Zejula
(Niraparib)ApprovedSmall molecule
Niraparib is used to treat certain types of ovarian and breast cancers by helping to prevent cancer cells from repairing their DNA damage, which causes them to die.[2] Zejula is currently approved and in use across 50 indications[4].[1]
Zejula is one of 848 small molecule programs targeting Ovarian Cancer. It is currently in Approved.
50
Indications
186
Total Trials
76
Active Trials
847
Competitors
7
FDA Applications
NDA/BLA/ANDA regulatory filings
3
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 50 indications
Competition
Competitive Landscape
744 competitors in Breast Cancer
#DrugCompanyPhaseTrials
1Zejula
GGlaxo Dba Glaxosmithkline
Approved
Blenoxane
Bristol-Myers SquibbPreclinical
Spravato
WWim Janssens
Preclinical
Chantix
PPrism Pharmaceuticals
Preclinical
Nubain
AAultman Health Foundation
Preclinical
Feraheme
AAzurity Pharmaceuticals
Preclinical
Systemic Therapy
Bristol-Myers SquibbPreclinical
Beta Blocker
WWeill Medical College of Cornell University
Preclinical
Neoadjuvant Treatment
SShanghai Zhongshan Hospital
Preclinical
Tianeptine
PfizerPreclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Q4 2026
Phase 1Active, not recruiting
Low Grade Glioma
NCT05406700
Phase 3Active, not recruiting
Endometrial Cancer
NCT03981796
Phase 1Active, not recruiting
Metastatic or Locally Advanced Unresectable Solid Tumors
NCT04170153
Phase 2Recruiting
Ovarian Cancer
NCT03983226
Phase 2Active, not recruiting
Metastatic Colorectal Cancer
NCT03983993
Phase 3Recruiting
Metastatic Prostate Cancer
NCT03903835
Clinical
Trials by Indication[1]
Ovarian Cancer51 trials
The Real World Efficacy and Safety of Niraparib in Korean Women With Primary and Recurrent Epithelial Ovarian Cancer
Completed·—··NCT06086665·850 enrolled
Niraparib Versus Niraparib-bevacizumab Combination in Women With Platinum-sensitive Epithelial Ovarian Cancer
Completed·NNordic Society of Gynaecological Oncology - Clinical Trials Unit·Phase 1/2·NCT02354131·108 enrolled
Show 48 more trials
A Study of Niraparib in Combination With Abemaciclib for Late Line Treatment of Ovarian Cancer (NICHOL TRIAL)
Recruiting·FFondazione IRCCS Istituto Nazionale dei Tumori, Milano·Phase 1/2·NCT06594679·73 enrolled
Niraparib and Selenium for the Treatment of Recurrent BRCA Negative Platinum Resistant Ovarian Cancer
Withdrawn·—·Phase 1/2·NCT05672095
A Study of Azenosertib (ZN-c3) and Niraparib in Subjects With Platinum-Resistant Ovarian Cancer
Completed·KK-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.·Phase 1/2·NCT05198804·117 enrolled
Breast Cancer14 trials
Show 11 more trials
Niraparib + Dostarlimab In BRCA Mutated Breast Cancer
Active, not recruiting·—·Phase 2·NCT04584255·62 enrolled
Prostate Cancer10 trials
Show 7 more trials
Enzalutamide and Niraparib in the Treatment of Metastatic Castrate-Resistant Prostate Cancer (CRPC)
Terminated·—·Phase 1·NCT02500901·2 enrolled
A Trial of Niraparib in Platinum-Sensitive Castration-Resistant Prostate Cancer With DNA Repair Defects
Completed·—·Phase 2·NCT04288687·11 enrolled
A Multi-Center Trial of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibition and Stereotactic Body Radiotherapy in Prostate Cancer
Active, not recruiting·UUniversity of Michigan Rogel Cancer Center·Phase 1/2·NCT04194554·102 enrolled
Niraparib Before Surgery in Treating Patients With High Risk Localized Prostate Cancer and DNA Damage Response Defects
Active, not recruiting·—·Phase 2·NCT04030559·11 enrolled
Endometrial Cancer5 trials
Pancreatic Cancer4 trials
Niraparib in Patients With Pancreatic Cancer
Completed·—·Phase 2·NCT03601923·32 enrolled
78 more indications
Glioblastoma4 trials
Niraparib and Temozolomide in Patients Glioblastoma
Not yet recruiting·—·Phase 1/2·NCT06258018·86 enrolled
Serous Carcinoma3 trials
Solid Tumors3 trials
Treatment3 trials
Maintenance Treatment3 trials
Advanced Solid Tumors2 trials
Small Cell Lung Cancer2 trials
