Is Omaveloxolone registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Omaveloxolone, including skyclarys (50 mg, Capsule, hard, SAR 127050.00).

Is Omaveloxolone approved by the US FDA?

Drugs@FDA lists 1 application product line for Omaveloxolone, including SKYCLARYS (Prescription).

Is Omaveloxolone authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Omaveloxolone: Skyclarys.

Are there safety signals or safety updates for Omaveloxolone?

US FDA: 1 entry (latest 2024-12-20).

Active substance

Omaveloxolone

SFDA 1
US FDA 1
EMA 1
Health Canada 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
skyclarys	50 mg	Capsule, hard · Oral use	90 Bottle	SAR 127050.00	NCE · Prescription	Biogen Idec B.V-Natherland	Valid

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
SKYCLARYS	50MG	capsule · oral	BIOGEN US	Prescription	28 Feb 2023

EMA European Union — centrally authorised medicines

Skyclarys Biogen Netherlands B.V. · Authorised · authorised 9 Feb 2024 · ATC N07XX25

Therapeutic indication (EMA)

The treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
SKYCLARYS	02556219	50 MG	CAPSULE · ORAL	BIOGEN CANADA INC

Safety signals and safety-related labeling changes

US FDA 20 Dec 2024 SKYCLARYS — safety-related labeling change
Labeling sections changed: Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for omaveloxolone →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.