FDA rejects Intercept Pharma's drug for NASH for now

Intercept Pharmaceuticals, Inc. (USA) announced that it has received a notification from the FDA that it will not approve the application for FXAR agonist (OCA) for liver fibrosis by NASH on June 29, 2020.


OCA has reported to have side efects such as itching and an increase in total cholesterol level. The announce is expected to accelerate the development of next-generation FXR agonists, which are expeceted to improve these side effects.


In our STAMTM mouse mode, we hveevaluted next-generation FXR agonists such as Tropifexor and EDP-305, and these compounds are currently in Phase 2 clnical trials.


For detail information, see below the papers.

Title: “Tropifexor-Mediated Abrogation of Steatohepatitis and Fibrosis is Associated with the Antioxidative Gene Expression Profile in Rodents”


Title: “Characterization of EDP-305, a Highly Potent and Selective Farnesoid X Receptor Agonist, for the Treatment of Non-alcoholic Steatohepatitis”