Intercept Pharmaceuticals

Intercept Pharmaceuticals is a U.S.-based biopharma company that pioneered therapies targeting the Farnesoid X Receptor (FXR) for liver diseases. Its first commercial product, Ocaliva (obeticholic acid), was approved for primary biliary cholangitis (PBC) but was recently voluntarily withdrawn from the market. The company, now part of Alfasigma, is refocusing its pipeline on other severe liver conditions, including severe alcohol-associated hepatitis (sAH), while navigating significant regulatory and commercial challenges.

Farnesoid X Receptor (FXR) biology platform for modulating bile acid, inflammatory, fibrotic, and metabolic pathways in the liver.

In sAH, Intercept would compete against standard of care (corticosteroids) and other investigational agents, but faces no approved drug competition. In the broader liver disease space, numerous companies are developing therapies for fibrotic and metabolic liver conditions, but Intercept's narrowed focus on severe, acute conditions through FXR modulation may differentiate it.