NDAORALTABLET
Approved
Dec 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
5/8 — 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. Approved for huntington disease. First approved in 1997.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
URSO FORTE (ursodiol) is an oral bile acid replacement therapy approved for Huntington Disease. It works by replacing toxic endogenous bile acids with a hydrophilic alternative while providing cytoprotection and immunomodulatory effects to hepatocytes and cholangiocytes. Ursodiol increases bile acid secretion and inhibits apoptosis in liver disease.
$0.392MPart D
LOE ApproachingLate-stage lifecycle product with minimal Part D penetration (304 claims) signals limited commercial expansion opportunities and likely streamlined 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
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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.