Omaveloxolone
Omaveloxolone is an oral medication approved for the treatment of Friedreich's ataxia, a rare genetic neurodegenerative disorder. It works by activating the Nrf2 pathway, which helps reduce oxidative stress and mitochondrial dysfunction believed to contribute to neuronal damage in this condition.
Omaveloxolone is an Nrf2 activator used to treat Friedreich's ataxia by targeting oxidative stress pathways.
Key facts at a glance
- ATC
- N07XX25
- RxNorm
- 2631931
- Generic
- Omaveloxolone
- Class
- atc-n07
- Brands
- Skyclarys
- Availability
- rx
- Lactation
- unknown
- Routes
- oral
- Forms
- capsule
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Omaveloxolone is indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older. Friedreich's ataxia is a rare inherited disorder caused by mutations in the FXN gene, leading to progressive loss of coordination, muscle weakness, and cardiac complications.
Omaveloxolone activates the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway, a key regulator of cellular antioxidant and cytoprotective responses. By activating Nrf2, the drug promotes the expression of genes involved in mitochondrial function and reduces oxidative stress, which is elevated in Friedreich's ataxia patients.
Common side effects may include liver enzyme elevations, weight gain, and gastrointestinal symptoms. Patients should have liver function monitored during treatment. Omaveloxolone may interact with certain medications metabolized through CYP enzymes. It is not recommended during pregnancy. The drug is typically used as part of a comprehensive management plan for Friedreich's ataxia.
Official drug label
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This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy