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Drug

Abiraterone Acetate

Approved · FDA
ClassCytochrome P450 17A1 inhibitorEmerging researchLate-stage developmentRising momentum

Also known as Abirtega, Akeega, Yonsa, Zytiga.

RxNorm1100071ChEMBLCHEMBL271227UNIIEM5OCB9YJ6
4
Research papers
57
Active clinical trials
CYP17A1
Primary target
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 2, Open-label, Multi-cohort Study to Assess the Efficacy and Safety of ASP5541 in Participants With Advanced Prostate Cancer

Clinical trial2026-07-15Results expected Q2 2032 · ClinicalTrials.gov

Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)

Clinical trial2026-07-13Results expected Q4 2027 · ClinicalTrials.gov

A Phase 1b-2 Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer

Clinical trial2026-07-07Results posted · ClinicalTrials.gov

Prostate Specific Membrane Antigen (PSMA) or Fluciclovine (FACBC) PET/CT Site-Directed Therapy of OLigometASTatic Prostate Cancer (P-Flu-BLAST-PC): A Multicenter Study

Clinical trial2026-07-07Results expected Q3 2032 · ClinicalTrials.gov

A Phase 1, Multicenter, Open-Label, Dose-Escalation, and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of ARX517 as Monotherapy and in Combination With Androgen Receptor Pathway Inhibitors in Subjects With Metastatic Prostate Cancer

Clinical trial2026-07-06Results expected Q4 2026 · ClinicalTrials.gov

A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)

Clinical trial2026-07-06Results posted · ClinicalTrials.gov

Label change: ABIRATERONE ACETATE (ANDA208371)

Regulatory2026-06-05FDA

Niraparib and abiraterone acetate plus prednisone for HRR-deficient metastatic castration-sensitive prostate cancer: a randomized phase 3 trial.

Research2025-10-07Nature medicine

Approval: ABIRATERONE ACETATE (ANDA208371)

Regulatory2019-02-25FDA

Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer.

Research2017-06-04The New England journal of medicine

Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy.

Research2017-06-03The New England journal of medicine

Abiraterone in metastatic prostate cancer without previous chemotherapy.

Research2012-12-10The New England journal of medicine

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Abiraterone Acetate
Aliases & brands
AbirtegaAkeegaYonsaZytiga
RxNorm CUI
1100071
ChEMBL ID
CHEMBL271227
UNII
EM5OCB9YJ6
Primary mechanism
Cytochrome P450 17A1 inhibitor
Regulatory jurisdictions
fda

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Steroid 17-alpha-hydroxylase/17,20 lyase
CYP17A1 · P05093
INHIBITORCytochrome P450 17A1 inhibitor

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2019-02-25
Latest approval
2019-02-25
Authorities
FDA
Total events
2
fdaU.S. Food and Drug Administration· 2 events
2026-06-05Label change
Label change: ABIRATERONE ACETATE (ANDA208371)
Evidence ↗
2019-02-25Approval
Approval: ABIRATERONE ACETATE (ANDA208371)
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

168 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
168
registered trials across all phases
LATEST COMPLETION 2025
57
Active studies
24
Recruiting
31
Late-stage (III+)
75
Completed
36
Discontinued
PHASE DISTRIBUTIONn = 168
Early Phase 12Phase 129Phase 1 / 216Phase 290Phase 2 / 31Phase 323Phase 45Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Cognitive Effects of Androgen Receptor (AR) Directed Therapies for Advanced Prostate Cancer

Active, not recruitingPH IVNorthwestern Universityn=1002029

A Randomized, Open-label Study to Assess the Efficacy and Safety of Olaparib Versus Enzalutamide or Abiraterone Acetate in Chinese Men With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have BRCA1/2 Mutations (PROfound-CN)

Active, not recruitingPH IVAstraZenecan=432026

The Effect of Abiraterone on the Metabolism of Oxycodone

RecruitingPH IVDeventer Ziekenhuisn=292026

A Randomized, Open Label, Multicenter Study of Cabazitaxel Versus an Androgen Receptor (AR)-Targeted Agent (Abiraterone or Enzalutamide) in mCRPC Patients Previously Treated With Docetaxel and Who Rapidly Failed a Prior AR-targeted Agent (CARD)

CompletedPH IVSanofin=2552021

A Phase 4 Study of Zytiga in Poor-risk mCRPC (Metastatic Castration-Resistant Prostate Cancer) Patients Who Was Failed the First-line CAB (Combined Androgen Blockade) Therapy

CompletedPH IVJanssen Pharmaceutical K.K.n=512017

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase I Trial of Apalutamide Plus Abiraterone Acetate, Docetaxel, and Prednisone in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC)

CompletedPH IWeill Medical College of Cornell Universityn=162025

A Phase 1b Clinical Trial of Cabozantinib and Abiraterone With Checkpoint Inhibitor Immunotherapy in Metastatic Hormone Sensitive Prostate Cancer (CABIOS Trial)

CompletedPH IWashington University School of Medicinen=182025

An Open-label Phase I/IIa Study to Evaluate the Safety and Efficacy of CCS1477 as Monotherapy and in Combination, in Patients With Advanced Solid/Metastatic Tumours.

CompletedPH I/IICellCentric Ltd.n=2202025

A Phase 3 Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer

CompletedPH IIIAlliance Foundation Trials, LLC.n=5042025

Phase II Clinical Trial of Abiraterone Acetate Without Exogenous Glucocorticoids in Men With Castration-resistant Prostate Cancer With Correlative Assessment of Hormone Intermediates.

CompletedPH IIDana-Farber Cancer Instituten=602025

Phase 2 Trial Pembrolizumab or Pembrolizumab in Combination With Intratumoral SD-101 Therapy in Patients With Hormone-Naïve Oligometastatic Prostate Cancer Receiving Stereotactic Body Radiation Therapy and Intermittent Androgen Deprivation Therapy

CompletedPH IIDavid Ohn=232025

Research activity

4 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20132025
Major research themes7
Abiraterone Acetate1Antineoplastic Combined Chemotherapy Protocols1Indazoles1Piperidines1Prednisone1Prostatic Neoplasms, Castration-Resistant1Recombinational DNA Repair1
Journals, researchers & institutions
Top journals
  • The New England journal of medicine3
  • Nature medicine1
Leading researchers
  • Attard G2
  • Chi KN2
  • de Bono JS2
  • Efstathiou E2
  • Fizazi K2
  • Kheoh T2
  • Özgüroğlu M2
  • Protheroe A2
Leading institutions
free-text, unnormalised
  • BC Cancer - Vancouver Center1
  • Cancer Institute1
  • Chongqing University Cancer Hospital1
  • Fred Hutchinson Cancer Center1
  • From the Institute of Cancer and Genomic Sciences1
  • Helen Diller Family Comprehensive Cancer Center1

Related diseases

2 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Related drugs

3 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Prednisolone

Studied across 3 of the same disease areas as Abiraterone Acetate in the shared literature.

3 shared diseases2 shared papers
Prednisone

Studied across 3 of the same disease areas as Abiraterone Acetate in the shared literature.

3 shared diseases2 shared papers
Niraparib

Studied across 3 of the same disease areas as Abiraterone Acetate in the shared literature.

3 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.