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Valziflocept (SM101) is a recombinant, soluble, non-glycosylated human Fc gamma receptor IIb (FcγRIIb) that serves as a decoy receptor to modulate immune responses. By competing with membrane-bound FcγR for binding to IgG-containing immune complexes, it neutralizes pathogenic IgG and prevents the activation of inflammatory pathways. Originally developed by Suppremol and subsequently acquired by Baxalta, Shire, and Takeda, valziflocept has been investigated for various autoimmune conditions. While a Phase 2 trial in Immunoglobulin A nephropathy (IgAN) was initiated, it was later withdrawn. The drug has also shown potential in Phase 2 studies for systemic lupus erythematosus (SLE) and immune thrombocytopenia (ITP), where it holds orphan drug designation in the US and Europe.
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