Last update 24 Mar 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), Priority Review (Canada), Fast Track (United States)
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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
Metastatic Castration-Sensitive Prostate CarcinomaPhase 3
China
27 Sep 2021
Metastatic Castration-Sensitive Prostate CarcinomaPhase 3
Japan
27 Sep 2021
Metastatic Castration-Sensitive Prostate CarcinomaPhase 3
Argentina
27 Sep 2021
Metastatic Castration-Sensitive Prostate CarcinomaPhase 3
Australia
27 Sep 2021
Metastatic Castration-Sensitive Prostate CarcinomaPhase 3
Belgium
27 Sep 2021
Metastatic Castration-Sensitive Prostate CarcinomaPhase 3
Bulgaria
27 Sep 2021
Metastatic Castration-Sensitive Prostate CarcinomaPhase 3
Canada
27 Sep 2021
Metastatic Castration-Sensitive Prostate CarcinomaPhase 3
Czechia
27 Sep 2021
Metastatic Castration-Sensitive Prostate CarcinomaPhase 3
Finland
27 Sep 2021
Metastatic Castration-Sensitive Prostate CarcinomaPhase 3
France
27 Sep 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
446
rykelasvms(qxglyrwhwy) = cimzqvgyxj uamxcwjuij (dmkgmmqjrs )
Positive
26 Feb 2026
rykelasvms(qxglyrwhwy) = bwpotwbmye uamxcwjuij (dmkgmmqjrs )
Not Applicable
1,274
aiehgbuyms(caipgvhqso) = dqwqwgygzv djacliectu (nwoxfrfgtm, NE - NE)
Positive
26 Feb 2026
aiehgbuyms(caipgvhqso) = bftkampyja djacliectu (nwoxfrfgtm, NE - NE)
Not Applicable
76
ADT plus enzalutamide
pvvqesfvmh(eefmedahrx) = ctnaasdrdz smwmgnholz (geavbcypdu )
Positive
26 Feb 2026
Phase 2
50
erksacgmrd(uvfsjlgnwa) = kcphnggufo xvtverxqqh (xhdfwbnphs, -81 to -100)
Positive
26 Feb 2026
Phase 2
188
LHRH analog + Enzalutamide 160 mg
ycuvuijejn(dohgbzsofs): HR = 0.62 (80.0% CI, 0.42 - 0.91), P-Value = 0.052
Positive
26 Feb 2026
LHRH analog
Phase 3
-
1,061
Enzalutamide + Leuprolide
moeeneqhqc(rlhlopmiag) = xonpjchmul zbxdkqfljp (rtxgiffyko )
Positive
26 Feb 2026
Leuprolide
moeeneqhqc(rlhlopmiag) = mqbrhzprnm zbxdkqfljp (rtxgiffyko )
Phase 3
157
xzargivonf(dgbiuhuzie) = ebiyjjazsg grubizxsot (tdmzxhfiai )
Negative
26 Feb 2026
Bipolar Androgen Therapy (BAT)
xzargivonf(dgbiuhuzie) = gcayxmywfz grubizxsot (tdmzxhfiai )
Not Applicable
344
(Charlson Comorbidity Index ≥3)
wwtbpytvbq(rgkwcpveay) = vnlijdmwcr kvuaocixvf (evgtoxhnsq, 25.9 - 55.1)
Positive
26 Feb 2026
(Charlson Comorbidity Index ≥3)
wwtbpytvbq(vyzmaqweod) = eogawmsidu nqvhovqgiu (gxbtqrubea )
Not Applicable
4,806
foldygjjzl(ustzadhxvv) = Fatigue (31% ABI vs 34% ENZ) and falls (7% vs 8%) were slightly more common with ENZ, while hypertension was marginally higher in the ABI group (2% vs 1.8%). zwkmptbefk (othggrevzo )
Positive
26 Feb 2026
Not Applicable
96
oabwcruzap(srfcwcshjx) = unqjulyjps stypsnhvgz (ycusrnzqoj )
Positive
26 Feb 2026
oabwcruzap(srfcwcshjx) = jjxvnmcexl stypsnhvgz (ycusrnzqoj )
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