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GL-2045 is a recombinant human immunoglobulin G1 (IgG1)–based Fc multimer designed to mimic the anti-inflammatory activities of intravenous immunoglobulin (IVIG). It acts as an IVIG mimetic, binding C1q and inhibiting complement-dependent cytotoxicity, while also inducing self-limited complement activation governed by factors H and I, resulting in increased levels of the anti-inflammatory molecule iC3b. GL-2045 binds with high avidity to low-affinity human Fcγ receptors and interferes with immune complex interactions, blocking antibody-dependent cellular phagocytosis and cytotoxicity. The drug is being developed primarily for chronic inflammatory demyelinating polyneuropathy (CIDP), a rare neurological autoimmune disorder characterized by progressive weakness and sensory impairment. It has received orphan drug designation for CIDP. Preclinical studies have demonstrated its efficacy in models of autoimmune disease, showing enhanced potency compared to IVIG[1][3][4][5][7].
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