Drug intelligence / Profile preview

GL-2045

Development stage
Phase 1
Lead developer
Pfizer
Modality
Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes
Administration
Intravenous
01

Overview

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].

Other names
Recombinant human IgG1 Fc multimerRecombinant Multimerized Human IgG1 Fc
02

Targets

FcγRIIIa (Low affinity immunoglobulin gamma Fc region receptor III-A)CFH (Complement factor H)C1Q (Complement C1q)FCGR2A (Low affinity immunoglobulin gamma Fc receptor II-a)FCGR2B (Fc gamma receptor IIB)CFI (Complement factor I)

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