Last update 23 Oct 2026

Enzalutamide

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Enolen, Enzalutamide (JAN/USAN), 恩杂鲁胺
+ [10]
Target
Action
antagonists
Mechanism
AR antagonists(Androgen Receptor antagonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (United States), Fast Track (United States), Priority Review (Canada)
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Structure/Sequence

Molecular FormulaC21H16F4N4O2S
InChIKeyWXCXUHSOUPDCQV-UHFFFAOYSA-N
CAS Registry915087-33-1

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Prostatic Cancer
South Korea
03 Dec 2024
Castration-sensitive prostate cancer
United States
16 Nov 2023
HRR Gene-mutated Castration-Resistant Prostate Cancer
United States
20 Jun 2023
Metastatic Prostate Carcinoma
Japan
29 May 2020
Castration-Resistant Prostatic Cancer
European Union
21 Jun 2013
Castration-Resistant Prostatic Cancer
Iceland
21 Jun 2013
Castration-Resistant Prostatic Cancer
Liechtenstein
21 Jun 2013
Castration-Resistant Prostatic Cancer
Norway
21 Jun 2013
Hormone-dependent prostate cancer
European Union
21 Jun 2013
Hormone-dependent prostate cancer
Iceland
21 Jun 2013
Hormone-dependent prostate cancer
Liechtenstein
21 Jun 2013
Hormone-dependent prostate cancer
Norway
21 Jun 2013
Metastatic castration-resistant prostate cancer
United States
31 Aug 2012
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Advanced Triple-Negative Breast CarcinomaPhase 3
United States
01 Sep 2016
Advanced Triple-Negative Breast CarcinomaPhase 3
United States
01 Sep 2016
Advanced Triple-Negative Breast CarcinomaPhase 3
United States
01 Sep 2016
Adenocarcinoma of prostatePhase 3
United States
22 Jan 2014
Adenocarcinoma of prostatePhase 3
United States
22 Jan 2014
Adenocarcinoma of prostatePhase 3
Canada
22 Jan 2014
Adenocarcinoma of prostatePhase 3
Canada
22 Jan 2014
Recurrent Prostate CarcinomaPhase 3
United States
22 Jan 2014
Recurrent Prostate CarcinomaPhase 3
United States
22 Jan 2014
Recurrent Prostate CarcinomaPhase 3
Canada
22 Jan 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
1,072
Enzalutamide + Leuprolide
hgtxabeiiw(eqxtjumawx) = ifqfpmwkke lihyyopchz (ypnhnybaks, 0.1–61.0)
Positive
23 Oct 2026
Leuprolide
hgtxabeiiw(eqxtjumawx) = gidxfrrfip lihyyopchz (ypnhnybaks, 2.3–60.5)
Not Applicable
59
(Whole-body TV-PSMA <129 mL)
ffwxselcpg(trdsffkjyh) = tmvjkvlxlv eyajpiswps (mhjgqyoxhd )
Negative
23 Oct 2026
(Whole-body TV-PSMA ≥129 mL)
ffwxselcpg(trdsffkjyh) = bjrudaskim eyajpiswps (mhjgqyoxhd )
Phase 3
1,125
LHRH analog + Enzalutamide
qpahrjxhcm(ibubckysgu) = znspbehcig dsmbuxxdjb (wzxjhugiqe )
Positive
23 Oct 2026
LHRH analog + NSAAs
qpahrjxhcm(ibubckysgu) = xhakvuzwoh dsmbuxxdjb (wzxjhugiqe )
Not Applicable
669
lybjtgozgc(mgwzeyzjhi): HR = 0.91 (95.0% CI, 0.61 - 1.36)
Positive
23 Oct 2026
Not Applicable
942
kavmlxdnxq(kutunvxyyw) = lwnbldmfbi onqrflvnpk (yjxlplfmnp )
Positive
23 Oct 2026
kavmlxdnxq(kutunvxyyw) = hblnekckes onqrflvnpk (yjxlplfmnp )
Not Applicable
1,593
Enzalutamiderivation therapy
rjtkuidyff(srhzwjfabf): HR = 0.885 (95.0% CI, 0.623 - 1.253)
Positive
23 Oct 2026
Apalutamideprivation therapy
Not Applicable
627
loeuijzbct(obmrfibdrk) = 14.9% vs 2.4% bqorsuaxth (hsnichtozk )
Positive
23 Oct 2026
Not Applicable
1,076
hixlmkncjb(uurmoedrpx) = wnfhxlimkw cihhhhcewo (urtgvfptck )
Positive
23 Oct 2026
Not Applicable
Hormone-dependent prostate cancer
androgen receptor pathway inhibitors
18,626
hudbveiqlx(evtgxcygxk): HR = 1.27 (95.0% CI, 1.09 - 1.47)
Positive
23 Oct 2026
Not Applicable
26
pknvuxhbxy(gfjufulkut) = tadbvytgvf coklbypocj (xpmjfbekxa )
Positive
23 Oct 2026
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