# Elamipretide

Elamipretide has 29 registered human trials. It is marketed for 4 different uses.

**In short**

- 29 registered human trials exist for Elamipretide.
- Elamipretide is FDA-approved — 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 has actually been studied: mitochondrial myopathies, mitochondrial pathology, mitochondrial dna mutation.
- Last checked against ClinicalTrials.gov on 2026-07-27.

## What it is sold for

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

## What has actually been tested

- Mitochondrial Myopathies
- Mitochondrial Pathology
- Mitochondrial DNA Mutation
- Mitochondrial Diseases
- Mitochondrial DNA Deletion
- Mitochondrial DNA Depletion
- Mitochondrial Metabolism Defect
- Mitochondrial Complex I Deficiency
- Healthy
- Fuchs' Corneal Endothelial Dystrophy (FCED)
- Primary Mitochondrial Disease
- Leber's Hereditary Optic Neuropathy
- Reperfusion Injury
- STEMI
- Renal Artery Obstruction
- Hypertension, Renovascular
- Ischemia Reperfusion Injury
- Age-related Macular Degeneration
- Normal and Impaired Renal Function
- Barth Syndrome
- Age-Related Macular Degeneration
- Skeletal Muscle Mitochondrial Dysfunction in the Elderly
- Friedreich Ataxia
- Congestive Heart Failure
- Heart Failure
- Healthy Volunteers
- Diabetic Macular Edema
- Primary Mitochondrial Myopathy
- Age Related Macular Degeneration (ARMD)
- Mitochondrial Myopathy
- Chronic Heart Failure
- Aging, Healthy

## Every trial on record

| Trial ID | Title | Condition | Phase | Status | Enrolled |
|---|---|---|---|---|---|
| [NCT05162768](https://clinicaltrials.gov/study/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](https://clinicaltrials.gov/study/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](https://clinicaltrials.gov/study/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](https://clinicaltrials.gov/study/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](https://clinicaltrials.gov/study/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 |
| [NCT02976038](https://clinicaltrials.gov/study/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 | TERMINATED | 28 |
| [NCT01572909](https://clinicaltrials.gov/study/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 |
| [NCT01755858](https://clinicaltrials.gov/study/NCT01755858) | Effects of Intravenous Bendavia™ on Reperfusion Injury in Patients Undergoing Angioplasty of the Renal Artery | Renal Artery Obstruction, Hypertension, Renovascular | Phase 2 | TERMINATED | 16 |
| [NCT03891875](https://clinicaltrials.gov/study/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](https://clinicaltrials.gov/study/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](https://clinicaltrials.gov/study/NCT03098797) | A Trial to Evaluate Safety, Tolerability and Efficacy of Elamipretide in Subjects With Barth Syndrome | Barth Syndrome | Phase 3 | COMPLETED | 12 |
| [NCT02848313](https://clinicaltrials.gov/study/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](https://clinicaltrials.gov/study/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](https://clinicaltrials.gov/study/NCT05168774) | FRDA Investigator Initiated Study (IIS) With Elamipretide | Friedreich Ataxia | Phase 2 | COMPLETED | 20 |
| [NCT02388464](https://clinicaltrials.gov/study/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](https://clinicaltrials.gov/study/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](https://clinicaltrials.gov/study/NCT02788747) | Effect of Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Reduced Ejection Fraction | Heart Failure | Phase 2 | COMPLETED | 71 |
| [NCT07531251](https://clinicaltrials.gov/study/NCT07531251) | Clinical Trial in Patients With Barth Syndrome- 4TAZPower | Barth Syndrome | Phase 4 | RECRUITING | 48 |
| [NCT02388529](https://clinicaltrials.gov/study/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 | 0 |
| [NCT01513200](https://clinicaltrials.gov/study/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](https://clinicaltrials.gov/study/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](https://clinicaltrials.gov/study/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 |
| [NCT03323749](https://clinicaltrials.gov/study/NCT03323749) | A Trial to Evaluate Safety and Efficacy of Elamipretide Primary Mitochondrial Myopathy Followed by Open-Label Extension | Primary Mitochondrial Myopathy | Phase 3 | TERMINATED | 218 |
| [NCT01518985](https://clinicaltrials.gov/study/NCT01518985) | The Impact of Intravenous Bendavia™ on Endothelial Reactivity Dysfunction in Cigarette Smoking | Healthy Volunteers | Phase 1 | COMPLETED | 6 |
| [NCT06373731](https://clinicaltrials.gov/study/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 | ACTIVE_NOT_RECRUITING | 313 |
| [NCT02367014](https://clinicaltrials.gov/study/NCT02367014) | Safety, Tolerability, and Efficacy of MTP-131 for the Treatment of Mitochondrial Myopathy | Mitochondrial Myopathy | Phase 2 | COMPLETED | 36 |
| [NCT01786915](https://clinicaltrials.gov/study/NCT01786915) | Safety and Pharmacokinetic (PK) Study of Oral Bendavia Administered for 7 Days | Healthy Volunteers | Phase 1 | COMPLETED | 30 |
| [NCT02814097](https://clinicaltrials.gov/study/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 |
| [NCT07275424](https://clinicaltrials.gov/study/NCT07275424) | Study of Healthy Aging and Physical Function With Elamipretide | Aging, Healthy | Phase 2 | RECRUITING | 30 |

## Common questions

**How many human trials does Elamipretide have?**
29, each listed above with a link to its original record.

**Is Elamipretide FDA approved?**
Yes — 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.

**Where does this data come from?**
ClinicalTrials.gov. We count interventional human studies only. Every trial
links to its original record.

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*Automated aggregation from public registries. Not medical advice. No physician
has reviewed this page. Source: https://www.whatsactuallyknown.com/compounds/elamipretide*