Edgewise Therapeutics, Inc. Clinical Trials
Studies registered on ClinicalTrials.gov (U.S. National Library of Medicine) with the company as lead sponsor or collaborator, newest start first. Values are as registered.
- 2026-08-25: Study NCT07795814; Company role Lead sponsor; Phase Phase 2; Status Recruiting.
- 2026-03-10: Study NCT07456059; Company role Lead sponsor; Phase Phase 1; Status Completed.
- 2026-01-26: Study NCT07324616; Company role Lead sponsor; Phase Phase 1; Status Completed.
- 2025-08-20: Study NCT07177066; Company role Lead sponsor; Phase Phase 1; Status Completed.
| Start date | Study | Company role | Phase | Status | Conditions | Enrollment | Completion date |
|---|---|---|---|---|---|---|---|
| 2026-08-25 | NCT07795814 A Study of EDG-15400 in Adults With Heart Failure With Preserved Ejection Fraction (EQUINOX-HFpEF) | Lead sponsor | Phase 2 | Recruiting | Heart Failure With Preserved Ejection Fraction | 90 | 2027-12 |
| 2026-03-10 | NCT07456059 A Study to Evaluate EDG-7500 in Caucasian and Japanese Adults | Lead sponsor | Phase 1 | Completed | Healthy Adult Participants | 24 | 2026-06-01 |
| 2026-01-26 | NCT07324616 A Study to Evaluate EDG-7500 in Adults With Hepatic Impairment | Lead sponsor | Phase 1 | Completed | Hepatic Impairment (HI) | 25 | 2026-04-07 |
| 2025-08-20 | NCT07177066 A Study of EDG-15400 in Healthy Adults | Lead sponsor | Phase 1 | Completed | Healthy Adults | 84 | 2026-04-29 |
| 2025-07-22 | NCT07034768 A Study to Evaluate EDG-7500 in People With Renal Impairment | Lead sponsor | Phase 1 | Completed | Renal Impairments | 37 | 2025-12-26 |
| 2025-01-08 | NCT06916897 A Study to Evaluate Effect of Verapamil and Food of Sevasemten in Healthy Volunteers | Lead sponsor | Phase 1 | Completed | Healthy Subjects | 42 | 2025-02-22 |
| 2024-12-03 | NCT06738836 A Study to Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C]-EDG-7500 | Lead sponsor | Phase 1 | Completed | Healthy Volunteer | 8 | 2025-01-17 |
| 2024-04-11 | NCT06347159 A Study of EDG-7500 in Adults With Hypertrophic Cardiomyopathy (CIRRUS-HCM) | Lead sponsor | Phase 2 | Active not recruiting | Hypertrophic Cardiomyopathy | 79 | 2027-12 |
| 2024-03-22 | NCT06100887 Phase 2 Study of EDG-5506 in Children and Adolescents With Duchenne Muscular Dystrophy Previously Treated With Gene Therapy | Lead sponsor | Phase 2 | Active not recruiting | Duchenne Muscular Dystrophy | 43 | 2027-03 |
| 2023-11-02 | NCT06066580 Open-Label Extension of EDG-5506 in Participants With Becker Muscular Dystrophy | Lead sponsor | Phase 2 | Enrolling by invitation | Becker Muscular Dystrophy | 260 | 2031-02 |
| 2023-08-14 | NCT06011317 A Study of EDG-7500 in Healthy Adults | Lead sponsor | Phase 1 | Completed | Healthy Subjects | 84 | 2024-06-20 |
| 2023-01-12 | NCT05730842 Absorption, Metabolism, Excretion and Absolute Bioavailability of EDG-5506 in Healthy Volunteers | Lead sponsor | Phase 1 | Completed | Healthy Volunteer; Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, Inborn | 15 | 2023-04-06 |
| 2022-11-10 | NCT05291091 Phase 2 Study of EDG-5506 in Becker Muscular Dystrophy (GRAND CANYON) | Lead sponsor | Phase 2 | Completed | Becker Muscular Dystrophy | 244 | 2026-09-07 |
| 2022-10-24 | NCT05540860 A Study of EDG-5506 in Children With Duchenne Muscular Dystrophy (LYNX) | Lead sponsor | Phase 2 | Active not recruiting | Duchenne Muscular Dystrophy | 76 | 2027-01 |
| 2022-08-12 | NCT05492734 A Study to Assess the Feasibility of Non-invasive Dried Blood Sampling | Lead sponsor | Phase 1 | Completed | Muscular Dystrophies | 10 | 2022-08-19 |
| 2022-04-13 | NCT05257473 Defining Endpoints in Becker Muscular Dystrophy | Collaborator Lead: Virginia Commonwealth University | Observational | Active not recruiting | Becker Muscular Dystrophy; Muscular Dystrophies; Muscular Dystrophy in Children; Muscular Dystrophy, Becker | 80 | 2026-09-30 |
| 2021-12-28 | NCT05160415 A Study of EDG-5506 in Adult Males With Becker Muscular Dystrophy | Lead sponsor | Phase 1 | Completed Results posted | Becker Muscular Dystrophy | 12 | 2024-03-01 |
| 2020-10-12 | NCT04585464 A Study to Assess Safety, Tolerability, and PK of EDG-5506 in Healthy Volunteers and Becker Muscular Dystrophy Adults | Lead sponsor | Phase 1 | Completed | Healthy Volunteer; Becker Muscular Dystrophy | 127 | 2021-12-27 |
| 2020-06-01 | NCT04349566 Fast Troponin as a Biomarker to Assess Exercise-induced Muscle Damage in Muscle Diseases | Collaborator Lead: Mads Peter Godtfeldt Stemmerik | Observational | Completed | Becker Muscular Dystrophy; McArdle Disease; Limb-Girdle Muscular Dystrophy Type 2 | 36 | 2021-12-20 |
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