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ASC42 is a novel, orally available, non-steroidal, selective and potent farnesoid X receptor (FXR) agonist developed by Gannex Pharma, a wholly-owned subsidiary of Ascletis Pharma. It is being investigated primarily for chronic liver diseases including nonalcoholic steatohepatitis (NASH), primary biliary cholangitis (PBC), and chronic hepatitis B. FXR agonists like ASC42 can reduce hepatic steatosis, inflammation, and fibrosis. In preclinical models and early clinical studies in healthy volunteers, ASC42 demonstrated dose-dependent increases in fibroblast growth factor 19 (FGF19) and decreases in 7α-hydroxy-4-cholesten-3-one (C4), with an acceptable safety profile at therapeutic doses. For hepatitis B virus infection specifically, ASC42 inhibits the transcription of HBV covalently closed circular DNA into HBV RNA—thereby reducing HBsAg production—and may also destabilize cccDNA[1][2][3][4][5][6][8].
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