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What does Ocaliva treat?

Medically reviewed by Last updated on April 11, 2019.

Official Answer


Ocaliva (generic name: obeticholic acid) is combined with ursodeoxycholic acid (UDCA) in adults with an inadequate UDCA response or as the only treatment in adults unable to tolerate UDCA. Ocaliva is a first-in-class farnesoid X receptor (FXR) agonist for the treatment of primary biliary cholangitis (PBC), previously known as biliary cirrhosis. FXR is a nuclear receptor expressed in the liver and intestine and a key regulator of bile acid, inflammatory, fibrotic and metabolic pathways.

PBC is a rare liver disease that primarily results from autoimmune destruction of the bile ducts that transport bile acids out of the liver, resulting in cholestasis. Cholestasis occurs when the flow of bile from the liver decreases. Symptoms of cholestasis include itching, dark-colored urine, stomach pain, yellowing of the eyes or skin (jaundice), and pale-colored stools.

Ocaliva was given accelerated FDA approval in May 2016, and is the first new treatment for PBC in nearly 20 years.