Drug · Small Molecule

Abiraterone

CI-DRUG-00000036Explore in graph →NCIt C77333 CHEMBL254328 CIViC Approved

Regulatory

Approvals (8)

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

openfdaRegulatory6 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2019-06-03 (see label)	approved	Jun 3, 2019	openfda
US FDA	Castration-Resistant Prostate Carcinoma	Abiraterone Acetate is indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer. Abiraterone Acetate is a CYP17 inhibitor indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). ( 1 )	approved	May 22, 2018	openfda
US FDA	—	Efficacy supplement 2018-02-07 (see label)	approved	Feb 7, 2018	openfda
US FDA	—	Efficacy supplement 2015-03-20 (see label)	approved

Data updated 15 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	45	24	19	103	8	EU, US	Apr 28, 2011	Jul 8, 2005
Malignant Prostate Neoplasm	Approved	Phase 4	30	18	13	74	3	EU, US	Sep 5, 2011	Jul 8, 2005
Malignant Kidney Neoplasm	Phase3	Phase 3	1	0	1	1	0	—	—	Jul 30, 2026
Malignant Liver Neoplasm	Phase3	Phase 3	1	0	1	1	0

Curated evidence

Clinical evidence (14)

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

civicCuratedShowing 1–14 of 14 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
BRCA1 Mutation + BRCA2 MutationBRCA2 BRCA11

Clinical trials

Trials with this intervention (111)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 101–111 of 111 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
NCT02758132	Denosumab Plus Enzalutamide, Abiraterone and Prednisone Compared to Denosumab Plus Enzalutamide Alone for Men With Castrate Resistant Prostate Cancer (CRPC) With Bone Metastases	terminated	Phase 2	1	University of HawaiiOTHER	1	Nov 8, 2019	clinicaltrials
NCT01553188	AMG 386 and Abiraterone for Advanced Prostate Cancer	completed

Molecule

Record

Kind: Small Molecule
Mechanism: Cytochrome P450 17A1 inhibitor; Androgen Receptor antagonist; Steroid 5-alpha-reductase inhibitor
Targets: 5 genes
UNII: EM5OCB9YJ6
Aliases: 17-(3-Pyridyl)androsta-5,16-dien-3beta-ol, Abiraterona, Abiraterone, Abiraterone Accord, ABIRATERONE ACETATE, ABIRTEGA, CB 7598, NSC-741232, YONSA, ZYTIGA

Data updated 18 hours agoSource updated unknown

Identifiers

Codes (3)

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

System	Code	Label
ATC (WHO)	L02BX03	Endocrine therapy
EMA product	EMEA/H/C/002321	Zytiga
EMA product	EMEA/H/C/005408	Abiraterone Accord

Regulatory status is jurisdiction-specific and time-bound. Nothing on this page is a treatment recommendation.

AR AR-V78
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
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

TSPYL1 P62S2
Abiraterone	Malignant Prostate Neoplasm	Predictive	D	Does Not Support Sensitivity Response	2	submitted	EID8947 Prostate cancer cell lines over-expressing TSPYL1 P62S had similar levels of cell proliferation as control cells normally expressing TSPYL1 wildtype when treated with abiraterone. Authors note that TS… (full text at CIViC) PMID 29027195 · Qin et al., 2018 · Open in CIViC	civic
Abiraterone + PrednisoneCombination	Malignant Prostate Neoplasm	Predictive	B	Does Not Support Sensitivity Response	4	submitted	EID5861 In a prospective clinical trial, 87 metastatic castration resistant prostate cancer (mCRPC) patients treated with abiraterone acetate/prednisone (AA/P) showed that TSPYL1 R62S (NC_000006.11:g.11660081… (full text at CIViC) PMID 29027195 · Qin et al., 2018 · Open in CIViC	civic