Drug updated on 4/16/2024

Dosage FormCapsule (oral; 50 mg)
Drug ClassNuclear factor (erythroid-derived 2)-like 2 (Nrf2) activators
Ongoing and
Completed Studies


  • Indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older.

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  • Omaveloxolone (Skyclarys) is indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older.
  • Information was derived from a systematic literature review, which included one study covering 32 publications on therapeutic interventions for Friedreich's ataxia.
  • Among the drugs studied, Omaveloxolone (Skyclarys) was investigated in three publications. However, specific outcomes related to this drug were not provided in the study.
  • In terms of safety profile comparison with other drugs used for treating Friedreich's Ataxia, such as Idebenone or recombinant erythropoietin, it is noted that these therapeutic interventions, including Omaveloxolone, were generally well-tolerated across most studies. Serious adverse events like atrial fibrillation, craniocerebral injury, and ventricular tachycardia occurred rarely, but it wasn't specified which drug they are associated with.
  • Efficacy measures frequently reported through scales like ICARS, FARS-neuro, etc., showed patients deteriorating regardless of treatment or found inconclusive results. There is no specific mention about the efficacy of Omaveloxolone compared to other drugs, making direct comparison difficult based on available data.
  • Studies included a wide age range from 8 to 73 years old with varied disease durations, indicating no subgroup considerations specifically related to the effectiveness or safety of Omaveloxolone detailed out in the reviewed document.

Product Monograph / Prescribing Information

Document TitleYearSource
Skyclarys (omaveloxolone) Prescribing Information. 2023Reata Pharmaceuticals, Inc., Plano, TX

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Clinical evidence of interventions assessed in Friedreich ataxia: a systematic review. 2022Therapeutic Advances in Rare Disease