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Tregalizumab is a humanized monoclonal antibody that selectively binds to the CD4 molecule on T cells. Its unique mechanism of action involves modulating regulatory T cell (Treg) activity by binding to a specific epitope on CD4, leading to activation of Tregs without depleting them. This immunomodulatory effect is being explored for the treatment of autoimmune and inflammatory diseases, as well as for prevention of acute graft-versus-host disease (aGvHD). The drug has demonstrated biological activity in clinical studies by downmodulating CD4 and activating regulatory pathways but has not shown significant clinical efficacy in rheumatoid arthritis trials. It has received orphan drug status from the FDA for prevention of acute graft-versus-host disease[6][7][10].
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