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Apitegromab - Scholar Rock

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Drug Profile

Apitegromab - Scholar Rock

Alternative Names: SRK-015

Latest Information Update: 26 Sep 2025

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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
  • No development reported Spinal cord injuries

Most Recent Events

  • 23 Sep 2025 Scholar Rock plans to initiate launch Apitegromab for Spinal muscular atrophy in Europe in the second half of 2026.
  • 23 Sep 2025 Scholar Rock receives complete response letter from the FDA for apitegromab in Spinal Muscular Atrophy
  • 23 Sep 2025 Scholar Rock expects a decision on marketing authorisation application (MAA) by European Medicines Agency near mid-2026.

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