FXR314

FXR314 is a novel, orally administered small molecule farnesoid X receptor (FXR) agonist developed for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and other inflammatory diseases. Unlike traditional FXR agonists, FXR314 is a nonsteroidal, non-bile acid compound with a unique chemical scaffold that confers selective intestinal activation of the FXR pathway. This selectivity aims to maximize efficacy while minimizing adverse events commonly associated with systemic or hepatic FXR activation, such as pruritus and LDL-C elevation. In Phase 2 clinical trials in MASH patients, once-daily oral administration of FXR314 resulted in statistically significant reductions in liver fat content and improvements in biomarkers of liver function without evidence of typical class-related side effects. Preclinical data also support its potential utility in inflammatory bowel disease (IBD), including ulcerative colitis, by modulating innate lymphoid cell responses and protecting intestinal barrier integrity[1][3][4][5][6][7][8].