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ACE-031

ACVR2B-Fc · Bimagrumab precursor

IGF Axis & MusclePhase II
From$18.00/mgCompare prices

ACE-031, also known as Ramatercept, is a dimeric fusion protein that combines a fragment of the human activin receptor IIB (ACVR2B) with the Fc region of human IgG1. Researchers primarily study ACE-031 for its potential to inhibit myostatin, a protein that negatively regulates muscle growth, making it a candidate for addressing conditions like Duchenne muscular dystrophy and other muscle-wasting disorders. Key findings from clinical trials indicate that ACE-031 administration may lead to increases in lean body mass and improvements in muscle-related metrics, although safety concerns have led to the discontinuation of some studies. Current research status reveals that while ACE-031 has not yet received pharmaceutical approval and is banned by the World Anti-Doping Agency, it continues to be explored in various contexts, including its detection in black market products.

Chemical Profile

Chemical Profile

Half-Life

INIntranasal

Not applicable

POOral

Not applicable

The pharmacokinetic profile suggests a long half-life suitable for less frequent dosing, but specific data is limited.

Mechanism

Mechanism of Action

ACE-031, a dimeric fusion protein of activin receptor type IIB (ACVR2B) and IgG1-Fc, functions as a myostatin decoy receptor, binding to myostatin and related ligands to inhibit their signaling through the TGF-β superfamily pathways. This blockade disrupts the negative regulation of muscle growth, promoting muscle stem cell proliferation and differentiation, and enhancing protein accretion in skeletal muscle. While the precise downstream signaling mechanisms remain to be fully elucidated, ACE-031's action is believed to involve modulation of pathways associated with muscle hypertrophy and metabolism, such as the Akt/mTOR signaling pathway.

Research

16 Research Publications

568

Total Citations

4

Human/RCT

3.3

Avg. Influence

2025

Latest

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#01

Myostatin inhibitor ACE-031 treatment of ambulatory boys with Duchenne muscular dystrophy: Results of a randomized, placebo-controlled clinical trial.

HumanInfluence5.0
218
The study demonstrated that ACE-031 administration in boys with Duchenne muscular dystrophy resulted in trends for increased lean body mass and improved 6-minute walk test performance, despite safety concerns leading to trial discontinuation.
0.02-3 mg/kgsubcutaneous(human)3 mg/kg(human)29 days
PubMed
#02

A single ascending-dose study of muscle regulator ACE-031 in healthy volunteers.

HumanInfluence4.0
172
The study demonstrated that a single dose of ACE-031 in healthy postmenopausal women resulted in statistically significant increases in total body lean mass and thigh muscle volume, with generally well-tolerated safety profiles.
0.02-3 mg/kgsubcutaneous(human)3 mg/kg(human)29 days
PubMed
#03

Administration of a soluble activin type IIB receptor promotes skeletal muscle growth independent of fiber type.

AnimalInfluence3.0
141
The study demonstrated that ACE-031 administration in mice resulted in significant increases in muscle mass independent of fiber type, suggesting its potential as a therapeutic for musculoskeletal diseases.
0.02-3 mg/kgsubcutaneous(human)3 mg/kg(human)29 days
PubMed
#04

Emerging drugs affecting skeletal muscle function and mitochondrial biogenesis - Potential implications for sports drug testing programs.

ReviewInfluence1.0
36
The study demonstrated that numerous compounds, including ACE-031, may enhance skeletal muscle function and mitochondrial biogenesis, necessitating monitoring for potential misuse in sports drug testing.
0.02-3 mg/kgsubcutaneous(human)3 mg/kg(human)29 days
PubMed
#05

Gel Electrophoretic Detection of Black Market ACE-031.

Reichel Christian, et al. · Drug testing and analysis · 2025

In Vitro
1
Researchers observed that black market ACE-031 products primarily contained full-length human activin receptor IIB rather than the intended fusion protein, indicating a significant discrepancy in the composition of these substances.

Key findings

  1. 01Of 14 tested black market products, 12 contained a protein that was not ACE-031 but rather the full-length human activin receptor IIB.
  2. 02The study developed a detection method that successfully identified these products in rat serum for up to 48 hours after administration.
  3. 03The presence of additional proteins in the black market products indicates potential risks associated with their use.
0.02-3 mg/kgsubcutaneous(human)3 mg/kg(human)29 days
PubMed
#06

[Anti-myostatin antibody therapy for myopathies].

Review
Researchers observed that various approaches, including the myostatin decoy receptor ACE-031, are being explored for anti-myostatin therapy to address muscular dystrophies, although further safety evaluations are needed.
0.02-3 mg/kgsubcutaneous(human)3 mg/kg(human)29 days
PubMed
#07

[Myostatin blockade therapy for muscular atrophy].

