Uses
SKYCLARYS is indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older.
Source: US FDA prescribing information
- Presentations
- 1
- Brands
- 1
- Manufacturers
- 1
- Available from stock
- 0
Omaveloxolone is a prescription medicine indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older. It is available as capsules for oral use. MedsAcross supplies Omaveloxolone for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- Pharmacological class
- Cytochrome P450 2C8 Inducers, Cytochrome P450 3A4 Inducers
- ATC classification
- N07XX25 Omaveloxolone · Other nervous system medicines, subgroup N07X, subgroup N07XX
- US FDA first approval
- 28 February 2023
- EU status
- Authorised
- Orphan designation
- Yes
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Oral
- Dosage forms
- Capsule
- Identifiers
- UNII G69Z98951QCAS 1474034-05-3DrugBank DB12513Q21098900
Clinical information
From the regulator-approved product information. Each section names its source.
How it works
The precise mechanism by which omaveloxolone exerts its therapeutic effect in patients with Friedreich's ataxia is unknown. Omaveloxolone has 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.
Source: US FDA prescribing information
Dosing overview
Obtain alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, B-type natriuretic peptide (BNP), and lipid parameters prior to initiating SKYCLARYS and during treatment. Recommended dosage is 150 mg (3 capsules) taken orally once daily. Administer SKYCLARYS on an empty stomach, at least 1 hour before or 2 hours after eating. Swallow SKYCLARYS capsules whole or open and sprinkle the entire contents of both halves of the capsule onto applesauce and mix. Do not crush or chew capsules. Moderate and Severe Hepatic Impairment: The recommended dosage of SKYCLARYS is 100 mg once daily for patients with moderate hepatic impairment. If adverse reactions emerge, further reduce the dosage to 50 mg once daily. Avoid use in patients with severe hepatic impairment.
Source: US FDA prescribing information
Contraindications
None. None.
Source: US FDA prescribing information
Warnings and precautions
Elevation of Aminotransferases: Monitor ALT, AST, and total bilirubin prior to initiation, every month for the first 3 months of treatment, and periodically thereafter. Elevation of B-type Natriuretic Peptide (BNP): Advise patients of signs and symptoms of fluid overload. Lipid Abnormalities: Monitor cholesterol periodically during treatment.
Source: US FDA prescribing information
Side effects
The following clinically significant adverse reactions are described in greater detail in other labeling sections: Elevation of aminotransferases Elevation of BNP Lipid abnormalities Most common adverse reactions (incidence ≥20% and greater than placebo) are elevated liver enzymes (AST/ALT), headache, nausea, abdominal pain, fatigue, diarrhea, and musculoskeletal pain.
Source: US FDA prescribing information
Interactions
Moderate or Strong CYP3A4 Inhibitors: Avoid concomitant use. Consider SKYCLARYS dosage reduction with monitoring if use is unavoidable. Moderate or Strong CYP3A4 Inducers: Avoid concomitant use.
Source: US FDA prescribing information
Storage
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
All presentations
1 presentations of Omaveloxolone, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Skyclarys 50 mg capsuleOral | Biogen | US FDA | Available on request |
Brands by market
1 brand names across 1 markets.
United States
Manufacturers
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions
Conditions linked to Omaveloxolone in public data. This is not a list of approved uses, see the clinical information.
Questions and answers
Is Omaveloxolone available for export from India?
Yes, on request. MedsAcross lists 1 presentations of Omaveloxolone and sources them for licensed hospitals, importers and physicians against valid import documents.
What brand names does Omaveloxolone have?
The catalogue lists 1 brand names for Omaveloxolone, including Skyclarys.
Is Omaveloxolone approved by the US FDA?
Yes. The US FDA first approved Omaveloxolone on 28 February 2023, according to Drugs@FDA.
Is Omaveloxolone authorised in the European Union?
Yes. Omaveloxolone has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
Does Omaveloxolone need cold chain shipping?
No listed presentation of Omaveloxolone is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Which ATC class is Omaveloxolone in?
Omaveloxolone is classified under ATC code N07XX25 (Omaveloxolone).
References
- SKYCLARYS prescribing information (Biogen). U.S. National Library of Medicine, DailyMed. Retrieved 6 April 2026
- Skyclarys: European public assessment report (EPAR). European Medicines Agency. Retrieved 20 October 2026
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