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degarelix acetate

Trade name: firmagon

Peptideapproved

Approved

Dec 24, 2008

DEGARELIX (FIRMAGON®) is a synthetic linear decapeptide amide containing seven unnatural amino acids, five of which are D-amino acids. It is a GnRH receptor antagonist. It binds reversibly to the pituitary GnRH receptors, thereby reducing the release of gonadotropins and consequently testosterone. DEGARELIX (FIRMAGON®) is effective in achieving and maintaining testosterone suppression below the castration level of 50 ng/dL and is indicated for the treatment of patients with advanced prostate cancer. — NCATS

Clinical trial activity

111 trials · 82 clinical orgs · 2 marketing orgs

Phase 1
15
Phase 2
86
Phase 3
35
Phase 4
6

Earliest trial started Mar 1, 2001 (NCT00819247)

Timeline

2000s

  1. Jan 1, 2001

    Ferring — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2006

    Ferring — Earliest Phase 3 Sponsor(trial)

  3. Dec 24, 2008

    Ferring — Earliest FDA Approval

  4. Dec 24, 2008

    Ferring — NDA Organization

2010s

  1. Jan 1, 2011

    Earliest Phase 1 Sponsor(trial)

2020s

  1. Aug 18, 2025

    Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedDec 24, 2008

Chemistry & pharmacology

Loading structure…

SMILES

CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O
Mol. weight
1632.29 g/mol
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • ac-2nal-4cpa-3pal-ser-4aph(hydroorotyl)-4aph(carbamoyl)-leu-ilys-pro-ala-nh2
  • acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ilys-prolyl-alaninamide
  • asp3550
  • asp3550
  • degarelix
  • degarelix
  • degarelix
  • degarelix
  • degarelix
  • degarelix
  • degarelix
  • degarelix
  • degarelix
  • degarelix
  • degarelix acetate
  • degarelix acetate
  • degarelix acetate
  • degarelix acetate
  • degarelix acetate
  • fe200486
  • fe 200486
  • fe-200486
  • fe-200486
  • fe-200486
  • fe-200486 (free base)
  • fe-200486 (free base)
  • firmagon
  • firmagon
  • firmagon
  • firmagon
  • firmagon
  • gonax
  • uglypeptide1

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06378866Phase 2Jun 3, 2024Mayo Clinic
NCT06264882Phase 4Jun 1, 2024National Institute on Aging (NIA), University of Colorado, University of Colorado, Denver
NCT06397703Phase 3Apr 16, 2024New York University
NCT06218667Phase 1/Phase 2 (Phase 2)Jan 11, 2024Memorial Sloan-Kettering Cancer Center
NCT06066437Phase 1/Phase 2 (Phase 2)Dec 31, 2023Bracco, University of Texas at Houston
NCT06282588Phase 2/Phase 3 (Phase 3)Dec 13, 2023Bayer, Cancer Research Antwerp, University of Antwerp, Veracyte, Inc.
NCT05839119Phase 1Oct 2, 2023Brown University, Cures Within Reach
NCT05873192Phase 2Sep 30, 2023University of Texas at Houston
NCT05917860Phase 1Jul 1, 2023University of Turku
NCT05617885Phase 1/Phase 2 (Phase 2)May 31, 2023Bayer, Eli Lilly, Harvard University
NCT05501704Phase 2Feb 28, 2023Eli Lilly, Harvard University, Translational Breast Cancer Research Consortium (TBCRC)
NCT05212857Phase 2Apr 30, 2022Fudan University
NCT04989946Phase 1/Phase 2 (Phase 2)Dec 31, 2021Department of Defense, Madison Vaccines Incorporated, University of Wisconsin
NCT05050084Phase 3Nov 11, 2021National Cancer Institute (NCI), NRG Oncology
NCT04787744Phase 2/Phase 3 (Phase 3)Jul 1, 2021Department of Veteran Affairs
NCT04734730Phase 2May 4, 2021City of Hope National Medical Center, National Cancer Institute (NCI)
NCT04455750Phase 3Jan 31, 2021Baylor University, National Cancer Institute (NCI)
NCT04513717Phase 3Dec 15, 2020National Cancer Institute (NCI), NRG Oncology
NCT04585932Phase 2Nov 30, 2020National Cancer Institute (NCI), University of Texas at Houston
NCT04397718Phase 2Jun 1, 2020Department of Veteran Affairs
Showing 20 of 111 trials
Page 1 / 6

Organizations

Research & Development (82)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
FerringFor profit513852001
National Cancer Institute (NCI)Government10132013
University of Texas at HoustonAcademic/Hospital7712011
Cornell UniversityAcademic/Hospital5432012
Johns Hopkins UniversityAcademic/Hospital5332012
Janssen Pharmaceutica NVFor profit4012012
BayerFor profit3022020
Bristol-Myers SquibbFor profit3022011
Columbia UniversityAcademic/Hospital3322018
University of Colorado, DenverAcademic/Hospital3332015
University of MilanAcademic/Hospital3222012
AstellasFor profit2222007
British Columbia Cancer AgencyAcademic/Hospital2212012
Cancer Research AntwerpAcademic/Hospital2222019
City of Hope National Medical CenterAcademic/Hospital2212018
Department of DefenseGovernment2022018
Department of Veteran AffairsGovernment2222020
Duke UniversityAcademic/Hospital2022012
Eli LillyFor profit2012023
Harvard UniversityAcademic/Hospital2212023
82 organizations
Page 1 / 5

Marketing (2)

OrganizationOrg typeRelationshipDate
FerringFor profitNDADec 24, 2008
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,LtdFor profitMKTGAug 18, 2025