Homologous Recombination Deficiency2 trials
Pancreatic Adenocarcinoma2 trials
Maintenance Niraparib Plus Ipilimumab in Patients With Metastatic Pancreatic Adenocarcinoma Whose Disease Has Not Progressed on Platinum-Based Chemotherapy
Recruiting·—·Phase 2·NCT06747845·68 enrolled
Abiraterone Acetate2 trials
Triple-Negative Breast Cancer2 trials
Non-Small Cell Lung Cancer2 trials
ESS2 trials
Advanced Urothelial Cancer2 trials
Metastatic Prostate Cancer2 trials
Solid Tumor2 trials
Prostatic Neoplasms2 trials
Efficacy and Safety1 trial
Quality of Life1 trial
Malignancies1 trial
Evaluation of the Safety and Tolerability of Niraparib With Everolimus in Advanced Gynecologic Malignancies and Breast
Completed·—·Phase 1·NCT03154281·14 enrolled
Primary Peritoneal Cancer1 trial
Metastatic Colorectal Cancer1 trial
Solid Tumor Malignancies1 trial
Progressive Cervix Cancer1 trial
Nasopharyngeal Carcinoma1 trial
Cervical Cancer1 trial
Niraparib Combined With Brivanib or Toripalimab in Patients With Cervical Cancer
Unknown status·—·Phase 2·NCT04395612·38 enrolled
Advanced or Metastatic Solid Tumor1 trial
Neuroendocrine Carcinoma1 trial
Metastatic1 trial
Cholangiocarcinoma1 trial
Maintenance Niraparib and Dostarlimab in Advanced Cholangiocarcinoma
Withdrawn·—·Phase 2·NCT04895046
Ovarian Clear Cell Carcinoma1 trial
Biomarker1 trial
Biomarker-based Study in R/M SCCHN
Unknown status·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT03088059·340 enrolled
Absorption1 trial
Leiomyosarcoma1 trial
Niraparib for the Treatment of Leiomyosarcoma
Withdrawn·—·Phase 2·NCT05174455
Rare Tumor1 trial
PLATFORM Study of Precision Medicine for Rare Tumors
Recruiting·—·Phase 2·NCT04423185·770 enrolled
Advanced or Metastatic Solid Tumors1 trial
Moderate Hepatic Impairment1 trial
Ewing sarcoma1 trial
Brain Metastases1 trial
Melanoma1 trial
Efficacy and Safety Study of Niraparib in Melanoma With Genetic Homologous Recombination (HR) Mutation
Unknown status·—·Phase 2·NCT03925350·41 enrolled
Gastric Adenocarcinoma1 trial
Chemotherapy1 trial
Neoplasms1 trial
Clinical Trial1 trial
GBM1 trial
Niraparib/TTFields in GBM
Active, not recruiting·—·Phase 2·NCT04221503·30 enrolled
Penile Carcinoma1 trial
SLFN11-positive1 trial
Epithelial Ovarian Cancer1 trial
Aggressive Variant Prostate Carcinoma1 trial
Ovarian Carcinosarcoma1 trial
Sarcoma,Soft Tissue1 trial
Metastatic Pancreatic Ductal Adenocarcinoma1 trial
Prostatic Neoplasms, Castration-Resistant1 trial
Anatomic Stage III Breast Cancer AJCC v81 trial
Metastatic or Locally Advanced Unresectable Solid Tumors1 trial
An Open-label, Multicenter Trial of the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of Tuvusertib (M1774) in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301)
Active, not recruiting·
EMD Serono Research & Development Institute, Inc.·Phase 1·NCT04170153·161 enrolled
EMD Serono Research & Development Institute, Inc.·Phase 1·NCT04170153·161 enrolledUrothelial Carcinoma1 trial
Low Grade Glioma1 trial
Metastatic Cancer1 trial
Ovarian Cancer Recurrent1 trial
Prostate Adenocarcinoma1 trial
Rectal Neoplasms1 trial
Ovarian Neoplasms1 trial
Prostate Carcinoma1 trial
Regulatory
FDA Approval Timeline[5]
Mar 27, 2017
ZEJULA
NDA NDA208447
Apr 26, 2023
ZEJULA
NDA NDA214876
Apr 26, 2023
ZEJULA
NDA NDA214876
Jun 18, 2025
ZEJULA
NDA NDA214876
Jun 18, 2025
ZEJULA
NDA NDA214876
Jul 18, 2025
ZEJULA
NDA NDA214876
Mar 27, 2026
ZEJULA
NDA NDA214876
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Zejula drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Niraparib. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]FDA Orange Book — Patent and exclusivity data for Zejula. U.S. Food & Drug Administration.
- [7]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Poly [ADP-Ribose] Polymerase 2 Inhibitor; Poly [ADP-Ribose] Polymerase-1 Inhibitor[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company
- GGlaxo Dba Glaxosmithkline