{"id":"igg-next-generation-bt595","safety":{"commonSideEffects":[{"rate":null,"effect":"Infusion reactions (headache, fever, chills)"},{"rate":null,"effect":"Thromboembolism"},{"rate":null,"effect":"Aseptic meningitis"},{"rate":null,"effect":"Hemolytic anemia"}]},"_chembl":{"chemblId":"CHEMBL307556","moleculeType":"Small molecule","molecularWeight":"971.05"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"As a next-generation IVIG, BT595 contains pooled immunoglobulin G from multiple human donors to provide broad-spectrum passive immunity. The 'next generation' designation suggests improvements in manufacturing, viral safety, stability, or reduced adverse event profiles compared to standard IVIG formulations. It functions by supplying exogenous antibodies to patients with immunodeficiency or autoimmune/inflammatory conditions.","oneSentence":"BT595 is a next-generation intravenous immunoglobulin (IVIG) product designed to provide passive immunity through polyclonal IgG antibodies with enhanced manufacturing and purification processes.","_ai_confidence":"low"},"_scrapedAt":"2026-03-28T01:15:30.953Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Primary immunodeficiency disorders"},{"name":"Secondary immunodeficiency"},{"name":"Autoimmune and inflammatory conditions (specific indications in Phase 3 trials not publicly detailed)"}]},"trialDetails":[{"nctId":"NCT02810444","phase":"PHASE3","title":"Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595 in Subjects With PID","status":"COMPLETED","sponsor":"Biotest","startDate":"2016-10-04","conditions":"Primary Immunodeficiency Disease","enrollment":81}],"_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":["Immune Globulin Intravenous (Human), 10% Liquid"],"phase":"phase_3","status":"active","brandName":"IgG Next Generation (BT595)","genericName":"IgG Next Generation (BT595)","companyName":"Biotest","companyId":"biotest","modality":"Biologic","firstApprovalDate":"","aiSummary":"IgG Next Generation (BT595) is a small molecule being studied for its efficacy, safety, and pharmacokinetics in subjects with Primary Immunodeficiency Disease. It is being investigated in an open-label, prospective, multicenter study.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}