Ursodeoxycholic acid, also known as ursodiol and abbreviated UDCA, is a secondary bile acid produced in humans and most other animal species through metabolism of primary bile acids by intestinal bacteria. It was first identified in the bile of bears and takes its name from the genus Ursus. In purified pharmaceutical form it is used to treat and prevent a range of liver and bile duct diseases, working through several mechanisms: it reduces the cholesterol saturation of bile, which can dissolve certain gallstones, and it also has immunomodulating and anti-inflammatory effects on the epithelial cells lining the gastrointestinal and biliary tracts. Ursodeoxycholic acid, in an application filed by Allergan, was approved for use in the United States in December 1987 and was granted orphan drug status; it is now available as a generic medication under numerous brand names including Actigall, Urso, Ursofalk and Ursosan. It is a prescription-only medicine in major markets including the United States, United Kingdom, Canada and Australia, and its chemical formula is C24H40O4.
Facts
Drug ClassGallstone dissolution agents 4 Mechanism of ActionDecreases the production of cholesterol and dissolves the cholesterol in bile to prevent stone formation 4 Approved UseDissolving gallstones in people who do not want or cannot have gallbladder surgery 4 First Approved / Isolated Year Classification
Approval Status ATC ClassSourced to the subject's own accountA: Alimentary Tract and Metabolism 2 Route of Administration Sources
1. EMBL-EBI ChEMBL: ChEMBL molecule record CHEMBL1551 (ursodiol)
EMBL-EBI ChEMBLfirst_approvalQuote, first_approval
"first_approval": 1987
View the Source 2. Anatomical Therapeutic Chemical Classification System (Wikipedia)
WikipediaFirst-level anatomical group codes, Code AQuote, First-level anatomical group codes, Code A
Alimentary tract and metabolism
View the Source 3. Ursodeoxycholic acid (Wikipedia)
WikipediaInfobox drug, routes_of_administrationQuote, Infobox drug, routes_of_administration
By mouth
View the Source 4. Ursodiol: MedlinePlus Drug Information
Why is this medication prescribed, classification sentence
Ursodiol is in a class of medications called gallstone dissolution agents.
Why is this medication prescribed, first sentence
Ursodiol is used to dissolve gallstones in people who do not want surgery or cannot have surgery to remove gallstones.
Why is this medication prescribed, mechanism sentence
It works by decreasing the production of cholesterol and by dissolving the cholesterol in bile to prevent stone formation
View the Source5. Federal Register: Determination That ACTIGALL (Ursodiol) Was Not Withdrawn for Safety Reasons
NDA 019594 approval historyQuote, NDA 019594 approval history
ACTIGALL (Ursodiol) Capsule, 150 Milligrams, was initially approved by the FDA on December 31, 1987
View the Source Ursodeoxycholic acid (Wikipedia)
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