# Niraparib

Source: https://onco.cc/drugs/niraparib/  
OnCo record `niraparib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Niraparib is a DNA-repair inhibitor used after chemotherapy for selected ovarian cancers and with hormone treatment for selected BRCA-mutated prostate cancers.

## Summary

The current US Zejula label limits first-line maintenance to advanced epithelial ovarian, fallopian-tube or primary-peritoneal cancer that is homologous-recombination deficient through a deleterious BRCA alteration and/or genomic instability, after complete or partial response to platinum. An FDA-authorised companion diagnostic is required; myChoice CDx gained that companion indication in March 2026. Recurrent maintenance is limited to deleterious or suspected deleterious germline-BRCA-mutated disease after platinum response. The original 2017 and 2020 populations were broader, and should not be read as current eligibility. As Akeega with abiraterone and prednisone, niraparib is approved for BRCA-mutated metastatic castration-resistant prostate cancer (2023) and BRCA2-mutated metastatic castration-sensitive prostate cancer (December 2025). Trial-wide HRR populations are broader than some approved indications. There is no US breast-cancer indication for niraparib. Thrombocytopenia, anaemia and other marrow toxicities require monitoring.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-10-10
- Also known as: Niraparib Tosylate Monohydrate and Abiraterone Acetate; Akeega
- Brand: Zejula
- Modality: Small-molecule PARP inhibitor
- Mechanism: PARP1/2 inhibitor.
- Approvals: US 2017: Recurrent ovarian, fallopian-tube or primary-peritoneal maintenance after platinum response; current scope is germline BRCA-mutated; US 2020: First-line advanced ovarian, fallopian-tube or primary-peritoneal maintenance after platinum response; current scope is HRD-positive with FDA-authorised companion diagnostic; US 2023: With abiraterone and prednisone, BRCA-mutated metastatic castration-resistant prostate cancer; US 2025: With abiraterone and prednisone, BRCA2-mutated metastatic castration-sensitive prostate cancer
- Dosing: Oral; 200 mg once daily if <77 kg or platelets <150,000/µL; otherwise 300 mg once daily; 3 years first-line maintenance
- Toxicity (grade 3+): Thrombocytopenia 38%; Anaemia 31%; Neutropenia 17%

## Notes

- Niraparib with abiraterone acetate and prednisone has no NICE recommendation for prostate cancer in England. TA1032, terminated on 22 January 2025, records that NICE was unable to make a recommendation because Johnson and Johnson Innovative Medicine did not provide an evidence submission; the decision will be reviewed if the company submits.

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Niraparib
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Niraparib
- NICE TA1032: niraparib with abiraterone acetate and prednisone for untreated hormone-relapsed metastatic prostate cancer, terminated appraisal: https://www.nice.org.uk/guidance/terminated/ta1032
- Current Zejula label: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b7f675e2-159c-490c-b6f4-3f16d9492b7d
- FDA myChoice companion diagnostic supplement: https://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfpma/pma.cfm?ID=P190014S011
- FDA Akeega BRCA2 mCSPC approval: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-and-abiraterone-acetate-plus-prednisone-brca2-mutated-metastatic-castration

