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Clinical-Stage Companies / Stealth BioTherapeutics

Stealth BioTherapeutics

Pre-Approval PRO BETA
27
Total Trials
4
Phase 3
14
Phase 2
1
Recruiting
216
Score

Pipeline by Phase

Phase 3
4
Phase 2
14
Phase 1
13

Therapeutic Focus

Heart Failure Healthy Volunteers Barth Syndrome Age-related Macular Degeneration Primary Mitochondrial Disease

Clinical Trials (27)

NCT06373731 Phase 3 ACTIVE NOT RECRUITING

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

Started: 5/30/2024

NCT05162768 Phase 3 COMPLETED

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

Started: 4/29/2022

NCT03323749 Phase 3 TERMINATED

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

Started: 10/9/2017

NCT03891875 Phase 2 COMPLETED

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

Started: 3/27/2019

NCT03098797 Phase 2 COMPLETED

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

Started: 7/5/2017

NCT02976038 Phase 2 TERMINATED

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

Started: 12/1/2016

NCT02693119 Phase 2 COMPLETED

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

Started: 3/1/2016

NCT02914665 Phase 2 COMPLETED

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

Started: 10/20/2016

NCT02805790 Phase 2 COMPLETED

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

Started: 8/22/2016

NCT02245620 Phase 2 COMPLETED

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

Started: 1/15/2015

NCT01572909 Phase 2 COMPLETED

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

Started: 4/1/2012

NCT02788747 Phase 2 COMPLETED

Effect of Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Reduced Ejection Fraction

Started: 6/1/2016

NCT02814097 Phase 2 COMPLETED

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

Started: 9/2/2016

NCT02653391 Phase 1 COMPLETED

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

Started: 2/1/2016

NCT02848313 Phase 1 COMPLETED

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

Started: 10/28/2016

NCT01755858 Phase 1 TERMINATED

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

Started: 12/1/2012

NCT02367014 Phase 1 COMPLETED

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

Started: 2/1/2015

NCT02436447 Phase 1 COMPLETED

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

Started: 5/1/2015

NCT02314299 Phase 1 COMPLETED

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

Started: 11/1/2014

NCT02388529 Phase 1 WITHDRAWN

A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Bendavia™ (MTP-131) in Patients With Heart Failure

Started: 5/1/2015

NCT02388464 Phase 1 COMPLETED

A Study Investigating the Safety, Tolerability, and Pharmacokinetics of MTP-131 in Subjects With Congestive Heart Failure

Started: 7/1/2014

NCT01786915 Phase 1 COMPLETED

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

Started: 2/1/2013

NCT01754818 Phase 1 COMPLETED

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

Started: 11/1/2012

NCT01518985 Phase 1 COMPLETED

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

Started: 1/1/2012

NCT01513200 Phase 1 COMPLETED

Study to Assess the Pharmacodynamic Effects of Unfractionated Heparin (UFH) in Healthy Volunteers With and Without Bendavia

Started: 1/1/2012

NCT01115920 Phase 1 COMPLETED

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

Started: 5/1/2010

NCT07531251 Phase 4 NOT YET RECRUITING

Ph3b/4 Trial in Patients With Barth Syndrome

Started: 6/30/2026

Drug Candidates

Elamipretide Placebo elamipretide elamipretide (MTP-131) 1% topical ophthalmic solution Vehicle topical ophthalmic solution Part A Elamipretide 1.0% Ophthalmic Solution Part B Elamipretide 3.0% Ophthalmic Solution Part A Placebo Part B Placebo Bendavia
Activity Status: Active
Last Trial Started: 6/30/2026
Last Trial Ended: 12/4/2024
Trials (12 months): 1
Completed Trials: 21
Data sourced from ClinicalTrials.gov. This company has no FDA-approved drugs.