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Catalog/Apitegromab

Apitegromab

Also known as SRK-015 · SRK-439

A monoclonal antibody that selectively blocks pro/latent myostatin — the muscle brake — studied to preserve lean mass during GLP-1 weight loss.

Overview

Apitegromab is a fully human monoclonal antibody (Scholar Rock) and the first of the anti-myostatin biologics in this catalog. Where myostatin is the growth factor that brakes muscle and follistatin is the body’s natural antagonist, apitegromab is an engineered antagonist: an antibody that binds the inactive precursor forms of myostatin (pro- and latent myostatin) and prevents their activation. Its selectivity for those precursors — rather than mature myostatin or the related GDF11/activins — is its defining design feature.

Background

Apitegromab’s lead program is in spinal muscular atrophy (SMA), where it is added on top of SMN-targeted therapy to build motor-relevant muscle. The same mechanism underlies its forward-looking metabolic use: in the Phase 2 EMBRAZE study, adding apitegromab to tirzepatide preserved lean mass during weight loss compared with tirzepatide alone, and its precursor-selectivity was framed as a potential tolerability advantage over broader myostatin/activin blockers.

As a biologic it sits a full step beyond the protein hormones elsewhere in this catalog: it is an antibody (~150 kDa), produced in mammalian cells, designed to deplete a specific target. It is investigational — not an approved drug — and is included here as the antibody arm of the myostatin axis that myostatin and follistatin introduce.

Mechanism

Binds pro-myostatin and latent myostatin, blocking the proteolytic activation that releases mature, active myostatin. Lowering active myostatin disinhibits muscle growth via the ActRIIB/Smad pathway.

Key research findings

  • Precursor-selective — binds pro/latent myostatin rather than mature myostatin or GDF11/activins, the basis of its selectivity claim.
  • SMA — the lead clinical program, building muscle on top of SMN-directed therapy.
  • GLP-1 muscle preservation — Phase 2 EMBRAZE preserved lean mass when added to tirzepatide.
  • Antibody biologic — a ~150 kDa monoclonal antibody, the far end of the biologic spectrum from synthetic peptides.
  • Investigational — not FDA-approved.

How Apitegromab is made

Behind every vial of Apitegromab is the same exacting pipeline every research peptide runs — but the chemistry plays out differently for this molecule. Here is how Apitegromab, specifically, is brought into being.

  1. On paper first

    On paper, Apitegromab weighs in at roughly 150,000 daltons. Before a single bond is made, the target sequence, salt form, and purity threshold are written down as the contract the finished material must meet.

  2. Built residue by residue

    Apitegromab is assembled by solid-phase peptide synthesis — the chain grows one protected residue at a time on resin, and what you fail to build cleanly here you pay to remove later.

  3. Purity is won here

    The crude mixture — Apitegromab plus its deletions and side products — is then separated on preparative HPLC, and where the cut is taken decides the difference between a genuinely pure peptide and a barely-passable one.

  4. Proven, then protected

    A real batch of Apitegromab proves itself: identity confirmed by mass spectrometry against its ~150,000 Da, purity read directly off an analytical HPLC trace, water and counterion content measured. That batch-specific certificate of analysis is the only honest way to know what is actually in a vial of Apitegromab — and a short, cold, accountable chain of custody is how that purity survives the trip to your bench.

Walk the full synthesis pipeline

Handling, storage & why purity is hard

Apitegromab is a recombinant monoclonal antibody (~150 kDa) produced in mammalian cell culture — the most complex biologic class in this catalog, far removed from solid-phase peptide synthesis. Characterization is antibody-grade: glycan and charge-variant profiling, identity by mass spectrometry, and target-binding/cell-based potency, with host-cell-protein and endotoxin limits.

Storage
Monoclonal antibodies are stored refrigerated (2–8 °C), protected from light and freezing, and never shaken. Investigational handling follows the trial protocol.
Handling
A large folded, glycosylated antibody — sensitive to freezing, heat, and agitation, which can aggregate it. Aggregation is an immunogenicity concern.

Don't judge a vial by its cake. A fluffy, good-looking lyophilized powder reflects bulking agents and freeze-drying parameters — not purity. Insist on a batch-specific certificate of analysis.

How peptides are made — the full pipeline

Research areas

  • Spinal muscular atrophy
  • Muscle preservation
  • GLP-1 muscle preservation
  • Body composition

Research-area guides

Latest research

Recent clinical trials and publications mentioning Apitegromab, pulled automatically from ClinicalTrials.gov and PubMed and refreshed daily. Listings are unfiltered search results, not curated endorsements.

Frequently asked questions

What is apitegromab?+

A monoclonal antibody that selectively blocks the precursor forms of myostatin, the growth factor that limits muscle. It is studied in spinal muscular atrophy and, in combination with GLP-1/GIP drugs, to preserve muscle during weight loss.

How is it different from blocking mature myostatin?+

Apitegromab targets pro- and latent (inactive) myostatin before it is activated, rather than the mature protein — a selectivity intended to avoid hitting related factors and improve tolerability.

Is this medical advice?+

No — this is a research and educational reference. Apitegromab is an investigational antibody, not an approved drug.

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