Omaveloxolone - Biogen
Alternative Names: ABT-RTA-408; BIIB-141; RTA-408; SKYCLARYS; SkyclarysLatest Information Update: 28 Jun 2025
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
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- 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
- 28 Jun 2025 No recent reports of development identified for preclinical development in Brain-disorders in USA
- 11 Jun 2025 Biogen plans a phase I trial for Healthy volunteers in unknown location (PO, Capsule) in June 2025 (NCT07019064)
- 09 Jun 2025 Phase-III clinical trials in Friedreich's ataxia (In children, In adolescents) in USA (PO) (NCT06953583)