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.

emaRegulatory3 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
EU EMA	Castration-Resistant Prostate Carcinoma	Enzalutamide Viatris is indicated:• as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy (see section 5.1);• in combination with androgen deprivation therapy for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) (see section 5.1); • for the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1);• for the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1);• for the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.	approved	Aug 22, 2024	ema
EU EMA	Castration-Resistant Prostate Carcinoma	Xtandi is indicated for: as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high risk biochemical recurrent (BCR) non-metastatic hormone sensitive prostate cancer (nmHSPC) who are unsuitable for salvage radiotherapy (see section 5.1). the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1). the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1). the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1). the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.

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 14 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	100	50	48	274	35	CA, EU, US	Aug 31, 2012	Jul 8, 2005
Malignant Prostate Neoplasm	Approved	Phase 4	67	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 51–100 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
NCT06378866	Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial(DIVINE)	recruiting	Phase 2	532	Mayo ClinicOTHER	1	Jul 20, 2026	clinicaltrials
NCT04363164	Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression

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 17 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

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