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ACE-031

ACVR2B-Fc · Bimagrumab precursor

IGF Axis & MusclePhase II
From$29.99/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 and related ligands, which negatively regulate muscle growth, making it a candidate for addressing muscle-wasting conditions such as Duchenne muscular dystrophy. Key findings from clinical trials indicate that ACE-031 may lead to increases in lean body mass and muscle volume, while also showing trends for improved bone mineral density and reduced fat mass. However, studies have raised safety concerns, leading to the discontinuation of some clinical trials. Currently, ACE-031 remains unapproved for pharmaceutical use and is often found on the black market, highlighting the need for further research to evaluate its safety and efficacy.

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 is a dimeric fusion protein that acts as a decoy receptor for myostatin and related ligands by binding to activin receptor type IIB (ActRIIB), thereby inhibiting the myostatin signaling pathway, which normally suppresses muscle growth and differentiation. This inhibition promotes muscle hypertrophy and increases lean body mass by disrupting the negative regulation of muscle stem cell proliferation and differentiation. While the precise downstream signaling mechanisms remain to be fully elucidated, ACE-031's effects suggest modulation of pathways involved in muscle protein synthesis and metabolism, potentially including the Akt/mTOR pathway.

Research

16 Research Publications

557

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
211
The study demonstrated that ACE-031 treatment in ambulatory boys with Duchenne muscular dystrophy resulted in trends for increased lean body mass and bone mineral density, but was discontinued due to non-muscle-related adverse events.
0.02-3 mg/kgsubcutaneous(healthy volunteers)3 mg/kg(healthy postmenopausal women)at day 29
PubMed
#02

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

HumanInfluence4.0
170
Researchers observed that single-dose ACE-031 treatment in healthy postmenopausal women resulted in statistically significant increases in total body lean mass and thigh muscle volume, indicating its potential to promote muscle growth.
0.02-3 mg/kgsubcutaneous(healthy volunteers)3 mg/kg(healthy postmenopausal women)at day 29
PubMed
#03

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

AnimalInfluence3.0
139
Researchers observed that administration of ACE-031 in mice increased muscle mass independently of fiber-type expression, suggesting its potential as a therapeutic agent for musculoskeletal diseases.
0.02-3 mg/kgsubcutaneous(healthy volunteers)3 mg/kg(healthy postmenopausal women)at day 29
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(healthy volunteers)3 mg/kg(healthy postmenopausal women)at day 29
PubMed
#05

Gel Electrophoretic Detection of Black Market ACE-031.

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

Animal
1
Researchers observed that black market ACE-031 products contained full-length human activin receptor IIB instead of the intended dimeric fusion protein, highlighting the challenges in detecting illicit 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(healthy volunteers)3 mg/kg(healthy postmenopausal women)at day 29
PubMed
#06

[Myostatin blockade therapy for muscular atrophy].

Review
The review indicated that myostatin inhibition, including strategies like ACE-031, could be effective for various muscle-wasting conditions and metabolic disorders, warranting further investigation into safety and application.
0.02-3 mg/kgsubcutaneous(healthy volunteers)3 mg/kg(healthy postmenopausal women)at day 29
PubMed
#07

[Anti-myostatin antibody therapy for myopathies].

Review
The review highlighted various approaches, including ACE-031, for anti-myostatin therapy, emphasizing the need for further evaluation of safety and efficacy in treating muscular dystrophies and other muscle-wasting conditions.
0.02-3 mg/kgsubcutaneous(healthy volunteers)3 mg/kg(healthy postmenopausal women)at day 29
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

No comprehensive long-term studies in humans have been conducted to assess the sustained effects and safety of ACE-031 beyond the short-term trials. Additionally, the precise mechanisms by which ACE-031 promotes muscle growth and its potential impacts on various muscle fiber types remain unclear, necessitating further investigation into its pharmacodynamics and long-term metabolic consequences.

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