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omaveloxolone

Skyclarys · ATC code N07XX25

Also known as: Omaveloxolon

Key facts
Active substance
omaveloxolone
ATC code
N07XX25
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Skyclarys 50 mg hard capsules
Marketing authorisation holder
Biogen Netherlands B.V.
Information as of
2026-10-27

Key facts

Omaveloxolone (Skyclarys) is an oral medicine used to treat Friedreich's ataxia in adults and adolescents aged 16 years and older.

What it is used for

  • Friedreich's ataxia in adults and adolescents aged 16 years and older

Dosing

  • 150 mg (3 hard capsules of 50 mg) once daily on an empty stomach, at least 1 hour before or 2 hours after eating
  • With strong CYP3A4 inhibitors: avoid; if unavoidable, 50 mg once daily
  • With moderate CYP3A4 inhibitors: avoid; if unavoidable, 100 mg once daily, reduced to 50 mg if adverse reactions emerge
  • Moderate hepatic impairment (Child-Pugh B): 100 mg once daily; avoid in severe hepatic impairment
  • Capsules may be opened and sprinkled onto apple puree; do not double a missed dose

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Aminotransferase elevations: ≥ 3 × ULN in 29.4% of patients, mostly within the first 12 weeks
  • Monitor ALT, AST and bilirubin before starting, monthly for the first 3 months and periodically thereafter
  • Discontinue immediately if ALT or AST rises to > 5 × ULN
  • Observe interactions with CYP3A4 inhibitors and inducers

Side effects

  • Most frequent: ALT increased and headache (37.3% each), weight decreased (34.0%), nausea (33.3%)
  • AST increased and fatigue (21.6% each), diarrhoea (19.6%), oropharyngeal pain (17.6%), vomiting (15.7%)
  • Back pain, muscle spasms, influenza; hypersensitivity including urticaria and rash

Interactions

  • Omaveloxolone is a CYP3A4 substrate: strong or moderate CYP3A4 inhibitors and CYP3A4 inducers affect its levels

Pregnancy and breastfeeding

  • Should not be used in pregnancy or in women of childbearing potential not using contraception
  • Effective contraception before starting, during treatment and for 28 days after stopping

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • SkyclarysBiogen Netherlands B.V. · EMEA/H/C/006084

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Skyclarys
Liechtenstein
Skyclarys
Norway
Skyclarys

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

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Sources

  1. European Medicines Agency. Skyclarys – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/skyclarys-epar-product-information_en.pdf

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.