{"id":"pharmacokinetics-dosage-of-niraparib","safety":{"commonSideEffects":[{"rate":"33","effect":"Anemia"},{"rate":"29","effect":"Thrombocytopenia"},{"rate":"42","effect":"Nausea"},{"rate":"45","effect":"Fatigue"},{"rate":"32","effect":"Vomiting"},{"rate":"22","effect":"Constipation"},{"rate":"20","effect":"Leukopenia"}]},"_chembl":{"chemblId":"CHEMBL1094636","moleculeType":"Small molecule","molecularWeight":"320.40"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Niraparib is a PARP inhibitor that blocks PARP1 and PARP2, enzymes critical for single-strand DNA break repair. By inhibiting PARP, the drug causes accumulation of DNA damage in cancer cells, particularly those with BRCA1/2 mutations or homologous recombination deficiency, triggering apoptosis. This mechanism is especially effective in ovarian and breast cancers with defective DNA repair pathways.","oneSentence":"Niraparib inhibits poly(ADP-ribose) polymerase (PARP) enzymes, preventing DNA repair in cancer cells and leading to cell death.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:41:46.102Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Ovarian cancer (platinum-sensitive recurrent, BRCA-mutated, and homologous recombination deficient)"},{"name":"Metastatic breast cancer (BRCA-mutated)"},{"name":"Prostate cancer (BRCA-mutated, metastatic castration-resistant)"}]},"trialDetails":[{"nctId":"NCT06953323","phase":"PHASE1, PHASE2","title":"A Phase I/II Study of WJB001 Combination Therapy on Safety and Efficacy for Advanced Solid Tumors","status":"RECRUITING","sponsor":"Wigen Biomedicine Technology (Shanghai) Co., Ltd.","startDate":"2025-07-10","conditions":"Advanced Solid Tumor","enrollment":86},{"nctId":"NCT06077877","phase":"PHASE1, PHASE2","title":"A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid Tumors","status":"ACTIVE_NOT_RECRUITING","sponsor":"GlaxoSmithKline","startDate":"2023-10-24","conditions":"Neoplasms","enrollment":42},{"nctId":"NCT04991480","phase":"PHASE1","title":"A Study of ART4215 for the Treatment of Advanced or Metastatic Solid Tumors","status":"COMPLETED","sponsor":"Artios Pharma Ltd","startDate":"2021-09-13","conditions":"Advanced Cancer, Metastatic Cancer, Breast Cancer","enrollment":93},{"nctId":"NCT04861181","phase":"PHASE4","title":"NIRAPK : Study of the Relationship(s) Between Clinical, Biological and Pharmacokinetic Metrics and Toxicities When Niraparib is Used as Maintenance Treatment for Ovarian Cancer Patients.","status":"TERMINATED","sponsor":"Hospices Civils de Lyon","startDate":"2021-05-05","conditions":"Adult Patients With Platinum-sensitive, Relapsed, High Grade Serous Epithelial Ovarian Cancer","enrollment":12},{"nctId":"NCT03221400","phase":"PHASE1, PHASE2","title":"PEN-866 in Patients With Advanced Solid Malignancies","status":"UNKNOWN","sponsor":"Tarveda Therapeutics","startDate":"2017-08-29","conditions":"Carcinoma, Endometrial Adenocarcinoma, Neoplasms","enrollment":340},{"nctId":"NCT03359850","phase":"PHASE1","title":"Pharmacokinetic and Safety Study of Niraparib With Normal or Moderate Hepatic Impairment Patients","status":"COMPLETED","sponsor":"Tesaro, Inc.","startDate":"2018-02-20","conditions":"Ovarian Neoplasms, Neoplasms, Solid Tumor","enrollment":17},{"nctId":"NCT02924766","phase":"PHASE1","title":"A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE)","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2016-10-03","conditions":"Prostatic Neoplasms","enrollment":34},{"nctId":"NCT03551171","phase":"PHASE1","title":"The Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of ZL-2306 (Niraparib) in Patients With Ovarian Cancer","status":"COMPLETED","sponsor":"Zai Lab (Shanghai) Co., Ltd.","startDate":"2017-12-19","conditions":"Ovarian Cancer","enrollment":42}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":18,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Pharmacokinetics, Dosage of Niraparib","genericName":"Pharmacokinetics, Dosage of Niraparib","companyName":"Hospices Civils de Lyon","companyId":"hospices-civils-de-lyon","modality":"Biologic","firstApprovalDate":"","aiSummary":"Niraparib inhibits poly(ADP-ribose) polymerase (PARP) enzymes, preventing DNA repair in cancer cells and leading to cell death. Used for Ovarian cancer (platinum-sensitive recurrent, BRCA-mutated, and homologous recombination deficient), Metastatic breast cancer (BRCA-mutated), Prostate cancer (BRCA-mutated, metastatic castration-resistant).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}