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 940 small molecule programs targeting Glioma. It is currently in Approved.

Indications

185

Total Trials

Active Trials

939

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

GliomaActive, not recruiting

Prostate AdenocarcinomaApproved

Nasopharyngeal CarcinomaActive, not recruiting

LeiomyosarcomaActive, not recruiting

Prostate CarcinomaApproved

Lung CancerActive, not recruiting

LymphomaApproved

Gastric AdenocarcinomaActive, not recruiting

Urogenital NeoplasmApproved

MesotheliomaActive, not recruiting

GliomaPhase 1

Active, not recruiting

Prostate AdenocarcinomaApproved

Approved

Nasopharyngeal CarcinomaPhase 2

Active, not recruiting

LeiomyosarcomaPhase 2

Active, not recruiting

Prostate CarcinomaApproved

Approved

Lung CancerPhase 1

Active, not recruiting

LymphomaApproved

Approved

Gastric AdenocarcinomaPhase 2

Active, not recruiting

Urogenital NeoplasmApproved

Approved

MesotheliomaPhase 2

Active, not recruiting

Showing 10 of 50 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Zejula

GGlaxo Dba Glaxosmithkline

Approved

14 2

Tecentriq

Roche

Preclinical

36 3

Trodelvy

Gilead

Preclinical

37 4

Halaven

Eisai

Preclinical

38 5

Tykerb

GSK

Preclinical

80 6

Adriamycin

GGynecologic Oncology Group

Preclinical

87 7

Avastin

BBio-Thera Solutions

Preclinical

153 8

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Preclinical

78 9

Prolia

Amgen

Preclinical

14 10

Gemzar

GGynecologic Oncology Group

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2Active, not recruiting

Soft Tissue Sarcoma

NCT05515575

Phase 1Active, not recruiting

Primary Peritoneal Cancer

NCT04673448

Q4 2026

Phase 1Active, not recruiting

Glioma

NCT05406700

Phase 3Active, not recruiting

Endometrial Cancer

NCT03981796

Phase 3Recruiting

Metastatic Prostate Cancer

NCT03903835

Phase 2Recruiting

Ovarian Cancer

NCT03983226

Clinical

Trials by Indication[1]

Ovarian Cancer50 trials

Study to Evaluate the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (TSR-042) in Participants With Platinum Resistant Ovarian Cancer

Terminated·TTesaro, Inc.·Phase 2·NCT03955471·41 enrolled

Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression

Recruiting·MMedSIR·Phase 2·NCT06180356·30 enrolled

Niraparib and Neratinib in Advanced Solid Tumors With Expansion Cohort in Advanced Ovarian Cancer

Active, not recruiting·VVirginia Commonwealth University·Phase 1·NCT04502602·18 enrolled

Show 47 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 Bevacizumab Maintenance Therapy in Platinum-sensitive Recurrent Ovarian Cancer Patients Previously Treated With a PARP Inhibitor

Unknown status·YYonsei University·Phase 2·NCT04734665·44 enrolled

A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

Active, not recruiting·TTesaro, Inc.·Phase 3·NCT02655016·733 enrolled

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

Active, not recruiting·TTesaro, Inc.·Phase 3·NCT03602859·1,400 enrolled

Anlotinib and Niraparib Dual Therapy Evaluation in Platinum-resistant Recurrent Ovarian Cancer

Unknown status·JJihong Liu·Phase 2·NCT04376073·40 enrolled

Niraparib for the Neoadjuvant Treatment of Unresectable Ovarian Cancer

Active, not recruiting·TTongji Hospital·Phase 2·NCT04507841·67 enrolled

A Study Comparing Niraparib Versus Platinum-Taxane Doublet Chemotherapy as Neoadjuvant Treatment in Participants With Homologous Recombination-Deficient Stage III/IV Ovarian Cancer (COHORT-C)

Terminated·TTesaro, Inc.·Phase 2·NCT06964165·36 enrolled

ATR Inhibitor Elimusertib (BAY1895344) Plus Niraparib Phase 1b Study in Advanced Solid Tumors and Ovarian Cancer

Terminated· Bayer logo

Bayer·Phase 1·NCT04267939·14 enrolled

Niraparib and Selenium for the Treatment of Recurrent BRCA Negative Platinum Resistant Ovarian Cancer

Withdrawn·—·Phase 1/2·NCT05672095

Alternative Dosing Of Niraparib To Decrease Dose Interruption In First Line Maintenance Treatment For Ovarian Cancer

Recruiting·SSunnybrook Health Sciences Centre·Phase 2·NCT05961124·40 enrolled

A Chinese Patent Medicine Yangzhengxiaoji Capsule to Improve the Nausea of Niraparib in the Maintenance Treatment in Ovarian Cancer

Unknown status·SSichuan Cancer Hospital and Research Institute·Phase 2·NCT05641506·50 enrolled

