Govorestat (AT-007) is an aldose reductase inhibitor and experimental drug to treat galactosemia and sorbitol dehydrogenase deficiency.
After a report circulating on the internet accused the developer Applied Therapeutics of cutting corners in its studies of the drug, the FDA put a hold on it in 2020. Applied Therapeutics said that the report was a fraudulent attempt to manipulate its stock price.
In February 2024, the FDA granted priority review states to an application from Applied Therapeutics to use govorestat to treat galactosemia, a metabolic disease. The FDA then rejected the companyâÂÂs application in November 2024, and issued a warning letter to then-President Shoshana Shendelman informing her of âÂÂobjectionable conditionsâ observed during an FDA inspection earlier that year.
In December 2024, Advanz Pharma Limited withdrew its application for a marketing authorization of Nugalviq for the treatment of classic galactosaemia, a condition where the body cannot break down a sugar called galactose.