Abiraterone clinical trials
Abiraterone is named as an intervention in 36 current clinical trials in our USA, Australia, Canada, China, Spain, South Korea, Germany, France, Italy, UK, Taiwan, Japan, Brazil, Poland, Turkey, Switzerland, Netherlands, Israel, Mexico, Belgium, Sweden, Austria, Czechia, India, Singapore, Ireland, Denmark, Portugal and Norway registers. 22 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Novartis Pharmaceuticals (5). The most-studied condition is Metastatic Castration-resistant Prostate Cancer. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Abiraterone is approved
All regulators →Of the three regulators tracked here, the first to approve Abiraterone was the US, on 28 Apr 2011. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Abiraterone patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Abiraterone, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 2 listed patents; the last listed expires 20 May 2034 (US 10292990).
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Abiraterone
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Abiraterone works
All drug targets →- Cytochrome P450 17A1 inhibitor InhibitorTarget: CYP17A1 cytochrome P450 family 17 subfamily A member 1ChEMBL only
- Prostate adenocarcinomaPhase 2/3
- Cushing syndromePhase 2
- Adrenal cortex carcinomaPhase 2
- Bone metastasisPhase 2
- Breast cancerPhase 2
- CancerPhase 2
- Classic congenital adrenal hyperplasia due to 21-hydroxylase deficiencyPhase 2
- Congenital adrenal hyperplasiaPhase 2
- Non-small cell lung carcinomaPhase 2
- Salivary duct carcinomaPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL271227, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 9288, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Abiraterone
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 4 technology appraisals of Abiraterone. 3 are current, and 3 of these recommend it for at least some patients. 1 older appraisal was replaced or withdrawn.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Abiraterone (originator and generics) for treating newly diagnosed high-risk hormone‑sensitive metastatic prostate cancer NICE TA1110 | Recommended | 19 Nov 2025 | Current |
| Abiraterone for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated NICE TA387 | Recommended | 27 Apr 2016 Updated 27 Jul 2016 | Current |
| Abiraterone for castration-resistant metastatic prostate cancer previously treated with a docetaxel-containing regimen NICE TA259 | Recommended | 27 Jun 2012 Updated 27 Jul 2016 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Abiraterone
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 15 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Zytiga, Abiraterone Accord (generic), Abiraterone Krka (generic), Abiraterone Mylan (generic)EMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Abiraterone
- ChEMBL
- CHEMBL271227
- PubChem CID
- 9821849
- CAS number
- 154229-18-2
- FDA UNII
- EM5OCB9YJ6
- Wikidata
- Q27888393
- Wikipedia
- Abiraterone acetate
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Abiraterone
36 trialsRegisters 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.
Abiraterone in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Abiraterone. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
A Randomised, Double‑Blind, Placebo‑Controlled, 2‑Cohort, Phase III Study of Saruparib Combined with Physician’s Choice of Androgen Receptor Pathway Inhibitor in Patients With Metastatic Hormone‑Sensitive Prostate Cancer, Previously Treated With Docetaxel or PSMA‑directed 177Lutetium‑Containing Therapy Without Disease Progression, and With Prostate‑Specific Antigen ≥ 0.2 ng/mL: EvoPAR Prostate‑05
2026-526275-38-00 · CTIS ↗ · Male Urogenital Diseases
|
Phase 3 | Authorised | AstraZeneca AB | Poland, Hungary, France + 4 more |
Conditions studied with Abiraterone
36 conditionsAll 36 conditions
| Condition (as registered) | Trials |
|---|---|
| Metastatic Castration-resistant Prostate Cancer | 4 |
