lixudebart

Lixudebart (ALE.F02) is an investigational, first-in-class monoclonal antibody developed by Alentis Therapeutics for the treatment of multi-organ fibrosis, including kidney, liver, and lung fibrosis. Its mechanism of action involves specifically targeting and binding to exposed Claudin-1 (CLDN1) in fibrotic tissue. By blocking CLDN1 outside tight junctions—where it is overexpressed in fibrotic disease—lixudebart disrupts fibrotic signaling pathways and breaks down the collagen barrier that leads to organ dysfunction. The drug has shown a favorable safety profile in Phase 1 and 2 studies for conditions such as ANCA-associated vasculitis with rapidly progressive glomerulonephritis (RPGN), advanced liver fibrosis, and idiopathic pulmonary fibrosis (IPF). Lixudebart has received Orphan Drug designation from the FDA for IPF[1][2][5][6][7].

Other names

ALE.F02