European Trial on Enhanced DNA Repair Inhibition in Ovarian Cancer

Completed·UUniversitaire Ziekenhuizen KU Leuven·Phase 2·NCT03783949·122 enrolled

Niraparib Maintenance in Patients With Advanced Ovarian Cancer at Neoadjuvant Setting

Completed·TThe University of Hong Kong·Phase 2·NCT04284852·20 enrolled

Newton Study (NEW Dosing MainTenance Therapy Ovarian CaNcer)

Terminated· Mario Negri Institute for Pharmacological Research logo

Mario Negri Institute for Pharmacological Research·Phase 2·NCT03891576·83 enrolled

Expanded Access Protocol for Niraparib in Patients With Recurrent Ovarian Cancer

Approved for marketing·TTesaro, Inc.··NCT03025867

PARP Inhibitor Oral Maintenance in Low-Risk Ovarian Cancer

Unknown status·SSeoul National University Hospital·Phase 4·NCT05187208·102 enrolled

A Clinical Study of Cobimetinib Administered in Combination With Niraparib, With or Without Atezolizumab to Patients With Advanced Platinum-sensitive Ovarian Cancer

Completed· Roche logo

Roche·Phase 1·NCT03695380·77 enrolled

A Phase II Trial to Explore Niraparib and Anlotinib Maintenance Retreatment in Platinum-Sensitive Recurrent Ovarian Cancer Patients Previously Treated With PARPi

Unknown status·PPeking Union Medical College Hospital·Phase 2·NCT05385068·35 enrolled

A Study to Evaluate the Efficacy and Safety of Novel Treatment Combinations in Participants With Ovarian Cancer

Completed·TTesaro, Inc.·Phase 2·NCT03574779·77 enrolled

Using Genetic Profile to Determine the Treatment for Patients With Ovarian Cancer Who Previously Received a PARP-inhibitor

Unknown status·UUniversity Health Network, Toronto·Phase 2·NCT05065021·40 enrolled

Safety and Efficacy of AsiDNATM, a DNA Repair Inhibitor, Administered Intravenously in Addition to PARP Inhibitors in Patients With Relapsed Platinum Sensitive Ovarian Cancer Already Treated With PARP Inhibitors Since at Least 6 Months

Terminated·GGustave Roussy, Cancer Campus, Grand Paris·Phase 1/2·NCT04826198·13 enrolled

A Study of Niraparib Combined With Bevacizumab Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

Completed·TTesaro, Inc.·Phase 2·NCT03326193·105 enrolled

Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial)

Recruiting·SShanghai Gynecologic Oncology Group·Phase 2·NCT03983226·167 enrolled

Japan Phase 2 Study of Niraparib (Maintenance Therapy) in Participants With Relapsed Ovarian Cancer

Completed· Takeda logo

Takeda·Phase 2·NCT03759587·19 enrolled

A Study of Niraparib in Combination With Brivanib in Recurrent Ovarian Cancer

Unknown status·HHunan Cancer Hospital·Phase 1·NCT03895788·24 enrolled

Real-world Study of Niraparib Maintenance Treatment in Patients With Newly Diagnosed Ovarian Cancer

Unknown status·LLing-Ying Wu··NCT04986371·300 enrolled

Niraparib vs Niraparib Plus Bevacizumab in Patients With Platinum/Taxane-based Chemotherapy in Advanced Ovarian Cancer

Recruiting·AAGO Study Group·Phase 3·NCT05009082·970 enrolled

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

Recruiting·PPeking University Cancer Hospital & Institute·Phase 2·NCT06141265·116 enrolled

Niraparib as Maintenance Therapy in Patients With Platinum Sensitive Recurrent Ovarian Cancer

Completed·GGrupo Español de Investigación en Cáncer de Ovario··NCT04546373·316 enrolled

Effectiveness and Safety of Niraparib as First-line Maintenance Therapy for Ovarian Cancer: a Real-world Study

Completed·ZZhongda Hospital··NCT05734911·199 enrolled

Niraparib with BeVAcizumab After Complete CytoreductioN in Patients with OvArian Cancer

Recruiting·AARCAGY/ GINECO GROUP·Phase 2·NCT05183984·390 enrolled

Platinum-based Chemotherapy With Atezolizumab and Niraparib in Patients With Recurrent Ovarian Cancer

Completed·GGrupo Español de Investigación en Cáncer de Ovario·Phase 3·NCT03598270·417 enrolled

Japan Phase 2 Study of Niraparib in Participants With Advanced, Relapsed Ovarian Cancer

Completed· Takeda logo

Takeda·Phase 2·NCT03759600·20 enrolled

Efficacy and Safety of Niraparib Combined With Bevacizumab in Platinum Refractory/Resistant Recurrent Ovarian Cancer

Unknown status·XXiaoxiang Chen·Phase 2·NCT04556071·32 enrolled

A Study of Niraparib in Patients With Ovarian Cancer in Clinical Practice

Active, not recruiting· Takeda logo

Takeda··NCT05021562·354 enrolled

A Trial to Evaluate the Safety of Niraparib Tablets in Adult Female Participants With Advanced or Relapsed Epithelial Ovarian Cancer

