{"id":"ig-nextgen-10","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Chills"},{"rate":null,"effect":"Myalgia"},{"rate":null,"effect":"Infusion reactions"},{"rate":null,"effect":"Thromboembolism"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"As a next-generation IVIG formulation, it contains polyspecific human immunoglobulins (primarily IgG) derived from pooled plasma donations. It functions through multiple mechanisms including opsonization of pathogens, complement activation, Fc receptor engagement, and immune modulation to treat primary immunodeficiencies and autoimmune/inflammatory conditions.","oneSentence":"Ig NextGen 10% is an intravenous immunoglobulin (IVIG) product that provides passive immunity by delivering pooled human antibodies to modulate immune function and replace deficient immunoglobulins.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:48:15.998Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Primary immunodeficiency disorders"},{"name":"Secondary immunodeficiency conditions"},{"name":"Autoimmune and inflammatory disorders (e.g., immune thrombocytopenia, chronic inflammatory demyelinating polyneuropathy)"}]},"trialDetails":[{"nctId":"NCT00362349","phase":"PHASE3","title":"Ig NextGen 10% in Idiopathic Thrombocytopenic Purpura (ITP) Patients","status":"COMPLETED","sponsor":"CSL Limited","startDate":"2007-06","conditions":"Idiopathic Thrombocytopenic Purpura (ITP)","enrollment":19},{"nctId":"NCT00405184","phase":"PHASE3","title":"Ig NextGen 10% in Patients With Primary Immune Deficiency (PID)","status":"COMPLETED","sponsor":"CSL Limited","startDate":"2007-05","conditions":"Primary Immune Deficiency (PID)","enrollment":19}],"_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":[],"phase":"phase_3","status":"active","brandName":"Ig NextGen 10%","genericName":"Ig NextGen 10%","companyName":"CSL Limited","companyId":"csl-limited","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Ig NextGen 10% is an intravenous immunoglobulin (IVIG) product that provides passive immunity by delivering pooled human antibodies to modulate immune function and replace deficient immunoglobulins. Used for Primary immunodeficiency disorders, Secondary immunodeficiency conditions, Autoimmune and inflammatory disorders (e.g., immune thrombocytopenia, chronic inflammatory demyelinating polyneuropathy).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}