3 completed, 1 active not recruiting, 1 unknown, 1 withdrawn. 5 Phase 3, 3 Phase 2, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 5 | Completed 2, Active not recruiting 1, Unknown 1, Withdrawn 1 |
| Phase 2 | 3 | Completed 3 |
| Phase 1 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Confirmatory Study of Govorestat in CMT-SORD Govorestat, Placebo Control - Charcot-Marie-Tooth Disease With Sorbitol Dehydrogenase Deficiency (CMT-SORD) | Phase 3 | Withdrawn | Applied Therapeutics, Inc. | 2026-05-01 | 2026-05-29 | |
| Pharmacodynamic EffIcacy and Clinical Benefit of AT 007 in Patients With Sorbitol Dehydrogenase (SORD) Deficiency AT-007, Placebo - Hereditary Neuropathy Caused by SORD Deficiency | Phase 2 / Phase 3 | Completed | Applied Therapeutics, Inc. | 56 | 2022-01-01 | 2026-06-09 |
| AT-007 in Adult Subjects With Classic Galactosemia (CG) AT-007 - Classic Galactosemia | Phase 3 | Unknown | Applied Therapeutics, Inc. | 7 | 2021-10-01 | 2022-06-14 |
| Clinical Benefit, Safety, PK and PD Study of AT-007 in Pediatric Subjects With Classic Galactosemia AT-007, Placebo - Classic Galactosemia | Phase 2 / Phase 3 | Completed | Applied Therapeutics, Inc. | 47 | 2021-03-20 | 2025-10-29 |
| Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy AT-001, Placebo - Diabetic Cardiomyopathies | Phase 3 | Active not recruiting | Applied Therapeutics, Inc. | 675 | 2019-09-20 | 2022-12-08 |
| Safety and Pharmacokinetics of AT-007 in Healthy Subjects and in Adult Subjects With Classic Galactosemia AT-007, Placebo - Classic Galactosemia | Phase 1 / Phase 2 | Completed | Applied Therapeutics, Inc. | 114 | 2019-06-21 | 2024-05-30 |
Galactosemias (3) · Diabetes Mellitus, Type 2 (1) · Diabetic Cardiomyopathies (1)
caficrestat (1)
United States (6) · Australia (2) · Czechia (2) · France (2) · Germany (2) · Italy (2) · Spain (2) · United Kingdom (2) · Canada (1) · Hong Kong (1) · Poland (1) · Turkey (Türkiye) (1)
James L Januzzi, MD (1) · Jonathan W Mink, MD (1) · Michael E Shy, MD (1) · Robert Green, MD, MPH (1) · Susan E Waisbren, PhD (1)
PMID 38302936, PMID 38597864, PMID 38986667, PMID 38988185, PMID 39095808, PMID 39569553, PMID 39806375, PMID 39882614, PMID 40315802, PMID 40338768, PMID 42538062