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Our Pipeline

Our portfolio is based on novel scientific targets with the potential for therapeutic application across multiple liver diseases, with a focus on those with high unmet need.

We are leveraging our decades of research and background in bile acids and FXR agonism to expand our pipeline to deliver effective treatments for the growing number of people living with serious liver disease.

Intercept-Sponsored Clinical Trials

Severe alcohol-associated hepatitis (sAH)

The Phase 2a FRESH (FXR Effect on Severe Alcohol-Associated Hepatitis) study is a randomized, double-blind, dose-escalation study that is expected to enroll approximately 50 patients with saH across multiple clinical sites in the U.S., UK and France. The study aims to demonstrate and provide rationale for the selection of optimal dose(s) of INT-787 in the target patient population.

INT-787, Next-generation FXR agonist*

Phase 2

Preclinical
Phase 1
Phase 2
Phase 3
NDA Filing
FDA/Conditional Approval
Phase 4

INT-787 is Intercept's next-generation farnesoid X receptor (FXR) agonist. Its characteristics provide an opportunity to explore its potential in diseases that involve the gut as well as the liver, such as severe alcohol-associated hepatitis (sAH). INT-787 is currently being evaluated in a Phase 2a proof-of-concept study.

 

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*Investigational uses have not been approved by the FDA or any other worldwide regulatory agency. Safety and efficacy have not been established.