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Apitegromab - Scholar Rock

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Drug Profile

Apitegromab - Scholar Rock

Alternative Names: SRK-015

Latest Information Update: 08 Sep 2026

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At a glance

  • Originator Scholar Rock
  • Class Monoclonal antibodies; Obesity therapies
  • Mechanism of Action Myostatin inhibitors
  • Orphan Drug Status

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

    Yes - Spinal muscular atrophy; Facioscapulohumeral muscular dystrophy
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Spinal muscular atrophy
  • Phase II Facioscapulohumeral muscular dystrophy; Obesity
  • No development reported Muscular atrophy; Spinal cord injuries

Most Recent Events

  • 04 Sep 2026 Apitegromab - Scholar Rock receives Fast Track designation for Facioscapulohumeral muscular dystrophy [IV] in USA
  • 04 Sep 2026 Apitegromab - Scholar Rock receives Orphan Drug status for Facioscapulohumeral muscular dystrophy in USA
  • 24 Aug 2026 Scholar Rock has resolved the facility-related issues, and the BLA review is progressing well in the USA for the treatment of spinal muscular atrophy

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