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ClinicalTrials.gov public records Last synced Oct 22, 2026, 11:54 PM EDT

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Showing 1–20 of 20 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: MTP-131 Clear all
Completed Phase 3 Interventional

Study to Evaluate Efficacy and Safety of Elamipretide in Subjects With Primary Mitochondrial Disease From Nuclear DNA Mutations (nPMD)

NCT05162768
View directory record Official record
Conditions
Mitochondrial Myopathies, Mitochondrial Pathology, Mitochondrial DNA Mutation, Mitochondrial Diseases, Mitochondrial DNA Deletion, Mitochondrial DNA Depletion, Mitochondrial Metabolism Defect, Mitochondrial Complex I Deficiency
Interventions
Elamipretide, Placebo
Drug
Lead sponsor
Stealth BioTherapeutics Inc.
Industry
Eligibility
18 Years to 70 Years
Enrollment
102 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2024
U.S. locations
9
States / cities
San Diego, California • Atlanta, Georgia • Boston, Massachusetts + 6 more
Source: ClinicalTrials.gov public record
Updated Oct 24, 2025 · Synced Oct 22, 2026, 11:54 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of Intravenous (IV) Infusion of MTP-131 (Bendavia™) in Healthy Adults

NCT01115920
View directory record Official record
Conditions
Healthy
Interventions
MTP-131 (Bendavia™)
Drug
Lead sponsor
Stealth BioTherapeutics Inc.
Industry
Eligibility
18 Years and older
Enrollment
40 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2010
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Nov 18, 2010 · Synced Oct 22, 2026, 11:54 PM EDT
Completed Phase 1Phase 2 Interventional Results available

A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for the Treatment of Fuchs' Corneal Endothelial Dystrophy (FCED)

NCT02653391
View directory record Official record
Conditions
Fuchs' Corneal Endothelial Dystrophy (FCED)
Interventions
Part A Elamipretide 1.0% Ophthalmic Solution, Part B Elamipretide 3.0% Ophthalmic Solution, Part A Placebo, Part B Placebo
Drug
Lead sponsor
Stealth BioTherapeutics Inc.
Industry
Eligibility
18 Years and older
Enrollment
22 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2018
U.S. locations
2
States / cities
Edgewood, Kentucky • Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Sep 17, 2021 · Synced Oct 22, 2026, 11:54 PM EDT
Completed Phase 2 Interventional Results available

A Phase 2 Study to Evaluate the Impact of MTP-131 (Bendavia™) on Skeletal Muscle Function in Elderly

NCT02245620
View directory record Official record
Conditions
Skeletal Muscle Mitochondrial Dysfunction in the Elderly
Interventions
Elamipretide, Placebo
Drug
Lead sponsor
Stealth BioTherapeutics Inc.
Industry
Eligibility
60 Years to 85 Years
Enrollment
41 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
1
States / cities
Seattle, Washington
Source: ClinicalTrials.gov public record
Updated Jun 23, 2020 · Synced Oct 22, 2026, 11:54 PM EDT
Completed Phase 1 Interventional Results available

An Open-Label, Phase 1 Clinical Study to Evaluate the Safety and Tolerability of Subcutaneous Elamipretide in Subjects With Intermediate Age-Related Macular Degeneration

NCT02848313
View directory record Official record
Conditions
Age-Related Macular Degeneration
Interventions
Elamipretide
Drug
Lead sponsor
Stealth BioTherapeutics Inc.
Industry
Eligibility
55 Years and older
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2018
U.S. locations
1
States / cities
Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Oct 20, 2020 · Synced Oct 22, 2026, 11:54 PM EDT
Completed Phase 2 Interventional Results available

ReCLAIM-2 Study to Evaluate Safety,Efficacy & Pharmacokinetics of Elamipretide in Subjects With AMD With Non-central GA

NCT03891875
View directory record Official record
Conditions
Age-related Macular Degeneration
Interventions
Subcutaneous elamipretide through the elamipretide delivery system, Subcutaneos placebo through the elamipretide delivery system
Combination Product
Lead sponsor
Stealth BioTherapeutics Inc.
Industry
Eligibility
55 Years and older
Enrollment
176 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
37
States / cities
Peoria, Arizona • Phoenix, Arizona • Scottsdale, Arizona + 30 more
Source: ClinicalTrials.gov public record
Updated Jul 12, 2024 · Synced Oct 22, 2026, 11:54 PM EDT
Terminated Phase 3 Interventional Results available

