Clinical Trial in Patients With Barth Syndrome- 4TAZPower
Stealth BioTherapeutics Inc. · Barth Syndrome
Phase 4
Recruiting
48
2026-07
Evidence dashboardStudies since 2010Updated Jul 31, 2026
ElamipretideClinical Trials.
A source-linked view of every Elamipretide study in the current snapshot—status, phase, enrollment, results, publications, locations and changes over time.
- Total trials
- 29
- Recruiting
- 2
- Completed
- 21
- Terminated
- 3
- Results posted
- 14
- Average enrollment
- 73
- Countries
- 19
- Highest phase
- Phase 4
Largest indexed study
313 participants · NCT06373731 →Developer / research origin
Stealth BioTherapeutics
Evidence summary
Activity is not efficacy.
Elamipretide appears in 29 indexed studies: 2 recruiting, 21 completed and 14 with registry results posted. The highest registered development stage in this snapshot is Phase 4. These counts measure registry activity; they do not establish that Elamipretide is safe or effective.
Review the design, endpoints, population, protocol changes, statistical analysis and publications before drawing conclusions.
Current studies
Recruiting or active
Completed studies
Finished records
Stopped studies
Withdrawn or terminated
NCT IDStudyPhase / statusEnrollmentUpdated
ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD)
Stealth BioTherapeutics Inc. · Age Related Macular Degeneration (ARMD)
Phase 3
Active, not recruiting
313
2026-05
Study of Healthy Aging and Physical Function With Elamipretide
David Marcinek · Aging, Healthy
Phase 2
Recruiting
30
2025-12
NCT IDStudyPhase / statusEnrollmentUpdated
FRDA Investigator Initiated Study (IIS) With Elamipretide
Children's Hospital of Philadelphia · Friedreich Ataxia
Phase 1 / Phase 2
Completed
20
2025-12
Study to Evaluate Efficacy and Safety of Elamipretide in Subjects With Primary Mitochondrial Disease From Nuclear DNA Mutations (nPMD)
Stealth BioTherapeutics Inc. · Mitochondrial Myopathies · Mitochondrial Pathology
Phase 3
Completed
102
2025-10
ReCLAIM-2 Study to Evaluate Safety,Efficacy & Pharmacokinetics of Elamipretide in Subjects With AMD With Non-central GA
Stealth BioTherapeutics Inc. · Age-related Macular Degeneration
Phase 2
Completed
176
2024-07
A Trial to Evaluate Safety, Tolerability and Efficacy of Elamipretide in Subjects With Barth Syndrome
Stealth BioTherapeutics Inc. · Barth Syndrome
Phase 2 / Phase 3
Completed
12
2024-04
A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for Treatment of Leber's Hereditary Optic Neuropathy
Stealth BioTherapeutics Inc. · Leber's Hereditary Optic Neuropathy
Phase 2
Completed
12
2021-11
A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for the Treatment of Fuchs' Corneal Endothelial Dystrophy (FCED)
Stealth BioTherapeutics Inc. · Fuchs' Corneal Endothelial Dystrophy (FCED)
Phase 1 / Phase 2
Completed
22
2021-09
Showing 6 of 21 studies
NCT IDStudyPhase / statusEnrollmentUpdated
A Trial to Evaluate Safety and Efficacy of Elamipretide Primary Mitochondrial Myopathy Followed by Open-Label Extension
Stealth BioTherapeutics Inc. · Primary Mitochondrial Myopathy
Phase 3
Terminated
218
2022-01
Open-Label Extension Trial to Characterize the Long-term Safety and Tolerability of Elamipretide in Subjects With Genetically Confirmed Primary Mitochondrial Myopathy (PMM)
Stealth BioTherapeutics Inc. · Primary Mitochondrial Disease
Phase 2
Terminated
28
2021-12
Effects of Intravenous Bendavia™ on Reperfusion Injury in Patients Undergoing Angioplasty of the Renal Artery
Stealth BioTherapeutics Inc. · Renal Artery Obstruction · Hypertension, Renovascular
Phase 1 / Phase 2
Terminated
16
2020-08
A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Bendavia™ (MTP-131) in Patients With Heart Failure
Stealth BioTherapeutics Inc. · Heart Failure
Phase 1
Withdrawn
0
2015-10
Full study index
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29 matching studies
Last registry update first
Latest publications
Follow the paper trail.
