{"id":"placebo-matching-niraparib","safety":{"commonSideEffects":[]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"As a placebo, this formulation contains no active pharmaceutical ingredient and serves as a control comparator in clinical trials. The reference drug niraparib is a PARP inhibitor that traps PARP proteins on DNA and prevents homologous recombination repair, leading to synthetic lethality in BRCA-mutant and homologous recombination-deficient tumors.","oneSentence":"This is a placebo control arm matching the active drug niraparib, a PARP inhibitor that blocks poly(ADP-ribose) polymerase enzymes to prevent DNA repair in cancer cells.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:51:34.033Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Placebo control for ovarian cancer maintenance therapy trials (reference indication for niraparib)"}]},"trialDetails":[{"nctId":"NCT04497844","phase":"PHASE3","title":"A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Janssen Research & Development, LLC","startDate":"2020-09-23","conditions":"Metastatic Castration-sensitive Prostate Cancer","enrollment":696},{"nctId":"NCT03748641","phase":"PHASE3","title":"A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Janssen Research & Development, LLC","startDate":"2019-01-25","conditions":"Castration-Resistant Prostatic Cancer","enrollment":765},{"nctId":"NCT04475939","phase":"PHASE3","title":"Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-Small Cell Lung Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"GlaxoSmithKline","startDate":"2020-10-26","conditions":"Lung Cancer, Non-Small Cell","enrollment":666},{"nctId":"NCT03981796","phase":"PHASE3","title":"A Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Participants With Recurrent or Primary Advanced Endometrial Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Tesaro, Inc.","startDate":"2019-07-18","conditions":"Neoplasms","enrollment":785},{"nctId":"NCT04915755","phase":"PHASE3","title":"Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease","status":"ACTIVE_NOT_RECRUITING","sponsor":"GlaxoSmithKline","startDate":"2021-06-28","conditions":"Neoplasms, Breast","enrollment":40},{"nctId":"NCT03705156","phase":"PHASE3","title":"Clinical Trial Evaluating the Efficacy and Safety of ZL-2306 (Niraparib) in Ovarian Cancer Patient","status":"UNKNOWN","sponsor":"Zai Lab (Shanghai) Co., Ltd.","startDate":"2017-06-08","conditions":"Platinum-sensitive Relapsed Ovarian Cancer","enrollment":265}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Placebo matching Niraparib","genericName":"Placebo matching Niraparib","companyName":"Tesaro, Inc.","companyId":"tesaro-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Niraparib is a small molecule inhibitor of the Poly [ADP-ribose] polymerase 2 enzyme. It is being studied in clinical trials for the treatment of ovarian neoplasms malignant, among other conditions, and is also known as MK-4827, MK4827, JNJ-64091742, and NIRAPARIB.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}