NDAORALCAPSULEPriority Review
Approved
Dec 1987
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
5/8 — Partial
Priority Review
ACTIGALL (ursodiol) by Teva is clinical pharmacology about 90% of a therapeutic dose of ursodiol is absorbed in the small bowel after oral administration. Approved for huntington disease. First approved in 1987.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ACTIGALL (ursodiol) is an oral bile acid that suppresses hepatic cholesterol synthesis and inhibits intestinal cholesterol absorption. It is indicated for Huntington Disease and works by replacing toxic endogenous bile acids and providing cytoprotection to bile duct epithelial cells. Ursodiol undergoes efficient first-pass hepatic extraction and is conjugated with glycine or taurine before secretion into bile.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30%), signaling a consolidating team focused on margin protection rather than expansion.
Mechanism of Action
CLINICAL PHARMACOLOGY About 90% of a therapeutic dose of ursodiol is absorbed in the small bowel after oral administration. After absorption, ursodiol enters the portal vein and undergoes efficient extraction from portal blood by the liver (i.e., there is a large "first-pass" effect) where it is…
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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.