{"id":"diphtheria-antitoxin","safety":{"commonSideEffects":[{"rate":null,"effect":"Serum sickness"},{"rate":null,"effect":"Hypersensitivity reactions"},{"rate":null,"effect":"Anaphylaxis"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The antitoxin consists of antibodies (typically from immunized horses or humans) that directly bind to circulating diphtheria toxin, preventing it from damaging tissues. This provides rapid but temporary protection, as the antibodies are gradually cleared from the body. It is most effective when administered early in infection, before toxin has caused irreversible tissue damage.","oneSentence":"Diphtheria antitoxin is a passive immunotherapy that provides immediate neutralization of diphtheria toxin by binding and inactivating the exotoxin produced by Corynebacterium diphtheriae.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:44:49.961Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Diphtheria (treatment and prevention of complications from diphtheria toxin)"}]},"trialDetails":[{"nctId":"NCT06053853","phase":"PHASE4","title":"Post Marketing Surveillance of Diphtheria Antitoxin (DAT)","status":"COMPLETED","sponsor":"PT Bio Farma","startDate":"2023-01-31","conditions":"Safety Issues","enrollment":68},{"nctId":"NCT01917357","phase":"PHASE3","title":"A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject","status":"COMPLETED","sponsor":"Crucell Holland BV","startDate":"2013-09","conditions":"Diphtheria, Pertussis, Tetanus","enrollment":400},{"nctId":"NCT01362517","phase":"PHASE3","title":"Study of Quinvaxem for Vaccination Against Diphtheria, Pertussis, Tetanus, Hepatitis B and Diseases Caused by Haemophilus Influenzae Type B","status":"COMPLETED","sponsor":"Crucell Holland BV","startDate":"2010-04","conditions":"Diphtheria, Pertussis, Tetanus","enrollment":131},{"nctId":"NCT01357720","phase":"PHASE4","title":"Study to Assess if Quinvaxem Can be Interchanged With Other Pentavalent Vaccines During Standard Childhood Vaccination","status":"COMPLETED","sponsor":"Crucell Holland BV","startDate":"2011-05","conditions":"Diphtheria, Pertussis, Tetanus","enrollment":400}],"_emaApprovals":[],"_faersSignals":[{"count":7,"reaction":"DRUG INEFFECTIVE"},{"count":1,"reaction":"ACUTE KIDNEY INJURY"},{"count":1,"reaction":"COMA"},{"count":1,"reaction":"CONDITION AGGRAVATED"},{"count":1,"reaction":"DIPHTHERIA"},{"count":1,"reaction":"HYPOTENSION"},{"count":1,"reaction":"METABOLIC ACIDOSIS"},{"count":1,"reaction":"MULTIPLE ORGAN DYSFUNCTION SYNDROME"},{"count":1,"reaction":"MYOCARDITIS"},{"count":1,"reaction":"OFF LABEL USE"}],"_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":"marketed","status":"active","brandName":"Diphtheria Antitoxin","genericName":"Diphtheria Antitoxin","companyName":"PT Bio Farma","companyId":"pt-bio-farma","modality":"Biologic","firstApprovalDate":"","aiSummary":"Diphtheria Antitoxin is a protein-based treatment used to counteract diphtheria, a bacterial infection. It is studied in clinical trials for various conditions, including diphtheria, pertussis, tetanus, hepatitis B, and Haemophilus infections, often in combination with other vaccines.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}