{"id":"bcg-vesiculture","safety":{"commonSideEffects":[{"rate":null,"effect":"Dysuria"},{"rate":null,"effect":"Urinary frequency"},{"rate":null,"effect":"Hematuria"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Fatigue"}]},"_chembl":{"chemblId":"CHEMBL2108905","moleculeType":"Vaccine component"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"BCG is administered intravesically (directly into the bladder) where it colonizes the urothelium and triggers a robust local immune response, including activation of dendritic cells, T cells, and natural killer cells. This immune activation leads to recognition and destruction of bladder cancer cells, particularly urothelial carcinoma. The vesiculture formulation refers to the specific culture and preparation method used by Janssen to optimize immunogenicity.","oneSentence":"BCG Vesiculture is a live attenuated Bacillus Calmette-Guérin vaccine formulation designed to stimulate innate and adaptive immune responses against bladder cancer.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:03:41.168Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Non-muscle invasive bladder cancer (NMIBC), high-grade urothelial carcinoma"}]},"trialDetails":[{"nctId":"NCT05714202","phase":"PHASE3","title":"A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Janssen Research & Development, LLC","startDate":"2023-03-23","conditions":"Bladder Cancer","enrollment":1135}],"_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":"BCG Vesiculture","genericName":"BCG Vesiculture","companyName":"Janssen Research & Development, LLC","companyId":"janssen-research-development-llc","modality":"Biologic","firstApprovalDate":"","aiSummary":"BCG Vesiculture is a live attenuated Bacillus Calmette-Guérin vaccine formulation designed to stimulate innate and adaptive immune responses against bladder cancer. Used for Non-muscle invasive bladder cancer (NMIBC), high-grade urothelial carcinoma.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}