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: Fallopian Tube Cancer | Ovarian Cancer | Oncology Unspecified | Peritoneal Cancer
Known Adverse Events: Hypertension | Abdominal Pain | Back Pain | Dizziness | Dysgeusia | Headache | Pain Unspecified | Insomnia | Stomatitis | Nasopharyngitis | Pharyngitis | Mucositis | Anemia | Leukopenia | Thrombocytopenia | Arthralgia | Myalgia | Dyspnea | Asthenia | Constipation | Diarrhea | Dyspepsia
Company: GlaxoSmithKline
Company Location: BRENTFORD MIDDLESEX X0 TW8 9GS
Company CEO: Emma Walmsley
Additonal 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, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 134
Highest Development Phases
Phase 3: Biliary Tract Cancer|Brain Cancer|Breast Cancer|Carcinosarcoma|Clear Cell Sarcoma|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|Cholangiocarcinoma|Colorectal Cancer|Endometrioid Carcinoma|Esophageal Cancer|Glioma|Head and Neck Cancer|Hodgkin Lymphoma|Lung Cancer|Lymphoma, B-Cell|Lymphoma, Non-Hodgkin|Melanoma|Mesothelioma|Mouth Cancer|Multiple Myeloma|Neuroendocrine Carcinoma|Oncology Solid Tumor Unspecified|Oncology Unspecified|Pancreatic Cancer|Papillary Adenocarcinoma|Papillary Carcinoma|Papillary Cystadenocarcinoma|Pelvic Cancer|Penile Cancer|Pleural Cancer|Renal Cell Carcinoma|Sarcoma|Serous Cystadenocarcinoma|Small Cell Lung Cancer|Squamous Cell Carcinoma|Transitional Cell Carcinoma|Triple Negative Breast Cancer|Urologic Cancer|Uterine Cancer|Uveal Melanoma|Vision, Low
Phase 1: Ataxia Telangiectasia|Gastrointestinal Cancer|Lyme Disease|Neuroblastoma|Osteosarcoma|Parkinson's Disease|Unilateral Breast Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| STAMPEDE2 | P3 |
Recruiting |
Prostate Cancer |
2031-04-01 |
|
| 2018-002350-78 | P3 |
Active, not recruiting |
Prostate Cancer |
2030-03-30 |
|
| 2021-001271-16 | P3 |
Active, not recruiting |
Ovarian Cancer|Fallopian Tube Cancer|Peritoneal Cancer|Nose Cancer |
2030-02-01 |
|
| 213406 | P1 |
Temporary halt |
Unknown |
2029-07-31 |