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Applied Therapeutics

appliedtherapeutics.com ↗ · Midwest

Clinical Phase 3

We are building a pipeline of drugs to treat diseases with no treatment options. From company website Source · Oct 13, 2026

Keywords: rare disease galactosemia rare diseases Classic Galactosemia Hereditary Neuropathy Caused by SORD Deficiency Charcot-Marie-Tooth Disease With Sorbitol Dehydrogenase Deficiency Diabetic Cardiomyopathies AT-007 Govorestat AT-001

Profile checked Oct 10, 2026

6Trials (company is sponsor)

Timeline

  1. Trial start Phase 3: Confirmatory Study of Govorestat in CMT-SORD source ↗
  2. Trial start Phase 2/Phase 3: Pharmacodynamic EffIcacy and Clinical Benefit of AT 007 in Patients With Sorbitol Dehydrogenase (SORD) Deficiency source ↗
  3. Trial start Phase 3: AT-007 in Adult Subjects With Classic Galactosemia (CG) source ↗
  4. Trial start Phase 2/Phase 3: Clinical Benefit, Safety, PK and PD Study of AT-007 in Pediatric Subjects With Classic Galactosemia source ↗
  5. Trial start Phase 3: Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy source ↗
  6. Trial start Phase 1/Phase 2: Safety and Pharmacokinetics of AT-007 in Healthy Subjects and in Adult Subjects With Classic Galactosemia source ↗

Clinical trials (lead sponsor) 6

RecordTitlePhaseStatusStartPrimary completion
NCT05397665Pharmacodynamic EffIcacy and Clinical Benefit of AT 007 in Patients With Sorbitol Dehydrogenase (SORD) DeficiencyPhase 2/Phase 3CompletedJan 1, 2022Oct 12, 2024 (actual)
NCT07191912Confirmatory Study of Govorestat in CMT-SORDPhase 3Withdrawn2026-052028-10 (estimated)
NCT04902781Clinical Benefit, Safety, PK and PD Study of AT-007 in Pediatric Subjects With Classic GalactosemiaPhase 2/Phase 3CompletedMar 20, 2021Mar 3, 2023 (actual)
NCT04117711Safety and Pharmacokinetics of AT-007 in Healthy Subjects and in Adult Subjects With Classic GalactosemiaPhase 1/Phase 2CompletedJun 21, 2019Dec 14, 2021 (actual)
NCT04083339Safety and Efficacy of AT-001 in Patients With Diabetic CardiomyopathyPhase 3Active, not recruitingSep 20, 20192023-12 (estimated)
NCT05418829AT-007 in Adult Subjects With Classic Galactosemia (CG)Phase 3Unknown status (ClinicalTrials.gov)Oct 1, 20212022-11 (estimated)
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