Product Description
Niraparib (Zejula®), a poly (ADP-ribose) polymerase (PARP) inhibitor, is approved for the maintenance treatment of recurrent, epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who are in complete or partial response to platinum-based chemotherapy. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/30073633/)
Mechanisms of Action: PARP Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Brazil | Canada | Chile | China | Croatia | Czech | Denmark | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Japan | Korea | Latvia | Lithuania | Luxembourg | Netherlands | New Zealand | Norway | Poland | Portugal | Russia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | Turkey | United Arab Emirates | United Kingdom | United States
Approved Indications: None
Known Adverse Events: None
Company: GlaxoSmithKline
Company Location: Europe
Company CEO:
Additional Commercial Interests: Johnson & Johnson
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Korea, Malaysia, Mexico, Moldova, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Puerto Rico, Romania, Russia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 93
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Johnson & Johnson presented P3 Prostate Cancer results on 2025-06-03 for Niraparib
Highest Development Phases
Phase 3: Biliary Tract Cancer|Brain Cancer|Breast Cancer|Carcinosarcoma|Endometrial Cancer|Fallopian Tube Cancer|Glioblastoma|Mixed Tumor, Mullerian|Non-Small-Cell Lung Cancer|Nose Cancer|Ovarian Cancer|Peritoneal Cancer|Prostate Cancer
Phase 2: Abnormalities, Multiple|Adenocarcinoma|Bladder Cancer|Central Nervous System Cancer|Cervical Cancer|Colorectal Cancer|Endometrioid Carcinoma|Glioma|Head and Neck Cancer|Hereditary Sensory and Autonomic Neuropathies|Hodgkin Lymphoma|Lymphoma, B-Cell|Lymphoma, Non-Hodgkin|Multiple Myeloma|Neuroendocrine Carcinoma|Oncology Solid Tumor Unspecified|Pancreatic Cancer|Papillary Adenocarcinoma|Papillary Carcinoma|Papillary Cystadenocarcinoma|Penile Cancer|Renal Cell Carcinoma|Sarcoma|Serous Cystadenocarcinoma|Small Cell Carcinoma|Small Cell Lung Cancer|Squamous Cell Carcinoma|Transitional Cell Carcinoma|Uterine Cancer|Vision, Low
Phase 1: Ataxia Telangiectasia|Cholangiocarcinoma|Gastrointestinal Cancer|Lyme Disease|Melanoma|Parkinson's Disease|Triple Negative Breast Cancer|Unilateral Breast Cancer
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
2024-516066-11-00 |
AGO-OVAR 28 | P3 |
Recruiting |
Fallopian Tube Cancer|Nose Cancer|Peritoneal Cancer|Ovarian Cancer |
2031-12-31 |
2025-05-02 |
Treatments |
|
NCT05694715 |
NCI-2023-00373 | P1 |
Recruiting |
Prostate Cancer|Ovarian Cancer|Lyme Disease|Cholangiocarcinoma|Ataxia Telangiectasia|Gastrointestinal Cancer|Breast Cancer|Melanoma|Colorectal Cancer |
2028-01-31 |
12% |
2024-11-27 |
Primary Endpoints|Treatments |
NCT06433219 |
DDRiver EOC 302 | P2 |
Active, not recruiting |
Ovarian Cancer|Hereditary Sensory and Autonomic Neuropathies |
2028-01-10 |
2% |
2025-09-26 |
Patient Enrollment|Primary Endpoints |
NCT04592237 |
NCI-2020-07731 | P2 |
Active, not recruiting |
Neuroendocrine Carcinoma|Prostate Cancer|Small Cell Carcinoma |
2027-12-31 |
12% |
2025-12-24 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT06388733 |
IVY P3-24-021 | P3 |
Recruiting |
Brain Cancer|Glioblastoma |
