Drug intelligence / Profile preview

hydronidone

Development stage
Phase 3
Lead developer
Catalyst Biosciences
Modality
Small Molecules
Administration
Oral
01

Overview

Hydronidone (F351) is a novel small molecule anti-fibrotic agent developed by GNI Group and its subsidiary, Beijing Continent Pharmaceutical. It is a structural derivative of pirfenidone, designed to improve upon its anti-fibrotic potency and safety profile. Hydronidone primarily targets the transforming growth factor-beta 1 (TGF-β1) signaling pathway, specifically inhibiting the phosphorylation of Smad proteins (Smad2/3), which are critical mediators of fibrogenesis. By suppressing the activation and proliferation of hepatic stellate cells (HSCs) and reducing the expression of extracellular matrix proteins like collagen, hydronidone aims to reverse or halt the progression of liver fibrosis. It is currently being evaluated in Phase 3 clinical trials in China for the treatment of chronic hepatitis B-associated liver fibrosis, where it has demonstrated significant efficacy in reducing fibrosis scores.

Other names
5-methyl-1-(3-hydroxyphenyl)pyridin-2(1H)-one
02

Targets

MAPK12 (Mitogen-activated protein kinase 12)

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