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 46 indications[4].[1]

Zejula is one of 796 small molecule programs targeting Prostate Adenocarcinoma. It is currently in Approved.

Indications

186

Total Trials

Active Trials

795

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Prostate AdenocarcinomaCompleted

Prostate CarcinomaRecruiting

LymphomaApproved

Urogenital NeoplasmApproved

Ovarian CarcinomaApproved

Metastatic MelanomaApproved

Triple-Negative Breast CancerActive, not recruiting

Breast NeoplasmApproved

Penile CancerApproved

Metastatic Colorectal CancerActive, not recruiting

Prostate AdenocarcinomaApproved

Completed

Prostate CarcinomaApproved

Recruiting

LymphomaApproved

Approved

Urogenital NeoplasmApproved

Approved

Ovarian CarcinomaApproved

Approved

Metastatic MelanomaApproved

Approved

Triple-Negative Breast CancerPhase 3

Active, not recruiting

Breast NeoplasmApproved

Approved

Penile CancerApproved

Approved

Metastatic Colorectal CancerPhase 2

Active, not recruiting

Showing 10 of 46 indications

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Zejula

GGlaxo Dba Glaxosmithkline

Approved

13 2

Lexiscan

Astellas

Preclinical

1 3

Voltaren

Novartis

Preclinical

1 4

Zolymbus

AbbVie

Preclinical

1 5

Blenoxane

Bristol-Myers Squibb

Preclinical

1 6

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 7

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 8

Duragesic-100

CCephalon

Preclinical

2 9

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 10

Spravato

WWim Janssens

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Endometrial Cancer

NCT03981796

Phase 1Active, not recruiting

Metastatic or Locally Advanced Unresectable Solid Tumors

NCT04170153

Phase 3Recruiting

Metastatic Prostate Cancer

NCT03903835

Phase 2Recruiting

Ovarian Cancer

NCT03983226

Phase 2Active, not recruiting

Metastatic Colorectal Cancer

NCT03983993

Phase 2Active, not recruiting

Endometrial Cancer

NCT03016338

Clinical

Trials by Indication[1]

Ovarian Cancer50 trials

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

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

Niraparib with BeVAcizumab After Complete CytoreductioN in Patients with OvArian Cancer

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

Show 47 more trials

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

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

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

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

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

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

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

Completed·ZZhongda Hospital··NCT05734911·199 enrolled

The Real World Efficacy and Safety of Niraparib in Korean Women With Primary and Recurrent Epithelial Ovarian Cancer

Completed·—··NCT06086665·850 enrolled

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

Withdrawn·—·Phase 1/2·NCT05672095

Niraparib Maintenance in Patients With Advanced Ovarian Cancer at Neoadjuvant Setting

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

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

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 in Patients With Ovarian Cancer in Clinical Practice

Active, not recruiting· Takeda logo

Takeda··NCT05021562·354 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

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

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

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

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

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

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

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

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

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

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

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

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

An Open-label, Multicenter, Randomized Phase 2 Study of the ATR Inhibitor Tuvusertib in Combination With the PARP Inhibitor Niraparib or the ATM Inhibitor Lartesertib in Participants With BRCA Mutant and/or Homologous Recombination deﬁciency (HRD)-Positive Epithelial Ovarian Cancer That Progressed on Prior PARP Inhibitor Therapy (DDRiver EOC 302)

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

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

Real-World Study of Niraparib in First-Line Maintenance Therapy for Advanced Epithelial Ovarian Cancer and the Establishment and Promotion of Its Standardized Application System

Recruiting·FFudan University··NCT07783022·1,920 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 Cancer13 trials

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

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

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

Show 10 more trials

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

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

Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer

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

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

Completed·MMedSIR·Phase 2·NCT04240106·14 enrolled

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

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

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

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

Radiation, Immunotherapy and PARP Inhibitor in Triple Negative Breast Cancer

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

Prostate Cancer10 trials

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

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

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

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

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

Terminated·—·Phase 1·NCT02500901·2 enrolled

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

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

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

Endometrial Cancer5 trials

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

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

Show 2 more trials

Niraparib in High-grade Endometrial Cancer Trial

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

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 Cancer4 trials

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

Niraparib in Patients With Pancreatic Cancer

Completed·—·Phase 2·NCT03601923·32 enrolled

Show 1 more trial

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

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

81 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

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

Maintenance Treatment3 trials

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

Withdrawn·OOspedale Policlinico San Martino·Phase 2·NCT05412706

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

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

Solid Tumors3 trials

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

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

Serous Carcinoma3 trials

Trial of Maintenance With Niraparib- Uterine Serous Carcinoma

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

Niraparib Monotherapy as Maintain and Recurrent Treatment of Endometrial Serous Carcinoma

