URSO 250® (ursodiol, 250 mg) and URSO Forte™ (ursodiol, 500 mg) are available as film-coated tablets for oral administration. Ursodiol (ursodeoxycholic acid, UDCA) is a naturally occurring bile acid found in small quantities in normal human bile and in larger quantities in the biles of certain species of bears. It is a bitter-tasting white powder consisting of crystalline particles freely soluble in ethanol and glacial acetic acid, slightly soluble in chloroform, sparingly soluble in ether, and practically insoluble in water.
URSO 250® and URSO Forte™ (ursodiol) tablets are indicated for the treatment of patients with primary biliary cirrhosis.
Media Articles Related to Urso (Ursodiol)
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Primary Biliary Cirrhosis Treatment (PBC)
Source: MedicineNet cholestyramine Specialty [2014.04.30]
Title: Primary Biliary Cirrhosis Treatment (PBC)
Category: Diseases and Conditions
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Last Editorial Review: 4/30/2014 12:00:00 AM
Primary Biliary Cirrhosis (PBC)
Source: MedicineNet Liver Cancer Specialty [2014.04.23]
Title: Primary Biliary Cirrhosis (PBC)
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 4/23/2014 2:58:18 PM
Published Studies Related to Urso (Ursodiol)
Efficacy and safety of tauroursodeoxycholic acid in the treatment of liver
cirrhosis: a double-blind randomized controlled trial. 
No direct comparison of tauroursodeoxycholic acid (TUDCA) and ursodeoxycholic
acid (UDCA) has yet been carried out in the treatment of liver cirrhosis in
China... However, both
drugs exert no effect on the serum markers for liver fibrosis during 6-month
Oral solubilized ursodeoxycholic acid therapy in amyotrophic lateral sclerosis: a
randomized cross-over trial. 
To evaluate the efficacy and safety of ursodeoxycholic acid (UDCA) with oral
solubilized formula in amyotrophic lateral sclerosis (ALS) patients, patients
with probable or definite ALS were randomized to receive oral solubilized UDCA
(3.5 g/140 mL/day) or placebo for 3 months after a run-in period of 1 month and
switched to receive the other treatment for 3 months after a wash-out period of 1
Colchicine or methotrexate, with ursodiol, are effective after 20 years in a subset of patients with primary biliary cirrhosis. [2011.09]
BACKGROUND & AIMS: The combination of ursodeoxycholic acid (UDCA), colchicine, and methotrexate (MTX) is effective therapy for a subset of patients with primary biliary cirrhosis (PBC) who do not respond to UDCA. However, the durability of the response is unclear. We investigated whether the response to combination therapy was durable... CONCLUSIONS: Treatment with the combination of UDCA and MTX or UDCA and colchicine led to sustained clinical remission in a subset of patients with PBC. The response to the combination of UDCA and MTX appeared to be more durable than to UDCA and colchicine. Copyright (c) 2011 AGA Institute. Published by Elsevier Inc. All rights reserved.
High-dose ursodeoxycholic acid is associated with the development of colorectal neoplasia in patients with ulcerative colitis and primary sclerosing cholangitis. [2011.09]
OBJECTIVES: Some studies have suggested that ursodeoxycholic acid (UDCA) may have a chemopreventive effect on the development of colorectal neoplasia in patients with ulcerative colitis (UC) and primary sclerosing cholangitis (PSC). We examined the effects of high-dose (28-30 mg/kg/day) UDCA on the development of colorectal neoplasia in patients with UC and PSC... CONCLUSIONS: Long-term use of high-dose UDCA is associated with an increased risk of colorectal neoplasia in patients with UC and PSC.
A randomized controlled trial of high-dose ursodesoxycholic acid for nonalcoholic steatohepatitis. [2011.05]
BACKGROUND & AIMS: Nonalcoholic steatohepatitis (NASH) is a prevalent liver disease associated with increased morbidity and mortality. Ursodeoxycholic acid (UDCA) may have antioxidant, anti-inflammatory, and antifibrotic properties and may reduce liver injury in NASH. To date, no studies have assessed the efficacy and safety of high-dose UDCA (HD-UDCA) in patients with NASH... CONCLUSIONS: Treatment with HD-UDCA was safe, improved aminotransferase levels, serum fibrosis markers, and selected metabolic parameters. Studies with histologic end points are warranted. Copyright (c) 2011. Published by Elsevier B.V.
Clinical Trials Related to Urso (Ursodiol)
Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates [Recruiting]
The purpose of this study is to determine whether ursodiol is effective in the treatment of
parenteral nutrition associated cholestasis in neonates.
Ursodiol in Treating Patients With Barrett Esophagus and Low-Grade Dysplasia [Recruiting]
This phase II trial is studying how well ursodiol works in treating patients with Barrett
esophagus or low-grade dysplasia. Chemoprevention is the use of certain drugs to keep cancer
from forming. The use of ursodiol may in patients with Barrett esophagus or low-grade
Trial of High-Dose Urso in Primary Sclerosing Cholangitis [Completed]
This is a multicenter, randomized, controlled trial of high dose ursodiol versus placebo for
patients with primary sclerosing cholangitis (PSC). The average duration of follow-up will
be approximately five years with important clinical endpoints such as death, eligibility for
liver transplanation, changes in histology and cholangiogram as well as liver biochemistries
and quality of life data collected.
Ursodiol, Combination Chemotherapy, and Bevacizumab in Treating Patients With Stage IV Colorectal Cancer [Recruiting]
RATIONALE: Drugs used in chemotherapy, such as ursodiol, oxaliplatin, leucovorin, and
fluorouracil, work in different ways to stop the growth of tumor cells, either by killing
the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can
block tumor growth in different ways. Some block the ability of tumor cells to grow and
spread. Others find tumor cells and help kill them or carry tumor-killing substances to
PURPOSE: This phase I trial is studying the side effects and best dose of ursodiol when
given together with combination chemotherapy and bevacizumab in treating patients with stage
IV colorectal cancer.
Ursodiol in Huntington's Disease [Recruiting]
The purpose of this study is to evaluate the safety of the drug ursodiol (ursodeoxycholic
acid, UDCA) in people with Huntington's disease (HD) and to explore how the compound is
processed by the body.