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Niraparib

Niraparib is a PARP inhibitor approved as maintenance for ovarian cancer regardless of BRCA status, and in prostate cancer with abiraterone.

NOVA and PRIMA (first-line maintenance, all-comers; label later restricted to HRD+ in some settings); Akeega (niraparib + abiraterone) for BRCA-mutant mCRPC (MAGNITUDE, 2023). GSK.

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Niraparib
PubChem
Mechanism, step by step
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1.Niraparib binds and traps PARP1/2 on damaged DNA

Modality
Small-molecule PARP inhibitor
Mechanism
PARP1/2 inhibitor.
Brand / code
Zejula
Dosing & schedule
Route
Oral
Schedule
200 mg once daily if <77 kg or platelets <150,000/µL; otherwise 300 mg once daily; 3 years first-line maintenance
Dose modifications
Reduce for thrombocytopenia; hold for hypertension crisis
Monitoring
Blood counts weekly for the first month, monthly for 11 months; blood pressure; MDS/AML awareness

Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.

Medicare
Part D (self-administered)

Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026). Akeega (niraparib + abiraterone) is also Part D.

Commercial insurance
covered with prior authorisation

Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy.

Assistance programmes

Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.

Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.

Cancer Drugs FundNICE TA528 · 2018SMC: accepted
Appraised for
Maintenance for relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer
Notes
First-line maintenance after platinum (PRIMA): TA673 (2021, CDF then routine). Both indications now routinely commissioned regardless of BRCA status.
Cancer Drugs Fund
Entered the Cancer Drugs Fund under a managed access agreement; check the current CDF list for whether it has since moved to routine commissioning.
NHS England
Routinely funded for the appraised indication (or via managed access)

Sources: NICE TA528 · NHS England Cancer Drugs Fund list · SMC advice: niraparib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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  1. 27 Mar 2017ApprovalUS

    Maintenance in recurrent ovarian cancer regardless of BRCA (NOVA) source

  2. 29 Apr 2020ApprovalUS

    First-line ovarian maintenance, all-comers (PRIMA) source

  3. Nov 2022Label changeUS

    Second-line maintenance restricted to gBRCA after OS data source

  4. 11 Aug 2023ApprovalUS

    Niraparib + abiraterone (Akeega) for BRCA-mutated mCRPC (MAGNITUDE) source

Approvals

RegionYearIndication
US2017Recurrent ovarian cancer maintenance
US2020First-line ovarian maintenance

Safety

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Toxicity profile
Adverse eventAny gradeGrade 3+
Thrombocytopenia
PRIMA
66%
38%
Anaemia
PRIMA
65%
31%
Nausea
PRIMA
62%
Fatigue
PRIMA
52%
Neutropenia
PRIMA
17%
MDS/AML
vs 2.4% placebo, PRIMA long-term
3.3%

Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.

Cost & access

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Cost & access
CountryReimbursement
United StatesMedicare Part D (oral); commercial plans per formulary, often with prior authorisation
United KingdomNICE: recommended for ovarian maintenance (TA528, TA673) and with abiraterone in BRCA-mutant prostate cancer (Akeega)

List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
157 studies25 recruiting89 Phase 213 Phase 3
Search “Niraparib” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Niraparib
intervention: Niraparib
Open on ClinicalTrials.gov →

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Key papers

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Latest papers

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Literature trend166 papers in the last 12 months+15% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Niraparib" OR ABSTRACT:"Niraparib" OR TITLE:"Zejula" OR ABSTRACT:"Zejula") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Niraparib, not a curated reading list.

Connected

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