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Search results for uridine in Standardized Name (approximate match)
Status:
Possibly Marketed Outside US
Source:
BLA125796
(2024)
Source URL:
First approved in 2024
Source:
BLA125796
Source URL:
Class:
NUCLEIC ACID
Status:
Possibly Marketed Outside US
Source:
Moderna COVID-19 Vaccine by Moderna US, Inc.
(2023)
Source URL:
First approved in 2023
Source:
Moderna COVID-19 Vaccine by Moderna US, Inc.
Source URL:
Class:
NUCLEIC ACID
Status:
Possibly Marketed Outside US
Source:
BLA125752
(2022)
Source URL:
First approved in 2022
Source:
BLA125752
Source URL:
Class:
NUCLEIC ACID
Status:
Possibly Marketed Outside US
Source:
BLA125742
(2021)
Source URL:
First approved in 2021
Source:
BLA125742
Source URL:
Class:
NUCLEIC ACID
Status:
Possibly Marketed Outside US
Source:
BLA125742
(2021)
Source URL:
First approved in 2021
Source:
BLA125742
Source URL:
Class:
NUCLEIC ACID
Status:
Possibly Marketed Outside US
Source:
NCT04588480: Phase 4 Interventional Completed SARS-CoV-2 Infection
(2020)
Source URL:
Class:
NUCLEIC ACID
Status:
Investigational
Source:
NCT03223194: Phase 1 Interventional Terminated Crigler-Najjar Syndrome
(2017)
Source URL:
Class:
STRUCTURALLY DIVERSE
Status:
Other
Class:
CONCEPT
Status:
Other
Class:
CONCEPT
Status:
US Approved Rx
(2015)
Source:
NDA208169
(2015)
Source URL:
First approved in 2015
Source:
NDA208169
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Uridine triacetate (formally PN401) is an acetylated prodrug of uridine. Following oral administration, uridine triacetate is deacetylated by nonspecific esterases present throughout the body, yielding uridine in the circulation. Uridine triacetate under VISTOGARD trade name is a uridine replacement agent approved for the emergency treatment of fluorouracil or capecitabine overdose (regardless of the presence of symptoms) or early-onset severe or life-threatening cardiac or central nervous system (CNS) toxicity and/or early-onset unusually severe adverse reactions (eg, gastrointestinal [GI] toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration in adult and pediatric patients. Uridine competitively inhibits cell damage and cell death caused by fluorouracil. Fluorouracil is a cytotoxic antimetabolite that interferes with nucleic acid metabolism in normal and cancer cells. Cells anabolize fluorouracil to the cytotoxic intermediates 5-fluoro-2’-deoxyuridine-5’- monophosphate (FdUMP) and 5-fluorouridine triphosphate (FUTP). FdUMP inhibits thymidylate synthase, blocking thymidine synthesis. Thymidine is required for DNA replication and repair. Uridine is not found in DNA. The second source of fluorouracil cytotoxicity is the incorporation of its metabolite, FUTP, into RNA. This incorporation of FUTP into RNA is proportional to systemic fluorouracil exposure. Excess circulating uridine derived from VISTOGARD is converted into uridine triphosphate (UTP), which competes with FUTP for incorporation into RNA. Uridine triacetate is also approved for the treatment of hereditary orotic aciduria under XURIDEN trade name. Uridine triacetate provides uridine in the systemic circulation of patients with hereditary orotic aciduria who cannot synthesize adequate quantities of uridine due to a genetic defect in uridine nucleotide synthesis.