## Connected records

- biomarkers: [Germline BRCA1/2 pathogenic variant (gBRCAm)](https://onco.cc/biomarkers/brca-germline/), [Homologous recombination repair gene mutation in prostate cancer](https://onco.cc/biomarkers/hrr-gene-mutation/), [HRD-positive (genomic instability score)](https://onco.cc/biomarkers/hrd-positive/), [Tumour (somatic or germline) BRCA1/2 mutation and HRR gene alterations](https://onco.cc/biomarkers/brca-somatic/)
- cancers: [BRCA or PALB2-mutant pancreatic ductal adenocarcinoma](https://onco.cc/cancers/brca-palb2-pdac/), [High-grade serous ovarian cancer](https://onco.cc/cancers/high-grade-serous-ovarian-cancer/), [Metastatic castration-resistant prostate cancer](https://onco.cc/cancers/prostate-mcrpc/), [Ovarian cancer](https://onco.cc/cancers/ovarian/), [Platinum-sensitive ovarian cancer](https://onco.cc/cancers/platinum-sensitive-ovarian-cancer/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- technologies: [HRD genomic scar scores (GIS, LOH, HRDetect)](https://onco.cc/technologies/hrd-genomic-scar-scores/), [PARP inhibitors](https://onco.cc/technologies/parp-inhibitor/), [RAD51 foci assay (functional HRD test)](https://onco.cc/technologies/rad51-foci-assay/)
- targets: [PARP](https://onco.cc/targets/parp/)
- companies: [ARCAGY-GINECO](https://onco.cc/companies/arcagy-gineco/), [GSK](https://onco.cc/companies/gsk/), [Zai Lab](https://onco.cc/companies/zai-lab/)
- terms: [BRCA reversion mutations](https://onco.cc/terms/brca-reversion-mutations/), [Enrichment and biomarker-stratified designs](https://onco.cc/terms/biomarker-stratified-design/), [Genome-wide loss of heterozygosity (gLOH)](https://onco.cc/terms/genome-wide-loss-of-heterozygosity/), [Maintenance therapy](https://onco.cc/terms/maintenance-therapy/), [Platinum drugs and PARP inhibitors: the newer leukaemia risk](https://onco.cc/terms/rejuv-second-platinum-and-parp-inhibitors/), [Prostate cancer drugs in England: what NICE recommends, and what it refuses](https://onco.cc/terms/prostate-uk-drug-approvals/), [Who is eligible for a PARP inhibitor in prostate cancer, and why the gene matters](https://onco.cc/terms/prostate-hrr-eligibility/)
- trials: [A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer.](https://onco.cc/trials/nct05335993/), [A Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer](https://onco.cc/trials/nct03602859/), [A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study](https://onco.cc/trials/nct04641247/), [A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours](https://onco.cc/trials/nct06682780/), [A Phase I/II Study of WJB001 Combination Therapy on Safety and Efficacy for Advanced Solid Tumors](https://onco.cc/trials/nct06953323/), [A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer](https://onco.cc/trials/nct03431350/), [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)](https://onco.cc/trials/nct04497844/), [A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid Tumors](https://onco.cc/trials/nct06077877/), [Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease](https://onco.cc/trials/nct04915755/), [MAGNITUDE](https://onco.cc/trials/magnitude/), [Maintenance Niraparib Plus Ipilimumab in Patients With Metastatic Pancreatic Adenocarcinoma Whose Disease Has Not Progressed on Platinum-Based Chemotherapy](https://onco.cc/trials/nct06747845/), [Niraparib Added to Anti-PD-L1 Antibody Maintenance in SLFN11-positive, Extensive-disease SCLC](https://onco.cc/trials/nct05718323/), [Niraparib with postoperative radiotherapy in residual TNBC](https://onco.cc/trials/nct03945721/), [Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemotherapy in Newly Diagnosed Pat](https://onco.cc/trials/nct06915025/), [PRIMA / ENGOT-OV26](https://onco.cc/trials/prima/), [SAFIR-ABC10](https://onco.cc/trials/safir-abc10/)
- ideas: [ctDNA-guided duration of PARP maintenance](https://onco.cc/ideas/idea-ctdna-guided-parp-duration/), [Start low and step up: individualised titration of oral cancer drugs, randomised](https://onco.cc/ideas/idea-tr1-start-low-titrate-up-oral-agents/), [Test every man for DNA repair faults on the day his prostate cancer is found to have spread, not three treatments later](https://onco.cc/ideas/idea-prostate-hrr-testing-at-metastatic-diagnosis/)
- pathways: [Androgen receptor signalling](https://onco.cc/pathways/ar-signaling/), [Base excision repair, PARP & alkylation damage](https://onco.cc/pathways/base-excision-repair-parp/), [DNA damage response & homologous recombination](https://onco.cc/pathways/ddr/), [Double-strand break repair: HR versus end joining](https://onco.cc/pathways/homologous-recombination-repair/), [Prostate cancer (KEGG map)](https://onco.cc/pathways/prostate-cancer-signalling/), [Synthetic lethality: paired dependencies](https://onco.cc/pathways/synthetic-lethality-map/)
- pairings: [PARP inhibitor + AR pathway inhibitor (prostate)](https://onco.cc/pairings/parp-plus-arpi/)
- people: [Amit M. Oza](https://onco.cc/people/amit-oza/), [Kim N. Chi](https://onco.cc/people/kim-chi/), [Mansoor Raza Mirza](https://onco.cc/people/mansoor-raza-mirza/)
- key papers: [FDA's Project Optimus manifesto: cancer drugs are approved at doses that are too high](https://onco.cc/key-papers/paper-drug-dosing-conundrum-nejm-2021/), [PRIMA: niraparib maintenance in newly diagnosed advanced ovarian cancer](https://onco.cc/key-papers/paper-prima-niraparib-nejm-2019/)
- drugs: [myChoice CDx](https://onco.cc/drugs/mychoice-cdx/)

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