Edgewise Therapeutics, Inc. (EWTX)
Edgewise Therapeutics, Inc. is a biopharmaceutical firm dedicated to developing small-molecule treatments for a range of musculoskeletal disorders. Its leading investigational drug, EDG-5506, is an orally administered compound specifically engineered to tackle the fundamental genetic causes of dystrophinopathies, including Duchenne and Becker muscular dystrophy. This candidate has successfully concluded its Phase 1 clinical trial. Beyond EDG-5506, Edgewise maintains a pipeline of precision medicine candidates designed to modulate key muscle proteins, thereby addressing various genetically defined muscle conditions. Established in 2017, the company is headquartered in Boulder, Colorado.
Sector: Pharmaceutical Preparations
Industry: Biotechnology
Edgewise Therapeutics, Inc.
Trials need funding. See this company's dilution risk and cash position.
- Phase 2Completed
Phase 2 Study of EDG-5506 in Becker Muscular Dystrophy (GRAND CANYON)
Sevasemten 10 mg, Sevasemten 5 mg
Becker Muscular Dystrophy
NCT05291091Enrollment244StartNov 2022Primary CompletionSep 2026CompletionSep 2026 - Phase 2Active, not recruiting
A Study of EDG-5506 in Children With Duchenne Muscular Dystrophy (LYNX)
Sevasemten Dose 1, Sevasemten Dose 2
Duchenne Muscular Dystrophy
NCT05540860Enrollment76StartOct 2022Primary CompletionJan 2027est.CompletionJan 2027est. - Phase 2Enrolling by invitation
Open-Label Extension of EDG-5506 in Participants With Becker Muscular Dystrophy
Sevasemten
Becker Muscular Dystrophy
NCT06066580Enrollment260StartNov 2023Primary CompletionFeb 2031est.CompletionFeb 2031est. - Phase 2Active, not recruiting
Phase 2 Study of EDG-5506 in Children and Adolescents With Duchenne Muscular Dystrophy Previously Treated With Gene Therapy
Sevasemten Dose 1, Sevasemten Dose 2
Duchenne Muscular Dystrophy
NCT06100887Enrollment43StartMar 2024Primary CompletionMar 2027est.CompletionMar 2027est. - Phase 2Active, not recruiting
A Study of EDG-7500 in Adults With Hypertrophic Cardiomyopathy (CIRRUS-HCM)
EDG-7500, EDG-7500
Hypertrophic Cardiomyopathy
NCT06347159Enrollment79StartApr 2024Primary CompletionDec 2027est.CompletionDec 2027est. - Phase 2Recruiting
A Study of EDG-15400 in Adults With Heart Failure With Preserved Ejection Fraction (EQUINOX-HFpEF)
EDG-15400 25 mg, Placebo to match EDG-15400 25 mg or 50 mg
Heart Failure With Preserved Ejection Fraction
NCT07795814Enrollment90StartAug 2026Primary CompletionDec 2027est.CompletionDec 2027est. - Phase 1Completed
A Study to Assess Safety, Tolerability, and PK of EDG-5506 in Healthy Volunteers and Becker Muscular Dystrophy Adults
EDG-5506, Placebo
Healthy Volunteer, Becker Muscular Dystrophy
NCT04585464Enrollment127StartOct 2020Primary CompletionNov 2021CompletionDec 2021 - Phase 1Completed
A Study of EDG-5506 in Adult Males With Becker Muscular Dystrophy
Sevasemten
Becker Muscular Dystrophy
NCT05160415Enrollment12StartDec 2021Primary CompletionMar 2024CompletionMar 2024 - Phase 1Completed
A Study to Assess the Feasibility of Non-invasive Dried Blood Sampling
EDG-5506
Muscular Dystrophies
NCT05492734Enrollment10StartAug 2022Primary CompletionAug 2022CompletionAug 2022 - Phase 1Completed
Absorption, Metabolism, Excretion and Absolute Bioavailability of EDG-5506 in Healthy Volunteers
EDG-5506 Tablet, Radiolabeled EDG-5506 Suspension
Healthy Volunteer, Muscular Dystrophies +6
NCT05730842Enrollment15StartJan 2023Primary CompletionApr 2023CompletionApr 2023 - Phase 1Completed
A Study of EDG-7500 in Healthy Adults
EDG-7500, Placebo
Healthy Subjects
NCT06011317Enrollment84StartAug 2023Primary CompletionMay 2024CompletionJun 2024 - Phase 1Completed
A Study to Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C]-EDG-7500
[14C]-EDG-7500
Healthy Volunteer
NCT06738836Enrollment8StartDec 2024Primary CompletionJan 2025CompletionJan 2025 - Phase 1Completed
A Study to Evaluate Effect of Verapamil and Food of Sevasemten in Healthy Volunteers
sevasemten, Verapamil
Healthy Subjects
NCT06916897Enrollment42StartJan 2025Primary CompletionFeb 2025CompletionFeb 2025 - Phase 1Completed
A Study to Evaluate EDG-7500 in People With Renal Impairment
EDG-7500
Renal Impairments
NCT07034768Enrollment37StartJul 2025Primary CompletionDec 2025CompletionDec 2025 - Phase 1Completed
A Study of EDG-15400 in Healthy Adults
EDG-15400, Placebo
Healthy Adults
NCT07177066Enrollment84StartAug 2025Primary CompletionApr 2026CompletionApr 2026 - Phase 1Completed
A Study to Evaluate EDG-7500 in Adults With Hepatic Impairment
EDG-7500
Hepatic Impairment (HI)
NCT07324616Enrollment25StartJan 2026Primary CompletionApr 2026CompletionApr 2026 - Phase 1Completed
A Study to Evaluate EDG-7500 in Caucasian and Japanese Adults
EDG-7500
Healthy Adult Participants
NCT07456059Enrollment24StartMar 2026Primary CompletionJun 2026CompletionJun 2026
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 2 | Completed | Sevasemten 10 mg, Sevasemten 5 mg | NCT05291091 |
| Phase 2 | Active, not recruiting | Sevasemten Dose 1, Sevasemten Dose 2 | NCT05540860 |
| Phase 2 | Enrolling by invitation | Sevasemten | NCT06066580 |
| Phase 2 | Active, not recruiting | Sevasemten Dose 1, Sevasemten Dose 2 | NCT06100887 |
| Phase 2 | Active, not recruiting | EDG-7500, EDG-7500 | NCT06347159 |
| Phase 2 | Recruiting | EDG-15400 25 mg, Placebo to match EDG-15400 25 mg or 50 mg | NCT07795814 |
| Phase 1 | Completed | EDG-5506, Placebo | NCT04585464 |
| Phase 1 | Completed | Sevasemten | NCT05160415 |
| Phase 1 | Completed | EDG-5506 | NCT05492734 |
| Phase 1 | Completed | EDG-5506 Tablet, Radiolabeled EDG-5506 Suspension | NCT05730842 |
| Phase 1 | Completed | EDG-7500, Placebo | NCT06011317 |
| Phase 1 | Completed | [14C]-EDG-7500 | NCT06738836 |
| Phase 1 | Completed | sevasemten, Verapamil | NCT06916897 |
| Phase 1 | Completed | EDG-7500 | NCT07034768 |
| Phase 1 | Completed | EDG-15400, Placebo | NCT07177066 |
| Phase 1 | Completed | EDG-7500 | NCT07324616 |
| Phase 1 | Completed | EDG-7500 | NCT07456059 |