Drug · Small Molecule

Enzalutamide

CI-DRUG-00000216Explore in graph →NCIt C71744 CHEMBL1082407 CIViC Approved

Regulatory

Approvals (35)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

health-canada-dpdRegulatory35 approval records from 3 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as AURO-ENZALUTAMIDE (DIN 02494736) under ATC L02BB04 ENZALUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Mar 30, 2026	health-canada-dpd
CA Health Canada	—	Marketed in Canada as REDDY-ENZALUTAMIDE (DIN 02558424) under ATC L02BB04 ENZALUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Mar 30, 2026	health-canada-dpd
CA Health Canada	—	Marketed in Canada as APO-ENZALUTAMIDE (DIN 02562677) under ATC L02BB04 ENZALUTAMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Mar 30, 2026

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 18 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	99	50	48	274	35	CA, EU, US	Aug 31, 2012	Jul 8, 2005
Malignant Prostate Neoplasm	Approved	Phase 4	66	35	28	183	15	EU, US	Aug 31, 2012	Jul 8, 2005
Malignant Breast Neoplasm	Phase3	Phase 3	3	1	1	15	0	—	—	Apr 30, 2012
Malignant Kidney Neoplasm	Phase3	Phase 3	1	0	1	4

Curated evidence

Clinical evidence (20)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–20 of 20 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
ATM Mutation1
Enzalutamide + Talazoparib

Clinical trials

Trials with this intervention (299)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 299 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT03834493	Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-641/KEYNOTE-641)	terminated	Phase 3	1,244	Merck Sharp & Dohme LLCINDUSTRY	28	Sep 28, 2026	clinicaltrials
NCT04191096	Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991)

Molecule

Record

Kind: Small Molecule
Mechanism: Androgen Receptor antagonist
Targets: 1 gene
UNII: 93T0T9GKNU
Aliases: APO-ENZALUTAMIDE, ASP9785, AURO-ENZALUTAMIDE, Benzamide, 4-(3-(4-cyano-3-(trifluoromethyl)phenyl)-5,5-dimethyl-4-oxo-2-thioxo-1-imidazolidinyl)-2-fluoro-N-methyl-, Enzalutamida, Enzalutamide, Enzalutamide Accordpharma, Enzalutamide Viatris, JAMP ENZALUTAMIDE, MDV 3100, MDV-3100, MDV3100, PMS-ENZALUTAMIDE, PRO-ENZALUTAMIDE, REDDY-ENZALUTAMIDE, Xtandi, XTANDI

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (18)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L02BB04	ENZALUTAMIDE
DIN (Health Canada)	02407329	XTANDI

ATR Loss-of-function1

Enzalutamide + TalazoparibCombination

Castration-Resistant Prostate Carcinoma

Predictive

Supports Sensitivity Response

submitted

EID12217

In the phase 3 TALAPRO-2 trial 805 patients with castration-resistant prostate cancer were enrolled and randomized to talazoparib or placebo plus enzalutamide treatment. Patients were tested for homol… (full text at CIViC)

PMID 37285865 · Agarwal et al., 2023 · Open in CIViC

AR AR-V710
Abiraterone + EnzalutamideSubstitutes	Malignant Prostate Neoplasm	Predictive	B	Supports Resistance	4	accepted	EID9547 This multicenter clinical trial study (PROPHECY) enrolled 118 patients with metastatic castration-resistant prostate cancers (CRPC) on Abiraterone or Enzalutamide treatment. The Johns Hopkins Universi… (full text at CIViC) PMID 30865549 · Armstrong et al., 2019 · Open in CIViC	civic
〃	Malignant Prostate Neoplasm	Predictive	B	Does Not Support Resistance	3	submitted	EID9548 A clinical study including 37 patients with mCRPC commencing abiraterone or enzalutamide treatment shows no significant changes in PSA PFS response when AR-V7 is expressed (p = 0.4). The same result i… (full text at CIViC) PMID 29398263 · To et al., 2018 · Open in CIViC	civic
〃	Malignant Prostate Neoplasm	Predictive	B	Supports Resistance	4	submitted	EID9553 In a prospective clinical trial including 149 patients starting abiraterone or enzalutamide treatment AR-V7 expression is associated with worse PSA PFS, PFS and OS ( p < 0.001) in the overall cohort (… (full text at CIViC) PMID 28384066 · Antonarakis et al., 2017 · Open in CIViC	civic
〃	Malignant Prostate Neoplasm	Predictive	B	Supports Resistance	4	accepted	EID12463 A cross-sectional cohort study was performed in 161 men with metastatic prostate cancer undergoing a change in treatment to determine if pre-therapy AR-V7 nuclear protein expression in circulating tum… (full text at CIViC) PMID 27262168 · Scher et al., 2016 · Open in CIViC	civic
〃	Malignant Prostate Neoplasm	Predictive	B	Supports Resistance	4	accepted	EID12464 A blinded, multi-institutional cohort study was performed in 142 men with metastatic, castration-resistant prostate cancer to determine if pre-therapy nuclear-localized expression of AR-V7 protein in … (full text at CIViC) PMID 29955787 · Scher et al., 2018 · Open in CIViC	civic
Enzalutamide	Malignant Prostate Neoplasm	Predictive	B	Supports Resistance	4	submitted	EID9554 In a prospective clinical trial including 28 patients treated with enzalutamide, AR-V7 expression is significantly correlated with primary resistance (p = 0.018). PMID 24882673 · Efstathiou et al., 2015 · Open in CIViC	civic
Abiraterone + EnzalutamideSubstitutes	Malignant Prostate Neoplasm	Predictive	B	Supports Resistance	3	accepted	EID863 This prospective study enrolled 31 Enzalutamide-treated (group 1) and 31 Abiraterone-treated (group 2) patients with metastatic castration-resistant prostate cancers (CRPC). AR-V7 variant was detected… (full text at CIViC) PMID 25184630 · Antonarakis et al., 2014 · Open in CIViC	civic
〃	Malignant Prostate Neoplasm	Predictive	B	Supports Resistance	4	submitted	EID9555 In a prospective clinical trial including 37 patients treated with enzalutamide or abiraterone, AR-V7 expression is significantly associated with non PSA response to any subsequent treatment ( p < 0.0… (full text at CIViC) PMID 31289619 · Steinestel et al., 2019 · Open in CIViC	civic
〃	Malignant Prostate Neoplasm	Predictive	B	Supports Resistance	4	submitted	EID9576 In a clinical study including 37 patients treated with taxanes or enzalutamide and abiraterone: - AR-V7 is associated with resistance to enzalutamide and abiraterone, but its relevance in the context … (full text at CIViC) PMID 26181238 · Antonarakis et al., 2015 · Open in CIViC	civic
Enzalutamide + GaleteroneSubstitutes	Malignant Prostate Neoplasm	Predictive	B	Supports Sensitivity Response	2	submitted	EID9549 In a clinical study including 38 AR-V7 positive patients treated with Galeterone (19) and Enzalutamide (19), PSA50 response rates is 13% for Galeterone and 42% for Enzalutamide. Open in CIViC	civic