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Elamipretide - Stealth BioTherapeutics

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Drug Profile

Elamipretide - Stealth BioTherapeutics

Alternative Names: Bendavia; ELA 4; Elamipretide-hydrochloride; Elamipretide-hydrochloride - Stealth Biotherapeutics; MTP 131; Ocuvia; SBT-31; SPI-31; SS-31

Latest Information Update: 11 Apr 2024

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At a glance

  • Originator Cornell University; Institut de recherches cliniques de Montreal
  • Developer Stealth BioTherapeutics
  • Class Amides; Antihyperglycaemics; Eye disorder therapies; Heart failure therapies; Neuroprotectants; Oligopeptides; Peptides; Small molecules
  • Mechanism of Action Cardiolipin modulators; Free radical scavengers; Mitochondrial permeability transition pore inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Mitochondrial myopathies; Leber's hereditary optic atrophy; Barth syndrome; Duchenne muscular dystrophy; Friedreich's ataxia
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Preregistration Barth syndrome
  • Phase III Mitochondrial myopathies
  • Phase II Acute kidney injury; Corneal disorders; Dry age-related macular degeneration; Heart failure; Leber's hereditary optic atrophy; Mitochondrial disorders; Reperfusion injury
  • Phase I/II Diabetic macular oedema; Friedreich's ataxia
  • Preclinical Duchenne muscular dystrophy
  • No development reported Chronic heart failure; Diabetes mellitus; Eye disorders; Neurodegenerative disorders

Most Recent Events

  • 08 Apr 2024 The U.S. Food and Drug Administration accepts New Drug Application (NDA) for elamipretide for Barth syndrome for review (SC)
  • 28 Nov 2023 Stealth BioTherapeutics plans a phase III trial for Dry age-related macular degeneration
  • 11 Sep 2023 Stealth BioTherapeutics completes enrolment in its phase III NuPOWER trial for Mitochondrial myopathies in Australia, Germany, Hungary, Italy, Netherlands, New Zealand, Norway, Spain, United Kingdom, USA (SC) (NCT05162768)
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