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Idebenone - Chiesi Farmaceutici/Santhera Pharmaceuticals

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Drug Profile

Idebenone - Chiesi Farmaceutici/Santhera Pharmaceuticals

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

Latest Information Update: 25 Sep 2025

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At a glance

  • Originator Santhera Pharmaceuticals
  • Developer Chiesi Farmaceutici; 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 Yes

Highest Development Phases

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

Most Recent Events

  • 23 Sep 2025 Registered for Leber's hereditary optic atrophy (In adolescents, In adults) in Taiwan, Bahrain (PO) prior to September 2025
  • 23 Sep 2025 Efficacy data from the phase II RHODOS trial in in Leber's hereditary optic neuropathy released by Chiesi Global Rare Diseases
  • 22 Sep 2025 Preregistration for Leber's hereditary optic atrophy (In adolescents, In adults) in USA (PO)

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