2027-12-01 |
46% |
2024-06-28 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT05784012 |
RADIAN | P2 |
Recruiting |
Head and Neck Cancer|Squamous Cell Carcinoma |
2027-09-01 |
12% |
2023-11-19 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT02925234 |
DRUP | P2 |
Recruiting |
Multiple Myeloma|Hodgkin Lymphoma|Abnormalities, Multiple|Lymphoma, Non-Hodgkin|Vision, Low|Lymphoma, B-Cell |
2027-09-01 |
12% |
2024-01-25 |
Primary Endpoints |
NCT05615818 |
SAFIR-ABC10 | P3 |
Recruiting |
Biliary Tract Cancer |
2027-06-01 |
24% |
2024-06-26 |
Primary Endpoints|Treatments |
NCT03651206 |
ROCSAN | P3 |
Recruiting |
Mixed Tumor, Mullerian|Ovarian Cancer|Endometrial Cancer|Carcinosarcoma |
2027-06-01 |
43% |
2025-07-09 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT03945721 |
UNITY | P1 |
Active, not recruiting |
Triple Negative Breast Cancer |
2026-12-31 |
12% |
2025-09-30 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT05526989 |
MCC-21192 | P2 |
Recruiting |
Penile Cancer |
2026-11-01 |
12% |
2024-11-30 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT05515575 |
NCT05515575 | P2 |
Active, not recruiting |
Sarcoma |
2026-08-01 |
12% |
2023-11-04 |
Patient Enrollment|Primary Endpoints|Treatments|Trial Status |
NCT06237205 |
GAUSS | P2 |
Not yet recruiting |
Oncology Solid Tumor Unspecified |
2026-06-30 |
62% |
2024-06-06 |
Primary Endpoints|Treatments |
2023-508443-40-00 |
213400 | P3 |
Active, not recruiting |
Non-Small-Cell Lung Cancer |
2025-10-27 |
2025-05-02 |
Treatments |
|
NCT03830918 |
TRIO-US L-06 | P2 |
Active, not recruiting |
Small Cell Lung Cancer |
2026-01-03 |
52% |
2025-11-15 |
Patient Enrollment|Primary Endpoints|Treatments|Trial Status |
NCT05406700 |
NCT05406700 | P1 |
Active, not recruiting |
Glioma |
2026-01-01 |
2% |
2025-09-10 |
Primary Completion Date|Primary Endpoints|Treatments|Trial Status |
NCT04221503 |
NCT04221503 | P2 |
Active, not recruiting |
Glioblastoma |
2026-01-01 |
12% |
2025-05-31 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT04673448 |
RG1005140 | P1 |
Active, not recruiting |
Pancreatic Cancer|Ovarian Cancer|Breast Cancer|Fallopian Tube Cancer|Peritoneal Cancer |
2025-12-31 |
50% |
2025-04-16 |
Primary Endpoints|Treatments|Trial Status |
NCT04716686 |
ZL-2306-914 | P2 |
Recruiting |
Endometrial Cancer|Serous Cystadenocarcinoma |
2025-12-31 |
12% |
2024-01-06 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
NCT03601923 |
NCT03601923 | P2 |
Active, not recruiting |
Pancreatic Cancer |
2025-12-31 |
12% |
2025-10-30 |
Primary Completion Date|Primary Endpoints|Treatments |
NCT04030559 |
NCI-2019-04365 | P2 |
Active, not recruiting |
Prostate Cancer |
2025-12-01 |
12% |
2025-08-27 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT04068753 |
STAR | P2 |
Active, not recruiting |
Cervical Cancer|Uterine Cancer |
2025-12-01 |
12% |
2025-10-28 |
Primary Completion Date|Primary Endpoints |
NCT04992013 |
NCT04992013 | P2 |
Active, not recruiting |
Central Nervous System Cancer |
2025-12-01 |
2% |
2025-09-10 |
|
NCT03869190 |
MORPHEUS-UC | P2 |
Active, not recruiting |
Transitional Cell Carcinoma|Bladder Cancer |
2025-10-08 |
12% |
2025-11-11 |
|
NCT05961124 |
Dose Escalation | P2 |
Recruiting |
Adenocarcinoma|Ovarian Cancer |
2025-09-01 |
58% |
2025-08-27 |
Primary Endpoints|Treatments |