Drugs / Degarelix
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Degarelix

Other / unclassified targets GNRHR, TMPRSS2 via inhibition

Developed for
prostate cancer · prostate adenocarcinoma · prostate neoplasm · benign prostatic hyperplasia · metastatic prostate carcinoma · prostate carcinoma · adenocarcinoma in situ · COVID-19
+8 more · endometriosis · hormone receptor-positive breast cancer · infiltrating bladder urothelial carcinoma · invasive breast carcinoma · invasive ductal breast carcinoma · male breast carcinoma · ovarian hyperstimulation syndrome · ovarian ectopic pregnancy
Investigated by
Ferring Pharmaceuticals · Memorial Sloan Kettering Cancer Center · National Cancer Institute (NCI) · Turku University Hospital · Astellas Pharma Inc · M.D. Anderson Cancer Center
+65 more · Bayer · British Columbia Cancer Agency · Centre for Endocrinology and Reproductive Medicine, Italy · European Organisation for Research and Treatment of Cancer - EORTC · Ferring Pharmaceuticals Korea, Ltd. · Janssen Scientific Affairs, LLC · NRG Oncology · Rabin Medical Center · Radiation Therapy Oncology Group · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · University Health Network, Toronto · University of Texas Southwestern Medical Center · University of Washington · Assistance Publique - Hôpitaux de Paris · AstraZeneca · Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Baptist Health South Florida · BioSante Pharmaceuticals · Blue Earth Diagnostics · Blue Earth Therapeutics Ltd · Bristol-Myers Squibb · Brown University · Cambridge University Hospitals NHS Foundation Trust · Centre Leon Berard · City of Hope Medical Center · Cures Within Reach · David H. Koch Charitable Foundation · Duke Clinical Research Institute · Duke University · ETOP IBCSG Partners Foundation · Eli Lilly and Company · Endeavor Health · Eulji University Hospital · GU Research Network, LLC · Jose Pablo Leone · Kenneth Pienta, MD · Legorreta Cancer Center at Brown University · Lifespan · Medical University of South Carolina · NYU Langone Health · Northwestern University · OHSU Knight Cancer Institute · Ottawa Hospital Research Institute · Perlmutter New York University Cancer Center · Prostate Cancer Canada · Prostate Cancer Foundation · Prostate Cancer Foundation Norway · Rutgers Cancer Institute of New Jersey · Swedish Orphan Biovitrum · The University of Texas Health Science Center, Houston · Translational Breast Cancer Research Consortium (TBCRC) · UNICANCER · URC-CIC Paris Descartes Necker Cochin · United States Department of Defense · University of California, Los Angeles · University of Cambridge · University of Colorado, Denver · University of Michigan · University of North Carolina · University of Wisconsin, Madison · Urology of Virginia · VA Office of Research and Development · Wayne State University · Weill Medical College of Cornell University · Wonju Severance Christian Hospital

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Firmagon 2009-02-17 europa.eu
Approved US (FDA) FIRMAGON 2008-12-24 fda.gov

