Niraparib clinical trials
Niraparib is named as an intervention in 40 current clinical trials in our Spain, Italy, USA, France, Canada, Belgium, Israel, Germany, China, UK, Netherlands, Norway, Poland, Denmark, Switzerland, Sweden, Japan, Australia, Czechia, Brazil, Mexico, South Korea, Ireland, Austria, Portugal, Turkey, Taiwan and Singapore registers. 23 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is GlaxoSmithKline (3). The most-studied condition is Ovarian Cancer.
Where Niraparib is approved
All regulators →Of the three regulators tracked here, the first to approve Niraparib was the US, on 27 Mar 2017. 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.
Niraparib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Niraparib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 8 listed patents; the last listed expires 25 Jan 2039 (US 11730725).
- Latest patent on the drug substance itself: 27 Mar 2031 (US 8071623).
- Zejula for treatment of ovarian cancer: until 20 Nov 2029 (includes 24 months' paediatric extension). Union Register
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 Niraparib
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 Niraparib works
All drug targets →- Poly [ADP-ribose] polymerase 2 inhibitor InhibitorTarget: PARP2 poly(ADP-ribose) polymerase 2✓ In ChEMBL and the Guide to Pharmacology
- Poly [ADP-ribose] polymerase-1 inhibitor InhibitorTarget: PARP1 poly(ADP-ribose) polymerase 1✓ In ChEMBL and the Guide to Pharmacology
- Breast cancerPhase 3
- Endometrial cancerPhase 3
- Fallopian tube cancerPhase 3
- Fallopian tube carcinomaPhase 3
- GlioblastomaPhase 3
- Non-small cell lung carcinomaPhase 3
- Peritoneum cancerPhase 3
- Primary peritoneal carcinomaPhase 3
- Prostate cancerPhase 3
- Small cell lung carcinomaPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1094636, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 8275, 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 Niraparib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 5 technology appraisals of Niraparib. 4 are current, and 2 of these recommend it for at least some patients. 1 older appraisal was replaced or withdrawn.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Niraparib for maintenance treatment of advanced ovarian, fallopian tube and peritoneal cancer after response to first-line platinum-based chemotherapy NICE TA1129 | Optimised | 12 Feb 2026 | Current |
| Niraparib with abiraterone acetate and prednisone for untreated hormone-relapsed metastatic prostate cancer (terminated appraisal) NICE TA1032 | Terminated (no company submission) | 22 Jan 2025 | Current |
| Niraparib for maintenance treatment of relapsed, platinum-sensitive ovarian, fallopian tube and peritoneal cancer NICE TA784 | Optimised | 20 Apr 2022 | Current |
| Niraparib for maintenance treatment of advanced ovarian, fallopian tube and peritoneal cancer after response to first-line platinum-based chemotherapy NICE TA673 | Recommended (Cancer Drugs Fund) | 17 Feb 2021 | 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 Niraparib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 1 product on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: ZejulaEMA 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 Niraparib
- ATC code
- L01XX54
- ChEMBL
- CHEMBL1094636
- DrugBank
- DB11793
- PubChem CID
- 24958200
- CAS number
- 1038915-60-4
- FDA UNII
- HMC2H89N35
- Wikidata
- Q25326660
- Wikipedia
- Niraparib
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 Niraparib
40 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.
Niraparib across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
1 single-substance product containing Niraparib on the HPRA medicines list.
