{"id":"bacille-calmette-guerin","safety":{"commonSideEffects":[{"rate":"40-60","effect":"Dysuria (painful urination)"},{"rate":"40-60","effect":"Urinary frequency"},{"rate":"20-40","effect":"Hematuria (blood in urine)"},{"rate":"10-20","effect":"Fever"},{"rate":"10-20","effect":"Malaise/fatigue"},{"rate":"<1","effect":"BCG infection/sepsis (rare)"}]},"_chembl":{"chemblId":"CHEMBL2108905","moleculeType":"Vaccine component"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"BCG works as an immunotherapeutic agent by activating innate and adaptive immune responses against bladder cancer cells. When instilled directly into the bladder, it triggers local inflammation and recruits immune cells (macrophages, T cells, natural killer cells) that target and eliminate malignant urothelial cells. The mechanism involves pattern recognition receptor activation and non-specific immune stimulation rather than targeting a specific molecular pathway.","oneSentence":"Bacille Calmette-Guerin (BCG) is a live attenuated mycobacterial vaccine that stimulates the immune system to recognize and destroy cancer cells in the bladder.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:28:06.260Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Non-muscle invasive bladder cancer (NMIBC), high-grade or recurrent"},{"name":"Carcinoma in situ (CIS) of the bladder"}]},"trialDetails":[{"nctId":"NCT06845358","phase":"PHASE1","title":"Safety and Challenge Study of BCG TICE(R) Vaccination to Test Tuberculosis Immunity in Heathy Humans","status":"WITHDRAWN","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2025-11-26","conditions":"Tuberculosis","enrollment":""},{"nctId":"NCT04152161","phase":"PHASE2","title":"Bacille Calmette Guerin (BCG) Revaccination of Healthy Adolescents for the Prevention of Mycobacterium Tuberculosis Sustained Infection","status":"TERMINATED","sponsor":"Gates Medical Research Institute","startDate":"2019-10-16","conditions":"Tuberculosis","enrollment":1836},{"nctId":"NCT04884308","phase":"PHASE2","title":"Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections","status":"COMPLETED","sponsor":"Johns Hopkins University","startDate":"2021-04-28","conditions":"Cystic Fibrosis, Bronchiectasis Adult, Non-Tuberculous Mycobacteria","enrollment":30},{"nctId":"NCT05410730","phase":"PHASE1, PHASE2","title":"A Study of SHR-1501 Alone or in Combination With BCG or SHR-1316 in Subjects With NMIBC","status":"RECRUITING","sponsor":"Shanghai Hengrui Pharmaceutical Co., Ltd.","startDate":"2022-11-23","conditions":"High-risk NMIBC","enrollment":150},{"nctId":"NCT03888924","phase":"PHASE2","title":"Bacille Calmette-Guérin (BCG) Vaccine In Radiologically Isolated Syndrome (RIS)","status":"RECRUITING","sponsor":"S. 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Andrea Hospital","startDate":"2001-11","conditions":"Multiple Sclerosis","enrollment":80},{"nctId":"NCT01082510","phase":"PHASE3","title":"Study of the Efficacy of Maintenance Therapy Using Uracil-tegafur (UFT) or Bacille Calmette-Guerin (BCG) for the Prevention of Recurrences of Superficial Bladder Cancer (EMBARK Study)","status":"UNKNOWN","sponsor":"Urological Oncology Council of Northern Tokyo","startDate":"2010-01","conditions":"Bladder Cancer","enrollment":288},{"nctId":"NCT00653627","phase":"PHASE1","title":"A Study to Quantify Bacille Calmette Guerin (BCG) and Characterise the Immune Response After BCG Vaccination","status":"COMPLETED","sponsor":"University of Oxford","startDate":"2007-08","conditions":"Tuberculosis","enrollment":40},{"nctId":"NCT01074775","phase":"NA","title":"Human Innate Immune Responses To Mycobacterial Aerodigestive Tract Infection","status":"COMPLETED","sponsor":"St George's, University of London","startDate":"2006-09","conditions":"Bacterial Infections","enrollment":7},{"nctId":"NCT00331474","phase":"PHASE1, PHASE2","title":"The Effect of Bacille Calmette Guerin (BCG) Vaccination on Immune Responses in HIV-Exposed and Unexposed Infants","status":"UNKNOWN","sponsor":"University of Stellenbosch","startDate":"2006-05","conditions":"HIV Infections","enrollment":180},{"nctId":"NCT00126217","phase":"PHASE4","title":"Revaccination of Young Children With Bacille Calmette Guerin (BCG) Vaccine","status":"TERMINATED","sponsor":"Bandim Health Project","startDate":"2002-07","conditions":"Malaria","enrollment":2871},{"nctId":"NCT00654316","phase":"PHASE1","title":"Study of the Safety and Immunogenicity of Bacille Calmette Guerin (BCG) Vaccine","status":"COMPLETED","sponsor":"University of Oxford","startDate":"2004-02","conditions":"TB","enrollment":11},{"nctId":"NCT00242047","phase":"PHASE4","title":"Randomized Controlled Trial of Percutaneous and Intradermal BCG Vaccination.","status":"UNKNOWN","sponsor":"University of Cape Town","startDate":"2001-03","conditions":"Tuberculosis","enrollment":12000}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":3197,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["BCG"],"phase":"marketed","status":"active","brandName":"Bacille Calmette-Guerin","genericName":"Bacille Calmette-Guerin","companyName":"Urological Oncology Council of Northern Tokyo","companyId":"urological-oncology-council-of-northern-tokyo","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Bacille Calmette-Guerin (BCG) is a live attenuated mycobacterial vaccine that stimulates the immune system to recognize and destroy cancer cells in the bladder. Used for Non-muscle invasive bladder cancer (NMIBC), high-grade or recurrent, Carcinoma in situ (CIS) of the bladder.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}