NDAORALTABLETPriority Review
Approved
Apr 2011
Lifecycle
LOE Approaching
Competitive Pressure
45/100
Clinical Trials
21
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZYTIGA (abiraterone acetate) is an oral small-molecule androgen biosynthesis inhibitor approved in 2011 for metastatic castration-resistant prostate cancer (CRPC) in combination with prednisone. It works by inhibiting the CYP17 enzyme, which is required for androgen production in testicular, adrenal, and tumor tissues, thereby reducing testosterone levels and slowing cancer progression. ZYTIGA is a foundational hormone therapy in the CRPC treatment landscape but faces significant competition from newer androgen receptor antagonists and alternative hormonal agents.
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Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (21)
A Study of Talazoparib With or Without Enzalutamide in People With Prostate Cancer Who Have Previously Received Abiraterone Acetate
Started May 2026
126 enrolled
Prostate Cancer (Adenocarcinoma)mCRPC (Metastatic Castration-resistant Prostate Cancer)
Niraparib, Abiraterone Acetate and Prednisone for mHSPC With Deleterious Homologous Recombination Repair Alterations
Started Oct 2025
0Metastatic Hormone-sensitive Prostate Cancer (mHSPC)Deleterious HRR Gene MutationBRCA1 Gene Mutation+7 more
Race Impact on Efficacy of Niraparib Plus Abiraterone Acetate and Prednisone in Patients With Homologous Repair Deficient Castration-resistant Prostate Cancer
Started Apr 2025
0Prostate CancerCastrate Resistant Prostate CancerHomologous Recombination Deficiency
Open-Label Study of Pocenbrodib Alone and in Combination With Abiraterone Acetate, Olaparib, or 177Lu-PSMA-617
Started Feb 2025
252 enrolled
mCRPC (Metastatic Castration-resistant Prostate Cancer)Genital Neoplasms, MaleUrogenital Neoplasms+7 more
REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial
Started Jan 2025
72 enrolled
Recurrent Prostate CarcinomaStage III Prostate Cancer AJCC v8Stage IVA Prostate Cancer AJCC v8
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.