Uridine Triacetate and 5-FU

Uridine triacetate received orphan-drug designation as an antidote to treat patients at risk of excess 5-FU or capecitabine toxicity (i.e., 5-FU poisoning or overdose) by the FDA and the European Medicines Agency (EMA).

Uridine triacetate is provided to patients at risk of excess 5-FU or capecitabine toxicity under an expanded access protocol and under Food and Drug Administration (FDA) emergency treatment provisions in the United States, and under similar emergency use provisions in Europe and the rest of the world.