Drug intelligence / Profile preview

tregalizumab

Development stage
Phase 2
Lead developer
CD4 Therapeutics
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous, Subcutaneous
01

Overview

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].

Other names
tregalizumabhumanised anti-CD4 IgG1 monoclonal antibody
02

Targets

CD4 (T lymphocyte surface antigen)

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