Elamipretide - Stealth BioTherapeutics

Drug Profile

Elamipretide - Stealth BioTherapeutics

Alternative Names: Bendavia; ELA 4; MTP 131; Ocuvia; SBT-31; SPI-31; SS-31

Latest Information Update: 09 Nov 2017

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At a glance

  • Originator Stealth Peptides
  • Developer Stealth BioTherapeutics
  • Class Eye disorder therapies; Ischaemic heart disorder therapies; Oligopeptides; Peptides; Small molecules
  • Mechanism of Action 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
  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 06 Nov 2017 Phase-III clinical trials in Mitochondrial myopathies (In adults, In adolescents, In the elderly) in USA (SC) (NCT03323749)
  • 02 Oct 2017 Elamipretide receives Orphan Drug status for Mitochondrial myopathies (IV) in USA
  • 29 Jun 2017 Initial efficacy and adverse events data from phase II MMPOWER-2 trial in Mitochondrial-myopathies released by Stealth
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