{"id":"bezlotoxumab-injection","safety":{"commonSideEffects":[{"rate":null,"effect":"Infusion-related reactions"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Fatigue"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Bezlotoxumab specifically targets toxin B produced by C. difficile, one of the two major virulence factors responsible for disease pathogenesis. By neutralizing toxin B before it can damage intestinal cells, the drug reduces inflammation, prevents epithelial injury, and decreases the risk of recurrent C. difficile infection (CDI). This mechanism allows the host immune system and normal microbiota to recover without ongoing toxin-mediated damage.","oneSentence":"Bezlotoxumab is a monoclonal antibody that binds to and neutralizes Clostridioides difficile toxin B, preventing its pathogenic effects on the intestinal epithelium.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:40:31.704Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Clostridioides difficile infection (CDI) — to reduce recurrence in patients at high risk"}]},"trialDetails":[{"nctId":"NCT04075422","phase":"","title":"Bezlotoxumab - in \"Real Life\" - During the First Episode of Clostridium Difficile Infection in Patients With High Risk of Recurrence.","status":"COMPLETED","sponsor":"Fundacion SEIMC-GESIDA","startDate":"2019-10-01","conditions":"Clostridium Difficile Infection","enrollment":869},{"nctId":"NCT03937999","phase":"PHASE4","title":"Bezlotoxumab as Secondary Prophylaxis for C. Difficile in High-risk Hospitalized Patients Exposed to Antibiotics.","status":"TERMINATED","sponsor":"Montefiore Medical Center","startDate":"2019-08-30","conditions":"Clostridium Difficile","enrollment":1},{"nctId":"NCT04415918","phase":"PHASE4","title":"Bezlotoxumab Efficacy and Tolerability in Cancer Patient","status":"UNKNOWN","sponsor":"The Cooper Health System","startDate":"2020-07-01","conditions":"Clostridium Difficile Infection Recurrence","enrollment":132}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["No intervention"],"phase":"marketed","status":"active","brandName":"Bezlotoxumab Injection","genericName":"Bezlotoxumab Injection","companyName":"The Cooper Health System","companyId":"the-cooper-health-system","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Bezlotoxumab is a monoclonal antibody that binds to and neutralizes Clostridioides difficile toxin B, preventing its pathogenic effects on the intestinal epithelium. Used for Clostridioides difficile infection (CDI) — to reduce recurrence in patients at high risk.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":111,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}