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: 9
Highest Development Phases
Phase 3: 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: Adenocarcinoma|Central Nervous System Cancer|Cervical Cancer|Cholangiocarcinoma|Colorectal Cancer|Glioma|Head and Neck Cancer|Mesothelioma|Mouth Cancer|Neuroendocrine Carcinoma|Oncology Solid Tumor 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|Uterine Cancer|Uveal Melanoma
Phase 1: Ataxia Telangiectasia|Gastrointestinal Cancer|Lyme Disease|Melanoma|Neuroblastoma|Osteosarcoma|Unilateral Breast Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| AGO-OVAR 28 | P3 |
Unknown Status |
Ovarian Cancer|Fallopian Tube Cancer|Peritoneal Cancer|Nose Cancer |
2031-12-31 |
|
| 213406 | P1 |
Unknown Status |
Unknown |
2031-08-31 |
|
| 2021-001271-16 | P3 |
Active, not recruiting |
Nose Cancer|Peritoneal Cancer|Fallopian Tube Cancer|Ovarian Cancer |
2030-02-01 |
|
| SCOOP | P1 |
Recruiting |
Neuroblastoma|Osteosarcoma |
2029-10-29 |