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Apitegromab · Isembyld, SRK-015

Monoclonal antibody · Antagonist of pro-myostatin (MSTN) · developed by Scholar Rock

Approved FDA, Sep 2026
SRRK Developer
2 Registered trials

What is Apitegromab?

Apitegromab is a fully human IgG4 monoclonal antibody that binds to pro- and latent myostatin, inhibiting activation of this negative regulator of muscle growth and strength.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as
Isembyld, SRK-015
Drug type
Monoclonal antibody
Targets
pro-myostatin (MSTN)
Mechanism
Antagonist of pro-myostatin (MSTN)
Pathways
muscle growth, muscle strength
Therapy area
Neurology
Developer
Scholar Rock Inc (SRRK)
FDA status
Approved as Isembyld (September 11, 2026), BLA761463
UNII
UZ54216N0Y

🧪 Clinical trials

TrialPhaseConditionStatusSponsor
NCT05626855 Phase 3 Spinal Muscular Atrophy Active not recruiting SRRK
NCT03921528 Phase 2 Spinal Muscular Atrophy Completed SRRK

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Anti-myostatinAtrophyMuscular AtrophyMuscular Atrophy, SpinalNeuromuscular DiseasesNeuromuscular ManifestationsSMASpinal Muscular AtrophySpinal Muscular Atrophy Type 2Spinal Muscular Atrophy Type 3

More from Scholar Rock

Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the SRRK page.

Follow SRRK, the company behind Apitegromab

See SRRK's upcoming FDA decisions, trial readouts, cash runway and dilution risk, updated every day from SEC, FDA and ClinicalTrials.gov filings.

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z

This data is for informational purposes only, not investment advice. BioRadar does not provide buy/sell recommendations. Past performance does not guarantee future results. Always do your own due diligence.