What does ACE-031 do?

ACE-031 is described as an investigational ACVR2B-Fc fusion protein intended to reduce signaling from myostatin and related growth-limiting ligands. It was studied for muscle-related outcomes, including Duchenne muscular dystrophy research, but development was stopped and it is not an approved product.

How does ACE-031 work?

ACE-031 acts as a soluble decoy receptor based on activin receptor type IIB. By binding myostatin and related TGF-beta family ligands in circulation, it was designed to reduce their access to cell-surface receptors involved in limiting muscle growth. The same signaling network is also relevant outside muscle, which may help explain vascular and bleeding-related safety signals noted in trials.

Is ACE-031 FDA approved?

No. The source lists ACE-031 as not FDA approved and describes its development as halted because of safety concerns.

What side effects were reported for ACE-031?

The source reports nosebleeds, gum bleeding, telangiectasias, injection-site reactions and decreased FSH levels. It also notes that clinical development was discontinued after safety concerns emerged.

What dose information is available for ACE-031?

The source does not provide a reliable community dose beyond noting limited community data. In research settings, it reports 0.5-3 mg/kg every 2 weeks by subcutaneous injection in trials that were later discontinued.

Hormonal Clinical Trials - human trials under way

ACE-031

Also known as: ACVR2B-Fc, Myostatin Inhibitor

At a glance

PeptiGuide dataset · reviewed Aug 2026

What it is

Investigational ACVR2B-Fc myostatin-pathway inhibitor discontinued after safety concerns.

Status

Clinical Trials

Evidence level: human studies

Typical dose

Limited community data available

Subcutaneous injection

Researched for

Muscle growth research, muscular dystrophy

Trial progress

PrePreclinical
IPhase I
IIPhase II
IIIPhase III
IVPhase IV
FDAFDA approved

Phase II - Emerging human evidence with important limitations

Use the tools

In plain language

Investigational ACVR2B-Fc fusion protein studied for myostatin-pathway inhibition.
Researched for muscle growth and muscular dystrophy contexts, including Duchenne muscular dystrophy.
Not FDA approved; development is reported as halted after safety concerns.
Community dose information is limited, while research dosing came from discontinued trials.

How it's thought to work

ACE-031 is an ACVR2B-Fc fusion protein designed to function as a circulating ligand trap. The source describes it as binding myostatin and related TGF-beta superfamily ligands before they can signal through activin type IIB receptors on muscle. This pathway was investigated as a way to reduce growth-inhibitory signaling. Reported bleeding and telangiectasia findings are consistent with concern that activin-receptor signaling also affects vascular biology.

What the research shows

Where the research stands

The source describes ACE-031 as having been evaluated in humans, including single-ascending-dose work in healthy volunteers and an ascending-dose, placebo-controlled Phase 2 study in ambulatory boys with Duchenne muscular dystrophy. Reported study signals included changes related to lean mass, fat mass, bone measures and 6-minute walk distance. The Duchenne study stopped early after safety findings such as nosebleeds and telangiectasias, and the broader program was discontinued despite no serious or severe adverse events being formally attributed in the source summary.

What it shows

✓ Human studies

Emerging human evidence with important limitations

△ Limitations

Study protocols describe research and are not dosing recommendations.

Bottom line: Development halted due to safety concerns Not FDA Approved

Typical dosing

CommunityCommunity dataset

Limited community data available

See research protocols

Range: See research dosing

Community dosing information in the source is sparse and points back to research protocols rather than a well-established community regimen.

Research dosing

Study-specific protocolsHuman trials under way - protocols are study-specific

Doses observed in studies

0.5-3 mg/kg every 2 weeks in trials

Research literature observed in studies

Study protocols describe research and are not dosing recommendations.

Duration: Trials discontinued
Administration: Subcutaneous injection
Frequency: Every 2 weeks in trials

Timing & administration

Best time to take

Morning, same day each week

Once weekly

Food recommendation

With or without food

Why this timing?

The source suggests a morning schedule to make observation after use more practical, with weekly timing noted separately from the every-2-week research dosing row.

Possible side effects

Not everyone experiences these. Individual responses vary with dose, duration, and personal factors.

Nosebleeds
Gum bleeding
Spider veins (telangiectasias)
Injection-site reactions
FSH level decrease
Clinical trials discontinued due to safety concerns

Not everyone experiences side effects, and severity can vary by context, purity, route, and individual health factors.

Sources

PubMed ClinicalTrials.gov FDA.gov

Frequently asked questions

Sequence

GRGEAETRECIYYNANWELERTNQSGLERCEGEQDKRLHCYASWRNSSGTIELVKKGCWLDDFNCYDRQECVATEENPQVYFCCCEGNFCNERFTHLPEAGGPEVTYEPPPTAPTGGGTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPVPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK; ACVR2B-Fc dimer with KEGG-defined inter/intrachain disulfides and glycosylation sites

One open dataset

Every fact on this page - doses, side effects, references - comes from the same PeptiGuide dataset that powers the Tracker, Compare, and the Lab.

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Educational resource, not medical advice. Talk to your clinician before acting on anything here.

Community discussion

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ACE-031

In plain languageIn plain language

How it's thought to workHow it's thought to work

What the research showsWhat the research shows

Typical dosing

Research dosing

Timing & administrationTiming & administration

Possible side effectsPossible side effects

SourcesSources

Frequently asked questionsFrequently asked questions