Data edition of
Residue An evidence-graded reference for peptide science

Elamipretide clinical trials

Every study registered on ClinicalTrials.gov that lists Elamipretide as an intervention, as of the data edition — what is being tested, in whom, by whom, and how far it has got.

Registered studies
29
Active or recruiting
3
Completed
21
With posted results
14
Planned or actual enrollment
2,054participants, summed
Registered studies of Elamipretide by phase and status
PhaseStudiesBreakdown
Phase 1 8
7 completed, 0 active or recruiting, 1 stopped, 0 other
Phase 2 15
12 completed, 1 active or recruiting, 2 stopped, 0 other
Phase 3 4
2 completed, 1 active or recruiting, 1 stopped, 0 other
Phase 4 1
0 completed, 1 active or recruiting, 0 stopped, 0 other
Expanded access 1
0 completed, 0 active or recruiting, 0 stopped, 1 other
Figure 1. 29 studies on ClinicalTrials.gov match the registry search elamipretide OR SS-31 OR MTP-131. Multi-phase studies are counted at their highest phase. Open the full trial feed

Conditions studied

  1. Heart Failure3
  2. Barth Syndrome3
  3. Primary Mitochondrial Disease2
  4. Mitochondrial Diseases2
  5. Age-related Macular Degeneration2
  6. Healthy2
  7. Healthy Volunteers2
  8. Congestive Heart Failure1
  9. Mitochondrial Myopathy1
  10. Primary Mitochondrial Myopathy1
  11. Age Related Macular Degeneration (ARMD)1
  12. Mitochondrial Myopathies1

Lead sponsors

  1. Stealth BioTherapeutics Inc.27
  2. Children's Hospital of Philadelphia1
  3. David Marcinek1

The registry, study by study

Registration is not evidence of benefit; many registered studies never publish. Status and dates are as reported by sponsors to ClinicalTrials.gov.

