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A Phase 1-2, Dose-Escalating, 4-Part Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Doses of AT-007 in Healthy Adult Subjects and Adult Subjects With Classic Galactosemia

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Trial Profile

A Phase 1-2, Dose-Escalating, 4-Part Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Doses of AT-007 in Healthy Adult Subjects and Adult Subjects With Classic Galactosemia

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 29 Nov 2024

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At a glance

  • Drugs Govorestat (Primary)
  • Indications Galactosaemia
  • Focus Adverse reactions; First in man; Registrational
  • Acronyms ACTION-Galactosemia
  • Sponsors Applied Therapeutics

Most Recent Events

  • 27 Nov 2024 According to an Applied Therapeutics media release, results of this study were published in the Journal of Clinical Pharmacology.
  • 18 Sep 2024 According to an Applied Therapeutics media release, the company recently completed its late-cycle review meeting with the USFDA. The FDA communicated that an Advisory Committee meeting would no longer be required, which was previously tentatively scheduled for October 9, 2024. The FDA informed the Company that the Priority Review of the NDA is continuing as planned with alignment on post-marketing requirements expected in October 2024
  • 07 Aug 2024 According to an Applied Therapeutics media release, FDA Genetic Metabolic Diseases Advisory Committee (GeMDAC) Meeting to discuss NDA for govorestat for the treatment of Classic Galactosemia is scheduled for October 9, 2024.

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