A Trial to Evaluate Safety and Efficacy of Elamipretide Primary Mitochondrial Myopathy Followed by Open-Label Extension

NCT03323749
View directory record Official record
Conditions
Primary Mitochondrial Myopathy
Interventions
elamipretide, placebo comparator, elamipretide open label treatment
Combination Product
Lead sponsor
Stealth BioTherapeutics Inc.
Industry
Eligibility
16 Years to 80 Years
Enrollment
218 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2020
U.S. locations
13
States / cities
La Jolla, California • Palo Alto, California • Aurora, Colorado + 9 more
Source: ClinicalTrials.gov public record
Updated Jan 24, 2022 · Synced Oct 22, 2026, 11:54 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Safety and Pharmacokinetic (PK) Study of Oral Bendavia Administered for 7 Days

NCT01786915
View directory record Official record
Conditions
Healthy Volunteers
Interventions
Bendavia 10mg, Bendavia 50mg, Placebo
Drug
Lead sponsor
Stealth BioTherapeutics Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
30 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2013
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Apr 2, 2014 · Synced Oct 22, 2026, 11:54 PM EDT
Completed Phase 2 Interventional Results available

Evaluation of Myocardial Effects of MTP-131 for Reducing Reperfusion Injury in Patients With Acute Coronary Events

NCT01572909
View directory record Official record
Conditions
Reperfusion Injury, STEMI
Interventions
Bendavia (MTP-131), Placebo
Drug
Lead sponsor
Stealth BioTherapeutics Inc.
Industry
Eligibility
18 Years to 85 Years
Enrollment
300 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2015
U.S. locations
3
States / cities
Port Orange, Florida • Detroit, Michigan • Omaha, Nebraska
Source: ClinicalTrials.gov public record
Updated Jun 11, 2020 · Synced Oct 22, 2026, 11:54 PM EDT
Terminated Phase 1Phase 2 Interventional Results available

Effects of Intravenous Bendavia™ on Reperfusion Injury in Patients Undergoing Angioplasty of the Renal Artery

NCT01755858
View directory record Official record
Conditions
Renal Artery Obstruction, Hypertension, Renovascular, Ischemia Reperfusion Injury
Interventions
Bendavia, Placebo
Drug
Lead sponsor
Stealth BioTherapeutics Inc.
Industry
Eligibility
40 Years to 80 Years
Enrollment
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2016
U.S. locations
1
States / cities
Rochester, Minnesota
Source: ClinicalTrials.gov public record
Updated Aug 11, 2020 · Synced Oct 22, 2026, 11:54 PM EDT
Completed Phase 1Phase 2 Interventional Results available

Safety, Tolerability, and Efficacy of MTP-131 for the Treatment of Mitochondrial Myopathy

NCT02367014
View directory record Official record
Conditions
Mitochondrial Myopathy
Interventions
elamipretide (low dose), elamipretide (intermediate dose), elamipretide (high dose), Placebo
Drug
Lead sponsor
Stealth BioTherapeutics Inc.
Industry
Eligibility
16 Years to 65 Years
Enrollment
36 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
4
States / cities
San Diego, California • Boston, Massachusetts • Akron, Ohio + 1 more
Source: ClinicalTrials.gov public record
Updated Dec 27, 2019 · Synced Oct 22, 2026, 11:54 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

The Impact of Intravenous Bendavia™ on Endothelial Reactivity Dysfunction in Cigarette Smoking

NCT01518985
View directory record Official record
Conditions
Healthy Volunteers
Interventions
Bendavia, Sterile saline (0.9%), Cigarette smoking
Drug · Other
Lead sponsor
Stealth BioTherapeutics Inc.
Industry
Eligibility
18 Years to 65 Years · Male only
Enrollment
6 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2012
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Apr 19, 2012 · Synced Oct 22, 2026, 11:54 PM EDT
Completed Phase 1Phase 2 Interventional Results available

