{"id":"igm-enriched-ivig","safety":{"commonSideEffects":[{"rate":null,"effect":"Infusion reactions"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Thromboembolism"},{"rate":null,"effect":"Renal dysfunction"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"IgM-enriched intravenous immunoglobulin (IVIG) is an immunoglobulin preparation with elevated IgM content that acts as a passive immunotherapeutic agent. It functions by providing pre-formed antibodies that can neutralize pathogens, enhance complement activation, and modulate immune responses through Fc receptor engagement. This formulation is designed to provide broader immune coverage compared to standard IVIG, which is predominantly IgG.","oneSentence":"IgM-enriched IVIG provides passive immunotherapy by supplying immunoglobulin M antibodies to enhance immune response and modulate inflammatory pathways.","_ai_confidence":"low"},"_scrapedAt":"2026-03-28T00:48:16.042Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Immunodeficiency disorders"},{"name":"Sepsis and severe infections"},{"name":"Autoimmune and inflammatory conditions"}]},"trialDetails":[{"nctId":"NCT04041765","phase":"PHASE3","title":"IgM-Enriched Immunoglobulin for Neonatal Sepsis","status":"UNKNOWN","sponsor":"Fakultas Kedokteran Universitas Indonesia","startDate":"2019-09","conditions":"Neonatal Sepsis, Early-Onset, Very Low Birth Weight Infant, Inflammation","enrollment":70},{"nctId":"NCT02961166","phase":"","title":"Immunglobulin M Enriched Intra Venous Immunoglobulin (IVIG) Therapy in Adult Respiratory Distress Syndrom (ARDS) Patients","status":"COMPLETED","sponsor":"University Hospital Tuebingen","startDate":"2012-01","conditions":"Respiratory Distress Syndrome, Adult, Septic Shock","enrollment":57},{"nctId":"NCT01867645","phase":"PHASE1","title":"The Impact of IVIG Treatment on Critical Illness Polyneuropathy and/or Myopathy in Patients With MOF and SIRS/Sepsis","status":"TERMINATED","sponsor":"Medical University of Vienna","startDate":"2004-12","conditions":"Polyneuropathies","enrollment":38},{"nctId":"NCT01006499","phase":"PHASE4","title":"Role of 'Pentoxifylline and or IgM Enriched Intravenous Immunoglobulin in the Treatment of Neonatal Sepsis'","status":"UNKNOWN","sponsor":"Zekai Tahir Burak Women's Health Research and Education Hospital","startDate":"2009-08","conditions":"Sepsis of the Newborn","enrollment":204}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":20,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Pentaglobin®"],"phase":"phase_3","status":"active","brandName":"IgM-enriched IVIG","genericName":"IgM-enriched IVIG","companyName":"Fakultas Kedokteran Universitas Indonesia","companyId":"fakultas-kedokteran-universitas-indonesia","modality":"Small molecule","firstApprovalDate":"","aiSummary":"IgM-enriched IVIG provides passive immunotherapy by supplying immunoglobulin M antibodies to enhance immune response and modulate inflammatory pathways. Used for Immunodeficiency disorders, Sepsis and severe infections, Autoimmune and inflammatory conditions.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}