Drug Profile

Apitegromab - Scholar Rock

Alternative Names: SRK-015

Latest Information Update: 06 Oct 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 resubmit the BLA following resolution of the facility-related issues
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

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