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Omaveloxolone - Biogen

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Drug Profile

Omaveloxolone - Biogen

Alternative Names: ABT-RTA-408; BIIB-141; RTA-408; SKYCLARYS; Skyclarys

Latest Information Update: 10 Sep 2025

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At a glance

  • Originator Dartmouth College; University of Texas M. D. Anderson Cancer Center
  • Developer Biogen
  • Class Analgesics; Anti-inflammatories; Antineoplastics; Eye disorder therapies; Neuroprotectants; Radioprotectives; Small molecules; Triterpenes
  • Mechanism of Action NF-E2-related factor 2 stimulants
  • Orphan Drug Status

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

    Yes - Malignant melanoma; Friedreich's ataxia
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Friedreich's ataxia
  • Phase II Mitochondrial disorders; Ocular inflammation; Ocular pain
  • Phase I/II Malignant melanoma
  • No development reported Brain disorders
  • Discontinued Duchenne muscular dystrophy; Non-small cell lung cancer; Radiation-induced skin damage

Most Recent Events

  • 02 Sep 2025 Biogen plans a phase I trial (In volunteers) in September 2025 (PO, Capsule) (NCT07149415)
  • 29 Jul 2025 Canada's Drug Agency (CDA) Canadian Drug Expert Committee (CDEC) issues a positive drug reimbursement recommendation for Omaveloxolone (SKYCLARYS ™) in Friedreich ataxia (FA) (In adolescent, In adults)
  • 28 Jun 2025 No recent reports of development identified for preclinical development in Brain-disorders in USA

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