TheraRadar
Data updated: May 26, 2026

URSO 250 (ursodiol)

Metabolic Approved 1997-12-10
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
28
Years on Market

Details

Status
Discontinued
First Approved
1997-12-10
Routes
ORAL
Dosage Forms
TABLET

Companies

AbbVie
Active Ingredient: URSODIOL

URSO 250 Approval History

1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
18 FDA actions from 1997 to 2023 · 1 indication expansions
Jan 2023 SUPPL
Label · Labeling
FDA Letter Label
May 2021 SUPPL
Label · Labeling
FDA Letter Label
Sep 2013 SUPPL
Mfg · Manufacturing (CMC)

What URSO 250 Treats

2 FDA approvals

Originally approved for its first indication in 1997 . Covers 2 distinct patient populations.

  • Other (2)
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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
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

URSO 250 FDA Label Details

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Data Sources

FDA Approval: NDA020675 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.