Ursodiol · Urso 250, NSC-683769

What is Ursodiol?

Ursodiol is a naturally occurring hydrophilic bile acid that replaces toxic endogenous bile acids in cholestatic liver disease. It protects bile duct epithelial cells, inhibits hepatocyte apoptosis, and stimulates bile secretion. It is used to dissolve gallstones and treat primary biliary cholangitis.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as

Urso 250, NSC-683769, Ursodeoxycholic Acid

Drug type

Small molecule

Mechanism

Modulator

Pathways

bile acid metabolism, cholesterol synthesis, apoptosis inhibition

Therapy area

Gastroenterology

Developer

Teva Branded Pharm

In trials of

MIRM

FDA status

Approved as Urso 250 (December 31, 1987), NDA019594 · FDA label

UNII

724L30Y2QR

✅ FDA-approved uses

• Radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in patients at increased surgical risk
• Prevention of gallstone formation in obese patients experiencing rapid weight loss
• Primary biliary cholangitis

From the indications section of the FDA label (version of Jan 19, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

PBCPrimary Biliary Cirrhosis

Sources

• FDA label (DailyMed)
• FDA label Ursodiol (2026-01-19), indications
• FDA label Urso 250 (2023-01-12), indications
• NCI Thesaurus

Updated Oct 3, 2026.