Degarelix

Also known as: Firmagon · FE200486

FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval FDA-approved 2 applications
Randomized controlled trials 48 of 383 publications on PubMed
Registered clinical trials 170 51 active
Adverse event reports 5,879 3,926 classified as serious
  • Degarelix is an FDA-approved drug, marketed as Firmagon (first approval: December 24, 2008).
  • PubMed lists 383 publications mentioning it, including 48 randomized controlled trials and 30 animal-only studies.
  • ClinicalTrials.gov lists 170 registered studies testing it (51 active).
  • FDA's adverse event system (FAERS) holds 5,879 reports mentioning it; 3,926 classified as serious. Reports do not prove causation.

Research topics

  • Prostatic Neoplasms 92
  • Androgen Antagonists 61
  • Gonadotropin-Releasing Hormone 58
  • Antineoplastic Agents, Hormonal 28
  • Leuprolide 23
  • Testosterone 19
  • Cardiovascular Diseases 17
  • Androgens 16
  • Prostate-Specific Antigen 15
  • Neoadjuvant Therapy 14

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

Application Product Status First approval Sponsor
NDA022201 FIRMAGON Approved, marketed December 24, 2008 FERRING
ANDA215791 DEGARELIX ACETATE Tentative approval — CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD.

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

  • All publications 383
  • Human (MeSH) 253
  • Animal only 30
  • Clinical trials 65
  • Randomized controlled trials 48
  • Systematic reviews & meta-analyses 11
  • Case reports 28
  • Retracted 0

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered
170
Active
51
With posted results
58

