{"id":"gb-0998","safety":{"commonSideEffects":[{"rate":null,"effect":"Infusion-related reactions"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Thrombotic events"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"GB-0998 replaces or augments deficient or dysfunctional C1-inhibitor protein, which normally suppresses excessive activation of the complement cascade and bradykinin-generating contact system. By restoring C1-inhibitor function, the drug reduces uncontrolled vascular permeability and inflammation that characterize hereditary angioedema (HAE), thereby preventing acute angioedema episodes.","oneSentence":"GB-0998 is a recombinant human C1-inhibitor that regulates complement and contact system activation to prevent hereditary angioedema attacks.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:13:45.124Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hereditary angioedema (HAE) prophylaxis"}]},"trialDetails":[{"nctId":"NCT02184741","phase":"PHASE3","title":"A Study of the Efficacy and Safety of GB-0998 in Patients With Unexplained Recurrent Miscarriage","status":"COMPLETED","sponsor":"Japan Blood Products Organization","startDate":"2014-06-03","conditions":"Recurrent Miscarriage","enrollment":99},{"nctId":"NCT02032095","phase":"PHASE2, PHASE3","title":"The Desensitization Therapy With GB-0998 for Anti-donor Antibody-positive Recipients.","status":"COMPLETED","sponsor":"Japan Blood Products Organization","startDate":"2013-11","conditions":"End Stage Renal Disease","enrollment":17},{"nctId":"NCT02342184","phase":"PHASE3","title":"Efficacy and Safety Study of GB-0998 for Guillain-Barré Syndrome","status":"COMPLETED","sponsor":"Japan Blood Products Organization","startDate":"2014-08","conditions":"Guillain-Barré Syndrome","enrollment":21},{"nctId":"NCT00335985","phase":"PHASE3","title":"Efficacy and Safety Study of GB-0998 for Treatment of Steroid-resistant Polymyositis and Dermatomyositis (PM/DM)","status":"COMPLETED","sponsor":"Japan Blood Products Organization","startDate":"2006-06","conditions":"Polymyositis, Dermatomyositis","enrollment":26},{"nctId":"NCT00515450","phase":"PHASE3","title":"Efficacy and Safety Study of GB-0998 for Treatment of Generalized Myasthenia Gravis","status":"COMPLETED","sponsor":"Benesis Corporation","startDate":"2007-07","conditions":"Generalized Myasthenia Gravis","enrollment":46},{"nctId":"NCT00348296","phase":"PHASE3","title":"Efficacy and Safety Study of GB-0998 for Treatment of Systemic Sclerosis","status":"COMPLETED","sponsor":"Benesis Corporation","startDate":"2006-07","conditions":"Scleroderma, Systemic","enrollment":60}],"_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":["Intravenous immunoglobulin (Venoglobulin IH)","Venoglobulin-IH","High-dose intravenous immunoglobulin","Intravenous Immunoglobulin （Venoglobulin®IH，2.5g/50ml）"],"phase":"phase_3","status":"active","brandName":"GB-0998","genericName":"GB-0998","companyName":"Japan Blood Products Organization","companyId":"japan-blood-products-organization","modality":"Small molecule","firstApprovalDate":"","aiSummary":"GB-0998 is a recombinant human C1-inhibitor that regulates complement and contact system activation to prevent hereditary angioedema attacks. Used for Hereditary angioedema (HAE) prophylaxis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}