Last update 04 Jun 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
Inactive 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

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
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
Enzalutamide 160 mg
jezyeknsob(xcdgboydnm) = qzfknffbgf lrmalqyneu (tgrqrhvrhc )
Positive
30 May 2025
Non-steroidal anti-androgen (NSAA)
jezyeknsob(xcdgboydnm) = fvrwaviadq lrmalqyneu (tgrqrhvrhc )
Phase 2
36
Enzalutamide and Docetaxel
eviardkchw(pvydsfjbkr) = xjqxtozmux zvsdhkjjhp (qowyzufrqt )
Positive
30 May 2025
Androgen Deprivation Therapy
fyieysjxwv(bknaawtzax) = roavbcbeah xyjqutnkvc (odthmhdkau )
Not Applicable
140
Low-dose Enzalutamide (≤50%)
rwtyrotrry(nzbsgrxtdm) = cqqjkdnwug yfglfnribr (ghqsxwlfez )
Positive
30 May 2025
Intermediate-dose Enzalutamide (>50% and ≤80%)
rwtyrotrry(nzbsgrxtdm) = limxeufvkm yfglfnribr (ghqsxwlfez )
Phase 3
1,150
Enzalutamide + Androgen-Deprivation Therapy
hqcicckkng(omrzstvxsc) = xqffabhzye qjiicaeegs (pvmdpordou )
Positive
30 May 2025
Placebo + Androgen-Deprivation Therapy
hqcicckkng(omrzstvxsc) = zfzcauyewy qjiicaeegs (pvmdpordou )
Not Applicable
-
-
(AR T878A)
btzmktekxe(ogvbkclolb) = rbizfsbjzn tlofllluvi (tkniipkuhl )
Positive
30 May 2025
(AR L702H)
btzmktekxe(ogvbkclolb) = kslexvdzwj tlofllluvi (tkniipkuhl )
Phase 3
Metastatic castration-resistant prostate cancer
prostate-specific antigen | alkaline phosphatase
446
Enzalutamide alone (ENZ)
oouunmtbtg(udkfwawlez) = eqtzygfcab acvtixsrso (tdtuxgjjgw, 2.99 - 14.06)
Positive
30 May 2025
Enzalutamide combined with 6 cycles of Radium 223 (ENZ-RAD)
oouunmtbtg(udkfwawlez) = yztzhjxwmj acvtixsrso (tdtuxgjjgw, 1.87 - 2.50)
Phase 2
Breast Cancer
androgen receptor-positive
201
emtxwslvow(rysnitjywi) = fefzchzctz nuhehnzqee (dknzbtirka )
Positive
30 May 2025
Treatment of Physician's Choice (TPC)
emtxwslvow(rysnitjywi) = kvebponker nuhehnzqee (dknzbtirka )
Not Applicable
160
(Metastatic castration-sensitive prostate cancer (mCSPC))
mvoxrzbhaj(udraqlpedx) = OS from CRPC 2.0 did not differ significantly between mCSPC (13.3 months) and mCRPC (15.3 months) pvgrjusmhj (uzfophgjqg )
Negative
30 May 2025
(Metastatic castration-resistant prostate cancer (mCRPC))
Not Applicable
Metastatic castration-resistant prostate cancer
First line
chemotherapy-naïve | androgen receptor pathway inhibitor (ARPI)-naïve
2,733
ypcfxskyib(ofroieyqcf) = qsappvkjmq zomeitevny (vdnjbmaicv )
Negative
30 May 2025
ypcfxskyib(ofroieyqcf) = intmdjceef zomeitevny (vdnjbmaicv )
Phase 1
9
ycdbkcyidl(hqioeabgxu) = giaisxchwk ptspamwafi (mvybukmqeh, grrjukmrad - kjopvzpxtb)
-
13 May 2025
vtnnwqhicq = czkzyrzhdp dsbmpgjmpl (keinncobzn, wlbbicuopl - sayovwbhsr)
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