TheraRadar
Data updated: May 26, 2026

ABIRATERONE ACETATE

Oncology Approved 2018-10-31

Abiraterone acetate is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) and metastatic high-risk castration-sensitive prostate cancer (mCSPC).

Source: FDA Label • Teva
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How ABIRATERONE ACETATE Works

Abiraterone acetate is a prodrug converted in vivo to abiraterone, a potent inhibitor of the CYP17 enzyme complex (17α-hydroxylase and C17,20-lyase). This enzyme is expressed in testicular, adrenal, and prostatic tumor tissues and is essential for the biosynthesis of androgens. By inhibiting CYP17, the drug blocks the conversion of pregnenolone and progesterone into testosterone precursors (DHEA and androstenedione), thereby reducing serum testosterone levels. Concomitant prednisone is

Source: FDA Label
12
Indications
--
Phase 3 Trials
7
Years on Market

Details

Status
Discontinued
First Approved
2018-10-31
Routes
ORAL
Dosage Forms
TABLET

Companies

Teva Viatris NOVUGEN Dr. Reddy's Apotex AMNEAL PHARMS WOCKHARDT BIO AG RISING GLENMARK SPECLT QILU FLORIDA Hikma MSN
Active Ingredient: ABIRATERONE ACETATE

ABIRATERONE ACETATE Approval History

2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
71 FDA actions from 2018 to 2025
May 2025 SUPPL
Mfg · Manufacturing (CMC)
Oct 2024 SUPPL
Label · Labeling
Aug 2024 SUPPL
Label · Labeling

What ABIRATERONE ACETATE Treats

2 indications

ABIRATERONE ACETATE is approved for 2 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Metastatic Castration-Resistant Prostate Cancer
  • Metastatic Castration-Sensitive Prostate Cancer
Source: FDA Label

ABIRATERONE ACETATE Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

CONJUGATED ESTROGENS
NOVAST LABS
2025 6 indic.
BILDYOS
SHANGHAI HENLIUS
2025 4 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in ABIRATERONE ACETATE's indications

See all emerging drugs →

Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ABIRATERONE ACETATE treats. First-in-class if their pivotal trials read out positive.

Ceralasertib AZD6738 ~ Mixed — Ph3 readout
AstraZeneca
ATR · small-molecule ATR kinase inhibitor · 2 Phase 3 trials

Drugs Similar to ABIRATERONE ACETATE

3 of 5

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ZYTIGA
ABIRATERONE ACETATE
2 shared
Johnson & Johnson
Shared indications:
Metastatic Castration-Resistant Prostate CancerMetastatic Castration-Sensitive Prostate Cancer
APALUTAMIDE
APALUTAMIDE
1 shared
ZYDUS
Shared indications:
Metastatic Castration-Sensitive Prostate Cancer
ERLEADA
APALUTAMIDE
1 shared
Johnson & Johnson
Shared indications:
Metastatic Castration-Sensitive Prostate Cancer
View all 5 similar drugs Pro
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Clinical Trial Registry

