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Drug

Abiraterone

Approved · EMA
ClassAndrogen Receptor antagonistEmerging researchLate-stage developmentSteady momentum
Also known as Abirtega, Akeega, Yonsa, Zytiga+3 more

Abirtega, Akeega, Yonsa, Zytiga, Abiraterona, 17-(3-Pyridyl)androsta-5,16-dien-3beta-ol, Abiraterone Acetate.

8
Research papers
32
Active clinical trials
5
Protein targets
4
Regulatory events
Latest activity
beta

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

Circulating Tumor DNA Assessment for Treatment Monitoring Adds Value to PSA in Metastatic Castration-Resistant Prostate Cancer.

Research2024-09-01Clinical cancer research : an official journal of the American Association for Cancer Research

Rucaparib or Physician's Choice in Metastatic Prostate Cancer.

Research2023-02-16The New England journal of medicine

Approval: Abiraterone Mylan (EMA)

Regulatory2021-08-20EMA

Approval: Abiraterone Krka (EMA)

Regulatory2021-06-24EMA

Approval: Abiraterone Accord (EMA)

Regulatory2021-04-26EMA

Accelerated approval: Zytiga (EMA)

Regulatory2011-09-05EMA

Profile

Identifiers & mechanism

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

Canonical name
Abiraterone
Aliases & brands
AbirtegaAkeegaYonsaZytigaAbiraterona17-(3-Pyridyl)androsta-5,16-dien-3beta-olAbiraterone Acetate
RxNorm CUI
1100072
ChEMBL ID
CHEMBL254328
ATC codes
L02BX03
UNII
G819A456D0
Primary mechanism
Androgen Receptor antagonist
Regulatory jurisdictions
ema

Pharmacology & targets

5 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Androgen receptor
AR · P10275
ANTAGONISTAndrogen Receptor antagonist
INHIBITORCytochrome P450 17A1 inhibitor
INHIBITORSteroid 5-alpha-reductase inhibitor
INHIBITORSteroid 5-alpha-reductase inhibitor
Polyprenal reductase
SRD5A3 · Q9H8P0
INHIBITORSteroid 5-alpha-reductase inhibitor

Regulatory timeline

4 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
2011-09-05
Latest approval
2021-08-20
Authorities
EMA
Total events
4
emaEuropean Medicines Agency· 4 events
2021-08-20Approval
Approval: Abiraterone Mylan (EMA)
Indication: Abiraterone Mylan is indicated with prednisone or prednisolone for: the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult menShow full indication

Abiraterone Mylan is indicated with prednisone or prednisolone for: the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT). the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Evidence ↗
2021-06-24Approval
Approval: Abiraterone Krka (EMA)
Indication: Abiraterone Krka is indicated with prednisone or prednisolone for: the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men inShow full indication

Abiraterone Krka is indicated with prednisone or prednisolone for: the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) (see section 5.1) the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men 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 mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

Evidence ↗
2021-04-26Approval
Approval: Abiraterone Accord (EMA)
Indication: Abiraterone Accord is indicated with prednisone or prednisolone for: the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult menShow full indication

Abiraterone Accord is indicated with prednisone or prednisolone for: the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

86 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
86
registered trials across all phases
LATEST COMPLETION 2026
32
Active studies
23
Recruiting
18
Late-stage (III+)
30
Completed
24
Discontinued
PHASE DISTRIBUTIONn = 86
Early Phase 11Phase 119Phase 1 / 211Phase 237Phase 2 / 33Phase 313Phase 41Phase N / A1

Late-stage studies

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

Recent completions

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

Research activity

8 papers

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

Publications over time
20192024
Most influential

Olaparib for Metastatic Castration-Resistant Prostate Cancer.

The New England journal of medicine · 2020 · 1,688 cites

Genomic correlates of clinical outcome in advanced prostate cancer.

Proceedings of the National Academy of Sciences of the United States of America · 2019 · 1,163 cites

Cabazitaxel versus Abiraterone or Enzalutamide in Metastatic Prostate Cancer.

The New England journal of medicine · 2019 · 439 cites

Rucaparib or Physician's Choice in Metastatic Prostate Cancer.

The New England journal of medicine · 2023 · 332 cites

Circulating Tumor DNA Assessment for Treatment Monitoring Adds Value to PSA in Metastatic Castration-Resistant Prostate Cancer.

Clinical cancer research : an official journal of the American Association for Cancer Research · 2024 · 19 cites
Recent papers

Circulating Tumor DNA Assessment for Treatment Monitoring Adds Value to PSA in Metastatic Castration-Resistant Prostate Cancer.

Clinical cancer research : an official journal of the American Association for Cancer Research · 2024 · 19 cites

Rucaparib or Physician's Choice in Metastatic Prostate Cancer.

The New England journal of medicine · 2023 · 332 cites

Olaparib for Metastatic Castration-Resistant Prostate Cancer.

The New England journal of medicine · 2020 · 1,688 cites

Genomic correlates of clinical outcome in advanced prostate cancer.

Proceedings of the National Academy of Sciences of the United States of America · 2019 · 1,163 cites
Major research themes8
Prostatic Neoplasms, Castration-Resistant3Circulating Tumor DNA2Antineoplastic Agents1Antineoplastic Agents, Hormonal1Benzamides1Biomarkers, Tumor1Loss of Function Mutation1Phenylthiohydantoin1
Journals, researchers & institutions
Top journals
  • The New England journal of medicine3
  • Cancer biology & medicine1
  • Clinical cancer research : an official journal of the American Association for Cancer Research1
  • Nature communications1
  • Proceedings of the National Academy of Sciences of the United States of America1
  • The Lancet. Oncology1
Leading researchers
  • Fizazi K3
  • Abida W2
  • Beltran H2
  • de Bono J2
  • Heidenreich A2
  • Mateo J2
  • Nolè F2
  • Piulats JM2
Leading institutions
free-text, unnormalised
  • Memorial Sloan Kettering Cancer Center2
  • Barbara Ann Karmanos Cancer Institute1
  • Barretos Cancer Hospital1
  • Broad Institute1
  • Catalan Cancer Institute1
  • Cliniques Universitaires Saint-Luc1

Related diseases

2 conditions

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

Related drugs

6 matches

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

Acts on the same molecular target as Abiraterone, with 4 overlapping disease areas.

Shared target4 shared diseases6 shared papers

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

3 shared diseases1 shared paper

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

3 shared diseases1 shared paper

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

3 shared diseases1 shared paper

Studied across 2 of the same disease areas as Abiraterone in the shared literature.

2 shared diseases1 shared paper

Studied across the same disease area as Abiraterone in the shared literature.

1 shared disease1 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.