{"id":"intradermal-bcg-ssi-inj","safety":{"commonSideEffects":[{"rate":null,"effect":"Local injection site reaction (erythema, induration)"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"BCG-itis (systemic infection, rare)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"BCG is a live attenuated mycobacterium that triggers pattern recognition receptors on immune cells, promoting Th1 and Th17 cell differentiation, macrophage activation, and enhanced cytotoxic T-cell responses. This immunostimulation has been used clinically for bladder cancer and is being investigated for other malignancies and infectious diseases. The intradermal route delivers the vaccine to skin-resident immune cells for systemic immune priming.","oneSentence":"Intradermal BCG (Bacillus Calmette-Guérin) stimulates the immune system by activating innate and adaptive immunity to enhance anti-tumor or anti-infectious responses.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:16:39.299Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Non-muscle invasive bladder cancer (established use)"},{"name":"Melanoma or other solid tumors (investigational)"}]},"trialDetails":[{"nctId":"NCT03947138","phase":"PHASE3","title":"A Study of GC3107(BCG Vaccine) in Healthy Infants","status":"COMPLETED","sponsor":"Green Cross Corporation","startDate":"2019-08-06","conditions":"BCG Vaccination Reaction, Tuberculosis","enrollment":750}],"_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":"Intradermal BCG SSI inj.","genericName":"Intradermal BCG SSI inj.","companyName":"Green Cross Corporation","companyId":"green-cross-corporation","modality":"Biologic","firstApprovalDate":"","aiSummary":"Intradermal BCG (Bacillus Calmette-Guérin) stimulates the immune system by activating innate and adaptive immunity to enhance anti-tumor or anti-infectious responses. Used for Non-muscle invasive bladder cancer (established use), Melanoma or other solid tumors (investigational).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}