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Sevasemten - Edgewise Therapeutics

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Drug Profile

Sevasemten - Edgewise Therapeutics

Alternative Names: EDG-5506

Latest Information Update: 14 Apr 2026

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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

  • 10 Mar 2026 Efficacy data from the phase II MESA trial in Duchenne muscular dystrophy released by Edgewise Therapeutics
  • 13 Jan 2026 Edgewise Therapeutics plans the NDA submission of Becker muscular dystrophy to the US FDA in the first half of 2027
  • 06 Nov 2025 Edgewise Therapeutics plans to engage with the US FDA to review and align on the phase III clinical trial design, including the intended patient population and key efficacy endpoints

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