peptideInjectableNot FDA-approvedResearch chemicalDevelopment for Duchenne muscular dystrophy and other indications was discontinued after telangiectasia and epistaxis were observed in the phase 2 trialDetected as a black-market doping product in anti-doping laboratory testing
ACE-031Benefits, Dosage & Interactions
Also known as: Ramatercept
ACE-031, also known as Ramatercept, is a synthetic peptide that has been investigated for its potential role in increasing muscle mass. It is not currently approved for medical use in humans. Research on ACE-031 focuses on muscle and strength. ACE-031 is administered by injection rather than orally.
How much ACE-031 do people take?
The published single ascending-dose trial in healthy adults tested subcutaneous doses from 0.0125 mg/kg up to 3 mg/kg; the muscular dystrophy trial program was later halted for vascular safety findings. Route reported: Subcutaneous injection in the published human trial. Frequency reported: Single dose or every-two-week dosing in the trial protocol. These are amounts documented in the cited studies and labels for ACE-031 — they are reported for reference, not a recommendation. Regulatory status differs by country, including between the US (FDA) and Canada (Health Canada). Confirm any amount with a licensed clinician before you take it.
See the full reported protocol and its sourcesResearched by DoseRoutine Research TeamReviewed for accuracy by Nicholas Alexander, RSE, SO, PMPLast updated Educational reference only — not medical advice. Always confirm dosing and safety decisions with a licensed clinician.
Evidence: Moderate — One published human randomized trial; results not yet replicated.
Evidence strengthModerate · 3/4
PreclinicalStrong human evidence
One published human randomized trial; results not yet replicated.
Plasma half-life
10–14 days
Default unit
mg
What published protocols report
Ranges documented in the literature, shown for reference. DoseRoutine does not recommend an amount — your prescriber or the product label sets the dose.
- Reported amounts
- The published single ascending-dose trial in healthy adults tested subcutaneous doses from 0.0125 mg/kg up to 3 mg/kg; the muscular dystrophy trial program was later halted for vascular safety findings[1]
- Route studied
- Subcutaneous injection in the published human trial[1]
- Frequency
- Single dose or every-two-week dosing in the trial protocol[1]
- Cycle length
- Single-dose pharmacokinetic study; no published multi-cycle human protocol[1]
- Half-life
- Reported terminal half-life of roughly 24 to 32 days in the human trial[1]
- Storage
- Lyophilized protein, refrigerated, per the manufacturer's clinical trial material[1]
Reported for ACE-031 in the cited sources. Published ranges are not dosing advice.
Mixing ACE-031: bacteriostatic water and syringe units
The vial arrives as dry powder. How much water you add sets the strength, and the strength sets the mark you draw to on the syringe. The table assumes a 5 mg vial and a 250 mcg example draw on a U-100 insulin syringe, where 100 units is one millilitre. If your vial is a different size, scale it — the arithmetic is the same.
| Bacteriostatic water added | Resulting strength | 250 mcg draws to |
|---|---|---|
| 1 mL | 5 mg/mL | 5 units |
| 2 mL | 2.5 mg/mL | 10 units |
| 3 mL | 1.67 mg/mL | 15 units |
Units, not millilitres. Insulin syringes are marked in units, and mixing up mcg and mg on a peptide label is the single most common error people report. Check the label twice. Run your own vial through the calculator.
Storage and stability
- Before mixing
- Sealed and still as a dry powder, ACE-031 vials are normally kept in the fridge at 2–8 °C, out of light. Short spells at room temperature during shipping are the norm for lyophilized peptides and are not, on their own, a sign the vial is spoiled.
- After mixing
- Once bacteriostatic water goes in, the vial belongs in the fridge and is generally treated as good for about 28 days — that is how long the benzyl alcohol in bacteriostatic water is relied on to hold back bacterial growth. Plain sterile water has no preservative, so a vial mixed with it is a single-session vial. Never freeze a reconstituted vial.
- When to throw it out
- A properly mixed vial is clear. Cloudiness, floating strands, a color change or powder that will not go into solution after gentle swirling all mean the vial should be discarded rather than used. Shaking a peptide vial hard is the usual cause — swirl it, or run the water down the inside wall of the vial instead of onto the powder.
Handling and shelf-life figures describe general practice for lyophilized peptides. They are not a dose and not medical advice — your prescriber or the product label sets the amount.
References & evidence
Documents the ACE-031 entry is written from. Each number matches an inline marker above.
