Elamipretide
Sponsors
Stealth Biotherapeutics Inc., Stealth BioTherapeutics Inc., Children's Hospital of Philadelphia
Conditions
Age Related Macular Degeneration (ARMD)Age-Related Macular DegenerationBarth SyndromeChronic Heart FailureDry Age-Related Macular Degeneration (Dry AMD)Friedreich AtaxiaHeart FailureMitochondrial Complex I Deficiency
Phase 1
An Open-Label, Phase 1 Clinical Study to Evaluate the Safety and Tolerability of Subcutaneous Elamipretide in Subjects With Intermediate Age-Related Macular Degeneration
CompletedNCT02848313
Start: 2016-10-28End: 2018-04-10Updated: 2020-10-20
FRDA Investigator Initiated Study (IIS) With Elamipretide
CompletedNCT05168774
Start: 2022-03-03End: 2024-07-25Updated: 2025-12-12
Phase 2
A Phase 2 Study to Evaluate the Impact of MTP-131 (Bendavia™) on Skeletal Muscle Function in Elderly
CompletedNCT02245620
Start: 2015-01-15End: 2016-07-06Updated: 2020-06-23
Safety, Tolerability, Efficacy of MTP-131 for Treatment of Mitochondrial Disease in Subjects From the MMPOWER Study
CompletedNCT02805790
Start: 2016-08-22End: 2017-03-23Updated: 2020-07-17
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
CompletedNCT02814097
Start: 2016-09-02End: 2017-06-02Updated: 2017-09-07
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
CompletedNCT02914665
Start: 2016-10-20End: 2017-11-27Updated: 2020-07-28
Open-Label Extension Trial to Characterize the Long-term Safety and Tolerability of Elamipretide in Subjects With Genetically Confirmed Primary Mitochondrial Myopathy (PMM)
TerminatedNCT02976038
Start: 2016-12-31End: 2020-04-09Updated: 2021-12-17
A Trial to Evaluate Safety, Tolerability and Efficacy of Elamipretide in Subjects With Barth Syndrome
CompletedNCT03098797
Start: 2017-07-05End: 2021-10-11Updated: 2024-04-16
Phase 3
A Trial to Evaluate Safety and Efficacy of Elamipretide Primary Mitochondrial Myopathy Followed by Open-Label Extension
TerminatedNCT03323749
Start: 2017-10-09End: 2020-02-10Updated: 2022-01-24
Study to Evaluate Efficacy and Safety of Elamipretide in Subjects With Primary Mitochondrial Disease From Nuclear DNA Mutations (nPMD)
CompletedNCT05162768
Start: 2022-04-29End: 2024-12-04Updated: 2025-10-24
ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD)
Active, not recruitingNCT06373731
Start: 2024-05-30End: 2027-09-01Updated: 2026-09-17
ReNEW: A Phase 3, Randomized, Double-Masked, Placebo-Controlled Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects who have Dry Age-Related Macular Degeneration (Dry AMD)
Active, not recruitingCTIS2024-511482-11-00
Start: 2024-11-20Target: 95Updated: 2025-06-30
4TAZPower: A Phase 3b/4, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Trial to Evaluate the Efficacy and Safety of Daily Subcutaneous Injections of Elamipretide in Patients with Genetically Confirmed Barth Syndrome
Not yet recruitingCTIS2025-523837-25-00
Target: 11Updated: 2026-07-28