What Is Ocaliva, and Why Does It Matter?
Ocaliva (obeticholic acid) is a medicine used to treat a rare liver condition called primary biliary cholangitis (PBC). On Sept. 11, 2025, Intercept Pharmaceuticals announced the voluntary withdrawal of Ocaliva from the U.S. market following an FDA request. The FDA also placed all clinical trials involving obeticholic acid on hold.
PBC is a long-term autoimmune disease that damages the small bile ducts in the liver. This causes bile acid to build up, leading to inflammation, scarring, and eventually liver failure if left untreated. The condition mostly affects women over age 40.
Ocaliva was approved by the FDA in 2016 for adults with PBC who did not get help from or could not take another treatment called ursodeoxycholic acid. The drug works by activating the farnesoid X receptor, a protein that helps reduce bile acid levels in the liver.
Why Was It Withdrawn?
Ocaliva was initially granted accelerated approval by the FDA, allowing earlier access for patients with PBC while confirmatory studies were conducted. Since its accelerated approval, the FDA restricted its use in 2021 in patients with advanced liver cirrhosis because some patients developed liver failure. More recently, the FDA said patients with PBC who did not have cirrhosis may also experience serious liver injury.
Given these safety concerns, the FDA requested its removal from the U.S. market.
What Do I Need to Know?
If you are taking Ocaliva, do not stop the medicine on your own. Talk with your doctor about other treatments for PBC and the safest next steps.
If you have questions or need more information, you can reach out to Intercept’s Patient Support Services (Interconnect).