ACTIGALL (ursodiol) · Teva
ACTIGALL is FDA-approved to treat 2 conditions (same as URSODIOL).
Details
- Status
- Discontinued
- First Approved
- 1987-12-31
- Routes
- ORAL
- Dosage Forms
- CAPSULE
ACTIGALL Approval History
What ACTIGALL Treats
2 indicationsACTIGALL is approved for 2 conditions since its original approval in 1987. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Gallstones
- Obesity
Same approved indications as URSODIOL (same active ingredient).
Teva's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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.
ACTIGALL FDA Label Details
Indications & Usage
FDA Label (PDF)ACTIGALL is FDA-approved to treat 2 conditions — same approved indications as URSODIOL.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.