134 trials
Trial Sponsor ID Phase Status Title
NCT06136650 5684-004 MK-5684-004, jRCT2031240030 Ph 3 recruiting A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)
NCT02257736 results posted CR105505 56021927PCR3001, 2014-001718-25 Ph 3 active not recruiting An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)
NCT07213674 20230239 Ph 3 recruiting A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer
NCT06632977 PREDICT A032102 NCI-2024-04960 Ph 2 recruiting Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial
NCT04662580 ARX517 ARX517-2011 ARX517-2011 Ph 1 active not recruiting ARX517/JNJ-95298177 as Monotherapy or Combination Therapy in Subjects With Metastatic Prostate Cancer
NCT02123758 CR104358 56021927PCR1010, 2014-001426-14 Ph 1 active not recruiting A Study of JNJ-56021927 (ARN-509) and Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer
NCT03748641 MAGNITUDE results posted CR108534 64091742PCR3001, 2017-003364-12 Ph 3 active not recruiting A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer
NCT06136624 OMAHA-003 5684-003 2023-504899-25-00, MK-5684-003 Ph 3 recruiting Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
NCT04493853 CAPItello-281 D361BC00001 2023-504998-20-00, 2020-000346-33 Ph 3 active not recruiting Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency
NCT07005154 5541-CL-0201 Ph 2 recruiting A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer
NCT04194554 ASCLEPIuS UMCC 2019.117 HUM00167325 Ph 1, Ph 2 active not recruiting A Multi-Center Trial of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibition and Stereotactic Body Radiotherapy in Prostate Cancer
NCT03436654 17-646 PCCTC #: c16-183 Ph 2 active not recruiting Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma
NCT03706365 CYCLONE 2 results posted 16598 I3Y-MC-JPCM, 2016-004276-21 Ph 2, Ph 3 active not recruiting A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer
NCT05457257 results posted D081LC00002 Ph 4 active not recruiting Clinical Study to Assess the Efficacy and Safety of Olaparib in Chinese Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have BRCA1/2 Mutations
NCT02913196 1509016578 Ph 1 completed Phase I Trial of Apalutamide Plus Abiraterone Acetate, Docetaxel, and Prednisone in Patients With mCRPC
NCT03821792 2018-0533 NCI-2018-03599, 2018-0533 Ph 2 active not recruiting Abiraterone Acetate, Prednisone, and Apalutamide in Treating Patients With Hormone-Naive Metastatic Prostate Cancer
NCT02960022 9785-CL-0123 2016-001694-32, 2023-510298-33-00 Ph 2 recruiting A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
NCT06392841 HARMONY HCRN-GU23-626 Ph 2 withdrawn Niraparib, Abiraterone Acetate and Prednisone for mHSPC With Deleterious Homologous Recombination Repair Alterations
NCT06120491 EvoPAR-PR01 D9723C00001 2023-504214-30-00 Ph 3 recruiting Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents
NCT03419234 results posted EA8153 NCI-2017-00389, EA8153 Ph 2 active not recruiting Abiraterone Acetate and Antiandrogen Therapy With or Without Cabazitaxel and Prednisone in Treating Patients With Metastatic, Castration-Resistant Prostate Cancer Previously Treated With Docetaxel
NCT05593497 SNARE SPLP-001-21F Ph 2 recruiting A Single-Arm Phase II Study of Neoadjuvant Intensified Androgen Deprivation (Leuprolide and Abiraterone Acetate) in Combination With AKT Inhibition (Capivasertib) for High-Risk Localized Prostate Cancer With PTEN Loss
NCT06421935 MS202659_0001 2024-513492-41-00 Ph 1 active not recruiting M9466 Alone or in Combination in Advanced Solid Tumors (DDriver 501)
NCT03360721 2017-0060 NCI-2018-01054, 2017-0060 Ph 2 terminated Apalutamide, Abiraterone Acetate, and Prednisone in Treating Participants With Metastatic Castration Resistant Prostate Cancer
NCT05171816 results posted D081SC00001Sub Ph 3 active not recruiting Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (China Cohort)
NCT02703623 2014-0386 NCI-2016-00670, 2014-0386 Ph 2 active not recruiting Abiraterone Acetate, Prednisone, and Apalutamide With or Without Ipilimumab or Cabazitaxel and Carboplatin in Treating Patients With Metastatic Castration-Resistant Prostate Cancer
NCT06650579 STUDY00007557 P30CA138292, NCI-2024-07761 Ph 3 recruiting REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial
