Intercept Pharmaceuticals

Manufacturer pulls Ocaliva from U.S. market at request of FDA

September 12, 2025

Intercept Pharmaceuticals has voluntarily withdrawn Ocaliva (obeticholic acid) from the U.S. market for primary biliary cholangitis (PBC) following a request from the FDA. Concurrently, all U.S. clinical trials involving obeticholic acid have been placed on clinical hold.

Ocaliva, a farnesoid X receptor agonist, was granted accelerated approval in 2016 for adults with PBC who had an inadequate response to or intolerance of ursodeoxycholic acid (UDCA).

The decision follows a series of prior FDA safety actions:

• 2021: FDA restricted Ocaliva’s use to PBC patients without advanced cirrhosis after identifying 25 cases of serious liver injury, including liver failure and transplant. A contraindication for advanced cirrhosis was added to the prescribing information and boxed warning.
• 2024: A Drug Safety Communication highlighted serious liver injury in patients without cirrhosis. Postmarket trial data showed increased risks of liver transplant and death in Ocaliva-treated patients compared with placebo.

According to a manufacturer press release, physicians are advised to consult with patients currently on Ocaliva before making any treatment changes. The company says it will offer support and resources to HCPs and patients throughout the withdrawal process.

Source:

Intercept announces voluntary withdrawal of Ocaliva® for primary biliary cholangitis (PBC) from the US market; US clinical trials involving obeticholic acid placed on clinical hold [News release]. 2025. https://www.interceptpharma.com/about-us/news/?id=3148535

Ocaliva (obeticholic acid) by Intercept Pharmaceuticals: Drug Safety Communication - Due to Risk of Serious Liver Injury, FDA Restrics Use of Ocaliva in Primary Biliary Cholangitis Patients with Advanced Cirrhosis [News release]. 2021. https://www.fda.gov/safety/medical-product-safety-information/ocaliva-obeticholic-acid-intercept-pharmaceuticals-drug-safety-communication-due-risk-serious-liver

Serious liver injury being observed in patients without cirrhosis taking Ocaliva (obetichooic acid) to treat primary biliary cholangitis [News release]. 2024. https://www.fda.gov/drugs/drug-safety-and-availability/serious-liver-injury-being-observed-patients-without-cirrhosis-taking-ocaliva-obeticholic-acid-treat