Conditions studied

  • Prostate Cancer 93
  • Prostate Adenocarcinoma 9
  • Prostatic Neoplasms 7
  • Stage IV Prostate Cancer AJCC v8 5
  • Stage IVA Prostate Cancer AJCC v8 5
  • Stage IVB Prostate Cancer AJCC v8 5
  • Menopause 4
  • Stage IV Prostate Cancer 4
  • Metastatic Prostate Cancer 3
  • Recurrent Prostate Cancer 3
  • Biochemically Recurrent Prostate Carcinoma 3
  • Estrogen Deficiency 3
Study Status Phase Start
Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate Cancer
NCT07751133 University College, London
Recruiting Phase 3 August 28, 2026
Short Course ADT for High Risk Low/Intermediate Risk ARTERA Prostate Cancer
NCT07801664 NYU Langone Health
Recruiting Phase 2 August 6, 2026
Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT
NCT07455903 Baptist Health South Florida
Recruiting Phase 2 July 29, 2026
Radiotherapy After Prostatectomy for Node Positive Prostate Cancer
NCT07477626 Sun Yat-sen University
Recruiting Phase 3 March 20, 2026
Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response
NCT07142551 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Recruiting Phase 2 March 9, 2026
Safety and Efficacy Evaluation of LC-K76 in Patients With Metastatic Hormone-Sensitive Prostate Cancer
NCT07389174 Shanghai Changzheng Hospital
Not yet recruiting Early phase 1 Feb 2026
Safety and Preliminary Efficacy Evaluation of LC-K76 Plus Anti-PD-1 Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
NCT07389187 Shanghai Changzheng Hospital
Not yet recruiting Early phase 1 Feb 2026
A Study of BMS986365 in Combination With Degarelix in People With Prostate Cancer
NCT07335796 Memorial Sloan Kettering Cancer Center
Active, not recruiting Phase 2 January 9, 2026
CONVERT-HB1: Radical Prostatectomy After Systemic Therapy for High-volume Metastatic Hormone-sensitive Prostate Cancer
NCT07268794 Fudan University
Not yet recruiting Phase 2 November 30, 2025
Phase II Trial of PSA Response-based Androgen Deprivation Therapy and Nodal Coverage for Prostate Cancer Early Salvage Radiotherapy (RANGER)
NCT07313241 University of Texas Southwestern Medical Center
Recruiting Phase 2 November 14, 2025
Show 40 more studies
Study Status Phase Start
The COSMYC Trial (COmbined Suppression of MYC)
NCT06922318 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Recruiting Phase 2 August 19, 2025
Trial Evaluating the Safety and Efficacy Of MR-Linac-Guided Radiotherapy as Salvage Treatment After External Beam Radiotherapy Recurrence (TUMORNATOR II)
NCT07142967 NYU Langone Health
Recruiting N/A August 15, 2025
Presurgical Phase II Study of Talazoparib in Combination With Enzalutamide in Prostate Cancer
NCT05873192 M.D. Anderson Cancer Center
Recruiting Phase 2 June 3, 2025
Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer
NCT06734130 H. Lee Moffitt Cancer Center and Research Institute
Active, not recruiting Phase 2 January 10, 2025
A Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer: RADIOpharmaceutical DOSimetry Evaluation (RADIODOSE) Study
NCT06531499 Novartis Pharmaceuticals
Active, not recruiting Phase 1 November 11, 2024
NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.
NCT06379217 Novartis Pharmaceuticals
Active, not recruiting Phase 1 July 29, 2024
Study of Radiation Therapy in Combination With Darolutamide + Degarelix in Intermediate Risk Prostate Cancer
NCT04176081 University Health Network, Toronto
Not yet recruiting Phase 2 July 2, 2024
Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial
NCT06378866 Mayo Clinic
Recruiting Phase 2 June 3, 2024
Cardiometabolic Consequences of the Loss of Ovarian Function
NCT06264882 University of Colorado, Denver
Recruiting Phase 4 June 1, 2024
ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer
NCT06397703 NYU Langone Health
Recruiting Phase 2 April 16, 2024
NeoAdjuvant Theranostic Lutetium Study: The Nautilus Trial
NCT06066437 M.D. Anderson Cancer Center
Recruiting Phase 1, Phase 2 March 29, 2024
Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers
NCT06282588 Cancer Research Antwerp
Recruiting Phase 2, Phase 3 December 13, 2023
ETHAN - ET for Male BC
NCT05501704 Jose Pablo Leone
Recruiting Phase 2 October 11, 2023
Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer
NCT06059118 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Recruiting Phase 2 October 4, 2023
Neoadjuvant ADT With TULSA in the Treatment of Intermediate Risk Prostate Cancer
NCT05917860 Turku University Hospital
Active, not recruiting Phase 1 July 18, 2023
Adaptive Stereotactic Body Radiation Therapy to the Prostate and Pelvic Nodes With Simultaneous Integrated Boost to the MR-detected Nodule for Patients With High-risk and Unfavorable Intermediate-risk Prostate Cancer
NCT05628363 Washington University School of Medicine Results posted
Active, not recruiting N/A January 18, 2023
Prostate Medication, Metabolism and Gut Microbiota
NCT06001619 Turku University Hospital
Recruiting Phase 4 December 1, 2022
Testing Interruption of Hormonal Medications in Patients Responding Exceptionally to Therapy for Metastatic Prostate Cancer, (A-DREAM)