Trials 91 · started per year

today
US approved 2008
EU approved 2009
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2001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 02 trials
Phase 0 NCT03358563 Jan 2018 → Aug 2021 prostate cancer University of Wisconsin, Madison Completed No outcome recorded
Phase 0 NCT01852864 Jul 2011 → Jul 2015 prostate cancer University of Cambridge Unknown No outcome recorded
Phase 14 trials
Phase 1 NCT05839119 Oct 2023 → Jul 2025 infiltrating bladder urothelial carcinoma Brown University Terminated No outcome recorded
Phase 1 NCT05917860 Jul 2023 → Jan 2026 overdue prostate carcinoma Turku University Hospital Active not recruiting No outcome recorded
Phase 1 NCT02324998 Dec 2016 → May 2019 prostate cancer Cambridge University Hospitals NHS Foundation Trust Completed No outcome recorded
Phase 1 NCT02468284 Jul 2015 → Oct 2016 prostate cancer Ferring Pharmaceuticals Completed No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT06066437 Mar 2024 → Dec 2026 expected prostate cancer M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 1/2 NCT06218667 Jan 2024 → Jan 2027 prostate cancer Memorial Sloan Kettering Cancer Center Withdrawn No outcome recorded
Phase 1/2 NCT01696877 Jan 2013 → Aug 2017 adenocarcinoma in situ Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Completed No outcome recorded
Phase 243 trials
Phase 2 NCT07455903 Apr 2026 → Oct 2029 expected prostate carcinoma Baptist Health South Florida Recruiting No outcome recorded
Phase 2 NCT07335796 Jan 2026 → Jan 2030 expected prostate cancer Memorial Sloan Kettering Cancer Center Recruiting No outcome recorded
Phase 2 NCT07313241 Nov 2025 → Nov 2030 expected prostate cancer University of Texas Southwestern Medical Center Recruiting No outcome recorded
Phase 2 NCT04176081 Jul 2024 → Dec 2028 expected prostate cancer University Health Network, Toronto Not yet recruiting No outcome recorded
Phase 2 NCT06397703 Apr 2024 → Apr 2030 expected prostate cancer NYU Langone Health Recruiting No outcome recorded
Phase 2 NCT05501704 Oct 2023 → Apr 2027 expected hormone receptor-positive breast cancer, male breast carcinoma Jose Pablo Leone Recruiting No outcome recorded
Phase 2 NCT04585932 Nov 2020 → Jan 2021 metastatic prostate carcinoma M.D. Anderson Cancer Center Withdrawn No outcome recorded
Phase 2 NCT04391556 Sep 2020 → May 2023 prostate adenocarcinoma Centre Leon Berard Completed No outcome recorded
Phase 2 NCT04397718 Jul 2020 → Jun 2021 COVID-19 VA Office of Research and Development Completed No outcome recorded
Phase 2 NCT04182594 Jan 2020 → Jan 2023 prostate cancer Rabin Medical Center Unknown No outcome recorded
Phase 2/33 trials
Phase 2/3 NCT00268892 Jan 2006 → Sep 2009 prostate cancer Ferring Pharmaceuticals Completed No outcome recorded
Phase 2/3 NCT00117286 Mar 2005 → Sep 2009 prostate cancer Ferring Pharmaceuticals Completed No outcome recorded
Phase 2/3 NCT00215683 Feb 2005 → Oct 2009 prostate cancer Ferring Pharmaceuticals Completed No outcome recorded
Phase 325 trials
Phase 3 NCT02799706 Sep 2017 → Aug 2023 overdue prostate cancer European Organisation for Research and Treatment of Cancer - EORTC Active not recruiting No outcome recorded
Phase 3 NCT03056638 Mar 2017 → Aug 2023 prostate cancer Memorial Sloan Kettering Cancer Center Terminated No outcome recorded
Phase 3 NCT02663908 Apr 2016 → Mar 2021 prostate cancer Ferring Pharmaceuticals Terminated No outcome recorded
