1. 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. 2.
Details
- Status
- Prescription
- First Approved
- 1987-12-31
- Routes
- ORAL
- Dosage Forms
- TABLET, CAPSULE
Companies
URSODIOL Approval History
What URSODIOL Treats
2 indicationsURSODIOL is approved for 2 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Gallstones
- Obesity
URSODIOL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to URSODIOL
3 of 15FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00873275 | 08005 P30CA033572, CHNMC-08005 | Ph 1 | completed | Ursodiol, Combination Chemotherapy, and Bevacizumab in Treating Patients With Stage IV Colorectal Cancer |
| NCT02748616 results posted | 15-01348 | Ph 4 | completed | C. Difficile and Ursodiol |
| NCT00706381 results posted | 080165 08-DK-0165 | Ph 3 | completed | Thyroid Hormones Homeostasis and Energy Metabolism Changes During Stimulation of Endogenously Secreted Bile Acids (BAs) |
| NCT02033876 results posted | 13-004908 | Ph 2 | completed | Ursodiol on Insulin Sensitivity, Gastric Emptying and Body Weight With Type 2 Diabetes on Metformin |
| NCT01097304 results posted | NCI-2012-00450 NCI-2012-00450, CDR0000669111 | Ph 2 | completed | Ursodiol in Treating Patients With Barrett Esophagus and Low-Grade Dysplasia |
| NCT02385032 | DW_UDCA001 | Ph 1 | completed | Comparative Bioavailability Study of UDCA |
| NCT00846963 URSONEONAT | RC:127 | Ph 2, Ph 3 | completed | Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
URSODIOL FDA Label Details
Indications & Usage
1. 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. 2. Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.
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URSO 250
Full clinical data, patents, trials, and competitive landscape for ursodiol.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.