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Uridine triacetate

Alternative Names: uridine triacetate, xuriden, vistogard
Latest Update: 2023-07-13
Latest Update Note: News Article

Product Description

Uridine triacetate (Vistogard) was approved in 2015 for adult and pediatric patients who exhibit early-onset severe or life-threatening 5-FU/capecitabine toxicities or present with an overdose. Uridine triacetate delivers high concentrations of uridine, which competes with toxic 5-FU metabolites. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/27622829/)

Mechanisms of Action: Antimetabolite Inhibitor

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: N/A

FDA Designation: None *

Approval Status: Approved

Approved Countries: Greece | United Kingdom | United States

Approved Indications: Neutropenia

Known Adverse Events: Diarrhea

Company: Wellstat
Company Location:
Company CEO:
Additonal Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Uridine triacetate

Countries in Clinic:

Active Clinical Trial Count:

Highest Development Phases

Phase 3: Purine-Pyrimidine Metabolism, Inborn Errors

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success
NCT02110147

P3

Completed

Purine-Pyrimidine Metabolism, Inborn Errors

2014-12-01

NCT01432301

N/A

Approved for marketing

Neutropenia

None

Recent News Events

Date

Type

Title

07/13/2023

News Article

 SERB Pharmaceuticals acquires Vistogard® and Xuriden® from Wellstat Therapeutics

03/29/2019

News Article

 Statement by FDA Commissioner Scott Gottlieb, M.D., Director of FDA's Center for Drug Evaluation and Research Janet Woodcock, M.D. and Director of FDA's Center for Biologics Evaluation and Research Peter Marks, M.D. on Expanded Access -Looking Forward

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