Phase 3 NCT02526784 Dec 2015 → May 2017 prostate cancer Ferring Pharmaceuticals Completed No outcome recorded
Phase 3 NCT02015871 Jan 2014 → Aug 2017 prostate cancer Ferring Pharmaceuticals Completed No outcome recorded
Phase 3 NCT01964170 Aug 2013 → Jun 2015 prostate cancer Astellas Pharma Inc Completed No outcome recorded
Phase 3 NCT01744366 Jan 2013 → May 2015 prostate cancer Ferring Pharmaceuticals Completed No outcome recorded
Phase 3 NCT01712763 Nov 2012 → Mar 2016 endometriosis Centre for Endocrinology and Reproductive Medicine, Italy Completed No outcome recorded
Phase 3 NCT01709942 Nov 2012 → Dec 2015 infertility disorder, ovarian hyperstimulation syndrome, polycystic ovary syndrome Centre for Endocrinology and Reproductive Medicine, Italy Completed No outcome recorded
Phase 3 NCT01368588 Jul 2011 → Apr 2025 overdue prostate cancer Radiation Therapy Oncology Group Active not recruiting No outcome recorded
Phase 46 trials
Phase 4 NCT06001619 Dec 2022 → Oct 2024 overdue benign prostatic hyperplasia, prostate cancer Turku University Hospital Recruiting No outcome recorded
Phase 4 NCT05057546 Nov 2021 → Sep 2024 overdue University of Colorado, Denver Active not recruiting No outcome recorded
Phase 4 NCT04248621 Jan 2020 → Apr 2022 prostate neoplasm Wonju Severance Christian Hospital Unknown No outcome recorded
Phase 4 NCT03202381 Jun 2017 → Mar 2019 prostate cancer Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Unknown No outcome recorded
Phase 4 NCT02726009 May 2016 → May 2020 prostate cancer Ferring Pharmaceuticals Completed No outcome recorded
Phase 4 NCT02475057 Aug 2015 → Jul 2018 cardiovascular disorder, prostate cancer Rabin Medical Center Completed No outcome recorded
Phase not applicable5 trials
NCT03876912 Mar 2019 → Sep 2021 prostate cancer Turku University Hospital Unknown No outcome recorded
NCT03313726 Sep 2017 → Sep 2018 prostate cancer Turku University Hospital Unknown No outcome recorded
NCT01731912 May 2013 → Sep 2016 prostate adenocarcinoma University of Washington Completed No outcome recorded
NCT01542021 Feb 2012 → Sep 2024 prostate adenocarcinoma Memorial Sloan Kettering Cancer Center Completed No outcome recorded
NCT01344564 Apr 2011 → Aug 2012 prostate cancer Urology of Virginia Completed No outcome recorded
Also used as a comparator or background therapy in 53 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 03 trials
Phase 0 NCT07389187 Background Feb → Dec 2026 expected castration-resistant prostate carcinoma Shanghai Changzheng Hospital Not yet recruiting No outcome recorded
Phase 0 NCT07389174 Background Feb 2026 → Jan 2027 expected prostate adenocarcinoma Shanghai Changzheng Hospital Not yet recruiting No outcome recorded
Phase 0 NCT04301414 Comparator Feb 2020 → Mar 2025 prostate cancer Columbia University Completed No outcome recorded
Phase 15 trials
Phase 1 NCT06531499 Background Nov 2024 → Nov 2028 expected prostate carcinoma Novartis Pharmaceuticals Recruiting No outcome recorded
Phase 1 NCT06379217 Background Jul 2024 → Aug 2026 overdue prostate neuroendocrine neoplasm Novartis Pharmaceuticals Active not recruiting No outcome recorded
Phase 1 NCT05617885 Background Aug 2023 → Jul 2025 metastatic prostate carcinoma Praful Ravi, MB BCHir, MRCP Completed No outcome recorded
Phase 1 NCT02472275 Background Jun 2015 → Aug 2019 prostate adenocarcinoma Barbara Ann Karmanos Cancer Institute Completed No outcome recorded