Not yet recruiting· GSK logo

GSK·Phase 4·NCT06887933·67 enrolled

Trial Comparing Niraparib-bevacizumab-Dostarlimab and Niraparib-bevacizumab to Standard of Care in Recurrent Ovarian Cancer

Withdrawn·NNordic Society of Gynaecological Oncology - Clinical Trials Unit·Phase 3·NCT03806049

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

Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302)

Active, not recruiting· EMD Serono Research & Development Institute, Inc. logo

EMD Serono Research & Development Institute, Inc.·Phase 2·NCT06433219·63 enrolled

Bevacizumab and/or Niraparib in Patients With Recurrent Endometrial and/or Ovarian Cancer With ARID1A Mutation

Terminated·UUniversity of Oklahoma·Phase 2·NCT05523440·7 enrolled

Study to Evaluate the Safety and Efficacy of TSR-042, Bevacizumab, and Niraparib in Participants With Recurrent Ovarian Cancer

Completed·TTesaro, Inc.·Phase 2·NCT05751629·41 enrolled

A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens

Completed·TTesaro, Inc.·Phase 2·NCT02354586·463 enrolled

Efficacy and Safety of Niraparib Combined With Oral Etoposide in Platinum Resistant/Refractory Recurrent Ovarian Cancer

Unknown status·PPeking Union Medical College Hospital·Phase 2·NCT04217798·36 enrolled

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

A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer.

Active, not recruiting·CCanariaBio Inc.·Phase 2·NCT05335993·10 enrolled

Single-Arm, Prospective, Multicenter Study Evaluating Safety, Tolerability, and Metabolism of Niraparib as Maintenance Following Front-Line Treatment for Ovarian Cancer in Women of African Ancestry

Recruiting·UUniversity of Miami·Approved·NCT06412120·70 enrolled

Breast Cancer14 trials

A Phase 1b/2 Trial Evaluating Safety and Efficacy of CAPecitabine in Combination With Ni-rapaRIb in HER2-negative Advanced Breast canCEr

Not yet recruiting·IInstitut Paoli-Calmettes·Phase 1/2·NCT05519670·72 enrolled

Abemaciclib and Niraparib Before Surgery for the Treatment of Hormone Receptor Positive HER2 Negative Breast Cancer

Completed·OOHSU Knight Cancer Institute·Phase 1·NCT04481113·8 enrolled

Radiation, Immunotherapy and PARP Inhibitor in Triple Negative Breast Cancer

Active, not recruiting·MMassachusetts General Hospital·Phase 2·NCT04837209·32 enrolled

Show 11 more trials

A Phase I Study of Niraparib Administered Concurrently With Postoperative RT in Triple Negative Breast Cancer Patients

Active, not recruiting·MMassachusetts General Hospital·Phase 1·NCT03945721·21 enrolled

A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients

Terminated·TTesaro, Inc.·Phase 3·NCT01905592·216 enrolled

A Dose-escalation Study of the Safety and Pharmacology of DAN-222 in Subjects With Metastatic Breast Cancer

Completed·DDantari, Inc.·Phase 1·NCT05261269·30 enrolled

LCI-BRE-MTN-NIR-001:Ph I Study of Niraparib in Combo With Standard Chemo in Metastatic Trip Neg Breast Cancer

Withdrawn·WWake Forest University Health Sciences·Phase 1·NCT04762901

Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer

Recruiting·CCanadian Cancer Trials Group·Phase 2·NCT05601440·484 enrolled

A Feasibility Study of Niraparib for Advanced, BRCA1-like, HER2-negative Breast Cancer Patients

Terminated·TThe Netherlands Cancer Institute·Phase 2·NCT02826512·9 enrolled

Study Evaluating the Antitumor Activity and Safety of Niraparib as Neoadjuvant Treatment in Participants With Breast Cancer

Completed·TTesaro, Inc.·Phase 1·NCT03329937·21 enrolled

Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer

Active, not recruiting·UUniversity of Alabama at Birmingham·Phase 1/2·NCT03368729·46 enrolled

Niraparib + Dostarlimab In BRCA Mutated Breast Cancer

Active, not recruiting·—·Phase 2·NCT04584255·62 enrolled

PARP-inhibitor on Advanced Metastatic Breast Cancer in Germline PALB2 Mutations Carriers

Not yet recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT05232006·12 enrolled

Niraparib Plus Aromatase Inhibitors for Luminal-like(HER2-,ER+) and gBRCA or HDR+ Metastatic Breast Cancer (LUZERN)

Completed·MMedSIR·Phase 2·NCT04240106·14 enrolled

Prostate Cancer10 trials

Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer

Recruiting·UUniversity of British Columbia·Phase 2·NCT04812366·315 enrolled

177Lu-PSMA, Niraparib/AA Plus Prednisone for Prostate Cancer

Withdrawn·BBaptist Health South Florida·Phase 1/2·NCT06329830

A Trial of Niraparib in Platinum-Sensitive Castration-Resistant Prostate Cancer With DNA Repair Defects