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

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

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

Small Cell Lung Cancer2 trials

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

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

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

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

ESS2 trials

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

Completed·KKristina Lindemann··NCT04785716·106 enrolled

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

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

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

Metastatic Prostate Cancer2 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

Advanced Solid Tumors2 trials

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

Completed· Takeda logo

Takeda·Phase 1·NCT03497429·9 enrolled

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

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

Prostatic Neoplasms2 trials

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

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

Solid Tumor2 trials

A Dose-escalation, Dose-expansion and Efficacy Extension Phase I/II Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Preliminary Efficacy of WJB001 Combination Therapy in Patients With Advanced Solid Tumors

Recruiting·WWigen Biomedicine Technology (Shanghai) Co., Ltd.·Preclinical·NCT06953323·86 enrolled

An Open-label, Dose-escalation, and Dose-expansion Phase I/II Clinical Study of Safety, Tolerability, Pharmacokinetic Profile, and Initial Efficacy of LM-2417 for Injection Alone or in Combination With Other Antitumor Agents in Patients With Advanced Solid Tumors

Recruiting·LLaNova Medicines Limited·Preclinical·NCT06682780·320 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

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

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

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

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

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

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

Pancreatic Adenocarcinoma1 trial

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

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

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

NSCLC1 trial

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

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

Trial1 trial

The Drug Rediscovery Protocol (DRUP Trial)

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

Metastatic1 trial

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

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

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

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

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

Cholangiocarcinoma1 trial

Maintenance Niraparib and Dostarlimab in Advanced Cholangiocarcinoma

Withdrawn·—·Phase 2·NCT04895046

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

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

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

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

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

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

Biliary Cancer1 trial

Personalized Medicine for Advanced Biliary Cancer Patients

Recruiting·UUNICANCER·Phase 3·NCT05615818·800 enrolled

Mesothelioma1 trial

Niraparib Efficacy in Patient With Unresectable Mesothelioma

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

Colorectal Cancer1 trial

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

Withdrawn·IIbrahim Halil Sahin·Phase 2·NCT06365970

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

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

Glioma1 trial

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

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

Malignancies1 trial

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

Completed·—·Phase 1·NCT03154281·14 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

Pancreatic Adenocarcinoma Metastatic1 trial

ParpVax2: A Phase II Study Of Maintenance Niraparib Plus Ipilimumab In Patients With Metastatic Pancreatic Cancer Whose Disease Has Not Progressed On Platinum-Based Therapy

Recruiting·AAbramson Cancer Center at Penn Medicine·Phase 2·NCT06747845·68 enrolled

Lung Small Cell Carcinoma1 trial

Niraparib (PARP Inhibitor) Plus Dostarlimab (Anti-PD1) for Small Cell Lung Cancer (SCLC) and Other High-Grade Neuroendocrine Carcinomas (NEC)

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

Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma1 trial

Chemotherapy Combined With Bevacizumab Followed by Niraparib Monotherapy in Newly Diagnostic Advanced Ovarian Cancer With HRD Positive : A Perspective, Multicenter, Single-arm Phase II Trial

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

Breast Carcinoma1 trial

A Phase II Study of Niraparib With Dostarlimab Therapy as Neoadjuvant Treatment for Patients With BRCA-mutated Breast Cancer

Active, not recruiting·DDana-Farber Cancer Institute·Phase 2·NCT04584255·66 enrolled

Lung Cancer1 trial

Phase 1 Study of Niraparib in Combination With Osimertinib in EGFR-Mutated Advanced Lung Cancer

Terminated·MMassachusetts General Hospital·Phase 1·NCT03891615·20 enrolled

Aggressive Variant Prostate Carcinoma1 trial

Randomized Phase II Study of Platinum-Taxane-Cetrelimab Induction Followed by Niraparib Plus or Minus Cetrelimab Maintenance in Men With Aggressive Variant Prostate Cancers

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

Ovarian Carcinosarcoma1 trial

An International Multicentric Randomized Phase II Evaluating Dostarlimab in Combination With Niraparib Versus Niraparib Alone Compared to Chemotherapy in the Treatment of Metastatic or Recurrent Endometrial or Ovarian Carcinosarcoma After at Least One Line of Chemotherapy

