Currently Enrolling Trials
Skyclarys (omaveloxolone) activates the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway.
Skyclarys is specifically indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older.
Skyclarys is supplied as capsules for oral administration. Obtain ALT, AST, bilirubin, BNP, and lipid parameters prior to initiating and during treatment.
The recommended dosage of Skyclarys is 150 mg (3 capsules) taken orally once daily. Administer Skyclarys on an empty stomach at least one hour before eating. Capsules should be swallowed whole. Do not open, crush, or chew. If a dose of Skyclarys is missed, take the next dose at its scheduled time the following day. A double dose should not be taken to make up for a missed dose.
Mechanism of Action
The precise mechanism by which omaveloxolone exerts its therapeutic effect in patients with Friedreich’s ataxia is unknown. Omaveloxolone have been shown to activate the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway in vitro and in vivo in animals and humans. The Nrf2 pathway is involved in the cellular response to oxidative stress.
Side effects associated with the use of Skyclarys may include, but are not limited to, the following:
- elevated liver enzymes (AST/ALT)
- abdominal pain
- musculoskeletal pain
Clinical Trial Results
The FDA approval of Skyclarys was based on the MOXIe Part 2 trial and a post hoc Propensity-Matched Analysis of the open-label MOXIe Extension trial.