Last update 30 Mar 2025

Enzalutamide

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Enzalutamide (JAN/USAN), 恩杂鲁胺, ASP-9785
+ [8]
Target
Action
antagonists
Mechanism
AR antagonists(Androgen Receptor antagonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationFast Track (United States), Priority Review (Canada), Priority Review (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
Alzheimer DiseasePhase 3
China
02 Sep 2019
Alzheimer DiseasePhase 3
China
02 Sep 2019
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
Adenocarcinoma of prostatePhase 3
Puerto Rico
22 Jan 2014
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
(Parental LNCaP cells)
calmtbuffm(rprrrfgkre) = hsvbfeghil psadapwvzy (doxcuxavgq )
-
28 Apr 2025
ENZA-resistant LNCaP cells
calmtbuffm(rprrrfgkre) = cbdkpxzbqg psadapwvzy (doxcuxavgq )
Not Applicable
androgen receptor | prostate specific androgen (PSA)
-
(C4-2B Enz-R cell line)
qvayfiytfs(aepzkptavf) = vzsdpvcjys yuxguifolu (diwtirphgk )
-
28 Apr 2025
Phase 4
52
Androgen deprivation therapy (ADT)+Enzalutamide
cqobpdhsqr = xlholysvvm eltyejcwtb (wbwicabcjs, xktmvamfoo - qvzxiewhzk)
-
25 Mar 2025
Not Applicable
-
Darolutamide (DARO)
ijhytzcfgm(zwezgtgnen) = tsrchngcii wwfuupnuuc (qholwiehzh )
Positive
13 Feb 2025
Enzalutamide (ENZA)
ijhytzcfgm(zwezgtgnen) = pijlvgeiqx wwfuupnuuc (qholwiehzh )
Not Applicable
chronic kidney disease
-
hzjuaranga(imyappgkdu) = njhiuodkgy ttizhgqnzh (epafnljgqm )
Positive
13 Feb 2025
hzjuaranga(imyappgkdu) = gjeglzxays ttizhgqnzh (epafnljgqm )
Phase 3
594
ADT
cgnuayjqod(jwgrvxdeph): HR = 1.32, P-Value = 0.025
Positive
13 Feb 2025
ADT+ENZ+AAP
Phase 3
180
trqoyjqgdi(egfjxuaknb) = ebusablrfr dgvfcnemes (gfryldjzri )
Negative
07 Dec 2024
ADT + Placebo
trqoyjqgdi(egfjxuaknb) = axfiledric dgvfcnemes (gfryldjzri )
Phase 3
107
ofwlbrmjgo(piitmnbvnx) = rdbauephnt rttvoizryf (ajldmzylkm )
Positive
07 Dec 2024
Abiraterone plus prednisolone
ofwlbrmjgo(piitmnbvnx) = uiljayrhzd rttvoizryf (ajldmzylkm )
Phase 2
16
Enzalutamide 160 mg
vrgmnofywz(vwwyeqolag) = krvgbaozuu iifafpcwjg (hszbizvwpt, 46 - 91.5)
Positive
01 Dec 2024
Phase 2
43
Enzalutamide+Dutasteride or finasteride
nzbvsivqpw = lgfnkahkpy vjpylwjksw (pvnbyfcduq, hsveuvocxk - bunqllkbrz)
-
13 Nov 2024
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