Idebenone - Santhera Pharmaceuticals

Drug Profile

Idebenone - Santhera Pharmaceuticals

Alternative Names: Catena; CV-2619; Raxone; SNTMC17; Sovrima

Latest Information Update: 04 Nov 2018

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At a glance

  • Originator Santhera Pharmaceuticals
  • Developer Columbia University; National Institute of Neurological Disorders and Stroke; Santhera Pharmaceuticals; Takeda
  • Class Benzoquinones; Coenzymes; Eye disorder therapies; Neuroprotectants; Nootropics; Small molecules
  • Mechanism of Action Antioxidants; Electron transport chain complex protein modulators; Reactive oxygen species modulators
  • Orphan Drug Status

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

    Yes - Leber's hereditary optic atrophy; Friedreich's ataxia; Duchenne muscular dystrophy
  • New Molecular Entity No

Highest Development Phases

  • Marketed Leber's hereditary optic atrophy
  • Phase III Duchenne muscular dystrophy
  • Phase II Multiple sclerosis
  • Suspended Friedreich's ataxia
  • No development reported MELAS syndrome

Most Recent Events

  • 04 Sep 2018 Preregistration for Leber's hereditary optic atrophy in Serbia (PO) before September 2018
  • 04 Sep 2018 Santhera Pharmaceuticals announces intention to submit regulatory applications for Duchenne muscular dystrophy in EU and USA in 2019
  • 22 Jun 2018 The Medicines and Healthcare products Regulatory Agency (MHRA) renewed Early Access to Medicines Scheme (EAMS) scientific opinion for idebenone for the treatment of Duchenne muscular dystrophy in the UK
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