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Edgewise Therapeutics (EWTX)
NASDAQ:EWTX
Edg-15400
Healthy Adults
Phase I
Recruiting
A Study of EDG-15400 in Healthy Adults
Aug 27, 2025
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Edg-7500
Renal Impairments
Phase I
Recruiting
A Study to Evaluate EDG-7500 in People With Renal Impairment
Jun 09, 2025
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Verapamil, Sevasemten
Healthy Subjects
Phase I
Completed
A Study to Evaluate Effect of Verapamil and Food of Sevasemten in Healthy Volunteers
Feb 13, 2025
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[14C]-Edg-7500
Healthy Volunteer
Phase I
Completed
A Study to Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C]-EDG-7500
Dec 04, 2024
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Edg-7500
Hypertrophic Cardiomyopathy
Phase II
Recruiting
A Study of EDG-7500 in Adults With Hypertrophic Cardiomyopathy (CIRRUS-HCM)
Mar 18, 2024
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Sevasemten Dose 1, Sevasemten Dose 2, Sevasemten Dose 3
Duchenne Muscular Dystrophy
Phase II
Active Not Recruiting
Phase 2 Study of EDG-5506 in Children and Adolescents With Duchenne Muscular Dystrophy Previously Treated With Gene Therapy
Oct 20, 2023
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Sevasemten
Becker Muscular Dystrophy
Phase II
Enrolling By Invitation
Open-Label Extension of EDG-5506 in Participants With Becker Muscular Dystrophy
Sep 27, 2023
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Sevasemten Dose 1, Sevasemten Dose 2, Sevasemten Dose 3, Sevasemten Dose 4, Sevasemten Dose 5
Duchenne Muscular Dystrophy
Phase II
Active Not Recruiting
A Study of EDG-5506 in Children With Duchenne Muscular Dystrophy (LYNX)
Sep 06, 2022
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Sevasemten 10 Mg, Sevasemten 5 Mg, Sevasemten 12.5 Mg
Becker Muscular Dystrophy
Phase II
Active Not Recruiting
Phase 2 Study of EDG-5506 in Becker Muscular Dystrophy (GRAND CANYON)
Mar 14, 2022
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Sevasemten
Becker Muscular Dystrophy
Phase I
Completed
A Study of EDG-5506 in Adult Males With Becker Muscular Dystrophy
Dec 02, 2021
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Edgewise Therapeutics (EWTX) have in its pipeline
EWTX is currently developing the following drugs: Edg-15400, Edg-7500, Verapamil, Sevasemten. These drug candidates are in various stages of clinical development as the company works toward FDA approval.