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Compound · clinical trials

Abiraterone acetate clinical trials

Also listed in trial records as Zytiga
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 30 trials in our USA, UK, China, Ireland and India registers that name Abiraterone acetate as an intervention. Synced 25 Sep 2026
30Current trials
10Recruiting now
16Lead sponsors
5Country registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 โ€” Top 14 finalist
Compiled from ClinicalTrials.gov registry records ยท Last verified ยท Editorial standards
At a glance

Abiraterone acetate is named as an intervention in 30 current clinical trials in our USA, UK, China, Ireland and India registers. 10 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is AstraZeneca (6). The most-studied condition is Prostatic Neoplasms.

Trials by status

  • Recruiting1033%
  • Not yet open13%
  • Active, closed1963%

Trials by phase

  • Phase 31343%
  • Phase 1620%
  • Phase 2517%
  • Phase 1/227%
  • Observational27%
  • Phase 2/313%
  • Phase 413%
01

Clinical trials of Abiraterone acetate

30 trials
StudyPhaseStatusLead sponsorRegisters
Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
NCT06136624 · Prostate Cancer Metastatic
Phase 3 Recruiting Merck Sharp & Dohme LLC Ireland, UK, USA, China
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)
NCT06136650 · ClinicalTrials.gov ↗ · Metastatic Castration-resistant Prostate Cancer (mCRPC), Prostatic Neoplasms
Phase 3 Recruiting Merck Sharp & Dohme LLC Ireland, UK, USA, China
A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naรฏve Metastatic Castration-resistant Prostate Cancer
NCT07213674 · ClinicalTrials.gov ↗ · Metastatic Castration-resistant Prostate Cancer
Phase 3 Recruiting Amgen UK, USA
Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer
NCT05406999 · ClinicalTrials.gov ↗ · Neoadjuvant Therapy, High Risk Prostate Cancer, Locally Advanced Prostate Cancer
Phase 2 Recruiting The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School China
Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer.
NCT05422911 · ClinicalTrials.gov ↗ · Metastatic Cancer, Neoplasm, Prostate, Castrate-sensitive
Phase 2 Recruiting Sun Pharmaceutical Industries Limited USA
A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer
NCT07005154 · Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer, Metastatic Hormone Sensitive Prostate Cancer
Phase 2 Recruiting Astellas Pharma Global Development, Inc. UK, USA, China
A Clinical Study of QLC5508 and/or QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer
NCT07198633 · ClinicalTrials.gov ↗ · Advanced Prostate Cancer
Phase 1/2 Recruiting Qilu Pharmaceutical Co., Ltd. China
A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer
NCT05818683 · ClinicalTrials.gov ↗ · Metastatic Castration-resistant Prostate Neoplasms, Metastatic Hormone-sensitive Prostate Cancer
Phase 1 Recruiting Janssen Research & Development, LLC USA
Study of HRS-5041 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
NCT05942001 · ClinicalTrials.gov ↗ · Advanced Prostate Cancer
Phase 1 Recruiting Jiangsu HengRui Medicine Co., Ltd. China
A Study to Learn About Real-world Utilization and Outcomes of Darolutamide and Other Androgen Receptor Pathway Inhibitors (ARPIs) for Newly Diagnosed Metastatic Hormone-sensitive Prostate Cancer (de Novo mHSPC) in US Urology Clinics
NCT07406282 · ClinicalTrials.gov ↗ · Prostatic Neoplasms, Metastatic Hormone-Sensitive Prostate Cancer
Observational Recruiting Bayer USA
Phase III Study of Abiraterone Acetate (II) Versus Abiraterone Acetate in Patients with MCRPC
NCT06768255 · ClinicalTrials.gov ↗ · Abiraterone Acetate, MCRPC (metastatic Castration-resistant Prostate Cancer)
Phase 3 Not yet open Ding-Wei Ye China
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
NCT05457257 · ClinicalTrials.gov ↗ · Metastatic Castration-resistant Prostate Cancer
Phase 4 Active, closed AstraZeneca China