NCT03016741 NU 17U19 STU00206082, NCI-2016-01795 Ph 4 active not recruiting Cognitive Effects of Androgen Receptor Directed Therapies for Advanced Prostate Cancer
NCT01786265 2012-0993 NCI-2018-01856, 2012-0993 Ph 2 active not recruiting Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer
NCT04947254 2020-1039 NCI-2021-05724, 2020-1039 Ph 2 recruiting Androgen Ablation Therapy With or Without Niraparib After Radiation Therapy for the Treatment of High-Risk Localized or Locally Advanced Prostate Cancer
NCT06616597 J2485 IRB00453879 Ph 2 recruiting Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients With Metastatic Prostate Cancer
NCT03902951 18-001037 NCI-2019-00337 Ph 2 active not recruiting Antiandrogen Therapy and SBRT in Treating Patients With Recurrent, Metastatic Prostate Cancer
NCT03732820 results posted D081SC00001 2018-002011-10 Ph 3 active not recruiting Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer
NCT04734730 20476 NCI-2020-10199, 20476 Ph 2 recruiting Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer
NCT03565835 results posted 2017-8506 Ph 2 completed Abiraterone With Discontinuation of Gonadotropin-Releasing Hormone Analogues in Metastatic Prostate Cancer
NCT04267887 STUDY00016728 NCI-2020-00598, STUDY00016728 Ph 2 active not recruiting Advanced ChemoHormonal Therapy for Treatment Naive Metastatic Prostate Cancer
NCT02949284 Pro20160000563 NCI-2016-01496, Pro20160000563 Ph 2 active not recruiting Androgen Receptor Antagonist ARN-509 With or Without Abiraterone Acetate, Gonadotropin-Releasing Hormone Analog, and Prednisone in Treating Patients With High-Risk Prostate Cancer Undergoing Surgery
NCT06384222 235513 NCI-2024-03418 Ph 2 recruiting Hyperpolarized (HP) 13C Pyruvate Magnetic Resonance Imaging (MRI) for Response Monitoring to Neoadjuvant Abiraterone
NCT03009981 AFT-19 Ph 3 completed A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer
NCT04446117 CONTACT-02 results posted XL184-315 Ph 3 active not recruiting Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC
NCT04175431 RG1004972 NCI-2019-07437, 10349 Ph 2 recruiting Prostate Specific Membrane Antigen (PSMA) or (FACBC) PET/CT Site-Directed Therapy for Treatment of Prostate Cancer, Flu-BLAST-PC Study
NCT03833921 APRE H-44335 Ph 2 recruiting Evaluation of Response to Abiraterone/Prednisone by Race/Ethnicity and Other Factors in Metastatic Hormone Naive Prostate Cancer
NCT05367440 PETRANHA D9720C00003 2023-508536-64-00, 2021-006289-19 Ph 1, Ph 2 active not recruiting Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer
NCT03007732 results posted 16703 NCI-2017-01340 Ph 2 completed Pembrolizumab +/- SD-101 in Hormone-Naïve Oligometastatic Prostate Cancer With RT and iADT
NCT06369610 GMROA2256 NCI-2024-03020, 22-012591 Ph 2 recruiting Risk Stratified De-escalated Hormone Therapy With Radiation Therapy for the Treatment of Prostate Cancer
NCT04477512 202009082 Ph 1 completed Cabozantinib and Abiraterone With Checkpoint Inhibitor Immunotherapy in Metastatic Hormone Sensitive Prostate Cancer (CABIOS Trial)
NCT02574910 results posted STU 112014-087 1U01HD083493-01 Ph 1 terminated Androgen Reduction in Congenital Adrenal Hyperplasia, Phase 1
NCT03012321 NU_16U05 STU00203960, NCI-2016-01834 Ph 2 active not recruiting Abiraterone/Prednisone, Olaparib, or Abiraterone/Prednisone + Olaparib in Patients With Metastatic Castration-Resistant Prostate Cancer With DNA Repair Defects
NCT07198633 QLC5508-202 Ph 1, Ph 2 not yet recruiting A Clinical Study of QLC5508 and/or QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer
NCT03098836 PANTHER results posted Pro00075097 Ph 2 completed Apalutamide and Abiraterone Acetate in African American and Caucasian Men With Metastatic Castrate Resistant Prostate Cancer
NCT03568656 CCS1477-01 Ph 1, Ph 2 completed Study to Evaluate CCS1477 in Advanced Tumours

Showing 50 of 134 trials

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ABIRATERONE ACETATE FDA Label Details

Indications & Usage

ABIRATERONE ACETATE is indicated for the treatment of Metastatic Castration-Resistant Prostate Cancer; Metastatic Castration-Sensitive Prostate Cancer.

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Full clinical data, patents, trials, and competitive landscape for abiraterone acetate.

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Data Sources

FDA Approval: ANDA208432 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.