk Prostate Cancer

CompletedPH IPraful Ravi, MB BCHir, MRCPn=92026

A Phase I/II Study of High-Dose-Rate Brachytherapy as Monotherapy for Prostate Cancer

CompletedN/AStanford Universityn=1462026

Phase II-III Trial of Adjuvant Radiotherapy and Androgen Deprivation Following Radical Prostatectomy With or Without Adjuvant Docetaxel

CompletedPH II/IIINRG Oncologyn=6122025

A Pilot Study of Neoadjuvant Non-fucosylated Anti-CTLA-4 (BMS-986218) + Degarelix Acetate vs. Degarelix Acetate Alone in Men With High-risk Localized Prostate Cancer

CompletedPH IColumbia Universityn=262025

A Phase II Study of Docetaxel Before Medical Castration With Degarelix in Patients With Newly Diagnosed Metastatic Prostatic Adenocarcinoma.

CompletedPH IIMedical University of South Carolinan=522024

Research activity

3 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Journals, researchers & institutions
Top journals
  • BJU international1
  • European urology1
  • The Journal of urology1
Leading researchers
  • Jensen JK3
  • Persson BE3
  • Olesen TK2
  • Andreou C1
  • Boccon-Gibod L1
  • Cantor P1
  • de la Rosette JJ1
  • Gittelman M1
Leading institutions
free-text, unnormalised
  • University of Toronto1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.