- Zejula 100 mg Capsule, hardGlaxoSmithKline Trading Services Limited · EU/1/17/1235/001-003
Supply shortages
No entry for Niraparib in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Niraparib
52 conditionsAll 52 conditions
| Condition (as registered) | Trials |
|---|---|
| Ovarian Cancer | 7 |
| Ovarian Neoplasms | 3 |
| Neoplasms | 3 |
| Fallopian Tube Cancer | 3 |
| Cancer | 3 |
| Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma | 2 |
| Primary Peritoneal Carcinoma | 2 |
| Advanced Solid Tumor | 2 |
| Head and Neck Squamous Cell Carcinoma | 2 |
| Tumors | 2 |
| Neoplasia | 2 |
| Breast Cancer | 2 |
| Neoplasms, Breast | 1 |
| Prostatic Neoplasms | 1 |
| Prostatic Neoplasms, Castration-Resistant | 1 |
| Castration-Resistant Prostatic Cancer | 1 |
| Metastatic or Locally Advanced Unresectable Solid Tumors | 1 |
| Recurrent Ovarian Cancer | 1 |
| Recurrent Epithelial Cancer of Ovary | 1 |
| Recurrent Epithelial Ovarian Cancer | 1 |
| Recurrent Fallopian Tube Cancer | 1 |
| Breast Neoplasms | 1 |
| Epithelial Ovarian Cancer | 1 |
| Ovarian Cancer Recurrent | 1 |
| Endometrial Carcinoma | 1 |
| Serous Carcinoma | 1 |
| SCLC,Extensive Stage | 1 |
| SLFN11-positive | 1 |
| Peritoneal Cancer | 1 |
| Glioblastoma | 1 |
| GBM | 1 |
| Brain Neoplasms, Adult, Malignant | 1 |
| Brain Tumor | 1 |
| Ovarian Carcinosarcoma | 1 |
| Endometrial Carcinosarcoma | 1 |
| Biliary Tract Neoplasms | 1 |
| Ovarian Carcinoma | 1 |
| Oligometastatic Disease | 1 |
| Serous Ovarian Tumor | 1 |
| Glioma, Malignant | 1 |
| Neoplasm | 1 |
| Metastatic Castration-resistant Prostate Cancer (mCRPC) | 1 |
| Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) | 1 |
| Cancer Metastatic | 1 |
| Endometrial Cancer | 1 |
| Prostate Cancer | 1 |
| Stage III Ovarian Cancer | 1 |
| Stage IV Ovarian Cancer | 1 |
| High Grade Ovarian Serous Adenocarcinoma | 1 |
| Stage I Breast Cancer | 1 |
| Stage II Breast Cancer | 1 |
| Stage III Breast Cancer | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| GlaxoSmithKline | 3 |
| Tesaro, Inc | 3 |
| Janssen Research & Development, LLC | 3 |
| ARCAGY/ GINECO GROUP | 2 |
| EMD Serono Research & Development Institute, Inc | 1 |
| CanariaBio Inc | 1 |
| Imunon | 1 |
| Hoffmann-La Roche | 1 |
| Tongji Hospital | 1 |
| Wigen Biomedicine Technology (Shanghai) Co., Ltd | 1 |
| Peking University Cancer Hospital & Institute | 1 |
| LaNova Medicines Limited | 1 |
| Fudan University | 1 |
| Shanghai Gynecologic Oncology Group | 1 |
| Shandong University | 1 |
+ 18 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.
Related compounds
Questions about Niraparib trials
How many clinical trials are testing Niraparib?
40 current trials in our Spain, Italy, USA, France, Canada, Belgium, Israel, Germany, China, UK, Netherlands, Norway, Poland, Denmark, Switzerland, Sweden, Japan, Australia, Czechia, Brazil, Mexico, South Korea, Ireland, Austria, Portugal, Turkey, Taiwan and Singapore registers name Niraparib (also registered as JNJ-64091742) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Niraparib trials recruiting patients?
Yes. 23 of the 40 trials are recruiting: 5 with sites in Spain, 5 with sites in Italy, 2 with sites in USA, 6 with sites in France, 4 with sites in Canada, 2 with sites in Belgium, 2 with sites in Israel, 2 with sites in Germany, 6 with sites in China, 1 with sites in Netherlands, 2 with sites in Norway, 2 with sites in Denmark, 2 with sites in Switzerland, 1 with sites in Sweden, 1 with sites in Japan, 1 with sites in South Korea, 1 with sites in Austria and 1 with sites in Singapore. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Niraparib clinical trials?
GlaxoSmithKline (3), Tesaro, Inc (3), Janssen Research & Development, LLC (3) and ARCAGY/ GINECO GROUP (2), among 33 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Niraparib 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.
Is Niraparib licensed in Ireland?
Yes. The HPRA medicines list includes 1 single-substance product containing Niraparib, for example Zejula 100 mg Capsule, hard (GlaxoSmithKline Trading Services Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Niraparib shortage?
Not in the lists we track: Niraparib has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
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 Niraparib 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 Niraparib 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 Niraparib (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.