Aldose Reductase converts galactose into galactitol, a toxic metabolite that builds up in tissues and organs and can cause long-term disease complications.
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Feb 28, 2024 · ... (AT-007) for the treatment of Classic Galactosemia. The NDA was granted Priority Review status, and the FDA assigned a Prescription Drug User ...
AT-007 is an oral CNS penetrant aldose reductase inhibitor, which prevents conversion of galactose to toxic galactitol, that is in development for the treatment ...
Sep 6, 2023 · Applied Therapeutics Announces Successful Pre-NDA Meeting with the FDA and Confirms Plans to Submit NDA for Govorestat (AT-007) for Treatment of ...
The study is designed to assess the long-term safety of AT-007 in subjects with CG as well as the pharmacodynamics (PD) (inhibition of galactitol) and PK of AT- ...
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Govorestat (AT-007) is an orally active brain-penetrant aldose reductase inhibitor with an IC50 value of 100 pM. Govorestat has the potential for galactose-1- ...
Apr 24, 2023 · Applied Therapeutics Announces Clinical Benefit of Govorestat (AT-007) in ACTION-Galactosemia Kids Trial; Company Plans to Meet with FDA ...
Jan 3, 2024 · Applied Therapeutics Announces MAA Validation and NDA Submission of Govorestat (AT-007) for Treatment of Classic Galactosemia ... NEW YORK, Jan.
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AT-007 is an orally active central nervous system (CNS) penetrant Aldose Reductase inhibitor for treatment of Galactosemia with an IC50 value of 100 pM.
Mar 12, 2023 · EMA has granted orphan medicinal product designation to Applied Therapeutics' AT-007 (gavorestat) to treat Galactosemia (Galactosaemia).