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Edgewise Therapeutics

Edgewise Therapeutics logo
🇺🇸United States
Ownership
Public
Established
2017-01-01
Employees
88
Market Cap
-
Website
http://www.edgewisetx.com
Introduction

Edgewise Therapeutics, Inc. is a clinical-stage biopharmaceutical company. It focuses on the discovery, development and commercialization of innovative treatments for severe, rare muscle disorders for which there is significant unmet medical need. Its platform utilizes custom-built throughput and translatable systems that measure integrated muscle function in whole organ extracts to identify small molecule precision medicines regulating key proteins in muscle tissue, initially focused on addressing rare neuromuscular and cardiac diseases. The company was founded by Badreddin Edris, Alan Russel and Peter A. Thompson in 2017 and is headquartered in Boulder, CO.

A Study to Evaluate Effect of Verapamil and Food of Sevasemten in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy Subjects
Interventions
First Posted Date
2025-04-08
Last Posted Date
2025-04-08
Lead Sponsor
Edgewise Therapeutics, Inc.
Target Recruit Count
42
Registration Number
NCT06916897
Locations
🇺🇸

Celerion, Lincoln, Nebraska, United States

A Study to Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C]-EDG-7500

Phase 1
Completed
Conditions
Healthy Volunteer
Interventions
First Posted Date
2024-12-18
Last Posted Date
2025-04-16
Lead Sponsor
Edgewise Therapeutics, Inc.
Target Recruit Count
8
Registration Number
NCT06738836
Locations
🇺🇸

Pharmaron Clinical Pharmacology Center, Inc., Baltimore, Maryland, United States

A Study of EDG-7500 in Adults With Hypertrophic Cardiomyopathy (CIRRUS-HCM)

Phase 2
Recruiting
Conditions
Hypertrophic Cardiomyopathy
Interventions
First Posted Date
2024-04-04
Last Posted Date
2025-04-16
Lead Sponsor
Edgewise Therapeutics, Inc.
Target Recruit Count
75
Registration Number
NCT06347159
Locations
🇺🇸

Morristown Medical Center (Atlantic Health System), Morristown, New Jersey, United States

🇺🇸

University of California, San Francisco, San Francisco, California, United States

🇺🇸

Stanford University Hospital / Stanford Health Care, Stanford, California, United States

and more 11 locations

Phase 2 Study of EDG-5506 in Children and Adolescents With Duchenne Muscular Dystrophy Previously Treated With Gene Therapy

Phase 2
Active, not recruiting
Conditions
Duchenne Muscular Dystrophy
Interventions
Drug: Sevasemten Dose 3
Drug: Sevasemten Dose 1
Drug: Sevasemten Dose 2
Drug: Placebo
First Posted Date
2023-10-25
Last Posted Date
2025-05-18
Lead Sponsor
Edgewise Therapeutics, Inc.
Target Recruit Count
43
Registration Number
NCT06100887
Locations
🇺🇸

UCLA Medical Center, Los Angeles, California, United States

🇺🇸

UC Davis Medical Center, Sacramento, California, United States

🇺🇸

University of Florida, Gainesville, Florida, United States

and more 4 locations

Open-Label Extension of EDG-5506 in Participants With Becker Muscular Dystrophy

Phase 2
Conditions
Becker Muscular Dystrophy
Interventions
First Posted Date
2023-10-04
Last Posted Date
2025-03-11
Lead Sponsor
Edgewise Therapeutics, Inc.
Target Recruit Count
260
Registration Number
NCT06066580
Locations
🇺🇸

Arkansas Children's Hospital, Little Rock, Arkansas, United States

🇺🇸

UC San Diego, La Jolla, California, United States

🇺🇸

UCLA Medical Center, Los Angeles, California, United States

and more 38 locations

A Study of EDG-7500 in Healthy Adults

Phase 1
Completed
Conditions
Healthy Subjects
Interventions
Drug: Placebo
First Posted Date
2023-08-25
Last Posted Date
2024-07-16
Lead Sponsor
Edgewise Therapeutics, Inc.
Target Recruit Count
84
Registration Number
NCT06011317
Locations
🇺🇸

Celerion, Lincoln, Nebraska, United States

Absorption, Metabolism, Excretion and Absolute Bioavailability of EDG-5506 in Healthy Volunteers

Phase 1
Completed
Conditions
Genetic Diseases, Inborn
Muscular Dystrophies
Healthy Volunteer
Muscular Disorders, Atrophic
Musculoskeletal Diseases
Neuromuscular Diseases
Muscular Diseases
Nervous System Diseases
Interventions
Drug: Radiolabeled EDG-5506 Suspension
Drug: EDG-5506 Tablet
Drug: Radiolabeled EDG-5506 Intravenous
First Posted Date
2023-02-16
Last Posted Date
2023-04-18
Lead Sponsor
Edgewise Therapeutics, Inc.
Target Recruit Count
15
Registration Number
NCT05730842
Locations
🇺🇸

Labcorp Clinical Research Unit, Inc., Madison, Wisconsin, United States

A Study of EDG-5506 in Children With Duchenne Muscular Dystrophy (LYNX)

Phase 2
Active, not recruiting
Conditions
Duchenne Muscular Dystrophy
Interventions
Drug: Sevasemten Dose 2
Drug: Sevasemten Dose 3
Drug: Sevasemten Dose 4
Drug: Sevasemten Dose 5
Drug: Sevasemten Dose 1
Drug: Placebo
First Posted Date
2022-09-15
Last Posted Date
2024-12-27
Lead Sponsor
Edgewise Therapeutics, Inc.
Target Recruit Count
76
Registration Number
NCT05540860
Locations
🇺🇸

Arkansas Children's Hospital, Little Rock, Arkansas, United States

🇺🇸

UCLA Medical Center, Los Angeles, California, United States

🇺🇸

UC Davis Medical Center, Sacramento, California, United States

and more 11 locations

A Study to Assess the Feasibility of Non-invasive Dried Blood Sampling

Phase 1
Completed
Conditions
Muscular Dystrophies
Interventions
First Posted Date
2022-08-08
Last Posted Date
2022-09-02
Lead Sponsor
Edgewise Therapeutics, Inc.
Target Recruit Count
10
Registration Number
NCT05492734
Locations
🇺🇸

Celerion, Inc., Lincoln, Nebraska, United States

Phase 2 Study of EDG-5506 in Becker Muscular Dystrophy (GRAND CANYON)

Phase 2
Active, not recruiting
Conditions
Becker Muscular Dystrophy
Interventions
Drug: Sevasemten 10 mg
Drug: Sevasemten 5 mg
Drug: Sevasemten 12.5 mg
Drug: Placebo
First Posted Date
2022-03-22
Last Posted Date
2025-04-27
Lead Sponsor
Edgewise Therapeutics, Inc.
Target Recruit Count
175
Registration Number
NCT05291091
Locations
🇺🇸

UC Denver, Aurora, Colorado, United States

🇺🇸

University of Florida, Gainesville, Florida, United States

🇺🇸

Rare Disease Research, Atlanta, Georgia, United States

and more 48 locations
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