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Peptide Database

Growth hormone & endocrine research

ACE-031 (ACVR2B-Fc): Research Overview

Experimental myostatin-blocking protein whose clinical development was halted on safety grounds.

Also known as ACVR2B-Fc · ramatercept

Research use onlyStrongest evidence: controlled clinical trialReviewed
DatabaseReferences

What is ACE-031?

ACE-031 is a soluble form of the activin type IIB receptor (ActRIIB) fused to an IgG1 Fc domain. It functions as a decoy receptor, binding and neutralizing myostatin and other TGF-beta superfamily members that normally limit muscle growth.

What is ACE-031 researched for?

  • ACE-031 acts as a ligand trap for members of the TGF-beta superfamily. By mimicking the extracellular domain of the ActRIIB receptor, it intercepts myostatin (GDF-8), activin A, activin B, and GDF-11 before they can bind cell-surface receptors and activate Smad2/3 signaling.
  • Phase 1 data showed statistically significant lean mass increases (average +1.7%) after a single IV dose in healthy postmenopausal women.
  • Phase 2 trial in DMD patients showed improvements in lean body mass and bone mineral density, but trial was halted due to vascular adverse events.
  • Preclinical models demonstrate robust prevention of muscle loss in disease states through myostatin pathway inhibition.
  • Phase 1 trial subjects showed concurrent fat mass reductions alongside lean mass gains, suggesting favorable nutrient partitioning.
  • DMD trial data showed increases in bone mineral density, consistent with known effects of ActRIIB pathway modulation on bone metabolism.
  • ACE-031 has never been approved for human use and clinical development was discontinued. Any product sold as ACE-031 is of unknown origin and quality. The compound is a complex fusion protein sensitive to degradation, making DIY sourcing extremely risky with high contamination likelihood.

How does ACE-031 work?

No. ACE-031 is a soluble activin receptor that acts as a ligand trap, while follistatin directly binds myostatin. Both ultimately inhibit myostatin signaling, but through different mechanisms. Theoretically combined use might be synergistic, but clinical data on combinations doesn't exist.

Reported targets: ActRIIB, activin receptor

References

  1. A soluble activin receptor type IIB (ACE-031) increases lean body mass and muscle strength in healthy postmenopausal women

    Attie KM, Borgstein NG, Yang Y, et al. · Sherman ML Journal of Clinical Endocrinology & Metabolism · 2013

    Single ascending-dose Phase 1 trial in 48 postmenopausal women. ACE-031 produced statistically significant increases in total body lean mass (+1.7%) and thigh muscle volume (+5.1%) by day 29, with concurrent decreases in fat mass and leptin.

    Controlled clinical trial

  2. A phase 2 trial of ACE-031, a soluble activin receptor type IIB, in boys with Duchenne muscular dystrophy Campbell C, McMillan HJ, Mah JK, Tarnopolsky M, Selby K, McClure T, Wilson DM, Sherman ML, Bhatt SA, Trachtenberg FL, Kunkel LM, Bhatt RS Neuromuscular Disorders

    2017

    Phase 2 study in 12 DMD boys showed increases in lean body mass and bone mineral density. Trial was halted due to safety concerns including epistaxis, telangiectasia, and erythema. Preliminary efficacy signals were observed but could not be fully evaluated.

    Controlled clinical trial

  3. Pharmacokinetic, pharmacodynamic, and safety results from a first-in-human study of ACE-031, a novel activin receptor type IIB/Fc fusion protein

    Bhatt RS, Goss A, Wilson DM, et al. · Sherman ML Journal of Clinical Pharmacology · 2014

    ACE-031 demonstrated a half-life of approximately 12 days with dose-proportional pharmacokinetics. The compound suppressed circulating FSH levels, consistent with activin A neutralization, and showed a dose-dependent increase in lean mass biomarkers.

  4. Myostatin inhibition in health and disease Lee SJ Annual Review of

    Cell and Developmental Biology · 2004

    Comprehensive review establishing myostatin as a key negative regulator of skeletal muscle mass. Demonstrated that myostatin-null mice exhibit dramatic increases in muscle mass, providing the biological rationale for therapeutic myostatin inhibition strategies including soluble receptor approaches.

    Review or meta-analysis

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  8. Cardiovascular Disease and Gross Domestic Product in Spain: Correlation Analysis By Autonomous Community. Response to Related Letters

    Jiménez-Navarro M, Pérez-Belmonte LM, Gómez-Doblas JJ, et al. · Revista espanola de cardiologia (English ed.) · 2017

    PMID 28131562

  9. Regulation of muscle mass by myostatin

    Lee SJ · Annual review of cell and developmental biology · 2004

    PMID 15473835

  10. Referral bias in defining the phenotype and prevalence of obesity in polycystic ovary syndrome

    Ezeh U, Yildiz BO, Azziz R · The Journal of clinical endocrinology and metabolism · 2013

    PMID 23539721

  11. [Confidentiality and privacy in billing for medical services]

    Frigger UF · RoFo : Fortschritte auf dem Gebiete der Rontgenstrahlen und der Nuklearmedizin · 2014

    PMID 24691811