© The Author(s) 2020. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com British Medical Bulletin, 2020, 133:95–104 doi: 10.1093/bmb/ldaa006 Advance Access Publication Date: 13 April 2020 Invited Review Obeticholic acid—a new therapy in PBC and NASH Roger W. Chapman 1,2, * , and Kate D. Lynch 1,2,3,4 1 Nuffield Department of Medicine, University of Oxford, University Offices, Wellington Square, Oxford OX1 2JD, UK, 2 Translational Gastroenterology Unit, Oxford University Hospital, Oxford, UK, 3 Faculty of Health and Medical Sciences, University of Adelaide, Port Road, Adelaide SA 5005, Australia, and 4 Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Port Rd, Adelaide SA 5000, Australia *Correspondence address. Translational Gastroenterology Unit, Level 5, John Radcliffe Hospital, Headley Way, Headington, Oxford OX3 9DU, UK. E-mail: Roger.chapman@ndm.ox.ac.uk Received 13 October 2019; Revised 21 February 2020; Editorial Decision 3 March 2020 Abstract Introduction: Obeticholic acid (OCA) is a semi-synthetic hydrophobic bile acid (BA) analogue that is highly selective agonist of farnesoid X receptor (FXR), a key nuclear BA receptor, which induces expression of gut-derived hormones, in particular fibroblast growth factor 19. The resulting beneficial effects of OCA on glucose and lipid metabolism and particularly hepatic inflammation make it a candidate for the treatment of a variety of conditions including primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH). Sources of data: In PBC patients who have not initially responded to ursodeoxycholic acid, OCA has been shown in double-blind controlled clinical trials to significantly reduce serum alkaline phosphatase. To date, OCA is the only therapy licensed by the FDA, EMA and endorsed by NICE as second line therapy for PBC. No medications are currently approved in Europe or the USA for the treat- ment of NASH. Downloaded from https://academic.oup.com/bmb/article/133/1/95/5818043 by guest on 21 February 2023