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.
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 ID | Title | Condition | Phase | Status | Enrolled |
|---|---|---|---|---|---|
| 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 |
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.
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.
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.
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