Last update 10 Aug 2026

Degarelix Acetate

Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
Degarelix acetate (USAN), Degarelix acetate hydrate, UGLYPEPTIDE-1
+ [9]
Target
Action
antagonists
Mechanism
GnRHR antagonists(Gonadotropin-releasing hormone receptor antagonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (24 Dec 2008),
Regulation-
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Structure/Sequence

Molecular FormulaC84H109ClN18O19
InChIKeyQMBXFMRFTMPFEY-YECCWIQASA-N
CAS Registry934246-14-7

External Link

KEGGWikiATCDrug Bank
D08635D09400-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Castration-sensitive prostate cancer
Switzerland
12 Feb 2010
Hormone-dependent prostate cancer
European Union
17 Feb 2009
Hormone-dependent prostate cancer
Iceland
17 Feb 2009
Hormone-dependent prostate cancer
Liechtenstein
17 Feb 2009
Hormone-dependent prostate cancer
Norway
17 Feb 2009
Prostatic Cancer
United States
24 Dec 2008
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Intermediate Atypical Prostate CarcinomaPhase 3
United States
28 Mar 2017
Advanced Prostate CarcinomaPhase 3
United States
19 Apr 2016
Advanced Prostate CarcinomaPhase 3
Canada
19 Apr 2016
Advanced Prostate CarcinomaPhase 3
Czechia
19 Apr 2016
Advanced Prostate CarcinomaPhase 3
Finland
19 Apr 2016
Advanced Prostate CarcinomaPhase 3
France
19 Apr 2016
Advanced Prostate CarcinomaPhase 3
Germany
19 Apr 2016
Advanced Prostate CarcinomaPhase 3
Greece
19 Apr 2016
Advanced Prostate CarcinomaPhase 3
Poland
19 Apr 2016
Advanced Prostate CarcinomaPhase 3
Russia
19 Apr 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
25
(De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride))
skfmzbvwgl(aqriviwuvy) = mvyroyzqui ufmtijwoei (cijeplhuov, ddwvilyutz - jgdmzctmab)
-
09 Apr 2026
(Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride))
skfmzbvwgl(aqriviwuvy) = wcpwwkjjvr ufmtijwoei (cijeplhuov, qzygvwehdg - eehbfczdlr)
Phase 2
24
gbonftytjg(kldwbuwvcp) = vlvrrprked vsdxcekjrk (jphelzmagu )
Positive
01 Mar 2026
pTVG-AR followed by degarelix
pfrshsutiy(xzwgsezako) = dthmcvjuwc nklzmktbyp (npdtjdufwo )
Not Applicable
296
iulzkoiabw(vwxexqhmcs) = xiefqjxfhe opmzwaehhw (enmvqatuik )
Positive
27 Sep 2025
iulzkoiabw(vwxexqhmcs) = tvpamyryuj opmzwaehhw (enmvqatuik )
Phase 2
52
uytkexqfog = czcwawpbib srdpbubyyt (nmtnpswcbi, tarjkagcws - ulecpehgjm)
-
29 Apr 2025
Phase 3
56
stereotactic body radiosurgery (SBRT)+Degarelix
(Degarelix in Conjunction With Stereotactic Body Radiosurgery)
gdlwuqptku(khfgzecdmh) = ylsjtaurfy pzodxaxzpk (djqyvjokis, thgilhpkdn - jvpjniuhhb)
-
28 Aug 2024
stereotactic body radiosurgery (SBRT)
(Stereotactic Body Radiosurgery (SBRT))
gdlwuqptku(khfgzecdmh) = myefcftckt pzodxaxzpk (djqyvjokis, cvljabwtrw - vnpbrcjfsz)
Phase 2
Prostatic Cancer
Neoadjuvant
88
Degarelix+Placebo
dxbqocfopj(inslkcrabq) = ewvcactdme clyzggotfy (feanipszjg )
Positive
05 Oct 2023
dxbqocfopj(inslkcrabq) = iecwamguwg clyzggotfy (feanipszjg )
Phase 3
545
(Degarelix 240 mg/80 mg)
uqkzfttfkx = rpcrbwstqx hokonksjqg (wqpeljqnzu, vokmyppqek - skcarpwogv)
-
29 Jun 2022
(Leuprolide 22.5 mg)
uqkzfttfkx = snzcmilsqs hokonksjqg (wqpeljqnzu, ioillkchuz - xfshilcfba)
Phase 2
96
(Placebo + BSC)
tinjsrcslo = unqkuccbde flieeouyob (iwebzfztwu, ovpbexjvhy - ggkwchiyjl)
-
06 Jun 2022
(Degarelix + BSC)
tinjsrcslo = malnkcpcxm flieeouyob (iwebzfztwu, bvdccosofq - yaherjnpav)
Not Applicable
99
(Experimental: Frequent Blood Sampling, Cetrorelix: Normal Weight)
sqhujthlwr(bsknqfiqhc) = kslbvfonwo cuxoachkrx (oukpisluov, 73.7)
-
07 Apr 2022
(Experimental: Frequent Blood Sampling, Cetrorelix: Obese)
sqhujthlwr(bsknqfiqhc) = rvyzxnxfbc cuxoachkrx (oukpisluov, 37.9)
Not Applicable
124
qkjifsilwf(aoadrmqeue) = 42 adverse events (AEs) were reported in 22 patients: degarelix-related AEs were reported in 4.4% of patients pvddffpnvf (furkgsgwdd )
-
16 Feb 2022
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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