What are the indications for Obeticholic acid?

Obeticholic acid is a farnesoid X receptor (FXR) agonist that significantly improves cholestasis and liver damage by regulating hepatic bile acid metabolism and anti-inflammatory pathways. In clinical application, obeticholic acid is mainly used for adult patients with primary biliary cholangitis (PBC), especially for patients with inadequate response or poor tolerance to ursodeoxycholic acid (UDCA). UDCA has long been regarded as the standard first-line treatment for PBC, but some patients still have cholestasis that cannot be fully improved during use, liver function indicators continue to be abnormal, and the risk of disease progression increases. The emergence of obeticholic acid provides a new and effective treatment option for these refractory patients.

In terms of specific indications, obeticholic acid can be combined with UDCA to treat patients with insufficient response to UDCA. Applicable subjects include adult patients without cirrhosis or with compensated cirrhosis but without portal hypertension. The mechanism of combined medication is to reduce liver bile acid synthesis, enhance bile acid excretion, and regulate liver inflammatory response through FXR activation, thereby improving liver function indicators and delaying the progression of fibrosis. In addition, for patients with UDCA intolerance, obeticholic acid can be used as a single agent to exert a therapeutic effect under the same cirrhosis condition. This single-agent use provides a new treatment path for patients who are allergic or intolerant to UDCA.

In clinical practice, the use of obeticholic acid requires individualized evaluation. Doctors will determine the most appropriate dosage and regimen based on the patient's liver function, biliary tract structure, disease stage, and previous treatment history. Clinical data shows that obeticholic acid can not only improve key indicators such as serum alkaline phosphatase (ALP) and bilirubin, but may also improve patients' quality of life, including reducing fatigue and improving digestive system symptoms. Long-term follow-up observations also show that obeticholic acid has potential advantages in maintaining stable liver function and delaying disease progression.

Reference materials:https://en.wikipedia.org/wiki/Obeticholic_acid