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ursodiol

Generic: URSODIOL·Brand: ACTIGALL, URSO 250, URSO FORTE, URSODIOL

ursodiol: developed by 1 company · 1 clinical trial tracked · 1 FDA decision.

ursodiol evidence translation

What we can confirm

1 FDA record · 1 tracked trial

What it means

Source-backed records connect ursodiol to LCI; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could ursodiol → LCI affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 0 study sponsors

Related indications

Colorectal Cancer

Study sponsors

No additional listed-company sponsor is linked.

Development Pipeline (1)
CompanyPhase
LANNETT CO INC (LCI)Approved
Clinical Trials (1)

Phase I Study of Ursodeoxycholic Acid (Ursodiol)in Combination With 5-Fluorouracil, Leucovorin, Oxaliplatin and Bevacizumab in Patients With Metastatic Colorectal Cancer

NCT00873275·Phase 1
Completed

Primary endpoint: Maximum-tolerated dose of ursodiol

Interventionalopen11 enrolledStarted 2009-03Completion 2025-021 site · United StatesCity of Hope Medical Center
FDA Decisions1 records
ApprovalINDICATIONS AND USAGE Ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of Ursodiol beyond 24 months is not established. Ursodiol is indicated for the prevention of gallstone formation in obe(LCI)FDA ↗
ANDA079082OralCapsule

Frequently asked questions

Who is developing ursodiol?

ursodiol is being developed by LANNETT CO INC.

How many clinical trials involve ursodiol?

BioSniper tracks 1 clinical trial involving ursodiol.

What is ursodiol's latest FDA decision?

The most recent tracked FDA decision for ursodiol is Approval for INDICATIONS AND USAGE Ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of Ursodiol beyond 24 months is not established. Ursodiol is indicated for the prevention of gallstone formation in obe, dated December 15, 2008.