Recruiting·AARCAGY/ GINECO GROUP·Preclinical·NCT03651206·138 enrolled

Sarcoma,Soft Tissue1 trial

Phase II Study of Niraparib in Soft Tissue Sarcoma Patients With Altered DNA Damage Repair

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

Metastatic Pancreatic Ductal Adenocarcinoma1 trial

Phase II Study of Niraparib and TSR-042 in Patients With Germline or Somatic BRCA1/2 and PALB2-Related Pancreatic Cancer

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

Anatomic Stage III Breast Cancer AJCC v81 trial

Phase IB Trial of Niraparib and Dostarlimab (TSR-042) in Patients With BRCA-Mutated Breast, Pancreas or Ovary Cancer

Active, not recruiting·UUniversity of Washington·Phase 1·NCT04673448·18 enrolled

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. logo

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

Urothelial Carcinoma1 trial

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)

Terminated· Roche logo

Roche·Preclinical·NCT03869190·272 enrolled

Low Grade Glioma1 trial

A Phase 0 Clinical Trial to Evaluate Drug Concentrations and Pharmacodynamic Parameters of Niraparib in Tumor Tissue of Patients With Surgically Accessible Recurrent IDH 1/2 Gliomas

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

Metastatic Cancer1 trial

Genomically Guided Phase II Study to Evaluate the Clinical Benefit of Niraparib in Tumors Metastatic to the CNS

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

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

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

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

An Open Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (IMbrella B)

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

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]
ClinicalTrials.gov — 186 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

Zejula

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Ovarian Cancer50 trials

Breast Cancer13 trials

Prostate Cancer10 trials

Endometrial Cancer5 trials

Pancreatic Cancer4 trials

Glioblastoma4 trials

Treatment3 trials

Maintenance Treatment3 trials

Solid Tumors3 trials

Serous Carcinoma3 trials

Small Cell Lung Cancer2 trials

Non-Small Cell Lung Cancer2 trials

Homologous Recombination Deficiency2 trials

ESS2 trials

Abiraterone Acetate2 trials

Advanced Urothelial Cancer2 trials

Metastatic Prostate Cancer2 trials

Advanced Solid Tumors2 trials

Triple-Negative Breast Cancer2 trials

Prostatic Neoplasms2 trials

Solid Tumor2 trials

Neoplasms1 trial

Cancer1 trial

Clinical Trial1 trial

GBM1 trial

Penile Carcinoma1 trial

SLFN11-positive1 trial

Advanced or Metastatic Solid Tumors1 trial

Leiomyosarcoma1 trial

Rare Tumor1 trial

Nasopharyngeal Carcinoma1 trial

Cervical Cancer1 trial

Pancreatic Adenocarcinoma1 trial

Advanced or Metastatic Solid Tumor1 trial

NSCLC1 trial

Trial1 trial

Combination Therapy1 trial

Metastatic1 trial

Solid Tumor Malignancies1 trial

Progressive Cervix Cancer1 trial

Moderate Hepatic Impairment1 trial

Ewing sarcoma1 trial

Primary Peritoneal Cancer1 trial

Brain Metastases1 trial

Cholangiocarcinoma1 trial

Ovarian Clear Cell Carcinoma1 trial

Biomarker1 trial

Radiotherapy1 trial

Advanced Solid Malignancies1 trial

Head and Neck Squamous Cell Carcinoma1 trial

Melanoma1 trial

Gastric Adenocarcinoma1 trial

Chemotherapy1 trial

Biliary Cancer1 trial

Mesothelioma1 trial

Absorption1 trial

Colorectal Cancer1 trial

Metastatic Colorectal Cancer1 trial

Efficacy and Safety1 trial

Glioma1 trial

Quality of Life1 trial

Malignancies1 trial

Castration Resistant Prostatic Cancer1 trial

Epithelial Ovarian Cancer1 trial

Pancreatic Adenocarcinoma Metastatic1 trial

Lung Small Cell Carcinoma1 trial

Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma1 trial

Prostatic Neoplasms, Castration-Resistant1 trial

Breast Carcinoma1 trial

Lung Cancer1 trial

Aggressive Variant Prostate Carcinoma1 trial

Ovarian Carcinosarcoma1 trial

Sarcoma,Soft Tissue1 trial

Metastatic Pancreatic Ductal Adenocarcinoma1 trial