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Sevasemten - Edgewise Therapeutics

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Drug Profile

Sevasemten - Edgewise Therapeutics

Alternative Names: EDG-5506

Latest Information Update: 02 Jul 2025

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At a glance

  • Originator Edgewise Therapeutics
  • Class Ethers; Fluorinated hydrocarbons; Ketones; Pyridazines; Pyridines; Pyrimidines; Small molecules
  • Mechanism of Action Creatine kinase inhibitors; Myosin inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Duchenne muscular dystrophy
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Duchenne muscular dystrophy
  • Phase II Glycogen storage disease type V; Limb girdle muscular dystrophies

Most Recent Events

  • 26 Jun 2025 Edgewise Therapeutics completes a successful Type C meeting with the US FDA for registration path for Duchenne muscular dystrophy
  • 26 Jun 2025 Edgewise Therapeutics plans to meet USFDA to discuss a phase III design including input on the patient population and endpoints for Duchenne muscular dystrophy in the fourth quarter of 2025
  • 26 Jun 2025 Adverse events and efficacy data from a phase II MESA trial in Duchenne muscular dystrophy released by Edgewise Therapeutics

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