marked.bio

PARP inhibitor · small molecule

niraparib

13 active trials across 7 of our biomarkers, targeting PARP. 5 active approvals for a biomarker on marked.bio.

Also known as MK-4827, Zejula.

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
FDA, 2017
maintenance, deleterious germline BRCA-mutated recurrent ovarian cancer in response to platinum Approved 2017 for all patients; on 11 Nov 2022, at FDA request, limited to deleterious germline BRCA (NOVA overall-survival data). Year = first approval in this setting. Source
Zejula 		BRCA1/2 mutation ovarian Approved 2017 Not approved

NOVA (germline BRCA cohort) vs placebo, 138 vs 65 patients
PFS 21.0 months vs 5.5 months, HR 0.26 (0.17-0.41)OS 40.9 months vs 38.1 months, HR 0.85 (0.61-1.20), exploratory

Stopped for side effects 13%

Trial details and side effects
Patients
maintenance, germline BRCA-mutated recurrent ovarian cancer after response to platinum (NCT01847274)
Most common side effects
nausea 77%, thrombocytopenia 71%, fatigue 61%, anaemia 52%, vomiting 40%, constipation 38% (136 patients)
Notes
Zejula US label rev. 07/2026.
Source
US approval report
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
Akeegaabiraterone 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

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
BRCA1/2 mutation 10 25 Phase 2
IDH1/2 mutation 3 3 Phase 1/2
ALK fusion 1 1 Phase 2
BRAF V600E 1 1 Phase 2
EGFR exon 19 deletion / L858R 1 2 Phase 2
ROS1 fusion 1 1 Phase 2
MSI-H / dMMR 0 1 –

Trials

13 of 30 trials shown

  1. Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression

    Recruiting Phase 2 MedSIR Started 2024Primary completion 2028-01 NCT06180356

    niraparib FDA EU

    Note I: Patients with germline or somatic mutations in the BRCA1 or BRCA2 genes will be considered with the HR status known and classified as with homolo…

    BRCA1/2 mutationOvarian Cancer, Oligometastatic Disease, Serous Ovarian Tumor

  2. Niraparib and Temozolomide in Patients Glioblastoma

    Not yet recruiting Phase 1/2 Armando Santoro, MD Started 2024Primary completion 2026-12 NCT06258018

    temozolomideniraparib

    Patients with diagnosis of recurrent/progressive IDH mutant gliomas (WHO 2021, grade 2-4).

    IDH1/2 mutationStatus may be outdated, last updated 2024-08-30Glioma, Malignant

  3. Phase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET)

    Recruiting Phase 2 M.D. Anderson Cancer Center Started 2023Primary completion 2029-12 NCT05700721

    niraparib FDA EUdostarlimab

    Advanced BRCA1/2m cancer 2.

    BRCA1/2 mutationBrain Metastases

  4. Niraparib Maintenance in HRD-Positive Advanced Ovarian Cancer Following Front-Line Chemotherapy + Bevacizumab

    Recruiting Phase 2 Peking University Cancer Hospital & Institute Started 2023Primary completion 2027-03 NCT06141265

    niraparib FDA EU

    Genetic testing of tumor tissue indicates HRD positive or germline/somatic BRCA mutation prior to enrollment.

    BRCA1/2 mutationOvarian, Fallopian Tube and Primary Peritoneal Carcinoma

  5. Niraparib in Tumors Metastatic to the CNS

    Active, not recruiting Phase 2 Massachusetts General Hospital Started 2022Primary completion 2026-12 NCT04992013

    niraparib FDA EU

    …le negative breast cancer or ovarian cancer, or any cancer histology with the presence of alteration in BRCA1, BRCA2, PARP metabolism, DNA repair pathways and HRD (homologous recombination deficienc…

    BRCA1/2 mutationMetastatic Cancer, Central Nervous System Cancer

  6. Niraparib With beVAcizumab After Complete cytoreductioN in Patients With ovArian Cancer

    Recruiting Phase 2 ARCAGY/ GINECO GROUP Started 2022Primary completion 2027-02 NCT05183984

    Chemotherapybevacizumab FDA EUniraparib FDA EU

    …ther epithelial non mucinous and non-clear cell ovarian cancer in a patient with germline BRCA 1 or 2 deleterious mutation, c.

    BRCA1/2 mutationOvarian Cancer

  7. Niraparib + Dostarlimab In BRCA Mutated Breast Cancer

    Active, not recruiting Phase 2 Dana-Farber Cancer Institute Started 2021Primary completion 2025-07 NCT04584255

    niraparib FDA EUdostarlimab

    Participants must have documented germline mutation in BRCA1, BRCA2 or PALB2 that is deleterious or suspected to be deleterious (known or predicted t…

    BRCA1/2 mutationStage I Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer, Breast Cancer

  8. Niraparib for the Neoadjuvant Treatment of Unresectable Ovarian Cancer

    Active, not recruiting Phase 2 Tongji Hospital Started 2021Primary completion 2023-09 NCT04507841

    niraparib FDA EU

    BRCA1/2 gene mutation or HRD was confirmed by tissue or blood samples detected by the testing institution desig…

    BRCA1/2 mutationOvarian Cancer

  9. Niraparib Monotherapy as Maintain and Recurrent Treatment of Endometrial Serous Carcinoma

    Recruiting Phase 2 Shandong University Started 2021Primary completion 2025-12 NCT04716686

    niraparib FDA EU

    …f endometrial cancer have received \>2 lines of platinum containing chemotherapy and have BRCA mutation or be defined as HRD positive

    BRCA1/2 mutationStatus may be outdated, last updated 2024-01-05Endometrial Carcinoma, Serous Carcinoma

  10. PLATFORM Study of Precision Medicine for Rare Tumors

    Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences Started 2020Primary completion 2026-07 NCT04423185

    aumolertinibdacomitinib FDA EUalectinibcrizotinibpyrotinibimatinibniraparibpalbociclibvemurafenibsintilimabatezolizumab

    when obtaining EGFR mutation, ALK fusion, ROS-1 fusion, C-MET amplification, C-MET mutation, BRAF mutation, BRCA1/2 mu…

    EGFR exon 19 deletion / L858RBRAF V600EBRCA1/2 mutationALK fusionROS1 fusionRare Tumor

  11. Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer

    Active, not recruiting Phase 1 University of Washington Started 2021Primary completion 2025-12 NCT04673448

    dostarlimabniraparib FDA EU

    …n tube or primary peritoneal cancer that is unresectable or metastatic, with a pathogenic mutation in BRCA1 or BRCA2 (either germline or somatic) as confirmed by next generation gene sequencing su…

    BRCA1/2 mutationAnatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, BRCA-Associated Malignant Neoplasm, BRCA Hereditary Ovarian Carcinoma

  12. Niraparib In Recurrent IDH 1/2 Gliomas

    Active, not recruiting Early Phase 1 Massachusetts General Hospital Started 2023Primary completion 2026-07 NCT05406700

    niraparib

    …s must have histologically or cytologically confirmed glioma, with documented IDH1 and/or IDH2 gene-mutation at time of initial diagnosis

    IDH1/2 mutationLow-grade Glioma, IDH2 Gene Mutation, Recurrent Glioma, IDH1 Mutation

  13. Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma

    Active, not recruiting Early Phase 1 Nader Sanai Started 2021Primary completion 2024-03 NCT05076513

    niraparib

    …on who have had a prior resection of histologically diagnosed WHO grade II-IV glioma with IDH1 or IDH2 mutation and ATRX loss.

    IDH1/2 mutationGlioblastoma, Glioblastoma Multiforme, Glioma, GBM