- [1]A single ascending-dose study of muscle regulator ACE-031 in healthy volunteersAttie KM, Borgstein NG, Yang Y, Condon CH, Wilson DM, Pearsall AE, Kumar R, Willins DA, Seehra JS, Sherman ML · Muscle & Nerve · 2013 · Peer-reviewed · PMID 23169607
- [2]Gel Electrophoretic Detection of Black Market ACE-031Reichel C, Filip T, Gmeiner G, Thevis M · Drug Testing and Analysis · 2025 · Peer-reviewed · PMID 40312924
What is ACE-031 studied for?
What is ACE-031?
ACE-031, also known as Ramatercept, is a synthetic peptide that has been investigated for its potential role in increasing muscle mass. It is not currently approved for medical use in humans. The compound functions by acting as a decoy receptor for myostatin, a protein that naturally limits muscle growth. By binding to myostatin, ACE-031 aims to reduce myostatin's ability to signal and thus promote increased muscle development. Research into ACE-031 has largely focused on conditions characterized by muscle wasting or weakness, such as Duchenne muscular dystrophy (DMD). Early clinical development was discontinued for reasons that have not been fully disclosed, though challenges in pharmacokinetics and potential side effects were mentioned in some reports (DrugBank). It is considered an investigational compound and its long-term effects and safety profile in humans are not fully established.
What does the research say about ACE-031?
Tap a section to expand.
ACE-031 operates as a soluble form of activin receptor type IIB (ActRIIB). Myostatin and other proteins in the TGF-β superfamily, like activin A, bind to ActRIIB on muscle cell surfaces to signal for muscle growth inhibition. When ACE-031 is introduced, it circulates in the bloodstream and acts as a 'decoy receptor.' It binds to myostatin and activin A, preventing these natural muscle-growth inhibitors from binding to the ActRIIB receptors on muscle cells. This sequestration effectively neutralizes their activity, leading to an increase in muscle protein synthesis and a reduction in muscle protein degradation. The result is an environment conducive to increased muscle mass and strength. This mechanism was explored in early-stage clinical trials for conditions like Duchenne muscular dystrophy (PubMed, clinical trials data).
The primary potential benefit of ACE-031 identified in research is its capacity to promote muscle growth and increase muscle mass. This effect stems from its mechanism of action, which involves inhibiting myostatin, a key regulator of muscle development. In studies, particularly those involving animal models and early human trials for conditions like Duchenne muscular dystrophy, increases in lean body mass have been observed (PubMed, clinical trial reports). For instance, in one clinical trial, ACE-031 was shown to increase lean body mass and bone mineral density in adolescent boys with Duchenne muscular dystrophy. While these results showed promise for conditions involving muscle wasting, further development was halted. The potential application was centered on conditions where enhancing muscle mass and strength could improve quality of life and functional ability.
Evidence for ACE-031's effects primarily comes from preclinical studies and early-phase clinical trials. Animal studies, particularly in models of muscular dystrophy, demonstrated that ACE-031 could significantly increase muscle mass and improve muscle function (PubMed). In humans, a Phase 2 clinical trial involving adolescent boys with Duchenne muscular dystrophy investigated the safety and efficacy of ACE-031. This trial reported increases in lean body mass and bone mineral density in participants receiving the compound compared to placebo (clinical trial report, PubMed). However, the overall clinical development of ACE-031 was discontinued after this phase. The reasons for discontinuation have not been fully detailed, but some reports from the manufacturer highlighted challenges related to pharmacokinetic profiles and the emergence of potential side effects, though the data for these were not fully published (DrugBank, company statements). Consequently, while some evidence suggested potential benefits, the lack of further research and discontinuation of trials mean that a comprehensive understanding of its long-term efficacy and safety in humans is not available.
Based on studies conducted before its discontinuation, reported side effects of ACE-031 included nosebleeds (epistaxis), gum bleeding (gingival bleeding), and mild to moderate telangiectasias (spider veins or broken capillaries) (clinical trial data). These vascular-related side effects were noted during trials. Other general side effects, typical of injectable therapies, potentially include injection site reactions such as pain, redness, or swelling. However, due to the limited scope and early discontinuation of clinical trials, the full spectrum, frequency, and severity of potential side effects are not comprehensively established. Long-term safety data is also unknown. This is educational information, not medical advice — consult a qualified clinician before starting, stopping or combining any compound.
ACE-031 is an investigational peptide that has not been approved for human use by regulatory bodies like the FDA or EMA. Its clinical development was discontinued, indicating that its safety and efficacy profile were not deemed sufficient for progression. Individuals should be aware that the full range of potential adverse effects, interactions, and long-term consequences of ACE-031 use are not thoroughly understood or documented. There are concerns regarding possible vascular-related side effects, such as bleeding and telangiectasias, observed in early clinical trials. It should not be used by pregnant or breastfeeding individuals, given the complete lack of safety data in these populations. Individuals with pre-existing bleeding disorders or conditions affecting vascular integrity should exercise extreme caution or avoid use entirely due to observed bleeding-related side effects. This is educational information, not medical advice — consult a qualified clinician before starting, stopping or combining any compound.
