Section 12 · Monograph
Omaveloxolone
Reviewed Nov 2026FDA label
SkyclarysNrf2 activator
- Forms
- Cap: 50mg
- Dose
- 150mg (3 caps) once daily on empty stomach; reduce in hepatic impairment (Friedreich's ataxia, age 16+)
- MOA
- Activates Nrf2 pathway (exact mechanism unknown)
Indications
- Friedreich's ataxia in adults and adolescents 16 years of age and olderFDA-labeled
Mechanism of Action
- Activator of the Nrf2 pathway; the precise mechanism of therapeutic effect in Friedreich's ataxia is unknown
Full Dosing
Adult / usual
- 150mg (three 50mg capsules) once daily on an empty stomach at least 1 hour before eating; swallow whole (may be opened and mixed with applesauce; not for enteral tubes)
- Strong CYP3A4 inhibitors: avoid (if unavoidable reduce to 50mg daily); moderate inhibitors: 100mg daily; avoid strong or moderate CYP3A4 inducers
Hepatic
- Moderate hepatic impairment (Child-Pugh B): 100mg daily, reducing to 50mg if adverse reactions occur; severe: avoid
Contraindications
- None listed in labeling
Drug Interactions
- Strong and moderate CYP3A4 inhibitors raise exposure; inducers lower exposure
- May reduce effectiveness of hormonal contraceptives — consider an alternative or additional method
Adverse Effects
- Elevated ALT/AST (hepatotoxicity)
- BNP elevation and possible heart failure signal in patients with cardiomyopathy
- Elevated LDL and reduced HDL cholesterol; weight loss
- Nausea, headache, fatigue, diarrhea, muscle spasm
Monitoring Parameters
- ALT, AST and bilirubin before initiation and during treatment per label
- BNP and lipid parameters at baseline and during treatment
- Signs and symptoms of heart failure
Pregnancy & Lactation
- Limited data; weigh risk and benefit
- Unknown whether present in human milk