PMID 39605874 ↗Ehlers JP, Hu A, Boyer D, Cousins SW, Waheed NK, Rosenfeld PJ, Brown D, Kaiser PK, Abbruscato A, Gao G, Heier J; ReCLAIM-2 (SPIAM-202) Study Investigators. ReCLAIM-2: A Randomized Phase II Clinical Trial Evaluating Elamipretide in Age-related Macular Degeneration, Geographic Atrophy Growth, Visual Function, and Ellipsoid Zone Preservation. Ophthalmol Sci. 2024 Oct 9;5(1):100628. doi: 10.1016/j.xops.2024.100628. eCollection 2025 Jan-Feb.Linked from NCT03891875PMID 40281531 ↗Gwaltney C, Shields A, Love E, Ollis S, Stokes J, Mazar I, Arenson E, Aiudi A, Wirth RJ, Houts C. Initial Psychometric Evaluation of the Barth Syndrome Symptom Assessment (BTHS-SA) for Adolescents and Adults in a Phase 2 Clinical Study. Orphanet J Rare Dis. 2025 Apr 25;20(1):199. doi: 10.1186/s13023-025-03693-5.Linked from NCT03098797PMID 38602181 ↗Thompson WR, Manuel R, Abbruscato A, Carr J, Campbell J, Hornby B, Vaz FM, Vernon HJ. Long-term efficacy and safety of elamipretide in patients with Barth syndrome: 168-week open-label extension results of TAZPOWER. Genet Med. 2024 Jul;26(7):101138. doi: 10.1016/j.gim.2024.101138. Epub 2024 Apr 8.Linked from NCT03098797PMID 37180415 ↗Kim AY, Vernon H, Manuel R, Almuqbil M, Hornby B. Quality of life in Barth syndrome. Ther Adv Rare Dis. 2022 Jun 11;3:26330040221093743. doi: 10.1177/26330040221093743. eCollection 2022 Jan-Dec.Linked from NCT03098797PMID 39574155 ↗Karaa A, Bertini E, Carelli V, Cohen B, Ennes GM, Falk MJ, Goldstein A, Gorman G, Haas R, Hirano M, Klopstock T, Koenig MK, Kornblum C, Lamperti C, Lehman A, Longo N, Molnar MJ, Parikh S, Phan H, Pitceathly RDS, Saneto R, Scaglia F, Servidei S, Tarnopolsky M, Toscano A, Van Hove JLK, Vissing J, Vockley J, Finman JS, Abbruscato A, Brown DA, Sullivan A, Shiffer JA, Mancuso M; MMPOWER-3 Trial Investigators. Genotype-specific effects of elamipretide in patients with primary mitochondrial myopathy: a post hoc analysis of the MMPOWER-3 trial. Orphanet J Rare Dis. 2024 Nov 21;19(1):431. doi: 10.1186/s13023-024-03421-5.Linked from NCT03323749PMID 37268435 ↗Karaa A, Bertini E, Carelli V, Cohen BH, Enns GM, Falk MJ, Goldstein A, Gorman GS, Haas R, Hirano M, Klopstock T, Koenig MK, Kornblum C, Lamperti C, Lehman A, Longo N, Molnar MJ, Parikh S, Phan H, Pitceathly RDS, Saneto R, Scaglia F, Servidei S, Tarnopolsky M, Toscano A, Van Hove JLK, Vissing J, Vockley J, Finman JS, Brown DA, Shiffer JA, Mancuso M; MMPOWER-3 Trial Investigators. Efficacy and Safety of Elamipretide in Individuals With Primary Mitochondrial Myopathy: The MMPOWER-3 Randomized Clinical Trial. Neurology. 2023 Jul 18;101(3):e238-e252. doi: 10.1212/WNL.0000000000207402. Epub 2023 Jun 2.Linked from NCT03323749PMID 28916603 ↗Saad A, Herrmann SMS, Eirin A, Ferguson CM, Glockner JF, Bjarnason H, McKusick MA, Misra S, Lerman LO, Textor SC. Phase 2a Clinical Trial of Mitochondrial Protection (Elamipretide) During Stent Revascularization in Patients With Atherosclerotic Renal Artery Stenosis. Circ Cardiovasc Interv. 2017 Sep;10(9):e005487. doi: 10.1161/CIRCINTERVENTIONS.117.005487.Linked from NCT01755858PMID 36562873 ↗Gwaltney C, Stokes J, Aiudi A, Mazar I, Ollis S, Love E, Karaa A, Houts CR, Wirth RJ, Shields AL. Psychometric performance of the Primary Mitochondrial Myopathy Symptom Assessment (PMMSA) in a randomized, double-blind, placebo-controlled crossover study in subjects with mitochondrial disease. J Patient Rep Outcomes. 2022 Dec 23;6(1):129. doi: 10.1186/s41687-022-00534-y.Linked from NCT02805790
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