| Prostate Cancer | 4 |
| Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) | 3 |
| Metastatic Castration-Resistant Prostate Cancer | 2 |
| Metastatic Prostate Cancer | 2 |
| Metastatic Castration-resistant Prostate Cancer (mCRPC) | 2 |
| Advanced Solid Tumor | 2 |
| Salivary Gland Carcinoma | 2 |
| Castration-Resistant Prostatic Cancer | 1 |
| Metastasis | 1 |
| Prostatic Neoplasms | 1 |
| Neoplasm Metastasis | 1 |
| Urogenital Neoplasms | 1 |
| Physiological Effects of Drugs | 1 |
| Prostate Adenocarcinoma | 1 |
| PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC) With Prior Exposure to One Prior ARPI Who Are Candidates for Taxane-based Chemotherapy | 1 |
| Cancer | 1 |
| Renal Cell Carcinoma (RCC) | 1 |
| Pancreatic Neuroendocrine Tumors (pNET) | 1 |
| Extra-Pancreatic NET (epNET) | 1 |
| Metastatic Hormone-sensitive Prostate Cancer | 1 |
| Metastatic Hormone-sensitive Prostate Cancer (mHSPC) | 1 |
| Prostate Cancer Metastatic | 1 |
| Advanced Solid Tumors | 1 |
| Precision Therapy | 1 |
| Oligo-metastatic Prostate Carcinoma | 1 |
| Oligometastatic Prostate Carcinoma | 1 |
| Castration-resistant Prostate Cancer | 1 |
| mCRPC | 1 |
| Metastatic Hormone-Sensitive Prostate Cancer | 1 |
| Castration Levels of Testosterone | 1 |
| Metastatic Prostatic Adenocarcinoma | 1 |
| Stage IV Prostate Cancer AJCC v8 | 1 |
| Stage IVA Prostate Cancer AJCC v8 | 1 |
| Prostate Cancer (Adenocarcinoma) | 1 |
| Neoplasms, Prostate | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Novartis Pharmaceuticals | 5 |
| AstraZeneca | 3 |
| Amgen | 3 |
| Exelixis | 2 |
| Changhai Hospital | 2 |
| Merck Sharp & Dohme LLC | 1 |
| Celgene | 1 |
| Eli Lilly and Company | 1 |
| Hoffmann-La Roche | 1 |
| Telix Pharmaceuticals (Innovations) Pty Limited | 1 |
| POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company | 1 |
| ParVation Therapeutics, Inc | 1 |
| EMD Serono Research & Development Institute, Inc | 1 |
| DualityBio Inc | 1 |
| Peking Union Medical College | 1 |
+ 11 more sponsors in the trial list above.
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Abiraterone trials
How many clinical trials are testing Abiraterone?
36 current trials in our USA, Australia, Canada, China, Spain, South Korea, Germany, France, Italy, UK, Taiwan, Japan, Brazil, Poland, Turkey, Switzerland, Netherlands, Israel, Mexico, Belgium, Sweden, Austria, Czechia, India, Singapore, Ireland, Denmark, Portugal and Norway registers name Abiraterone (also registered as CB 7598) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Abiraterone trials recruiting patients?
Yes. 22 of the 36 trials are recruiting: 13 with sites in USA, 13 with sites in Australia, 12 with sites in Canada, 10 with sites in China, 10 with sites in Spain, 9 with sites in South Korea, 9 with sites in Germany, 8 with sites in France, 9 with sites in Italy, 7 with sites in UK, 6 with sites in Taiwan, 7 with sites in Japan, 6 with sites in Brazil, 4 with sites in Poland, 7 with sites in Turkey, 6 with sites in Switzerland, 3 with sites in Netherlands, 3 with sites in Israel, 3 with sites in Mexico, 4 with sites in Belgium, 3 with sites in Sweden, 3 with sites in Austria, 3 with sites in India, 1 with sites in Ireland, 1 with sites in Portugal and 1 with sites in Norway. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Abiraterone clinical trials?
Novartis Pharmaceuticals (5), AstraZeneca (3), Amgen (3) and Exelixis (2), among 26 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Abiraterone clinical trials in Ireland?
Yes. 2 trials in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.
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 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 — it is not written from memory, and nothing here describes how Abiraterone works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Abiraterone (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 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.