Drugs / Degarelix
last change 11 days ago re-read 9 days ago

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 · M.D. Anderson Cancer Center · Astellas Pharma Inc
+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 · NYU Langone Health · 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 · 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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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 · 1 met primary · 2 missed
Phase 2 NCT07801664 Aug 2026 → Aug 2028 expected prostate cancer NYU Langone Health Recruiting No outcome recorded
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 Active not 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 Missed primary
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 · 5 met primary · 2 missed
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 Stop: Enrollment
Phase 3 NCT02663908 Apr 2016 → Mar 2021 prostate cancer Ferring Pharmaceuticals Terminated No outcome recorded Stop: Enrollment
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 Met primary
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 Missed primary
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
Comparator or background therapy53 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 1 NCT06531499 Background Nov 2024 → Nov 2028 expected prostate carcinoma Novartis Pharmaceuticals Recruiting No outcome recorded
Phase 1 NCT06379217 Background Jul 2024 → Sep 2026 overdue prostate neuroendocrine neoplasm Novartis Pharmaceuticals Active not recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2017-11-30 Astellas Pharma Inc Regulatory Astellas Submits a New Drug Application for Gonax® 12-Week Extended-Release Formulation for Treatment of Prostate Cancer in Japan astellas.com ↗
Astellas Submits a New Drug Application for Gonax® 12-Week Extended-Release Formulation for Treatment of Prostate Cancer in Japan
2010-10-28 Astellas Pharma Inc Regulatory Astellas Pharma Inc.: Submits Application for Marketing Approval of Degarelix, an GnRH Antagonist for Prostate Cancer Treatment, in Japan astellas.com ↗
Tokyo, October 28, 2010 - Astellas Pharma Inc. (“Astellas”; headquarters: Tokyo; President and CEO: Masafumi Nogimori) announced today that it submitted a market authorization application for one month formulation of degarelix acetate (“degarelix”; generic name; development code: ASP3550) to the Ministry of Health, Labour and Welfare in Japan.

Evidence & citations 16 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 ↗
140

“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 ↗

“ADT will be delivered with monthly Degarelix, or Leuprolide injections or daily Relugolix pills which are all standard ADT interventions.” NCT07801664 ↗

“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 ↗

Show 130 more sources

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 acetate” NCT01696877 ↗

Known as Degarelix acetate hydrate ChEMBL registry synonym — accepted as the source's own label CHEMBL415606 ↗
Known as Degarelix acetate, FE200486 “Degarelix acetate, FE200486” NCT00117286 ↗
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 TMPRSS2” PMID 34225789 ↗ Jul 2021