XURIDEN (uridine triacetate)
Xuriden treats hereditary orotic aciduria in both adult and pediatric patients. This medication helps patients who have a genetic defect that prevents them from synthesizing enough uridine nucleotides on their own. It serves as a replacement therapy to ensure there is an adequate supply of uridine in the body's systemic circulation.
How XURIDEN Works
This medication works by delivering an acetylated form of uridine that the body converts into active uridine after oral administration. Once inside the body, enzymes called nonspecific esterases remove the acetyl groups, releasing uridine into the bloodstream. This process provides the necessary building blocks for patients who cannot produce sufficient quantities of uridine due to their genetic condition.
Details
- Status
- Prescription
- First Approved
- 2015-09-04
- Routes
- ORAL
- Dosage Forms
- GRANULE
XURIDEN Approval History
What XURIDEN Treats
1 indicationsXURIDEN is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hereditary Orotic Aciduria
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02110147 results posted | 401.13.001 | Ph 3 | completed | Open-Label Study of Uridine Triacetate in Pediatric Patients With Hereditary Orotic Aciduria |
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.
XURIDEN FDA Label Details
Indications & Usage
FDA Label (PDF)XURIDEN is indicated for the treatment of Hereditary Orotic Aciduria.
Track XURIDEN with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.