SKYCLARYS

This brand name is authorized in Austria, Estonia, France, Croatia, Lithuania, Romania, United States

Active ingredients

The drug SKYCLARYS contains one active pharmaceutical ingredient (API):

1 Omaveloxolone UNII G69Z98951Q - OMAVELOXOLONE

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. There is substantial evidence that Nrf2 levels and activity are suppressed in cells from patients with Friedreich’s ataxia. Read about Omaveloxolone

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
SKYCLARYS Capsule	FDA, National Drug Code (US)	MPI, US: SPL/PLR
SKYCLARYS Hard capsule	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
N07XX25		N Nervous system → N07 Other nervous system drugs → N07X Other nervous system drugs → N07XX Other nervous system drugs
Discover more medicines within N07XX25

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: EE	Ravimiamet	Identifier(s): 3073890, 3073902
Country: FR	Base de données publique des médicaments	Identifier(s): 63167621
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1098905, 1098906
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W70872001
Country: US	FDA, National Drug Code	Identifier(s): 73179-250