NDAORALTABLET
Approved
Dec 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
4/8 — Partial
URSO FORTE (ursodiol) by AbbVie is ursodiol, a naturally occurring hydrophilic bile acid, derived from cholesterol, is present as a minor fraction of the total human bile acid pool. First approved in 1997.
Drug data last refreshed 17h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
URSO FORTE (ursodiol) is an oral bile acid replacement therapy approved in 1997 for cholestatic liver diseases. It works by replacing toxic endogenous bile acids with ursodiol, a naturally occurring hydrophilic bile acid, while providing cytoprotection and immunomodulatory effects to damaged hepatocytes and cholangiocytes. The drug treats patients with primary biliary cirrhosis and primary sclerosing cholangitis.
$0.392MPart D
LOE ApproachingProduct approaching loss of exclusivity with modest Part D spending of $392K (304 claims in 2023), indicating a niche indication with limited commercial expansion potential and likely smaller team structure.
Mechanism of Action
Ursodiol, a naturally occurring hydrophilic bile acid, derived from cholesterol, is present as a minor fraction of the total human bile acid pool. Oral administration of ursodiol increases this fraction in a dose related manner, to become the major biliary acid, replacing/displacing toxic…
Pharmacologic Class:
Bile Acid
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
Study to Assess Safety & Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodiol.
Started Jun 2017
111 enrolled
Primary Biliary Cirrhosis
Ursodiol in Huntington's Disease
Started Aug 2007
21 enrolled
Huntington Disease
Ursodiol Tablets 500 mg Under Fasting Conditions
Started Dec 2006
80 enrolled
Healthy
Ursodiol 500 mg Tablets Under Fed Conditions
Started Sep 2006
92 enrolled
Healthy
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.