Compounds / Elamipretide

Elamipretide

SS-31 · MTP-131 · Bendavia · Forzinity

Elamipretide has 29 registered human trials — it is genuinely well studied. The question worth asking is what those trials were studying, because it is often not what the compound is sold for.

In short

  • 29 registered human trials exist for Elamipretide.
  • No registered trial lists anti-aging or energy as a studied condition.
  • Elamipretide is FDA-approved — but only for a specific indication, not general use.
  • What has actually been studied: barth syndrome, aging, healthy.
  • 2 studies are open to new participants, so this may change.
  • Last checked against ClinicalTrials.gov on 2026-07-27.
29
Registered human trials
3
Under way, incl. closed to enrolment
Yes
FDA approved
Pre
P1
P2
P3
Furthest stage reached

FDA-approved (Forzinity, accelerated approval) to improve muscle strength in Barth syndrome, an ultra-rare mitochondrial disease. Approval does not extend to general anti-aging use.

What it's sold for

  • Mitochondrial function
  • Anti-aging
  • Energy
  • Muscle performance

What has actually been tested

  • Healthy Volunteers
  • Heart Failure
  • Age-related Macular Degeneration
  • Barth Syndrome
  • Healthy
  • Primary Mitochondrial Disease
  • Age Related Macular Degeneration (ARMD)
  • Age-Related Macular Degeneration

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 Mitochondrial function
Not listed Anti-aging
Not listed Energy
Studied Muscle performance

