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: None *
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:
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: 98
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|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 Lung Cancer|Squamous Cell Carcinoma|Transitional Cell Carcinoma|Triple Negative Breast Cancer|Uterine Cancer|Vision, Low
Phase 1: Ataxia Telangiectasia|Cholangiocarcinoma|Gastrointestinal Cancer|Lyme Disease|Melanoma|Neuroblastoma|Osteosarcoma|Parkinson's Disease|Unilateral Breast Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| AGO-OVAR 28 | P3 |
Recruiting |
Peritoneal Cancer|Fallopian Tube Cancer|Nose Cancer|Ovarian Cancer |
2031-12-31 |
|
| STAMPEDE2 | P3 |
Recruiting |
Prostate Cancer |
2031-04-01 |
19% |
| 2018-002350-78 | P3 |
Active, not recruiting |
Prostate Cancer |
2030-03-30 |
|
| SCOOP | P1 |
Recruiting |
Osteosarcoma|Neuroblastoma |
2029-10-29 |
23% |
| Storytime | P2 |
Active, not recruiting |
Unknown |
2029-07-23 |
23% |
| S67130 | P3 |
Recruiting |
Prostate Cancer |
2029-07-15 |
|
| Niraparib vs Placebo in Participants with HER2- BRCAmut breast cancer or TNBC with Detectable ctDNA | P3 |
Completed |
Breast Cancer |
2029-06-29 |
9% |
| KNIGHTS | P2 |
Recruiting |
Prostate Cancer |
2028-12-31 |
12% |
| RADIAN | P2 |
Active, not recruiting |
Head and Neck Cancer|Squamous Cell Carcinoma |
2028-10-13 |
12% |
| ParpVax2 | P2 |
Recruiting |
Adenocarcinoma|Pancreatic Cancer |
2028-06-01 |
12% |
| NCI-2023-00373 | P1 |
Recruiting |
Cholangiocarcinoma|Gastrointestinal Cancer|Melanoma|Ataxia Telangiectasia|Prostate Cancer|Colorectal Cancer|Ovarian Cancer|Lyme Disease|Breast Cancer |
2028-01-31 |
23% |
| MS201924_0002 | P2 |
Recruiting |
Ovarian Cancer |
2028-01-25 |
12% |
| DDRiver EOC 302 | P2 |
Recruiting |
Ovarian Cancer |
2028-01-10 |
12% |
| IVY P3-24-021 | P3 |
Recruiting |
Brain Cancer|Glioblastoma |
2027-12-01 |
46% |
| REPRESENTATION | P2 |
Not yet recruiting |
Prostate Cancer |
2027-09-30 |
12% |
| CAPRICE | P2 |
Not yet recruiting |
Breast Cancer |
2027-09-01 |
71% |
| DRUP | P2 |
Recruiting |
Lymphoma, Non-Hodgkin|Lymphoma, B-Cell|Abnormalities, Multiple|Vision, Low|Multiple Myeloma|Hodgkin Lymphoma |
2027-09-01 |
12% |
| RADIAN | P2 |
Recruiting |
Squamous Cell Carcinoma|Head and Neck Cancer |
2027-09-01 |
12% |
| SAFIR-ABC10 | P3 |
Recruiting |
Biliary Tract Cancer |
2027-06-01 |
17% |
| 67652000PCR3002 | P3 |
Active, not recruiting |
Prostate Cancer |
2027-05-07 |
84% |
| HARMONY | P2 |
Recruiting |
Prostate Cancer |
2027-04-01 |
12% |
| NICHOL | P2 |
Recruiting |
Ovarian Cancer |
2027-03-20 |
12% |
| 64091742PCR3001 | P3 |
Active, not recruiting |
Prostate Cancer |
2027-02-19 |
|
| ONC-2022-001 | P2 |
Not yet recruiting |
Glioblastoma|Glioma |
2026-12-01 |
42% |
| ProBio | P3 |
Recruiting |
Prostate Cancer |
2026-12-01 |
43% |