{"id":"newgam","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":"Thrombosis (rare)"}]},"_chembl":{"chemblId":"CHEMBL1201599","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"NewGam functions as a replacement or supplementation therapy for patients with immunodeficiency or as an immunomodulatory agent in autoimmune and inflammatory conditions. The pooled immunoglobulins bind to pathogens and aberrant immune targets, facilitating their clearance and dampening pathogenic immune responses. It is derived from human plasma and contains a broad spectrum of antibodies against common infectious agents and self-antigens.","oneSentence":"NewGam is an intravenous immunoglobulin (IVIG) product that provides passive immunity by delivering pooled human antibodies to modulate immune responses.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:22:55.661Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Primary immunodeficiency disorders"},{"name":"Secondary immunodeficiency"},{"name":"Autoimmune and inflammatory conditions (e.g., immune thrombocytopenia, chronic inflammatory demyelinating polyneuropathy)"}]},"trialDetails":[{"nctId":"NCT01300728","phase":"PHASE2","title":"Study of Intravenous Immunoglobulin in Amnestic Mild Cognitive Impairment","status":"COMPLETED","sponsor":"Sutter Health","startDate":"2011-01-01","conditions":"Mild Cognitive Impairment","enrollment":52},{"nctId":"NCT02638207","phase":"PHASE3","title":"Study to Evaluate Safety and Efficacy of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly (Radiculo) Neuropathy","status":"COMPLETED","sponsor":"Octapharma","startDate":"2017-09-27","conditions":"Chronic Inflammatory Demyelinating Poly(Radiculo)Neuropathy","enrollment":142},{"nctId":"NCT01349790","phase":"PHASE3","title":"Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NewGam) in Primary Immune Thrombocytopenia","status":"COMPLETED","sponsor":"Octapharma","startDate":"2011-10","conditions":"Primary Thrombocytopenia","enrollment":40},{"nctId":"NCT01313507","phase":"PHASE3","title":"High Infusion Rate Study of Immunoglobulin Intravenous (Human) 10% (NewGam)","status":"COMPLETED","sponsor":"Octapharma","startDate":"2011-05","conditions":"Primary Immunodeficiency Disease","enrollment":21},{"nctId":"NCT01012323","phase":"PHASE3","title":"A Study of NewGam, Human Immunoglobulin 10%, in Patients With Primary Immunodeficiency Diseases","status":"COMPLETED","sponsor":"Octapharma","startDate":"2010-01","conditions":"Primary Immunodeficiency Diseases","enrollment":51},{"nctId":"NCT01225276","phase":"PHASE2, PHASE3","title":"Safety and Efficacy Study of Three Different Dosages of NewGam in Patients With CIDP","status":"TERMINATED","sponsor":"Octapharma","startDate":"2011-10","conditions":"Chronic Inflammatory Demyelinating Polyradiculoneuropathy","enrollment":2}],"_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":["Human normal immunoglobulin","Panzyga"],"phase":"phase_3","status":"active","brandName":"NewGam","genericName":"NewGam","companyName":"Octapharma","companyId":"octapharma","modality":"Biologic","firstApprovalDate":"","aiSummary":"NewGam is an intravenous immunoglobulin (IVIG) product that provides passive immunity by delivering pooled human antibodies to modulate immune responses. Used for Primary immunodeficiency disorders, Secondary immunodeficiency, Autoimmune and inflammatory conditions (e.g., immune thrombocytopenia, chronic inflammatory demyelinating polyneuropathy).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}