Drug Profile

Apitegromab - Scholar Rock

Alternative Names: SRK-015

Latest Information Update: 01 Dec 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 Muscular atrophy; Spinal cord injuries

Most Recent Events

14 Nov 2025 Scholar Rock completes a Type A meeting with the US FDA
14 Nov 2025 Scholar Rock plans to resubmit the BLA of apitegromab for Spinal muscular atrophy (In children, In adults) in 2026
14 Nov 2025 Scholar Rock expects approval of apitegromab for Spinal muscular atrophy (In children, In adults) in 2026

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