{"id":"opc-6535","safety":{"commonSideEffects":[]},"_chembl":{"chemblId":"CHEMBL332750","moleculeType":"Small molecule","molecularWeight":"370.43"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"P2X7 is an ATP-gated ion channel expressed on immune cells that plays a role in inflammasome activation and pro-inflammatory cytokine release. By blocking P2X7, OPC-6535 reduces excessive inflammatory responses and may provide therapeutic benefit in conditions driven by aberrant immune activation. This mechanism is being explored in neuropathic pain and other inflammatory conditions.","oneSentence":"OPC-6535 is a selective antagonist of the P2X7 receptor, which modulates purinergic signaling involved in inflammatory and immune responses.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:24:24.618Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Neuropathic pain"}]},"trialDetails":[{"nctId":"NCT00317356","phase":"PHASE2","title":"A Dose-finding Study of OPC-6535 in Patients With Active Ulcerative Colitis","status":"TERMINATED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2006-05","conditions":"Colitis, Ulcerative","enrollment":43},{"nctId":"NCT00917150","phase":"PHASE2","title":"To Investigate the Efficacy and Safety of OPC-6535 in Chronic Obstructive Pulmonary Disease (COPD) Patients","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2009-03","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":771},{"nctId":"NCT00989573","phase":"PHASE2, PHASE3","title":"A Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2009-10","conditions":"Crohn's Disease","enrollment":191},{"nctId":"NCT00317369","phase":"PHASE2","title":"A Dose-finding Study of OPC-6535 in Patients With Active Crohn's Disease","status":"TERMINATED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2006-05","conditions":"Crohn Disease","enrollment":29},{"nctId":"NCT00874497","phase":"PHASE2","title":"Pilot Study of Tetomilast in Chronic Obstructive Pulmonary Disease (COPD) Associated With Emphysema","status":"TERMINATED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2009-03","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":84},{"nctId":"NCT00064441","phase":"PHASE3","title":"FACTS I: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2003-05","conditions":"Ulcerative Colitis","enrollment":375},{"nctId":"NCT00064454","phase":"PHASE3","title":"FACTS II: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2003-05","conditions":"Ulcerative Colitis","enrollment":375},{"nctId":"NCT00092508","phase":"PHASE3","title":"CORE: A Study of OPC-6535 With Asacol® in Maintaining Ulcerative Colitis (UC) Remission","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2004-05","conditions":"Ulcerative Colitis","enrollment":1725}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":11,"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":"OPC-6535","genericName":"OPC-6535","companyName":"Otsuka Pharmaceutical Co., Ltd.","companyId":"otsuka-pharmaceutical-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"OPC-6535 is a selective antagonist of the P2X7 receptor, which modulates purinergic signaling involved in inflammatory and immune responses. Used for Neuropathic pain.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}