SKYCLARYS

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

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 more about Omaveloxolone

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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