NCT05241860 Alliance for Clinical Trials in Oncology Results posted
Active, not recruiting Phase 2 November 21, 2022
First Strike, Second Strike Therapies for High Risk Metastatic Castration Sensitive Prostate Cancer
NCT05189457 H. Lee Moffitt Cancer Center and Research Institute
Active, not recruiting Phase 2 January 25, 2022
Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Blockade, in Patients With Newly Diagnosed, High-Risk Prostate Cancer
NCT04989946 University of Wisconsin, Madison
Active, not recruiting Phase 1, Phase 2 December 16, 2021
Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial
NCT05050084 NRG Oncology
Active, not recruiting Phase 3 December 6, 2021
Ovarian Hormone Regulation of Central and Cerebrovascular Hemodynamics (NoMEN Study)
NCT05057546 University of Colorado, Denver
Active, not recruiting Phase 4 November 22, 2021
A Clinical Study Evaluating The Benefit of Adding Rucaparib to Enzalutamide for Men With Metastatic Prostate Cancer That Has Become Resistant To Testosterone-Deprivation Therapy
NCT04455750 Alliance for Clinical Trials in Oncology
Active, not recruiting Phase 3 October 14, 2021
Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer
NCT04787744 VA Office of Research and Development
Active, not recruiting Phase 2, Phase 3 July 1, 2021
Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer
NCT04734730 City of Hope Medical Center
Recruiting Phase 2 May 4, 2021
A Phase I/II Study of PDS01ADC With Docetaxel and Abiraterone in Adults With Metastatic Castration Sensitive and PDS01ADC With Docetaxel in Castration Resistant Prostate Cancer
NCT04633252 National Cancer Institute (NCI)
Recruiting Phase 1, Phase 2 February 23, 2021
Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial
NCT04513717 NRG Oncology
Active, not recruiting Phase 3 January 21, 2021
Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging
NCT04423211 ECOG-ACRIN Cancer Research Group
Recruiting Phase 3 October 8, 2020
Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors
NCT04126070 Xiao X. Wei, MD Results posted
Active, not recruiting Phase 2 May 11, 2020
Bioenergetic Effects of Aging and Menopause (BEAM)
NCT04043520 University of Colorado, Denver
Recruiting Phase 4 September 24, 2019
REGN2810 Followed by Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer
NCT03951831 Mark Stein
Active, not recruiting Phase 2 May 16, 2019
Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer
NCT03678025 SWOG Cancer Research Network
Recruiting Phase 3 September 24, 2018
Radium Ra 223 Dichloride, Hormone Therapy and Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Prostate Cancer
NCT03361735 City of Hope Medical Center Results posted
Active, not recruiting Phase 2 August 29, 2018
ODM-201 vs Androgen Deprivation Therapy in Hormone naïve Prostate Cancer
NCT02972060 European Organisation for Research and Treatment of Cancer - EORTC
Active, not recruiting Phase 2 December 1, 2017
Trial Comparing Irradiation Plus Long Term Adjuvant Androgen Deprivation With GnRH Antagonist Versus GnRH Agonist Plus Flare Protection in Patients With Very High Risk Localized or Locally Advanced Prostate Cancer
NCT02799706 European Organisation for Research and Treatment of Cancer - EORTC
Active, not recruiting Phase 3 September 25, 2017
Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery
NCT03070886 NRG Oncology
Active, not recruiting Phase 2, Phase 3 April 5, 2017
Real-life Evaluation of the Effect of ADT in Prostate Cancer Patients in Asia (READT Asia Study)
NCT03703778 Chinese University of Hong Kong
Active, not recruiting — May 22, 2016
Neoadjuvant Phase 2 Study Comparing the Effects of AR Inhibition With/Without SRC or MEK Inhibition in Prostate Cancer
NCT01990196 Jonsson Comprehensive Cancer Center
Active, not recruiting Phase 2 September 23, 2014
Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer
NCT01786265 M.D. Anderson Cancer Center
Active, not recruiting Phase 2 February 5, 2013
Palifermin With Leuprolide Acetate for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation
NCT01746849 Memorial Sloan Kettering Cancer Center
Active, not recruiting Phase 2 Dec 2012

All 170 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports
5,879
Serious
3,926
With death outcome
686

Most reported reactions

  • Fatigue 436
  • Injection site pain 424
  • Injection site erythema 351
  • Hot flush 348
  • Asthenia 246
  • Injection site swelling 245
  • Death 219
  • Product storage error 209
  • Pyrexia 195
  • Prostatic specific antigen increased 188
  • Fall 181
  • Pain 174

Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.

Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query

FDA prescribing information

Official US prescribing information. Dosing sections are intentionally not shown.

  • FIRMAGON HUMAN PRESCRIPTION DRUG Ferring Pharmaceuticals Inc. January 30, 2024

Source: DailyMed / openFDA

Change history

No changes since monitoring began on October 30, 2026.