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Edgewise Therapeutics (EWTX) Drug Pipeline

Drug pipeline
Drug NameConditionStageStatusStudy NameTrial Start DateArticle
Edg-15400 25 Mg, Edg-15400 50 MgHeart Failure With Preserved Ejection FractionPhase IIRecruitingA Study of EDG-15400 in Adults With Heart Failure With Preserved Ejection Fraction (EQUINOX-HFpEF)Aug 26, 2026―
Edg-7500Healthy Adult ParticipantsPhase ICompletedA Study to Evaluate EDG-7500 in Caucasian and Japanese AdultsMar 03, 2026
Edg-7500Hepatic Impairment (Hi)Phase ICompletedA Study to Evaluate EDG-7500 in Adults With Hepatic ImpairmentDec 23, 2025―
Edg-15400Healthy AdultsPhase ICompletedA Study of EDG-15400 in Healthy AdultsAug 27, 2025
Edg-7500Renal ImpairmentsPhase ICompletedA Study to Evaluate EDG-7500 in People With Renal ImpairmentJun 09, 2025
Verapamil, SevasemtenHealthy SubjectsPhase ICompletedA Study to Evaluate Effect of Verapamil and Food of Sevasemten in Healthy VolunteersFeb 13, 2025―
[14C]-Edg-7500Healthy VolunteerPhase ICompletedA Study to Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C]-EDG-7500Dec 04, 2024―
Edg-7500Hypertrophic CardiomyopathyPhase IIActive Not RecruitingA Study of EDG-7500 in Adults With Hypertrophic Cardiomyopathy (CIRRUS-HCM)Mar 18, 2024
Sevasemten Dose 1, Sevasemten Dose 2, Sevasemten Dose 3Duchenne Muscular DystrophyPhase IIActive Not RecruitingPhase 2 Study of EDG-5506 in Children and Adolescents With Duchenne Muscular Dystrophy Previously Treated With Gene TherapyOct 20, 2023―
SevasemtenBecker Muscular DystrophyPhase IIEnrolling By InvitationOpen-Label Extension of EDG-5506 in Participants With Becker Muscular DystrophySep 27, 2023

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
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, Inc. (EWTX) have in its pipeline
Edgewise Therapeutics EWTX is currently developing the following drugs: Edg-15400 25 Mg, Edg-15400 50 Mg, Edg-7500, Edg-15400, Verapamil, Sevasemten, [14C]-Edg-7500, Sevasemten Dose 1, Sevasemten Dose 2, Sevasemten Dose 3, Sevasemten, Sevasemten Dose 1, Sevasemten Dose 2, Sevasemten Dose 3, Sevasemten Dose 4, Sevasemten Dose 5, Sevasemten 10 Mg, Sevasemten 5 Mg, Sevasemten 12.5 Mg. These drug candidates are in various stages of clinical development as the company works toward FDA approval.