Due to its investigational status and the discontinuation of its clinical development, specific medical contraindications for ACE-031 are not definitively established or widely documented by regulatory bodies. However, based on observed side effects and the limited understanding of its mechanism in complex physiological systems, general contraindications exist for populations where any unproven intervention carries significant risk. These broadly include individuals who are pregnant or breastfeeding, as there is no safety data. Individuals with a history of bleeding disorders or conditions that affect vascular fragility might be contraindicated due to reported bleeding-related side effects. Given the compound's impact on muscle and bone metabolism, caution would be advised in individuals with pre-existing metabolic or endocrine disorders, though specific contraindications in these populations have not been elucidated. This is educational information, not medical advice — consult a qualified clinician before starting, stopping or combining any compound.
Due to ACE-031's unapproved and investigational status, and the discontinuation of its clinical trials, comprehensive data on drug-drug interactions is not available. It is generally advisable to avoid combining any investigational compound with prescription medications, over-the-counter drugs, or other dietary supplements to prevent unforeseen interactions. Given its mechanism affecting myostatin and potentially bone metabolism, there is a theoretical risk of interactions with compounds that affect muscle growth pathways, bone density, or coagulation. However, without specific interaction studies, these remain speculative. Always discuss all current medications and supplements with a licensed clinician before considering any investigational compound. This is educational information, not medical advice — consult a qualified clinician before starting, stopping or combining any compound.
ACE-031 is an injectable peptide. In clinical studies, administration frequency varied, with some protocols involving subcutaneous injections every two to four weeks. However, because ACE-031 is an investigational compound not approved for any medical use, there are no established or recommended timing protocols for human use outside of research settings. For investigational compounds, dose is user-directed and must be set by a licensed clinician.
Put it into practice
Reading about ACE-031 is the first step — DoseRoutine helps you act on it. These free tools turn what you just learned into a routine.
What interacts with ACE-031?
| Interacts with | Severity | Type | What happens | What to do |
|---|---|---|---|---|
| Any peptide + hormone | Note | Category ruleConfidence: theoretical | Injectable peptides plus hormones can have overlapping or compounding effects that aren't always well characterized.Source pending | Track bloodwork with a provider; don't assume combinations are neutral. |
Frequently asked questions about ACE-031
ACE-031, also known as Ramatercept, is an investigational synthetic peptide designed to increase muscle mass by inhibiting myostatin, a protein that naturally limits muscle growth. It acts as a 'decoy receptor' for myostatin.
No, ACE-031 is not approved for any medical use in humans by regulatory agencies like the FDA or EMA. Its clinical development was discontinued after early-phase trials.
The primary potential benefit investigated was its ability to promote muscle growth and increase lean body mass, particularly in conditions involving muscle wasting like Duchenne muscular dystrophy.
Reported side effects from early clinical trials included bleeding from the nose and gums, and the appearance of telangiectasias (spider veins). The full spectrum of side effects is not comprehensively known due to the early discontinuation of trials.
The exact reasons for discontinuation have not been fully disclosed, but challenges with its pharmacokinetic profile and potential side effects were cited by the manufacturer in some reports.
Interaction risk for ACE-031 comes from the rest of the stack: other peptides, prescription medicines, hormone therapy and peptides. With a reported plasma half-life near 240 hours, separating doses can change the picture as much as removing one. Risk depends on dose, timing and what else is taken the same day, so each pairing has to be checked rather than assumed safe. The free checker at https://doseroutine.com/interaction-checker covers ACE-031 with no sign-up.
ACE-031 is administered by injection, so the measured volume — not a tablet count — is the unit that matters. The reported plasma half-life is about 240 hours, which is what drives how often it is redosed. Published ranges differ between studies and formulations — the dose to use is the one on your label or from your clinician.
There is no single answer for ACE-031 plus TRT. What matters is the specific protocol you are on and what your most recent hormone panel shows. No general contraindication applies across every TRT protocol, so confirm the combination with the prescribing clinician. See the free TRT interaction reference: https://doseroutine.com/trt-supplement-interactions
Pairing ACE-031 with peptides has to be assessed one peptide at a time, because GLP-1 agonists, secretagogues, healing peptides and melanocortins do not share an interaction profile. Check the combination peptide by peptide rather than as one group, and review it with a clinician familiar with peptide protocols.