Status
Phase

29 shown

Registered studies of Elamipretide
StudyPhaseStatusStartnSponsor
NCT07531251Clinical Trial in Patients With Barth Syndrome- 4TAZPower Phase 4 Recruiting Jul 2026 48 Stealth BioTherapeutics Inc.
NCT07275424Study of Healthy Aging and Physical Function With Elamipretide Phase 2 Recruiting Nov 2025 30 David Marcinek
NCT06373731ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD) Phase 3 Active, not recruiting May 2024 313 Stealth BioTherapeutics Inc.
NCT05162768Study to Evaluate Efficacy and Safety of Elamipretide in Subjects With Primary Mitochondrial Disease From Nuclear DNA Mutations (nPMD) Phase 3 Completed Apr 2022 102 Stealth BioTherapeutics Inc.
NCT05168774FRDA Investigator Initiated Study (IIS) With ElamipretideResults posted Phase 1/Phase 2 Completed Mar 2022 20 Children's Hospital of Philadelphia
NCT03891875ReCLAIM-2 Study to Evaluate Safety,Efficacy & Pharmacokinetics of Elamipretide in Subjects With AMD With Non-central GAResults posted Phase 2 Completed Mar 2019 176 Stealth BioTherapeutics Inc.
NCT03323749A Trial to Evaluate Safety and Efficacy of Elamipretide Primary Mitochondrial Myopathy Followed by Open-Label ExtensionResults posted Phase 3 Terminated Oct 2017 218 Stealth BioTherapeutics Inc.
NCT03098797A Trial to Evaluate Safety, Tolerability and Efficacy of Elamipretide in Subjects With Barth SyndromeResults posted Phase 2/Phase 3 Completed Jul 2017 12 Stealth BioTherapeutics Inc.
NCT02976038Open-Label Extension Trial to Characterize the Long-term Safety and Tolerability of Elamipretide in Subjects With Genetically Confirmed Primary Mitochondrial Myopathy (PMM)Results posted Phase 2 Terminated Dec 2016 28 Stealth BioTherapeutics Inc.
NCT02848313An Open-Label, Phase 1 Clinical Study to Evaluate the Safety and Tolerability of Subcutaneous Elamipretide in Subjects With Intermediate Age-Related Macular DegenerationResults posted Phase 1 Completed Oct 2016 40 Stealth BioTherapeutics Inc.
NCT02914665A 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 Phase 2 Completed Oct 2016 308 Stealth BioTherapeutics Inc.
NCT02814097A 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 Phase 2 Completed Sep 2016 46 Stealth BioTherapeutics Inc.
NCT02805790Safety, Tolerability, Efficacy of MTP-131 for Treatment of Mitochondrial Disease in Subjects From the MMPOWER StudyResults posted Phase 2 Completed Aug 2016 30 Stealth BioTherapeutics Inc.
NCT02788747Effect of Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Reduced Ejection FractionResults posted Phase 2 Completed Jun 2016 71 Stealth BioTherapeutics Inc.
NCT02693119A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for Treatment of Leber's Hereditary Optic NeuropathyResults posted Phase 2 Completed Mar 2016 12 Stealth BioTherapeutics Inc.
NCT02653391A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for the Treatment of Fuchs' Corneal Endothelial Dystrophy (FCED)Results posted Phase 1/Phase 2 Completed Feb 2016 22 Stealth BioTherapeutics Inc.
NCT02436447A Phase 1 Study Investigating the Safety and Pharmacokinetics of Repeat-dose Intravenous Infusion of MTP-131 in Subjects With Impaired Renal Function Phase 1 Completed May 2015 23 Stealth BioTherapeutics Inc.
NCT02388529A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Bendavia™ (MTP-131) in Patients With Heart Failure Phase 1 Withdrawn May 2015 0 Stealth BioTherapeutics Inc.
NCT02367014Safety, Tolerability, and Efficacy of MTP-131 for the Treatment of Mitochondrial MyopathyResults posted Phase 1/Phase 2 Completed Feb 2015 36 Stealth BioTherapeutics Inc.
NCT02245620A Phase 2 Study to Evaluate the Impact of MTP-131 (Bendavia™) on Skeletal Muscle Function in ElderlyResults posted Phase 2 Completed Jan 2015 41 Stealth BioTherapeutics Inc.
NCT02314299A Study of MTP-131 Topical Ophthalmic Solution in Subjects With Diabetic Macular Edema and Non-Exudative Intermediate Age-related Macular Degeneration Phase 1/Phase 2 Completed Nov 2014 20 Stealth BioTherapeutics Inc.
NCT02388464A Study Investigating the Safety, Tolerability, and Pharmacokinetics of MTP-131 in Subjects With Congestive Heart Failure Phase 1 Completed Jul 2014 36 Stealth BioTherapeutics Inc.
NCT01786915Safety and Pharmacokinetic (PK) Study of Oral Bendavia Administered for 7 Days Phase 1 Completed Feb 2013 30 Stealth BioTherapeutics Inc.
NCT01755858Effects of Intravenous Bendavia™ on Reperfusion Injury in Patients Undergoing Angioplasty of the Renal ArteryResults posted Phase 1/Phase 2 Terminated Dec 2012 16 Stealth BioTherapeutics Inc.
NCT01754818A Phase 1 Study Examining the Pharmacokinetics and Tolerability of a Single Oral Dose of Bendavia (MTP-131) Phase 1 Completed Nov 2012 30 Stealth BioTherapeutics Inc.
NCT01572909Evaluation of Myocardial Effects of MTP-131 for Reducing Reperfusion Injury in Patients With Acute Coronary EventsResults posted Phase 2 Completed Apr 2012 300 Stealth BioTherapeutics Inc.
NCT01518985The Impact of Intravenous Bendavia™ on Endothelial Reactivity Dysfunction in Cigarette Smoking Phase 1 Completed Jan 2012 6 Stealth BioTherapeutics Inc.
NCT01115920Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of Intravenous (IV) Infusion of MTP-131 (Bendavia™) in Healthy Adults Phase 1 Completed May 2010 40 Stealth BioTherapeutics Inc.
NCT04689360An Intermediate Size Expanded Access Protocol of Elamipretide Expanded access Available — — Stealth BioTherapeutics Inc.

Run this search on ClinicalTrials.gov → Query term: elamipretide OR SS-31 OR MTP-131