Skyclarys
Skyclarys ingredients
| Active ingredient | Strength |
|---|---|
| Omaveloxolone | 50 mg/1 |
What Skyclarys is used for
The FDA lists the approved uses on the official label (below). In the EU, omaveloxolone is approved as Skyclarys for:
The treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older.
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Skyclarys
- Generic name
- Omaveloxolone
- Made by
- Biogen
- Forms
- Capsule
- Given
- Oral
- FDA approval
- New drug application (NDA) NDA216718
- On the US market since
- 2023
Official information
- Skyclarys prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Omaveloxolone)
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Skyclarys?
Skyclarys (Omaveloxolone) is a specialist medicine made by Biogen, approved by the US FDA.
What are the ingredients of Skyclarys?
Skyclarys contains Omaveloxolone (50 mg/1).
Is Skyclarys approved in Europe?
The same active substance is approved in the EU as Skyclarys.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA