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Apitegromab - Scholar Rock

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Drug Profile

Apitegromab - Scholar Rock

Alternative Names: SRK-015

Latest Information Update: 11 Mar 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
  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 03 Mar 2026 Scholar Rock plans to resubmit the BLA to the US FDA for apitegromab for Spinal muscular atrophy (In children, In adults) in 2026
  • 03 Mar 2026 Scholar Rock expects approval of Apitegromab for Spinal muscular atrophy by the EMA in mid-2026
  • 03 Mar 2026 Scholor Rock plans phase-II FORGE trial for Facioscapulohumeral muscular dystrophy (IV, Infusion) in August 2026 (NCT07435129)

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