Completed·—·Phase 2·NCT04288687·11 enrolled

Show 7 more trials

Race Impact on Efficacy of Niraparib Plus Abiraterone Acetate and Prednisone in Patients With Homologous Repair Deficient Castration-resistant Prostate Cancer

Withdrawn·LLatin American Cooperative Oncology Group·Phase 2·NCT06527690

Phase IB Trial of Radium-223 and Niraparib in Patients With Castrate Resistant Prostate Cancer (NiraRad)

Completed·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 1·NCT03076203·14 enrolled

Enzalutamide and Niraparib in the Treatment of Metastatic Castrate-Resistant Prostate Cancer (CRPC)

Terminated·—·Phase 1·NCT02500901·2 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

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

An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02854436·289 enrolled

A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE)

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02924766·34 enrolled

Endometrial Cancer5 trials

Niraparib in High-grade Endometrial Cancer Trial

Withdrawn·SSir Mortimer B. Davis - Jewish General Hospital·Phase 1·NCT05289648

An Open-label, Single Arm, Phase II Trial of Niraparib in Combination With Anti-PD1（Programmed Cell Death Protein 1） Antibody in Recurrent/ Advanced Stage Endometrial Cancer Patients

Unknown status·SSun Yat-sen University·Phase 2·NCT04885413·37 enrolled

A Study of Various Treatments in Serous or p53 Abnormal Endometrial Cancer

Terminated·UUniversity Health Network, Toronto·Phase 2/3·NCT04159155·11 enrolled

Show 2 more trials

A Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Participants With Recurrent or Primary Advanced Endometrial Cancer

Active, not recruiting·TTesaro, Inc.·Phase 3·NCT03981796·785 enrolled

A Phase II, Open Label Study of the Poly(ADP-ribose) Polymerase Inhibitor Niraparib in Monotherapy or in Combination With Anti-PD1 Inhibitor TSR-042 in Recurrent Endometrial Cancer

Active, not recruiting·UUniversity Health Network, Toronto·Phase 2·NCT03016338·51 enrolled

Pancreatic Cancer5 trials

Niraparib as First Line Therapy With Metastatic Homologous Repair-deficient Pancreatic Cancer

Terminated·CCentre Leon Berard·Phase 2·NCT05442749·2 enrolled

Niraparib in Metastatic Pancreatic Cancer After Previous Chemotherapy (NIRA-PANC): a Phase 2 Trial

Unknown status·UUniversity of Kansas Medical Center·Phase 2·NCT03553004·18 enrolled

Niraparib + Dostarlimab + RT in Pancreatic Cancer

Completed·MMassachusetts General Hospital·Phase 2·NCT04409002·18 enrolled

Show 2 more trials

Niraparib in Patients With Pancreatic Cancer

Completed·—·Phase 2·NCT03601923·32 enrolled

Niraparib and Dostarlimab for the Treatment of Germline or Somatic BRCA1/2 and PALB2 Mutated Metastatic Pancreatic Cancer

Completed·MMayo Clinic·Phase 2·NCT04493060·22 enrolled

74 more indications

Glioblastoma4 trials

Niraparib and Temozolomide in Patients Glioblastoma

Not yet recruiting·—·Phase 1/2·NCT06258018·86 enrolled

Reirradiation and Niraparib in Patients With Recurrent Glioblastoma

Withdrawn·UUniversity College, London·Phase 1·NCT05666349

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

Active, not recruiting·NNader Sanai·Phase 1·NCT05076513·42 enrolled

Show 1 more trial

A Phase 3, Open-label, Randomized 2-arm Study Comparing the Clinical Efficacy and Safety of Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma

Active, not recruiting·IIvy Brain Tumor Center·Phase 3·NCT06388733·450 enrolled

Solid Tumors3 trials

Dose Escalation and Cohort Expansion Study of Niraparib and Dostarlimab in Paediatric Participants With Solid Tumors (SCOOP)

Terminated· GSK logo

GSK·Phase 1·NCT04544995·47 enrolled

A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid Tumors

Active, not recruiting· GSK logo

GSK·Phase 1/2·NCT06077877·42 enrolled

ZEN003694 Combined With Niraparib in Patients With Metastatic or Recurrent Solid Tumors

Withdrawn·HHaider Mahdi·Phase 1·NCT06161493

Metastatic Prostate Cancer3 trials

High-Risk Metachronous Oligometastatic Prostate Cancer Trial

Recruiting·UUniversity of Maryland, Baltimore·Phase 2·NCT06212583·88 enrolled

ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer

Recruiting·KKarolinska Institutet·Phase 3·NCT03903835·750 enrolled

Cabazitaxel, Carboplatin, and Cetrelimab Followed by Niraparib With or Without Cetrelimab for the Treatment of Aggressive Variant Metastatic Prostate Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04592237·120 enrolled

Maintenance Treatment3 trials

Niraparib Maintenance Treatment in Patients With Newly Diagnosed Advanced Platinum- Sensitive, OC. The First Poland RWE Study.

