National Stroke Foundation


The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.


Approval Status:

Approved December 1997

Specific Treatments:

primary biliary cirrhosis

Therapeutic Areas

General Information

Urso has been approved for the treatment of primary biliary cirrhosis.

Clinical Results

The approval rested primarily on the results of two Phase III trials conducted in approximately 300 patients. A two-year 180-patient study performed by the Mayo Clinic dosed patients at 13-15 mg/kg per day with Urso tablets 250 mg four times daily. Among patients receiving Urso, 23% were considered treatment failures compared to 47% in the placebo group.