Quantitative Systems Toxicology Model Predicts Obeticholic Acid-Associated Liver Injury in Metabolic Dysfunction-Associated Steatotic Liver Disease.

Abigail K Mayo¹, James J Beaudoin², Jeffrey L Woodhead², Paul B Watkins¹, Kim L R Brouwer¹

¹Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

²Quantitative Systems Pharmacology Solutions, Simulations Plus, Inc., Chapel Hill, North Carolina, USA.

PubMed PMC DOI PDF

Abstract

Obeticholic acid (OCA), a synthetic analog of chenodeoxycholic acid, was approved in 2016 for the treatment of primary biliary cholangitis. Early clinical trials revealed elevated liver biomarkers in healthy subjects receiving supratherapeutic OCA doses (100-250 mg). OCA was also evaluated as a treatment for metabolic dysfunction-associated steatotic liver disease (MASLD) but was not approved by t…

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