Recruiting·PPomeranian Medical University Szczecin··NCT06614790·300 enrolled

Induction and Maintenance Treatment With PARP Inhibitor and Immunotherapy in HPV-negative HNSCC

Recruiting·GGruppo Oncologico del Nord-Ovest·Phase 2·NCT04681469·49 enrolled

Niraparib Maintenance Treatment in mCRC With a Partial o Complete Response After Oxaliplatin-based Induction Therapy

Withdrawn·OOspedale Policlinico San Martino·Phase 2·NCT05412706

Serous Carcinoma3 trials

Trial of Maintenance With Niraparib- Uterine Serous Carcinoma

Completed·NNorthwell Health·Phase 2·NCT04080284·22 enrolled

Combination Niraparib and Dostarlimab Therapy for Recurrent or Persistent Uterine Serous Carcinoma

Active, not recruiting·CCasey Cosgrove·Phase 2·NCT05870761·8 enrolled

Niraparib Monotherapy as Maintain and Recurrent Treatment of Endometrial Serous Carcinoma

Recruiting·SShandong University·Phase 2·NCT04716686·83 enrolled

Advanced Solid Tumors3 trials

Niraparib Combined With Anlotinib in Homologous Recombination Repair (HRR) Gene-mutated Advanced Solid Tumors

Unknown status·PPeking University Cancer Hospital & Institute·Phase 1·NCT04764084·52 enrolled

A Phase I/II Study of WJB001 Combination Therapy on Safety and Efficacy for Advanced Solid Tumors

Recruiting·WWigen Biomedicine Technology (Shanghai) Co., Ltd.·Phase 1/2·NCT06953323·86 enrolled

A Study of Niraparib as Single Agent in Participants With Advanced Solid Tumors

Completed· Takeda logo

Takeda·Phase 1·NCT03497429·9 enrolled

Treatment3 trials

Study to Estimate Efficacy of Combining Dostarlimab and Niraparib in Relapsed EOC After Treatment With PARPi

Withdrawn·AAGO Research GmbH·Phase 2·NCT05126342

Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors

Terminated·TTempus AI·Phase 2·NCT05169437·22 enrolled

SMMART Adaptive Clinical Treatment (ACT) Trial

Withdrawn·OOHSU Knight Cancer Institute·Phase 1·NCT05238831

ESS2 trials

Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Niraparib Tablet Compared to Niraparib Capsule

Completed·TTesaro, Inc.·Phase 1·NCT03329001·236 enrolled

Real-life Use of Niraparib in a Patient Access Program in Norway

Completed·KKristina Lindemann··NCT04785716·106 enrolled

Advanced Urothelial Cancer2 trials

Niraparib in Combination with Cabozantinib (XL184) in Patients with Advanced Urothelial Cancer (NICARAGUA)

Completed·FFundacion CRIS de Investigación para Vencer el Cáncer·Phase 1/2·NCT03425201·67 enrolled

Maintenance With Niraparib In Patients With Advanced Urothelial Cancer After 1st-line Platinum-based Chemotherapy

Completed·UUniversity of Turin, Italy·Phase 2·NCT03945084·58 enrolled

Abiraterone Acetate2 trials

Pre-approval Access Single Patient Request for Niraparib / Abiraterone Acetate Combination (Nira/AA Combination)

Approved for marketing· Johnson & Johnson logo

Johnson & Johnson··NCT05401214

Niraparib, Abiraterone Acetate and Prednisone for mHSPC With Deleterious Homologous Recombination Repair Alterations

Withdrawn·QQian Qin·Phase 2·NCT06392841

Pancreatic Adenocarcinoma2 trials

Niraparib + Ipilimumab or Nivolumab in Progression Free Pancreatic Adenocarcinoma After Platinum-Based Chemotherapy

Completed·UUniversity of Pennsylvania·Phase 1/2·NCT03404960·104 enrolled

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

Small Cell Lung Cancer2 trials

Niraparib, Temozolomide and Atezolizumab in Treating Patients With Advanced Solid Tumors and Extensive-Stage Small Cell Lung Cancer With a Complete or Partial Response to Platinum-Based First-Line Chemotherapy

Active, not recruiting·JJonsson Comprehensive Cancer Center·Phase 1/2·NCT03830918·59 enrolled

The Efficacy and Safety of Radiotherapy Plus Niraparib and Toripalimab in Patients With Recurrent Small Cell Lung Cancer

Unknown status·WWuhan University·Phase 2·NCT05162196·57 enrolled

Glioma2 trials

PARP Inhibition for Gliomas (PI-4G or π4g)

Terminated·UUniversity of Oklahoma·Phase 2·NCT05297864·15 enrolled

Niraparib In Recurrent IDH 1/2 Gliomas

Active, not recruiting·MMassachusetts General Hospital·Phase 1·NCT05406700·16 enrolled

