Novel compounds being developed for liver diseases
- Intercept’s lead product, OCALIVA® (obeticholic acid), was granted accelerated approval by U.S. Food and Drug Administration (FDA) in May of 2016 for the treatment of primary biliary cholangitis, previously known as primary biliary cirrhosis (PBC), in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. OCALIVA is the first PBC therapy that targets the farnesoid X receptor (FXR), a key regulator of bile acid, inflammatory, fibrotic and metabolic pathways. For more information, please visit ocaliva.com.
- Obeticholic acid (OCA) is also being evaluated for potential indications across a variety of additional chronic liver diseases, including nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC), and biliary atresia.*
- The pipeline chart above shows the target indications and current stages of development of all of our product candidates.
Investigators interested in consideration for possible clinical trial participation should refer to Intercept clinical trials on clinicaltrials.gov.
*The agent discussed is investigational and has not been approved by the FDA or any other worldwide regulatory agency as a treatment for any indication. Safety and efficacy has not been established.