VISTOGARD (uridine triacetate)
Vistogard is indicated for the emergency treatment of adult and pediatric patients following a fluorouracil or capecitabine overdose, regardless of the presence of symptoms. It is also used for patients who exhibit early-onset, severe, or life-threatening toxicity affecting the cardiac or central nervous system, or unusually severe adverse reactions (e.g., gastrointestinal toxicity or neutropenia) within 96 hours of chemotherapy administration. It is not recommended for the non-emergent treatment of side effects because it may diminish chemotherapy efficacy. The safety and efficacy of Vistogard initiated more than 96 hours after chemotherapy have not been established.
How VISTOGARD Works
Uridine triacetate is an oral acetylated prodrug of uridine. Following administration, it is deacetylated to uridine, which is then phosphorylated to uridine triphosphate (UTP). UTP competitively inhibits cell damage and death by competing with 5-fluorouridine triphosphate (FUTP)—a cytotoxic metabolite of fluorouracil—for incorporation into RNA. This competition mitigates the systemic toxicity caused by the interference of fluorouracil or capecitabine with normal cellular RNA metabolism.
Details
- Status
- Prescription
- First Approved
- 2015-12-11
- Patent Cliff
- 2027
- Routes
- ORAL
- Dosage Forms
- GRANULE
VISTOGARD Approval History
What VISTOGARD Treats
6 indicationsVISTOGARD is approved for 6 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Fluorouracil Overdose
- Capecitabine Overdose
- Cardiac Toxicity
- Central Nervous System Toxicity
- Gastrointestinal Toxicity
- Neutropenia
VISTOGARD 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 VISTOGARD
3 of 7FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
VISTOGARD FDA Label Details
Indications & Usage
FDA Label (PDF)VISTOGARD is indicated for the treatment of Fluorouracil Overdose; Capecitabine Overdose; Cardiac Toxicity; Central Nervous System Toxicity; Gastrointestinal Toxicity; Neutropenia.
VISTOGARD Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for VISTOGARD
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2027
- • 1 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 7 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.