This brand name is authorized in Austria, Estonia, France, Croatia, Lithuania, United States
The drug SKYCLARYS contains one active pharmaceutical ingredient (API):
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1
Omaveloxolone
UNII G69Z98951Q - OMAVELOXOLONE
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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. |
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 |
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: US | FDA, National Drug Code | Identifier(s): 73179-250 |
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