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M254 is a hypersialylated human immunoglobulin G (hsIgG) developed as a high-potency alternative to conventional intravenous immunoglobulin (IVIg). It is engineered to have increased sialylation, which enhances its anti-inflammatory activity. Preclinical studies demonstrated that M254 can be up to ten times more potent than standard IVIg in models of immune thrombocytopenic purpura (ITP) and other inflammatory diseases. The drug has been evaluated in Phase 1/2 clinical trials for ITP, with the primary efficacy objective being platelet response. M254 was originally developed by Momenta Pharmaceuticals and later in-licensed by Takeda[3][5][6][7].
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