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Apitegromab - Scholar Rock

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Drug Profile

Apitegromab - Scholar Rock

Alternative Names: SRK-015

Latest Information Update: 11 Oct 2024

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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

  • Phase III Spinal muscular atrophy
  • Phase II Obesity
  • No development reported Muscular atrophy; Spinal cord injuries

Most Recent Events

  • 07 Oct 2024 Scholar Rock announces intention to submit Biologics License Application (BLA) to USA and marketing authorisation application (MAA) to European Union for Spinal muscular atrophy in Q1 2025
  • 07 Oct 2024 Efficacy and adverse events data from phase-III SAPPHIRE trial in Spinal muscular atrophy released by Scholar Rock
  • 07 Oct 2024 Scholar Rock completes phase-III SAPPHIRE trial for Spinal muscular atrophy in USA, Belgium, France, Germany, Italy, Netherlands, Poland, Spain, and United Kingdom (NCT05156320)

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