The Food and Drug Administration (FDA) has approved Wellstat Therapeutics’ Vistogard (uridine triacetate) oral granules. This is the first post–5-fluorouracil (5-FU) or capecitabine overdose treatment available to patients. It is also indicated for patients exhibiting early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or those who experience severe adverse reactions within 96 hours following the end of 5-FU or capecitabine administration. 

5-FU is a standard chemotherapy agent used for various solid tumors, including those of the colon, pancreas, stomach, esophagus, breast, and head and neck cancers. Capecitabine is an oral chemotherapy prodrug of 5-FU that transforms into 5-FU in the body. In the body, uridine triacetate is deacetylated by nonspecific esterases present throughout the body, yielding uridine in the circulation. Uridine competitively inhibits cell damage and cell death caused by fluorouracil.

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The FDA approval announcement was made by BTG plc. The approval is based on data from a clinical program (n=135). This showed the efficacy and safety of a single course of Vistogard 10mg given orally every 6 hours for a total of 20 doses. Study data showed overall survival of patients with 5-FU toxicity who received Vistogard was 96% vs. 16% in historical cases that used standard supportive measures. Patients treated with Vistogard resumed chemotherapy sooner, with 33% resuming treatment within 30 days.