Obeticholic acid
OCALIVA
What it isFarnesoid X receptor agonist; primary biliary cholangitis after inadequate response to ursodiol.
Why this oneIt lowers alkaline phosphatase where ursodiol alone has failed.
What limits itHepatic decompensation and death when dosed incorrectly in cirrhosis — dosing must follow Child-Pugh class. Severe pruritus.
FDA-approved for
- primary biliary cholangitis (2016)
Off-label
- metabolic dysfunction-associated steatohepatitis (FDA declined approval 2023)
⚠ BOXED WARNING
- Hepatic decompensation and failure in cirrhosis with incorrect dosing
Generic entry2023
Classes and tags
Clinical profile
Legacy pregnancy categoryNot assigned — PLLR-era drug
Defining liabilityGenerally tolerated at therapeutic doses; clinically important risks are agent-specific and increase with interactions or organ impairment.