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Idebenone - Chiesi Farmaceutici/Santhera Pharmaceuticals

Drug Profile

Idebenone - Chiesi Farmaceutici/Santhera Pharmaceuticals

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

Latest Information Update: 24 Sep 2019

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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
  • Preregistration Duchenne muscular dystrophy
  • Phase II Multiple sclerosis
  • Suspended Friedreich's ataxia
  • No development reported MELAS syndrome

Most Recent Events

  • 04 Nov 2019 Santhera Pharmaceuticals anticipates to launch idebenone in Duchenne muscular dystrophy from 2020 onwards
  • 03 Sep 2019 Santhera Pharmaceuticals announces intention to submit NDA for Duchenne muscular dystrophy in second half of 2021
  • 26 Jun 2019 European Union validates MAA for Duchenne muscular dystrophy
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