Metastatic2 trials

Niraparib in Tumors Metastatic to the CNS

Active, not recruiting·MMassachusetts General Hospital·Phase 2·NCT04992013·20 enrolled

Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic HNSCC

Active, not recruiting·TTrisha Wise-Draper·Phase 2·NCT04313504·23 enrolled

Homologous Recombination Deficiency2 trials

Phase II Study of Niraparib in Metastatic TNBC Patients With Homologous Recombination Deficiency

Unknown status·ZZhejiang Cancer Hospital·Phase 2·NCT05461690·50 enrolled

Genome-Based Assessment of Niraparib (ZEJULA®) Efficacy in Advanced Solid TumorS With Homologous Recombination Deficiency

Not yet recruiting·KKorea University Anam Hospital·Phase 2·NCT06237205·33 enrolled

Triple-Negative Breast Cancer2 trials

Niraparib in Combination With Pembrolizumab in Patients With Triple-negative Breast Cancer or Ovarian Cancer

Completed·TTesaro, Inc.·Phase 1/2·NCT02657889·122 enrolled

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

Active, not recruiting· GSK logo

GSK·Phase 3·NCT04915755·40 enrolled

Primary Peritoneal Cancer2 trials

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·UUniversity of Washington·Phase 1·NCT04673448·18 enrolled

Trial on NIraparib-TSR-042 (Dostarlimab) vs Physician's Choice CHEmotherapy in Recurrent, Ovarian, Fallopian Tube or Primary Peritoneal Cancer Patients Not Candidate for Platinum Retreatment

Unknown status·FFondazione Policlinico Universitario Agostino Gemelli IRCCS·Phase 3·NCT04679064·427 enrolled

Non-Small Cell Lung Cancer2 trials

Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-Small Cell Lung Cancer

Active, not recruiting· GSK logo

GSK·Phase 3·NCT04475939·666 enrolled

Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants

Completed·TTesaro, Inc.·Phase 2·NCT03308942·53 enrolled

Efficacy and Safety1 trial

Basket Trial Exploring the Efficacy and Safety of the Combination of Niraparib and Dostarlimab

Terminated·GGustave Roussy, Cancer Campus, Grand Paris·Phase 2·NCT04779151·51 enrolled

Absorption1 trial

Absorption, Metabolism, Excretion, and the Determination of Absolute Bioavailability of Niraparib in Subjects With Cancer

Completed·TTesaro, Inc.·Phase 1·NCT02476552·12 enrolled

Leiomyosarcoma1 trial

Niraparib for the Treatment of Leiomyosarcoma

Withdrawn·—·Phase 2·NCT05174455

Advanced or Metastatic Solid Tumor1 trial

A Study of Niraparib Combined With MGD013 in Patients With Advanced or Metastatic Solid Tumor Who Failed Prior Treatment

Terminated·ZZai Lab (Shanghai) Co., Ltd.·Phase 1·NCT04178460·60 enrolled

Rare Tumor1 trial

PLATFORM Study of Precision Medicine for Rare Tumors

Recruiting·—·Phase 2·NCT04423185·770 enrolled

Nasopharyngeal Carcinoma1 trial

Niraparib And Sintilimab In Recurrent/Metastatic Nasopharyngeal Carcinoma

Unknown status·SSun Yat-sen University·Phase 2·NCT05162872·99 enrolled

Cervical Cancer1 trial

Niraparib Combined With Brivanib or Toripalimab in Patients With Cervical Cancer

Unknown status·—·Phase 2·NCT04395612·38 enrolled

NSCLC1 trial

UNITO-001- Study in HRR/PDL1 Positive MPM/NSCLC

Unknown status·UUniversity of Turin, Italy·Phase 2·NCT04940637·70 enrolled

Neuroendocrine Carcinoma1 trial

Niraparib and Dostarlimab for the Treatment of Small Cell Lung Cancer and Other High-Grade Neuroendocrine Carcinomas

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04701307·48 enrolled

Quality of Life1 trial

NIraparib and Quality of LifE is a Longitudinal Study Evaluating in Real Life the Tolerability of Niraparib.

Completed·AARCAGY/ GINECO GROUP·Phase 4·NCT03752216·141 enrolled

GBM1 trial

Niraparib/TTFields in GBM

Active, not recruiting·—·Phase 2·NCT04221503·30 enrolled

Penile Carcinoma1 trial

Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma

Recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT05526989·25 enrolled

Combination Therapy1 trial

Combination Therapy in Cancers With Mutations in DNA Repair Genes

Recruiting·UUniversity of California, San Francisco·Phase 1·NCT05694715·24 enrolled

SLFN11-positive1 trial

Niraparib Added to Anti-PD-L1 Antibody Maintenance in SLFN11-positive, Extensive-disease SCLC

Recruiting·EETOP IBCSG Partners Foundation·Phase 2·NCT05718323·44 enrolled

Solid Tumor Malignancies1 trial

Niraparib Plus Carboplatin in Patients With Homologous Recombination Deficient Advanced Solid Tumor Malignancies

Terminated·GGeorgetown University·Phase 1·NCT03209401·23 enrolled

Moderate Hepatic Impairment1 trial

Pharmacokinetic and Safety Study of Niraparib With Normal or Moderate Hepatic Impairment Patients

Completed·TTesaro, Inc.·Phase 1·NCT03359850·17 enrolled

Ovarian Clear Cell Carcinoma1 trial

Anlotinib Combined With Niraparib Dual Therapy in Platinum-resistant Recurrent Ovarian Clear Cell Carcinoma.

