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Elamipretide

Alternative Names: elamipretide, bendavia, mtp-131, mtp131
Latest Update: 2024-12-04
Latest Update Note: Clinical Trial Update

Product Description

Elamipretide, is a peptide compound that readily penetrates cell membranes, and targets the inner mitochondrial membrane where it binds reversibly to cardiolipin. (Sourced from: https://www.stealthbt.com/programs-pipeline/)

Mechanisms of Action: MPTP Inhibitor,Apoptosis Inhibitor

Novel Mechanism: Yes

Modality: Small Molecule

Route of Administration: Intravenous,Subcutaneous

FDA Designation:
Orphan Drug - Barth Syndrome
Orphan Drug - Friedreich Ataxia|Ataxia
Orphan Drug - Mitochondrial Myopathies
Orphan Drug - Muscular Dystrophies|Muscular Dystrophy, Duchenne
Priority Review - Barth Syndrome *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: Stealth Biotherapeutics
Company Location: GRAND CAYMAN E9 KY1-9005
Company CEO:
Additonal Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Elamipretide

Countries in Clinic: Australia, Czech Republic, Germany, Hungary, Italy, Netherlands, New Zealand, Norway, Spain, United Kingdom, United States

Active Clinical Trial Count: 6

Highest Development Phases

Phase 3: Deficiency Diseases|Macular Degeneration|Mitochondrial Diseases|Mitochondrial Myopathies

Phase 2: Cerebellar Ataxia|Friedreich Ataxia|Geographic Atrophy

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success
SPIAM-301

P3

Unknown Status

Macular Degeneration

2027-12-28

ReNEW

P3

Recruiting

Macular Degeneration

2026-08-01

NuPower

P3

Active, not recruiting

Mitochondrial Myopathies|Mitochondrial Diseases|Deficiency Diseases

2024-09-01

ELViS-FA

P2

Completed

Cerebellar Ataxia|Friedreich Ataxia

2024-06-25

Recent News Events

Date

Type

Title

11/06/2024

News Article

 Duchenne Muscular Dystrophy (DMD) Therapeutics Market to Grow by USD 4.37 Billion from 2024-2028, Driven by High Unmet Needs and AI-Powered Market Evolution - Technavio

10/11/2024

News Article

 Stealth BioTherapeutics Announces Positive Vote from FDA Advisory Committee Meeting Supporting Potential Approval of Elamipretide for the Treatment of Barth Syndrome

09/27/2024

News Article

 Stealth BioTherapeutics to Present at UBS Virtual Ophthalmology Day

09/18/2024

News Article

 Stealth BioTherapeutics Presents New Bevemipretide (SBT-272) Data at Keystone Symposium Targeting Dry Age-Related Macular Degeneration

05/13/2024

PubMed

 Silver nanoparticle-induced cell damage via impaired mtROS-JNK/MnSOD signaling pathway.

05/09/2024

PubMed

 Comprehensive dry eye therapy: overcoming ocular surface barrier and combating inflammation, oxidation, and mitochondrial damage.

05/01/2024

PubMed

 Mitochondrial antioxidant elamipretide improves learning and memory impairment induced by chronic sleep deprivation in mice.

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