Review
Researchers observed that myostatin inhibition, including the use of ACE-031, could be beneficial for muscle-wasting conditions beyond muscular dystrophy, highlighting its potential applications in various metabolic disorders.
0.02-3 mg/kgsubcutaneous(human)3 mg/kg(human)29 days
PubMed
#08

Combined rapamycin and mesenchymal stem/stromal cells derived from induced pluripotent stem cells-mediated delivery of ACVR2B-Fc fusion protein reduces heterotopic ossification in a mouse model of fibrodysplasia ossificans progressiva.

Gao Pan, et al. · JBMR plus · 2025

Animal
Researchers studied a genetic condition called fibrodysplasia ossificans progressiva (FOP), which causes abnormal bone growth. They found that combining a specific protein treatment with stem cells from induced pluripotent stem cells significantly reduced this abnormal bone formation in a mouse model.

Key findings

  1. 01Researchers observed that the combination of rapamycin and stem cells effectively reduced heterotopic ossification in mice with FOP.
  2. 02The study highlighted the role of the ACVR2B-Fc fusion protein in managing the effects of the disease.
  3. 03Findings suggest a potential new approach for addressing abnormal bone growth associated with FOP.
PubMed
#09

iMSC-mediated delivery of ACVR2B-Fc fusion protein reduces heterotopic ossification in a mouse model of fibrodysplasia ossificans progressiva.

Gao Pan, et al. · Stem cell research & therapy · 2024

In Vitro
Researchers studied a rare genetic disease called fibrodysplasia ossificans progressiva (FOP), which causes abnormal bone growth. They found that using a specific type of stem cell, combined with a candidate drug, reduced this abnormal bone formation in a mouse model, suggesting a potential new approach for treatment.

Key findings

  1. 01Researchers observed that stem cells expressing ACVR2B-Fc reduced abnormal bone growth in a mouse model of FOP.
  2. 02The study found that ACVR2B-Fc secreted by these stem cells decreased signaling pathways that lead to bone formation.
  3. 03Local injections of these modified stem cells improved movement performance in the mice.
PubMed
#10

Sex specificity of pancreatic cancer cachexia phenotypes, mechanisms, and treatment in mice and humans: role of Activin.

Zhong Xiaoling, et al. · Journal of cachexia, sarcopenia and muscle · 2022

Human
Researchers studied the effects of pancreatic cancer cachexia, a severe muscle-wasting condition, in both mice and humans, focusing on how it differs between sexes. They found that male mice experienced more severe muscle loss compared to females, and this pattern was mirrored in human patients, where men showed greater muscle wasting than women. The hormone Activin was identified as a key factor driving this muscle loss, highlighting the need for sex-specific approaches in treatment development.

Key findings

  1. 01Male mice with pancreatic cancer exhibited earlier and more severe muscle loss compared to female mice.
  2. 02In human patients, men experienced greater and faster muscle wasting than women during treatment for pancreatic cancer.
  3. 03The hormone Activin plays a significant role in muscle loss, particularly in males, suggesting that sex differences are crucial for understanding and treating cachexia.
PubMed
Safety

Safety & Handling

Research Gaps

The long-term effects of ACE-031 on muscle growth and overall health in humans remain unknown, as existing studies have primarily focused on short-term outcomes and safety. Additionally, the specific mechanisms by which ACE-031 influences muscle metabolism and its potential effects on non-muscle-related health issues are not yet fully understood.

Solubility

Soluble in water and saline solutions, limited solubility in organic solvents.

Storage & Handling

Lyophilized

Stable for 2+ years at -20°C, 12 months at 4°C

Reconstituted

Use within 14 days when refrigerated at 4°C

Avoid

Avoid repeated freeze-thaw cycles, direct light

Solvent

Bacteriostatic water or sterile saline recommended

Safety information is derived from published research and may not reflect all known risks. This is not medical advice.

Legal Status

Legal Status

🇩🇪DE

Not approved as a medicinal product. Not a controlled substance. Sale as research chemical is a legal grey area.

🇺🇸US

Not approved by the FDA as a medicinal product. Not scheduled by the DEA.

🇦🇺AU

Not listed in the Australian Register of Therapeutic Goods (ARTG).

🇬🇧UK

Not approved by the MHRA as a medicinal product.

Legal status information is provided for general reference only and may not reflect the most current regulatory changes. Always verify with official government sources before making any decisions.

Community Insights

Community Insights

Publications per Year

7 total
1
10
2
11
1
13
1
16
1
17
1
25
Pricing

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Mechanism

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Mechanism

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Legal Disclaimer

This page is for informational and research purposes only. All information is based on published scientific literature and does not constitute medical advice, diagnosis, or treatment recommendations. Many substances listed may not be approved for human use and may be subject to drug regulation laws (e.g., AMG in Germany, FDA in the US). PepStack does not encourage the use of any substance on humans. Always consult a qualified healthcare professional before making any health-related decisions. Use of this information is entirely at your own risk. PepStack assumes no liability for the accuracy, completeness, or timeliness of the content provided. Full disclaimer