FXY-1

FXY-1 is a first-in-class, selective small molecule activator of the transcription factor Forkhead box O3 (FoxO3), developed by Refoxy Pharmaceuticals for the treatment of idiopathic pulmonary fibrosis (IPF) and other age-related diseases. FoxO3 is a critical integrator of pro-fibrotic signaling and is typically downregulated or excluded from the cell nucleus in human IPF tissue and experimental models. By reconstituting FoxO3 activity, FXY-1 aims to inhibit the fibroblast-to-myofibroblast transition (FMT) and epithelial-to-mesenchymal transition (EMT), thereby reducing collagen production and fibrotic burden. Preclinical studies in human lung fibroblasts and mouse bleomycin models have demonstrated its potential to reduce alpha-SMA production and improve histopathological Ashcroft scores, showing disease-modifying potential comparable to or exceeding current standards of care like nintedanib in certain cellular assays.