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Cilofexor + firsocostat is an investigational fixed-dose combination of two oral small molecule drugs developed for the treatment of metabolic dysfunction-associated steatohepatitis (MASH, previously known as nonalcoholic steatohepatitis or NASH), particularly in patients with advanced fibrosis or cirrhosis. Cilofexor is a nonsteroidal farnesoid X receptor (FXR) agonist that modulates bile acid metabolism and reduces hepatic inflammation and fibrosis. Firsocostat is a liver-targeted inhibitor of acetyl-coenzyme A carboxylase (ACC), which decreases hepatic de novo lipogenesis and may reduce liver fat accumulation. The combination targets different pathogenic pathways in NASH, aiming to improve both fibrosis and disease resolution. Both agents have been evaluated individually and together in phase 2 clinical trials, including studies with semaglutide, for their safety, pharmacokinetics, and efficacy in adults with compensated cirrhosis due to NASH[1][3][4][5][6].
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