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Omaveloxolone - Biogen

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Drug Profile

Omaveloxolone - Biogen

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

Latest Information Update: 14 Nov 2024

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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; 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
  • Preclinical Brain disorders
  • Discontinued Duchenne muscular dystrophy; Non-small cell lung cancer; Radiation-induced skin damage

Most Recent Events

  • 18 Oct 2024 Biogen initiates enrolment in a phase I pharmacokinetics trial (In volunteers) in USA (PO) (NCT06612879)
  • 03 Oct 2024 Reata plans pharmacokinetics phase I trial (In healthy volunteers, In adults) (PO) (NCT06612879)
  • 17 Sep 2024 Biogen anticipates a regulatory decision from Health Canada on the New Drug Submission for Friedreich's ataxia in early 2025

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