FRDA Investigator Initiated Study (IIS) With Elamipretide

NCT05168774
View directory record Official record
Conditions
Friedreich Ataxia
Interventions
Elamipretide
Drug
Lead sponsor
Children's Hospital of Philadelphia
Other
Eligibility
16 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2024
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Dec 12, 2025 · Synced Oct 22, 2026, 11:54 PM EDT
Completed Phase 2 Interventional Results available

A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for Treatment of Leber's Hereditary Optic Neuropathy

NCT02693119
View directory record Official record
Conditions
Leber's Hereditary Optic Neuropathy
Interventions
elamipretide (MTP-131) 1% topical ophthalmic solution, Vehicle topical ophthalmic solution
Drug
Lead sponsor
Stealth BioTherapeutics Inc.
Industry
Eligibility
18 Years to 50 Years
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2019
U.S. locations
1
States / cities
Pasadena, California
Source: ClinicalTrials.gov public record
Updated Nov 30, 2021 · Synced Oct 22, 2026, 11:54 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Phase 1 Study Examining the Pharmacokinetics and Tolerability of a Single Oral Dose of Bendavia (MTP-131)

NCT01754818
View directory record Official record
Conditions
Healthy
Interventions
Bendavia 10mg, Bendavia 50mg, Bendavia 100mg, Placebo
Drug
Lead sponsor
Stealth BioTherapeutics Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
30 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2012 – 2013
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Feb 6, 2013 · Synced Oct 22, 2026, 11:54 PM EDT
Completed Phase 2Phase 3 Interventional Results available

A Trial to Evaluate Safety, Tolerability and Efficacy of Elamipretide in Subjects With Barth Syndrome

NCT03098797
View directory record Official record
Conditions
Barth Syndrome
Interventions
Elamipretide, Placebo
Drug
Lead sponsor
Stealth BioTherapeutics Inc.
Industry
Eligibility
12 Years and older · Male only
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2021
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Apr 16, 2024 · Synced Oct 22, 2026, 11:54 PM EDT
Completed Phase 1Phase 2 Interventional

A Study of MTP-131 Topical Ophthalmic Solution in Subjects With Diabetic Macular Edema and Non-Exudative Intermediate Age-related Macular Degeneration

NCT02314299
View directory record Official record
Conditions
Diabetic Macular Edema, Age-related Macular Degeneration
Interventions
MTP-131
Drug
Lead sponsor
Stealth BioTherapeutics Inc.
Industry
Eligibility
18 Years to 80 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Oct 26, 2015 · Synced Oct 22, 2026, 11:54 PM EDT
Active, not recruiting Phase 3 Interventional

ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD)

NCT06373731
View directory record Official record
Conditions
Age Related Macular Degeneration (ARMD)
Interventions
Elamipretide, Placebo
Drug
Lead sponsor
Stealth BioTherapeutics Inc.
Industry
Eligibility
55 Years and older
Enrollment
313 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
31
States / cities
Phoenix, Arizona • Sun City, Arizona • Huntington Beach, California + 28 more
Source: ClinicalTrials.gov public record
Updated Sep 17, 2026 · Synced Oct 22, 2026, 11:54 PM EDT
Completed Phase 2 Interventional Results available

Safety, Tolerability, Efficacy of MTP-131 for Treatment of Mitochondrial Disease in Subjects From the MMPOWER Study

NCT02805790
View directory record Official record
Conditions
Primary Mitochondrial Disease
Interventions
Elamipretide, Placebo
Drug
Lead sponsor
Stealth BioTherapeutics Inc.
Industry
Eligibility
16 Years and older
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2017
U.S. locations
4
States / cities
San Diego, California • Boston, Massachusetts • Akron, Ohio + 1 more
Source: ClinicalTrials.gov public record
Updated Jul 17, 2020 · Synced Oct 22, 2026, 11:54 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Phase 1 Study Investigating the Safety and Pharmacokinetics of Repeat-dose Intravenous Infusion of MTP-131 in Subjects With Impaired Renal Function

NCT02436447
View directory record Official record
Conditions
Normal and Impaired Renal Function
Interventions
MTP-131
Drug
Lead sponsor
Stealth BioTherapeutics Inc.
Industry
Eligibility
18 Years and older
Enrollment
23 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015
U.S. locations
1
States / cities
Maimi, Florida
Source: ClinicalTrials.gov public record
Updated Nov 18, 2015 · Synced Oct 22, 2026, 11:54 PM EDT