Completed·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 2·NCT05130515·6 enrolled

Melanoma1 trial

Efficacy and Safety Study of Niraparib in Melanoma With Genetic Homologous Recombination (HR) Mutation

Unknown status·—·Phase 2·NCT03925350·41 enrolled

Chemotherapy1 trial

Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042

Completed·TTesaro, Inc.·Phase 1·NCT03307785·60 enrolled

Advanced Solid Tumours1 trial

A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours

Recruiting·LLaNova Medicines Limited·Phase 1/2·NCT06682780·320 enrolled

Soft Tissue Sarcoma1 trial

A Study of Niraparib in People With Soft Tissue Sarcoma Who Have Changes in Their Tumor DNA

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT05515575·8 enrolled

Metastatic Colorectal Cancer1 trial

Niraparib and Panitumumab in Patients With Advanced or Metastatic Colorectal Cancer

Active, not recruiting·EEmory University·Phase 2·NCT03983993·26 enrolled

Mesothelioma1 trial

Niraparib Efficacy in Patient With Unresectable Mesothelioma

Completed·UUniversity Hospital Southampton NHS Foundation Trust·Phase 2·NCT05455424·88 enrolled

Malignancies1 trial

Evaluation of the Safety and Tolerability of Niraparib With Everolimus in Advanced Gynecologic Malignancies and Breast

Completed·—·Phase 1·NCT03154281·14 enrolled

Biliary Cancer1 trial

Personalized Medicine for Advanced Biliary Cancer Patients

Recruiting·UUNICANCER·Phase 3·NCT05615818·800 enrolled

Urothelial Carcinoma1 trial

Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)

Completed· Roche logo

Roche·Phase 1/2·NCT03869190·272 enrolled

Advanced or Metastatic Solid Tumors1 trial

A Study of ART4215 for the Treatment of Advanced or Metastatic Solid Tumors

Completed·AArtios Pharma Ltd·Phase 1·NCT04991480·93 enrolled

Ewing sarcoma1 trial

ESP1/SARC025 Global Collaboration: A Phase I Study of a Combination of the PARP Inhibitor, Niraparib and Temozolomide and/or Irinotecan Patients With Previously Treated, Incurable Ewing Sarcoma

Completed·SSarcoma Alliance for Research through Collaboration·Phase 1·NCT02044120·34 enrolled

Advanced Solid Malignancies1 trial

PEN-866 in Patients With Advanced Solid Malignancies

Unknown status·TTarveda Therapeutics·Phase 1/2·NCT03221400·340 enrolled

Head and Neck Squamous Cell Carcinoma1 trial

Two-cohort Study of Niraparib and Dostarlimab Plus (Chemo)RadIotherapy in Locally-Advanced Head and Neck Squamous Cell Carcinoma

Recruiting·GGrupo Español de Tratamiento de Tumores de Cabeza y Cuello·Phase 1/2·NCT05784012·34 enrolled

Neoplasms1 trial

A Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001)

Completed·UUniversity of Florida·Phase 2·NCT03207347·37 enrolled

Cancer1 trial

A MolEcularly Guided Anti-Cancer Drug Off-Label Trial

Active, not recruiting·UUppsala University Hospital·Phase 2·NCT04185831·167 enrolled

Metastatic or Locally Advanced Unresectable Solid Tumors1 trial

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. logo

EMD Serono Research & Development Institute, Inc.·Phase 1·NCT04170153·161 enrolled

Trial1 trial

The Drug Rediscovery Protocol (DRUP Trial)

Recruiting·TThe Netherlands Cancer Institute·Phase 2·NCT02925234·1,550 enrolled

Clinical Trial1 trial

ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling

Recruiting·UUlrik Lassen·Phase 2·NCT04341181·300 enrolled

Lung Cancer1 trial

Niraparib in Combination With Osimertinib in EGFR-Mutated Advanced Lung Cancer

Unknown status·MMassachusetts General Hospital·Phase 1·NCT03891615·30 enrolled

Cholangiocarcinoma1 trial

Maintenance Niraparib and Dostarlimab in Advanced Cholangiocarcinoma

Withdrawn·—·Phase 2·NCT04895046

Carcinosarcoma1 trial

Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib

Recruiting·AARCAGY/ GINECO GROUP·Phase 2/3·NCT03651206·138 enrolled

Brain Metastases1 trial

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·MM.D. Anderson Cancer Center·Phase 2·NCT05700721·120 enrolled

