marked.bio

androgen synthesis inhibitor · small molecule

abiraterone

3 active trials across 3 of our biomarkers, targeting CYP17. 5 active approvals for a biomarker on marked.bio.

Also known as abiraterone acetate, Zytiga.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

TherapyBiomarkerTumourUnited StatesEuropean Union
niraparib with abiraterone acetate + prednisone
FDA, 2023
mCRPC, deleterious BRCA mutation FDA approval 11/08/2023. Source
FDA, 2025
mCSPC, deleterious or suspected deleterious BRCA2 mutation FDA approval 12/12/2025. Restricted to BRCA2 (BRCA1 not included). Source
EU (EMA), 2023
mCRPC, BRCA1/2 mutation (germline and/or somatic), chemotherapy not indicated MA 19/04/2023. mHSPC BRCA1/2 indication added 2026 (own row). Source
EU (EMA), 2026
mHSPC with BRCA1/2 mutations (germline and/or somatic), with hormone therapy CHMP opinion 29/01/2026, EC decision 05/03/2026. Source
Akeeganiraparib page 		BRCA1/2 mutation prostate Approved 2023 Approved 2023

In the US label

MAGNITUDE (BRCA cohort) vs placebo + abiraterone + prednisone, 113 vs 112 patients
rPFS 16.6 months vs 10.9 months, HR 0.53 (0.36-0.79)OS 30.4 months vs 28.6 months, HR 0.79 (0.55-1.12), exploratory

Serious side effects 41%Stopped for side effects 15%Fatal 9%

Trial details and side effects
Patients
BRCA-mutated mCRPC (NCT03748641)
Most common side effects
musculoskeletal pain 44%, fatigue 43%, constipation 34%, hypertension 33%, nausea 33% (113 patients)
Notes
Niraparib with abiraterone (Akeega). US label rev. 12/2025.
Source
US label

In the EU product information

MAGNITUDE (BRCA cohort) vs placebo + abiraterone + prednisone, 113 vs 112 patients
rPFS 16.6 months vs 10.9 months, HR 0.53 (0.36-0.79)OS HR 0.79 (0.55-1.12), final analysis

Trial details and side effects
Patients
BRCA-mutated mCRPC (NCT03748641)
Most common side effects
musculoskeletal pain 44%, fatigue 43%, constipation 34%, hypertension 33%, nausea 33% (113 patients)
Notes
EU SmPC section 5.1 (MAGNITUDE BRCA cohort). Side effects from the US label.
Source
EU product information

In the EU product information

AMPLITUDE (BRCA2 subgroup) vs placebo + abiraterone + prednisone, 191 vs 196 patients
rPFS not reached vs 26.0 months, HR 0.52 (0.37-0.72)

Trial details and side effects
Patients
BRCA1/2-mutated metastatic hormone-sensitive prostate cancer (NCT04497844)
Most common side effects
hypertension 51%, musculoskeletal pain 45%, constipation 41%, fatigue 39%, nausea 30% (162 patients)
Notes
EU SmPC section 5.1 (AMPLITUDE BRCA1/2 population; the US label describes the BRCA2 subgroup). Side effects from the US label.
Source
EU product information
olaparib with abiraterone + prednisone
FDA, 2023
mCRPC, deleterious BRCA mutation FDA approval 31/05/2023; current label 1.8. The EU combination is not BRCA-restricted. Source
Lynparzaolaparib page 		BRCA1/2 mutation prostate Approved 2023 Not approved

PROpel (BRCA-mutated subgroup) vs placebo + abiraterone, 85 (BRCA-mutated)
rPFS not reached vs 8 months, HR 0.24 (0.12-0.45)OS HR 0.30 (0.15-0.59)

Serious side effects 39%Stopped for side effects 16%

Trial details and side effects
Patients
BRCA-mutated mCRPC (NCT03732820)
Most common side effects
anaemia 48%, fatigue 38%, nausea 30%, diarrhoea 19% (398 (all patients) patients)
Notes
Olaparib with abiraterone and prednisone. The approval is limited to BRCA-mutated patients. Side effects from the Lynparza US label (all patients).
Source
US approval report

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
BRCA1/2 mutation 3 3 Phase 4
MSI-H / dMMR 0 1 –
NRG1 fusion 0 1 –

Sponsors

Industry sponsors leading active biomarker-selected trials of abiraterone.

  1. AstraZeneca 2

Trials

3 of 5 trials shown

  1. 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

    Active, not recruiting Phase 4 AstraZeneca Started 2022Primary completion 2024-10 NCT05457257

    olaparib FDA EUenzalutamide FDAabiraterone FDA EUprednisone

    Deleterious or suspected deleterious BRCA1/2 mutation in tumor tissue.

    BRCA1/2 mutationMetastatic Castration-resistant Prostate Cancer

  2. A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation

    Recruiting Phase 3 AstraZeneca Started 2025Primary completion 2033-03 NCT06952803

    saruparibabiraterone FDA EUprednisoneAndrogen Deprivation Therapy (ADT)

    …uparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation

    BRCA1/2 mutationProstate Cancer

  3. Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial

    Recruiting Phase 2 Alliance for Clinical Trials in Oncology Started 2025Primary completion 2030-04 NCT06632977

    Valemetostat TosylatecarboplatinCabazitaxelabiraterone FDA EUenzalutamide FDALutetium Lu 177 Vipivotide Tetraxetan

    Patients with known germline or somatic deleterious BRCA 1/2 mutations must have received a prior PARPi.

    BRCA1/2 mutationCastration-Resistant Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8