Phase 1 NCT01862835 Background May 2013 → Sep 2016 Mayo Clinic Completed No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT04989946 Background Dec 2021 → Dec 2026 expected prostate cancer University of Wisconsin, Madison Active not recruiting No outcome recorded
Phase 1/2 NCT04633252 Background Feb 2021 → Dec 2026 expected prostate cancer National Cancer Institute (NCI) Recruiting No outcome recorded
Phase 1/2 NCT03689699 Background Oct 2018 → Sep 2023 overdue prostate adenocarcinoma Mark Stein Active not recruiting No outcome recorded
Phase 223 trials
Phase 2 NCT07142551 Background Mar 2026 → Jun 2030 expected castration-resistant prostate carcinoma Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting No outcome recorded
Phase 2 NCT07268794 Background Nov 2025 → Apr 2027 expected metastatic prostate carcinoma, prostate adenocarcinoma Fudan University Not yet recruiting No outcome recorded
Phase 2 NCT06922318 Background Aug 2025 → Aug 2031 expected castration-resistant prostate carcinoma Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting No outcome recorded
Phase 2 NCT05873192 Background Jun 2025 → Dec 2026 expected prostate cancer M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 2 NCT06528210 Background Apr 2025 → Jun 2026 prostate adenocarcinoma OHSU Knight Cancer Institute Withdrawn No outcome recorded
Phase 2/33 trials
Phase 2/3 NCT06282588 Background Dec 2023 → Jul 2030 expected prostate cancer Cancer Research Antwerp Recruiting No outcome recorded
Phase 2/3 NCT04787744 Background Jul 2021 → Sep 2026 expected metastatic prostate carcinoma VA Office of Research and Development Recruiting No outcome recorded
Phase 2/3 NCT03070886 Background Apr 2017 → Oct 2025 prostate adenocarcinoma NRG Oncology Completed No outcome recorded
Phase 38 trials
Phase 3 NCT07477626 Background Mar 2026 → Dec 2033 expected metastatic malignant neoplasm in the lymph nodes, prostate cancer Sun Yat-sen University Recruiting No outcome recorded
Phase 3 NCT05050084 Background Dec 2021 → Nov 2026 expected prostate adenocarcinoma NRG Oncology Active not recruiting No outcome recorded
Phase 3 NCT04455750 Background Oct 2021 → Mar 2027 expected castration-resistant prostate carcinoma, prostate adenocarcinoma Alliance for Clinical Trials in Oncology Active not recruiting No outcome recorded
Phase 3 NCT04513717 Background Jan 2021 → Dec 2033 expected prostate adenocarcinoma NRG Oncology Active not recruiting No outcome recorded
Phase 3 NCT04423211 Background Oct 2020 → Dec 2032 expected metastatic prostate carcinoma, prostate adenocarcinoma ECOG-ACRIN Cancer Research Group Recruiting No outcome recorded
Phase 42 trials
Phase 4 NCT06264882 Background Jun 2024 → May 2028 expected University of Colorado, Denver Recruiting No outcome recorded
Phase 4 NCT01512472 Comparator Jan 2012 → Jan 2018 prostate cancer Canadian Urology Research Consortium Terminated No outcome recorded
Phase not applicable6 trials
NCT07142967 Background Aug 2025 → Aug 2028 expected prostate cancer NYU Langone Health Recruiting No outcome recorded
NCT05628363 Background Jan 2023 → Oct 2025 overdue prostate cancer Washington University School of Medicine Active not recruiting No outcome recorded
NCT04134130 Background Sep → Dec 2019 prostate cancer Lund University Completed No outcome recorded
NCT02489357 Background Dec 2015 → Nov 2017 prostate cancer Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Completed No outcome recorded
NCT02478775 Background Jul 2015 → Jun 2021 infertility disorder, obesity disorder University of Colorado, Denver Completed No outcome recorded