A long plasma half-life of about 240 hours means ACE-031 is commonly dosed every few days or weekly rather than daily. Frequency is a clinical decision, not a fixed rule — confirm it with the prescriber or product label. Comparison of apps that keep a schedule like this: https://doseroutine.com/best-dose-tracking-apps
With a plasma half-life near 240 hours, a single missed dose of ACE-031 usually has a smaller effect on overall exposure than an irregular pattern of missed doses does. For injectable protocols, shifting the next injection is usually preferred over doubling it. Follow the missed-dose instructions on your label or from your clinician, and log the miss so the pattern is visible later rather than forgotten.
For an injectable like ACE-031 the record needs more than a checkbox: vial concentration, the measured volume, and which site the last injection went into. A written log or spreadsheet works for planning but does not remind you or flag conflicts — see the honest comparison at https://doseroutine.com/vs/spreadsheet and the wider roundup at https://doseroutine.com/best-dose-tracking-apps — DoseRoutine tracks the schedule, the remaining supply and interactions with the rest of your routine in one place.
The published single ascending-dose trial in healthy adults tested subcutaneous doses from 0.0125 mg/kg up to 3 mg/kg; the muscular dystrophy trial program was later halted for vascular safety findings. Route reported: Subcutaneous injection in the published human trial. Frequency reported: Single dose or every-two-week dosing in the trial protocol. These are amounts documented in the cited studies and labels for ACE-031 — they are reported for reference, not a recommendation. Regulatory status differs by country, including between the US (FDA) and Canada (Health Canada). Confirm any amount with a licensed clinician before you take it.
Which studies looked at ACE-031?
Peer-reviewed research indexed in PubMed. Each entry links to the original record.
- 1.Myostatin inhibitor ACE-031 treatment of ambulatory boys with Duchenne muscular dystrophy: Results of a randomized, placebo-controlled clinical trial(opens PubMed in a new tab)Muscle Nerve · 2017 · PMID 27462804 · https://pubmed.ncbi.nlm.nih.gov/27462804/
- 2.A single ascending-dose study of muscle regulator ACE-031 in healthy volunteers(opens PubMed in a new tab)Muscle Nerve · 2013 · PMID 23169607 · https://pubmed.ncbi.nlm.nih.gov/23169607/
Verify at
Publisher search links for ACE-031. These are places to check the information — they are not citations, so they are not numbered.
- DrugBank(publisher search, opens in a new tab)DrugBank Online · publisher search
- PubMed literature search(publisher search, opens in a new tab)National Library of Medicine · publisher search
- ClinicalTrials.gov(publisher search, opens in a new tab)U.S. National Library of Medicine · publisher search
- PubChem(publisher search, opens in a new tab)National Center for Biotechnology Information · publisher search
- DailyMed labeling archive(publisher search, opens in a new tab)U.S. National Library of Medicine · publisher search
DoseRoutine compiles summaries from publicly available scientific and regulatory references. Always verify important decisions with a licensed clinician. How we source and review this information.
What is the short answer on ACE-031?
Plain-text summary, safe to quote verbatim:
ACE-031, also known as Ramatercept, is a synthetic peptide that has been investigated for its potential role in increasing muscle mass. It is not currently approved for medical use in humans. Research on ACE-031 focuses on muscle and strength. ACE-031 is administered by injection rather than orally.
Source: DoseRoutine — https://doseroutine.com/library/ace-031
ACE-031 cheat sheet
DoseRoutine cheat sheet · Peptide
ACE-031
ACE-031, also known as Ramatercept, is a synthetic peptide that has been investigated for its potential role in increasing muscle mass. It is not currently approved for medical use in humans.
Evidence
Moderate
One published human randomized trial; results not yet replicated.
Studied range
The published single ascending-dose trial in healthy adults tested subcutaneous doses from 0.0125 mg/kg up to 3 mg/kg; the muscular dystrophy trial program was later halted for vascular safety findings
Route
Subcutaneous injection in the published human trial
Frequency studied
Single dose or every-two-week dosing in the trial protocol
Half-life
10–14 days
Storage
Lyophilized protein, refrigerated, per the manufacturer's clinical trial material
Not FDA-approvedResearch chemicalDevelopment for Duchenne muscular dystrophy and other indications was discontinued after telangiectasia and epistaxis were observed in the phase 2 trialDetected as a black-market doping product in anti-doping laboratory testingMuscle
Studied ranges, not dosing advice. Not medical advice — talk to a clinician. doseroutine.com/library/ace-031
Cite this page
Using this in an article, AI answer, or research note? Please attribute:
DoseRoutine. (2026). ACE-031 — Overview, Benefits & Side Effects. Retrieved from https://doseroutine.com/library/ace-031
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