Every trial on record

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

Trial IDTitleConditionPhaseStatusEnrolled
NCT07531251 Clinical Trial in Patients With Barth Syndrome- 4TAZPower Barth Syndrome Phase 4 Recruiting now 48
NCT07275424 Study of Healthy Aging and Physical Function With Elamipretide Aging, Healthy Phase 2 Recruiting now 30
NCT05162768 Study to Evaluate Efficacy and Safety of Elamipretide in Subjects With Primary Mitochondrial Disease From Nuclear DNA Mutations (nPMD) Mitochondrial Myopathies, Mitochondrial Pathology Phase 3 Completed 102
NCT01754818 A Phase 1 Study Examining the Pharmacokinetics and Tolerability of a Single Oral Dose of Bendavia (MTP-131) Healthy Phase 1 Completed 30
NCT02653391 A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for the Treatment of Fuchs' Corneal Endothelial Dystrophy (FCED) Fuchs' Corneal Endothelial Dystrophy (FCED) Phase 2 Completed 22
NCT02805790 Safety, Tolerability, Efficacy of MTP-131 for Treatment of Mitochondrial Disease in Subjects From the MMPOWER Study Primary Mitochondrial Disease Phase 2 Completed 30
NCT02693119 A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for Treatment of Leber's Hereditary Optic Neuropathy Leber's Hereditary Optic Neuropathy Phase 2 Completed 12
NCT01572909 Evaluation of Myocardial Effects of MTP-131 for Reducing Reperfusion Injury in Patients With Acute Coronary Events Reperfusion Injury, STEMI Phase 2 Completed 300
NCT03891875 ReCLAIM-2 Study to Evaluate Safety,Efficacy & Pharmacokinetics of Elamipretide in Subjects With AMD With Non-central GA Age-related Macular Degeneration Phase 2 Completed 176
NCT02436447 A Phase 1 Study Investigating the Safety and Pharmacokinetics of Repeat-dose Intravenous Infusion of MTP-131 in Subjects With Impaired Renal Function Normal and Impaired Renal Function Phase 1 Completed 23
NCT03098797 A Trial to Evaluate Safety, Tolerability and Efficacy of Elamipretide in Subjects With Barth Syndrome Barth Syndrome Phase 3 Completed 12
NCT02848313 An Open-Label, Phase 1 Clinical Study to Evaluate the Safety and Tolerability of Subcutaneous Elamipretide in Subjects With Intermediate Age-Related Macular Degeneration Age-Related Macular Degeneration Phase 1 Completed 40
NCT02245620 A Phase 2 Study to Evaluate the Impact of MTP-131 (Bendavia™) on Skeletal Muscle Function in Elderly Skeletal Muscle Mitochondrial Dysfunction in the Elderly Phase 2 Completed 41
NCT05168774 FRDA Investigator Initiated Study (IIS) With Elamipretide Friedreich Ataxia Phase 2 Completed 20
NCT02388464 A Study Investigating the Safety, Tolerability, and Pharmacokinetics of MTP-131 in Subjects With Congestive Heart Failure Congestive Heart Failure Phase 1 Completed 36
NCT01115920 Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of Intravenous (IV) Infusion of MTP-131 (Bendavia™) in Healthy Adults Healthy Phase 1 Completed 40
NCT02788747 Effect of Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Reduced Ejection Fraction Heart Failure Phase 2 Completed 71
NCT01513200 Study to Assess the Pharmacodynamic Effects of Unfractionated Heparin (UFH) in Healthy Volunteers With and Without Bendavia Healthy Volunteers Phase 1 Completed 12
NCT02314299 A Study of MTP-131 Topical Ophthalmic Solution in Subjects With Diabetic Macular Edema and Non-Exudative Intermediate Age-related Macular Degeneration Diabetic Macular Edema, Age-related Macular Degeneration Phase 2 Completed 20
NCT02914665 A Phase 2 Study to Evaluate the Cardiac and Renal Effects of Short Term Treatment With Elamipretide in Patients Hospitalized With Congestion Due to Heart Failure Heart Failure Phase 2 Completed 308
NCT01518985 The Impact of Intravenous Bendavia™ on Endothelial Reactivity Dysfunction in Cigarette Smoking Healthy Volunteers Phase 1 Completed 6
NCT02367014 Safety, Tolerability, and Efficacy of MTP-131 for the Treatment of Mitochondrial Myopathy Mitochondrial Myopathy Phase 2 Completed 36
NCT01786915 Safety and Pharmacokinetic (PK) Study of Oral Bendavia Administered for 7 Days Healthy Volunteers Phase 1 Completed 30
NCT02814097 A Study to Evaluate the Effects of 4 Weeks Treatment With Subcutaneous Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Preserved Ejection Fraction Chronic Heart Failure Phase 2 Completed 46
NCT02976038 Open-Label Extension Trial to Characterize the Long-term Safety and Tolerability of Elamipretide in Subjects With Genetically Confirmed Primary Mitochondrial Myopathy (PMM) Primary Mitochondrial Disease Phase 2 Stopped early 28
NCT01755858 Effects of Intravenous Bendavia™ on Reperfusion Injury in Patients Undergoing Angioplasty of the Renal Artery Renal Artery Obstruction, Hypertension, Renovascular Phase 2 Stopped early 16
NCT02388529 A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Bendavia™ (MTP-131) in Patients With Heart Failure Heart Failure Phase 1 Withdrawn before enrolling 0 — nobody enrolled
NCT03323749 A Trial to Evaluate Safety and Efficacy of Elamipretide Primary Mitochondrial Myopathy Followed by Open-Label Extension Primary Mitochondrial Myopathy Phase 3 Stopped early 218
NCT06373731 ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD) Age Related Macular Degeneration (ARMD) Phase 3 Running, closed to new participants 313
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 Elamipretide 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.

29
Registered human trials the number we publish
Interventional studies in people, listed on ClinicalTrials.gov, at any status.
22
Completed
Registered trials whose status is "completed".
3
Still running
Recruiting, not yet recruiting, or active.
4
Stopped early
Terminated, withdrawn, or suspended.
29
With a stated phase
Registered trials tagged Phase 1-4.
6
100+ participants
Registered trials enrolling at least 100 people.
0
Observational studies
Studies that watch rather than intervene.
You may see a lower number than 29.

Sources that count only completed studies get 22. 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", 29 is the honest answer, with the caveat that 22 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 Elamipretide

How many human trials does Elamipretide have?

29. 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 Elamipretide FDA approved?

Yes, but read the detail: FDA-approved (Forzinity, accelerated approval) to improve muscle strength in Barth syndrome, an ultra-rare mitochondrial disease. Approval does not extend to general anti-aging use. An approval for one condition is not an approval for everything it is marketed for.

What is Elamipretide actually being tested for?

Registered studies cover: barth syndrome, aging, healthy, mitochondrial myopathies. 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.

Get told when this changes

One email a week: what moved in the research, and which claims the record doesn't support. Free, and you can leave in one click.