Evidence & citations 17 cited values

Every value below carries the sentence it was read from. 147 sources stand behind the page.

FieldValueCited text
Known as Degarelix “All patients receive neoadjuvant androgen-deprivation therapy comprising bicalutamide orally (PO) once daily or flutamide PO thrice daily for 4-6 months, and luteinizing...” NCT01368588
139

“Either leuprolide acetate (Lupron Depot, 22.5 mg or 45 mg IM), triptorelin pamoate (Trelstar, 11.25 mg or 22.5 mg IM), goserelin acetate (Zoladex, 10.8mg SC) or degarelix...” NCT03311555

“Patients receive multitargeted tyrosine kinase inhibitor PLX3397 orally (PO) twice daily (BID) for 6 months, undergo radiation therapy for 2 months daily (Monday-Friday)...” NCT02472275

“All subjects will receive androgen deprivation therapy with a LHRH agonist (any LHRH agonist such as leuprolide acetate or goserelin acetate is acceptable) or a LHRH antagonist...” NCT02582749

“This regimen consists of Androgen Deprivation Therapy (ADT) (e.g., Goserelin, Leuprorelin, Triptorelin, or Degarelix) combined with an oral Androgen Receptor (AR) inhibitor...” NCT07389174

“Patients will continue on ADT with LHRH agonist (i.e. Zoladex, Trelstar, Eligard, or Lupron) or LHRH antagonist (Degarelix or Relugolix) if not surgically castrated throughout...” NCT06922318

“For mCSPC patients: Androgen Deprivation Therapy (ADT) may include GnRH agonist or monthly degarelix converted to GnRH agonist after 3 months.” NCT04633252

“luteinizing hormone-releasing hormone (LHRH) agonist (i.e. Zoladex, Trelstar, Eligard, or Lupron) or LHRH antagonist (Degarelix or Relugolix)” NCT06059118

“Androgen deprivation therapy includes available GnRH agonists and antagonists, such as Triptorelin, Leuprolide, Goserelin and Degarelix.” NCT07477626

“The starting dose in prostatic cancer patient cohort of LHRH antagonist degarelix is 120 MGx2 and the maintenance dose is 80 MGx1.” NCT06001619

“Maintenance of ADT using GnRH agonist or antagonist (e.g., Goserelin, Leuprorelin, Triptorelin, or Degarelix).” NCT07389187

“LHRH agonist (antagonist) therapy consists of leuprolide, goserelin, buserelin, triptorelin, or degarelix.” NCT00936390

“GnRH agonist or antagonist (leuprolide, goserelin, degarelix) administered as per institutional standard.” NCT07313241

“ADT will be administered via Leuprolide or Degarelix monthly injections or daily Relugolix pills.” NCT07142967

“ADT is defined as a GnRH agonist/antagonist (leuprolide, goserelin, degarelix, or relugolix).” NCT05628363

“A 68Ga-PSMA-11 PET/MRI was performed once before and 3 times post-ADT (degarelix, Firmagon).” PMID 31879814 Dec 2019

“GNRH agonist (leuprolide, goserelin, triptorelin) or GNRH antagonist (relugolix, degarelix)” NCT06528210

Degarelix: Patients will receive subcutaneous injections every 28 days (+/- 3 days).” NCT03009981

“or degarelix (Firmagon) subcutaneously every month per standard of care” NCT04126070

