inebilizumab

Inebilizumab is a humanized, afucosylated IgG1 monoclonal antibody that targets the B-cell surface antigen CD19. By binding to CD19, which is broadly expressed on pre-B and mature B lymphocytes (including plasmablasts and some plasma cells), inebilizumab induces antibody-dependent cellular cytolysis leading to B-cell depletion. This mechanism underlies its therapeutic effect in autoimmune conditions characterized by pathogenic autoantibody production, such as neuromyelitis optica spectrum disorder (NMOSD) and immunoglobulin G4-related disease (IgG4-RD). Inebilizumab was originally developed by Duke University and further developed by MedImmune, Viela Bio, Horizon Therapeutics, Mitsubishi Tanabe Pharma Corporation, and Jiangsu Hansoh Pharmaceutical. It received FDA approval for NMOSD in June 2020 and for IgG4-RD in April 2025; it is the first FDA-approved treatment for IgG4-RD[1][2][5][6].

Brand names

Uplizna

Other names

inebilizumab-cdon