A Phase III Study for Patients With Metastatic Hormone-naรฏve Prostate Cancer
NCT01957436 · ClinicalTrials.gov ↗ · Metastatic Prostate Cancer
Phase 3 Active, closed UNICANCER Ireland
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)
NCT02257736 · ClinicalTrials.gov ↗ · Prostatic Neoplasms
Phase 3 Active, closed Aragon Pharmaceuticals, Inc. UK, USA
Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer
NCT03732820 · ClinicalTrials.gov ↗ · Metastatic Castration-resistant Prostate Cancer
Phase 3 Active, closed AstraZeneca UK, USA
A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer
NCT03748641 · ClinicalTrials.gov ↗ · Castration-Resistant Prostatic Cancer
Phase 3 Active, closed Janssen Research & Development, LLC UK, USA, China
Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC
NCT04446117 · ClinicalTrials.gov ↗ · Metastatic Prostate Cancer, Prostate Adenocarcinoma
Phase 3 Active, closed Exelixis UK, USA
Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency
NCT04493853 · ClinicalTrials.gov ↗ · Hormone-Sensitive Prostate Cancer
Phase 3 Active, closed AstraZeneca UK, USA, India, China
A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-MutatedProstatic Neoplasms (mCSPC)
NCT04497844 · ClinicalTrials.gov ↗ · Prostatic Neoplasms
Phase 3 Active, closed Janssen Research & Development, LLC UK, USA, China
Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (China Cohort)
NCT05171816 · ClinicalTrials.gov ↗ · Metastatic Castration-resistant Prostate Cancer
Phase 3 Active, closed AstraZeneca China
Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents
NCT06120491 · ClinicalTrials.gov ↗ · Metastatic Castration-Sensitive Prostate Cancer
Phase 3 Active, closed AstraZeneca UK, USA, India, China
A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer
NCT03706365 · ClinicalTrials.gov ↗ · Prostate Cancer
Phase 2/3 Active, closed Eli Lilly and Company USA, China
A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
NCT02960022 · ClinicalTrials.gov ↗ · Prostate Cancer
Phase 2 Active, closed Astellas Pharma Global Development, Inc. UK, USA, China
A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer
NCT03431350 · ClinicalTrials.gov ↗ · Prostatic Neoplasms, Castration-Resistant
Phase 2 Active, closed Janssen Research & Development, LLC UK, USA
Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer
NCT05367440 · ClinicalTrials.gov ↗ · Metastatic Prostate Cancer
Phase 1/2 Active, closed AstraZeneca UK, USA
A Study of JNJ-56021927 (ARN-509) and Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer
NCT02123758 · ClinicalTrials.gov ↗ · Prostatic Neoplasms, Metastatic Castration-Resistant Prostate Cancer
Phase 1 Active, closed Aragon Pharmaceuticals, Inc. UK, USA
A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer
NCT04577833 · ClinicalTrials.gov ↗ · Prostatic Neoplasms
Phase 1 Active, closed Janssen Research & Development, LLC UK, USA
ARX517/JNJ-95298177 as Monotherapy or Combination Therapy in Subjects With Metastatic Prostate Cancer
NCT04662580 · ClinicalTrials.gov ↗ · Metastatic Prostate Cancer
Phase 1 Active, closed Janssen Research & Development, LLC USA
M9466 Alone or in Combination in Advanced Solid Tumors (DDriver 501)
NCT06421935 · ClinicalTrials.gov ↗ · Advanced Solid Tumor
Phase 1 Active, closed EMD Serono Research & Development Institute, Inc. USA
Observing the Real-world Non-interventional Study of Abiraterone Acetate Tablets (II) in Treating Chinese Patients With Metastatic Prostate Cancer
NCT07721532 · ClinicalTrials.gov ↗ · Diagnosed With Metastatic Prostate Cancer
Observational Active, closed The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School China

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Abiraterone acetate across our data

Ireland · EU · US

The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.

Licensed in Ireland (HPRA)

15 single-substance products containing Abiraterone acetate on the HPRA medicines list.

