Elamipretide

Generic Name
Elamipretide
Brand Names
-
Drug Type
Small Molecule
Chemical Formula
C32H49N9O5
CAS Number
736992-21-5
Unique Ingredient Identifier
87GWG91S09
Background

Elamipretide has been used in trials studying the treatment of Leber's Hereditary Optic Neuropathy.

Associated Conditions
-
Associated Therapies
-

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

First Posted Date
2024-04-18
Last Posted Date
2024-12-12
Lead Sponsor
Stealth BioTherapeutics Inc.
Target Recruit Count
360
Registration Number
NCT06373731
Locations
🇬🇧

Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom

🇺🇸

Associated Retina Consultants, Phoenix, Arizona, United States

🇺🇸

Barnet Dulaney Perkins Eye Center, Sun City, Arizona, United States

and more 40 locations

FRDA Investigator Initiated Study (IIS) With Elamipretide

Phase 1
Completed
Conditions
Interventions
First Posted Date
2021-12-23
Last Posted Date
2024-08-15
Lead Sponsor
Children's Hospital of Philadelphia
Target Recruit Count
20
Registration Number
NCT05168774
Locations
🇺🇸

Children's Hospital of Philadelphia - Neurology, Philadelphia, Pennsylvania, United States

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

First Posted Date
2021-12-17
Last Posted Date
2023-12-12
Lead Sponsor
Stealth BioTherapeutics Inc.
Target Recruit Count
102
Registration Number
NCT05162768
Locations
🇺🇸

Rare Disease Research, LLC, Atlanta, Georgia, United States

🇺🇸

University of Pittsburgh School of Medicine Children's Hospital of Pittsburgh of UPMC Department of Genetics, Pittsburgh, Pennsylvania, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

and more 29 locations

An Intermediate Size Expanded Access Protocol of Elamipretide

First Posted Date
2020-12-30
Last Posted Date
2024-07-03
Lead Sponsor
Stealth BioTherapeutics Inc.
Registration Number
NCT04689360

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

Phase 2
Completed
Conditions
Interventions
First Posted Date
2017-04-04
Last Posted Date
2024-04-16
Lead Sponsor
Stealth BioTherapeutics Inc.
Target Recruit Count
12
Registration Number
NCT03098797
Locations
🇺🇸

McKusick-Nathans Institute of Genetic Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States

Open-Label Extension Trial to Characterize the Long-term Safety and Tolerability of Elamipretide in Subjects With Genetically Confirmed Primary Mitochondrial Myopathy (PMM)

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2016-11-29
Last Posted Date
2021-12-17
Lead Sponsor
Stealth BioTherapeutics Inc.
Target Recruit Count
28
Registration Number
NCT02976038
Locations
🇺🇸

University of California, San Diego, California, United States

🇺🇸

Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

and more 1 locations

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

Phase 2
Completed
Conditions
Interventions
First Posted Date
2016-09-26
Last Posted Date
2020-07-28
Lead Sponsor
Stealth BioTherapeutics Inc.
Target Recruit Count
308
Registration Number
NCT02914665
Locations
🇬🇧

Torbay Hospital, Torquay, United Kingdom

🇪🇸

Hospital Clínico San Carlos, Madrid, Spain

🇪🇸

Hospital Universitario de Bellvitge, Barcelona, Spain

and more 43 locations

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

Phase 1
Completed
Conditions
Interventions
First Posted Date
2016-07-28
Last Posted Date
2020-10-20
Lead Sponsor
Stealth BioTherapeutics Inc.
Target Recruit Count
40
Registration Number
NCT02848313
Locations
🇺🇸

Duke University School of Medicine / Dept. of Ophthalmology (Duke Eye Center), Durham, North Carolina, United States

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

Phase 2
Completed
Conditions
Interventions
First Posted Date
2016-06-27
Last Posted Date
2017-09-07
Lead Sponsor
Stealth BioTherapeutics Inc.
Target Recruit Count
46
Registration Number
NCT02814097
Locations
🇷🇸

Clinical Center Niš, Clinic for Cardiology, Niš, Serbia

🇷🇸

Clinical Hospital Center "Dr Dragiša Mišović-Dedinje", Department of Cardiology, Belgrade, Serbia

🇷🇸

Clinical Hospital Center "Bežanijska Kosa", Department of Cardiology, Belgrade, Serbia

and more 6 locations

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

First Posted Date
2016-06-20
Last Posted Date
2020-07-17
Lead Sponsor
Stealth BioTherapeutics Inc.
Target Recruit Count
30
Registration Number
NCT02805790
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

University of California, San Diego, California, United States

🇺🇸

Children's Hospital of Pittsburg of UPMC, Pittsburgh, Pennsylvania, United States

and more 1 locations
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