Drugs / uridine triacetate
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | XURIDEN | — | 2019-12-02 | fda.gov ↗ |
| Approved | US (FDA) | XURIDEN | — | 2015-09-04 | fda.gov ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial | ||||||
| Phase 3 | NCT02110147 | Apr → Dec 2014 | orotic aciduria | Wellstat Therapeutics | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT01432301 | — | chemotherapy-induced toxicity | Wellstat Therapeutics | Approved for marketing | No outcome recorded |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | uridine triacetate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01432301 ↗ |
| Route | Oral | “oral administration of uridine triacetate” NCT02110147 ↗ |