Compounds / ACE-031

ACE-031

Ramatercept · ActRIIB-IgG1

ACE-031 has 4 registered human trials on record. It is marketed for 2 different uses.

In short

  • 4 registered human trials exist for ACE-031.
  • No registered trial lists strength as a studied condition.
  • ACE-031 is not FDA-approved for any use.
  • What has actually been studied: muscle loss, muscular atrophy.
  • No study is currently open to new participants.
  • Last checked against ClinicalTrials.gov on 2026-07-27.
4
Registered human trials
0
Under way, incl. closed to enrolment
No
FDA approved
Pre
P1
P2
P3
Furthest stage reached

Not FDA-approved. Development was discontinued.

What it's sold for

  • Muscle growth
  • Strength

What has actually been tested

  • Duchenne Muscular Dystrophy
  • Muscle Loss
  • Muscular Atrophy

Is it studied for what it's sold for?

Each claim below is matched against the condition and title fields of every registered trial. Not listed means no trial names it as a studied condition — not that it has been disproven, and not that no trial touches it indirectly.

Studied Muscle growth
Not listed Strength

Every trial on record

Every registered human study we can find for ACE-031. Click any ID to read the original record — we would rather you checked us than trusted us.

Trial IDTitleConditionPhaseStatusEnrolled
NCT00755638 A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 (ActRIIB-IgG1)in Healthy Postmenopausal Volunteers Muscle Loss Phase 1 Completed 48
NCT00952887 A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 in Healthy Postmenopausal Women Muscular Atrophy Phase 1 Completed 70
NCT01239758 Extension Study of ACE-031 in Subjects With Duchenne Muscular Dystrophy Duchenne Muscular Dystrophy Phase 2 Stopped early 11
NCT01099761 Study of ACE-031 in Subjects With Duchenne Muscular Dystrophy Duchenne Muscular Dystrophy Phase 2 Stopped early 24
Read this
A trial count is not a verdict
These numbers describe how much has been formally studied in humans, not whether something works or is safe for you. A compound can be tested for one condition and sold for another — which is usually the story. This page is automated aggregation from public registries; no physician has reviewed it. Take anything here to a clinician.

Why sources disagree on this number

Different sites publish different counts for ACE-031 because they are answering different questions. Here is every way of counting the same set of studies, so you can see which rule produces which number.

4
Registered human trials the number we publish
Interventional studies in people, listed on ClinicalTrials.gov, at any status.
2
Completed
Registered trials whose status is "completed".
0
Still running
Recruiting, not yet recruiting, or active.
2
Stopped early
Terminated, withdrawn, or suspended.
4
With a stated phase
Registered trials tagged Phase 1-4.
0
100+ participants
Registered trials enrolling at least 100 people.
0
Observational studies
Studies that watch rather than intervene.
You may see it said that there are "no large clinical trials" of ACE-031.

That is accurate under a specific definition. 4 registered human trials exist, but none enrol 100 or more people. Both statements describe the same registry. They differ only in what counts as "large".

You may see a lower number than 4.

Sources that count only completed studies get 2. We count registered trials at any status, because a trial that is recruiting is still a real trial and is the thing most likely to change this page. Neither number is wrong; they answer different questions.

Which number should you use?

For "how much human evidence exists", 4 is the honest answer, with the caveat that 2 have actually finished. Every trial is listed on this page with its ID — if you disagree with how we count, you can recount it yourself in about a minute.

Common questions about ACE-031

How many human trials does ACE-031 have?

4. That is the number of registered interventional human studies we can find, each listed on this page with a link to its original record.

Is ACE-031 FDA approved?

No. ACE-031 is not approved by the FDA for any indication. Compounded or "research use only" preparations are not FDA-approved and receive no premarket review for safety, effectiveness, or manufacturing quality.

What is ACE-031 actually being tested for?

Registered studies cover: muscle loss, muscular atrophy, duchenne muscular dystrophy. Compare that to what it is marketed for — the two lists are often different, which is the whole point of this page.

Where does this data come from?

ClinicalTrials.gov, the US public registry of clinical studies. We count interventional human studies only — observational studies are not evidence of effect. Every trial on this page links to its original record so you can check us rather than trust us.

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