Obeticholic acid (Ocaliva(TM)) is a farnesoid-X receptor (FXR) agonist that is 
being developed by Intercept Pharmaceuticals for the treatment of various liver 
diseases, and has recently been granted accelerated approval in the USA for the 
treatment of primary biliary cholangitis in combination with ursodeoxycholic 
acid in adults with an inadequate response to ursodeoxycholic acid, or as 
monotherapy in adults unable to tolerate ursodeoxycholic acid. The drug is in 
preregistration for this indication in the EU. This article summarizes the 
milestones in the development of obeticholic acid leading to this first approval 
for primary biliary cholangitis.