All 15 Irish products →

Supply shortages

  • Abirateron HEXAL 1000 mg FilmtablettenGermany (BfArM) · Other reason · 21 Jan 2026 to 6 Nov 2026
  • Abirateron HEXAL 1000 mg FilmtablettenGermany (BfArM) · Other reason · 21 Jan 2026 to 6 Nov 2026
  • Abirateron HEXAL 500 mg FilmtablettenGermany (BfArM) · Other reason · 11 Feb 2026 to 2 Oct 2026
03

Conditions studied with Abiraterone acetate

29 conditions
Prostatic Neoplasms6Metastatic Prostate Cancer4Metastatic Castration-resistant Prostate Cancer4Prostate Cancer3Metastatic Castration-Resistant Prostate Cancer2Advanced Prostate Cancer2Prostate Cancer Metastatic1Metastatic Castration-resistant Prostate Cancer (mCRPC)1Metastatic Hormone Sensitive Prostate Cancer1Prostatic Neoplasms, Castration-Resistant1Castration-Resistant Prostatic Cancer1Hormone-Sensitive Prostate Cancer1
All 29 conditions
Condition (as registered)Trials
Prostatic Neoplasms6
Metastatic Prostate Cancer4
Metastatic Castration-resistant Prostate Cancer4
Prostate Cancer3
Metastatic Castration-Resistant Prostate Cancer2
Advanced Prostate Cancer2
Prostate Cancer Metastatic1
Metastatic Castration-resistant Prostate Cancer (mCRPC)1
Metastatic Hormone Sensitive Prostate Cancer1
Prostatic Neoplasms, Castration-Resistant1
Castration-Resistant Prostatic Cancer1
Hormone-Sensitive Prostate Cancer1
Prostate Adenocarcinoma1
Metastatic Castration-Sensitive Prostate Cancer1
Metastatic Castration-resistant Prostate Neoplasms1
Metastatic Hormone-sensitive Prostate Cancer1
Metastatic Cancer1
Neoplasm, Prostate1
Castrate-sensitive1
Castrate-sensitive Prostate Cancer1
Advanced Solid Tumor1
Metastatic Hormone-Sensitive Prostate Cancer1
Neoadjuvant Therapy1
High Risk Prostate Cancer1
Locally Advanced Prostate Cancer1
Intense Endocrine Therapy1
Abiraterone Acetate1
MCRPC (metastatic Castration-resistant Prostate Cancer)1
Diagnosed With Metastatic Prostate Cancer1
04

Sponsors

lead sponsor per trial
Lead sponsorTrials
AstraZeneca6
Janssen Research & Development, LLC6
Merck Sharp & Dohme LLC2
Astellas Pharma Global Development, Inc.2
Aragon Pharmaceuticals, Inc.2
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School2
UNICANCER1
Amgen1
Exelixis1
Sun Pharmaceutical Industries Limited1
EMD Serono Research & Development Institute, Inc.1
Eli Lilly and Company1
Bayer1
Ding-Wei Ye1
Qilu Pharmaceutical Co., Ltd.1

+ 1 more sponsors in the trial list above.

05

By country register

RegisterTrialsRecruiting
Clinical trials in USA227
Clinical trials in UK164
Clinical trials in China166
Clinical trials in Ireland32
Clinical trials in India20

A trial with sites in more than one country appears in each of those registers.

06

Related compounds

07

Questions about Abiraterone acetate trials

How many clinical trials are testing Abiraterone acetate?

30 current trials in our USA, UK, China, Ireland and India registers name Abiraterone acetate as a drug or biological intervention, as of the registry sync on 25 September 2026. Completed and withdrawn studies are not counted.

Are Abiraterone acetate trials recruiting patients?

Yes. 10 of the 30 trials are recruiting: 7 with sites in USA, 4 with sites in UK, 6 with sites in China and 2 with sites in Ireland. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Abiraterone acetate clinical trials?

AstraZeneca (6), Janssen Research & Development, LLC (6), Merck Sharp & Dohme LLC (2) and Astellas Pharma Global Development, Inc (2), among 16 lead sponsors in total. The number in brackets is how many trials each organisation leads.

Is Abiraterone acetate licensed in Ireland?

Yes. The HPRA medicines list includes 15 single-substance products containing Abiraterone acetate, for example Abiraterone Aristo 500 mg film-coated tablets (Aristo Pharma GmbH). A licence does not mean a product is currently marketed or reimbursed; see each product's record.

Is there a Abiraterone acetate shortage?

The registers we track list 3 entries for Abiraterone acetate: 3 German notices. Shortages are product- and country-specific; check with a pharmacist.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Abiraterone acetate works or whether it is effective, and it is not medical advice.

How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records โ€” it is not written from memory, and nothing here describes how Abiraterone acetate works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Abiraterone acetate (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 25 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician โ€” our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us โ€” we correct promptly and log it.