“sub-cutaneous injection of GnRH-antagonist (Degarelix, Firmagon®)” NCT03876912

“This includes leuprolide, goserelin, triptorelin, and degarelix.” NCT02972060

“abarelix, degarelix, or relugolix” NCT06379217

Degarelix, Relugolix” NCT06531499

DegarelixNCT05189457

DegarelixNCT06734130

NCT05839119

NCT01786265

NCT01674270

NCT05917860

NCT01512472

NCT00117949

NCT03947151

NCT02726009

NCT01990196

NCT06264882

NCT02799706

NCT01446991

NCT00738673

NCT04397718

NCT00434122

NCT04513717

NCT01731912

NCT03951831

NCT01852864

NCT02468284

NCT01712763

NCT04734730

NCT00819247

NCT00468286

NCT05050084

NCT03358563

NCT00884273

NCT00947882

NCT06066437

NCT05617885

NCT02849990

NCT07142551

NCT04585932

NCT04176081

NCT01746849

NCT02494713

NCT00527488

NCT02478775

NCT05873192

NCT02560051

NCT02020070

NCT00728533

NCT06378866

NCT01071915

NCT03056638

NCT01964170

NCT03678025

NCT03689699

NCT00245466

NCT01344564

NCT01751451

NCT02015871

NCT02489357

NCT02135445

NCT03202381

NCT02663908

NCT01220869

NCT04423211

NCT02475057

NCT01630967

NCT06397703

NCT05501704

NCT00117312

NCT02005887

NCT01696877

NCT03899077

NCT00818623

NCT01862835

NCT02346253

NCT04134130

NCT04787744

NCT03070886

NCT01377389

NCT00946920

NCT00819156

NCT02278185

NCT00117286

NCT07268794

NCT07455903

NCT01545882

NCT03361735

NCT00928434

NCT00268892

NCT03240159

NCT01261572

NCT02324998

NCT04182594

NCT00833248

NCT01215513

NCT01709942

NCT01994239

NCT03069937

NCT02526784

NCT00831233

NCT01491971

NCT01542021

NCT04301414

NCT04248621

NCT07335796

NCT04455750

NCT03080116

NCT02159690

NCT06218667

NCT00295750

NCT00967018

NCT00451958

NCT00215683

NCT00215657

NCT00801242

NCT01744366

NCT05212857

NCT01242748

NCT00116779

NCT04989946

NCT00116753

Known as ASP3550 ClinicalTrials.gov intervention name — accepted as the source's own label NCT00568516
Known as Degarelix (as acetate) ChEMBL registry synonym — accepted as the source's own label CHEMBL415606
Known as Degarelix (Firmagon) Degarelix (Firmagon)NCT03009981
Known as Degarelix accord ChEMBL registry synonym — accepted as the source's own label CHEMBL415606
Known as degarelix acetate “Gonadotropin releasing hormone (GnRH) antagonist is degarelix acetate, 80 mg, delivered once as a subcutaneous injection.” NCT05057546
3

“80-mg subcutaneous injection of degarelix acetate (20 mg/mL; Ferring Pharmaceuticals Inc, Parsippany, NJ)” NCT06264882

Degarelix acetate, 1 mo depot for 3 months” NCT01344564

“Drug: degarelix acetateNCT01696877

Known as Degarelix acetate hydrate ChEMBL registry synonym — accepted as the source's own label CHEMBL415606
Known as Degarelix acetate, FE200486 Degarelix acetate, FE200486NCT00117286
Known as FE-200486 ChEMBL registry synonym — accepted as the source's own label CHEMBL415606
Known as FE200486 (AS ACETATE SALT) ChEMBL registry synonym — accepted as the source's own label CHEMBL415606
Known as FE200486 (FREE BASE) ChEMBL registry synonym — accepted as the source's own label CHEMBL415606
Known as Firmagon “Either leuprolide acetate (Lupron Depot, 22.5 mg or 45 mg IM), triptorelin pamoate (Trelstar, 11.25 mg or 22.5 mg IM), goserelin acetate (Zoladex, 10.8mg SC) or degarelix...” NCT03311555
8

“Study the effectiveness of the association of a short duration hormonal therapy by degarelix (Firmagon ®) and radiotherapy, with radiotherapy alone on survival without events...” NCT01994239

“Degarelix (Firmagon ®), a testosterone lowering agent given as a monthly injection, is FDA approved for the treatment of patients with advanced prostate cancer.” NCT01751451

“Degarelix (Firmagon®) will be administered as a subcutaneous injection in the abdominal region every 28 days” NCT03202381

“A 68Ga-PSMA-11 PET/MRI was performed once before and 3 times post-ADT (degarelix, Firmagon).” PMID 31879814 Dec 2019

“comparing 10 months versus 4 months of degarelix (Firmagon®) therapy” NCT01512472

“sub-cutaneous injection of GnRH-antagonist (Degarelix, Firmagon®)” NCT03876912

NCT04391556

NCT06282588

Action Inhibit “Degarelix is a gonadotropin-releasing hormone receptor antagonist (blocker)” PMID 18801505 Sep 2008
1

“Gonadotropin-releasing hormone receptor antagonist” CHEMBL415606

Modality Other / unclassified “novel GnRH antagonist, degarelix” NCT00884273
Route Subcutaneous “Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose” NCT00116753
Target GNRHR “Gonadotropin-releasing hormone receptor antagonist” CHEMBL415606
Target TMPRSS2 “suppress TMPRSS2PMID 34225789 Jul 2021