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

Radiotherapy1 trial

Niraparib Combined With Radiotherapy in rGBM

Unknown status·TTianjin Huanhu Hospital·Phase 2·NCT04715620·30 enrolled

Progressive Cervix Cancer1 trial

Niraparib in Combination With Dostarlimab in Patients With Recurrent or Progressive Cervix Cancer

Active, not recruiting·UUniversity of Oklahoma·Phase 2·NCT04068753·66 enrolled

Gastric Adenocarcinoma1 trial

A Study Evaluating Safety and Efficacy of Niraparib in Patients With Previously Treated Metastatic Esophageal/Gastroesophageal Junction/Proximal Gastric Adenocarcinoma

Terminated·SShadia Jalal, MD·Phase 2·NCT03840967·14 enrolled

Colorectal Cancer1 trial

Niraparib and Dostarlimab for Patients With MMR-D/MSI-H Colorectal Cancers

Withdrawn·IIbrahim Halil Sahin·Phase 2·NCT06365970

Ovarian Cancer Recurrent1 trial

SOPRANO: Stereotactic Radiotherapy Alone or Followed by Niraparib for Oligometastases or Oligoprogression in Ovarian Cancer Following PARP Inhibitor Therapy

Recruiting·IInstitute of Cancer Research, United Kingdom·Phase 2·NCT05990192·42 enrolled

Prostate Adenocarcinoma1 trial

Randomized Phase II Trial of Niraparib With Standard Combination Radiotherapy and Androgen Deprivation Therapy (ADT) in High Risk Prostate Cancer (With Initial Phase I) (NADIR*) *Randomized Phase II Trial of Niraparib With Standard Combination Androgen DeprIvation Therapy (ADT) and Radiotherapy in High Risk Prostate Cancer (With Initial Phase I)

Completed·NNRG Oncology·Preclinical·NCT04037254·22 enrolled

Prostatic Neoplasms, Castration-Resistant1 trial

A Phase 1b-2 Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT03431350·136 enrolled

Metastatic Castration-sensitive Prostate Cancer1 trial

A Phase 3 Randomized, Placebo-controlled, Double-blind 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-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT04497844·696 enrolled

Castration Resistant Prostatic Cancer1 trial

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT03748641·765 enrolled

Epithelial Ovarian Cancer1 trial

A Randomized Phase 3 Trial Evaluating the Safety & Efficacy of IP IMNN-001 Administered in Combination w/ Standard Neoadjuvant & Adjuvant Chemotherapy in Newly Diagnosed Patients w/ Advanced EOC, Fallopian Tube or Primary Peritoneal Cancer

Recruiting·IImunon·Phase 3·NCT06915025·500 enrolled

Prostatic Neoplasms1 trial

An Open-label, Randomized Study to Assess the Relative Bioavailability (BA) and Bioequivalence (BE) of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04577833·136 enrolled

Rectal Neoplasms1 trial

A Phase 1b/2 Trial of Preoperative Niraparib, Dostarlimab, and Hypofractionated Radiotherapy for the Treatment of Locally-advanced Rectal Cancers.

Terminated·UUniversity of Iowa·Phase 1·NCT04926324·3 enrolled

Ovarian Neoplasms1 trial

An Open-Label, Multicenter, Long-term Treatment Extension Study in Subjects Who Have Completed a Prior GlaxoSmithKline/TESARO-Sponsored Niraparib Study and Are Judged by the Investigator to Benefit From Continued Treatment With Niraparib

Recruiting· GSK logo

GSK·Phase 2·NCT04641247·37 enrolled

Prostate Carcinoma1 trial

Phase II Trial of Primary Radiotherapy With Androgen Ablation With or Without Adjuvant Niraparib for Selected High-Risk Locoregional Prostate Cancer

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04947254·200 enrolled

Deleterious BRCA1 Gene Mutation1 trial

A Phase Ib Study of the Oral PARP Inhibitor Niraparib With the Intravenous PI3K Inhibitor Copanlisib for Recurrent Endometrial and Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT03586661·31 enrolled

Unspecified2 trials

Study of M4344 in Combination With Niraparib

Withdrawn· EMD Serono Research & Development Institute, Inc. logo

EMD Serono Research & Development Institute, Inc.·Phase 1/2·NCT04655183

A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study

Active, not recruiting· Roche logo

Roche·Phase 3·NCT03768063·1,000 enrolled

Regulatory

FDA Approval Timeline[5]

Mar 27, 2017

ZEJULA

NDA NDA208447

Apr 26, 2023

ZEJULA

NDA NDA214876

Sources

References

[1]
ClinicalTrials.gov — 185 trial records for Niraparib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Zejula drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Niraparib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Niraparib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA214876). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Zejula. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Glaxo Dba Glaxosmithkline company filings. U.S. Securities and Exchange Commission.

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

Patent Landscape[6]

Patent Cliff

Apr 24, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8436185Apr 24, 2029

11091459Mar 27, 2038

11730725Jan 25, 2039