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Omaveloxolone · Skyclarys, BIIB141

Small molecule · Activator of Nuclear factor (erythroid-derived 2)-like 2 (NFE2L2) · developed by Biogen Us

Approved FDA, Feb 2023

BIIB Developer

2 Registered trials

What is Omaveloxolone?

Omaveloxolone is a small-molecule activator of the Nrf2 pathway, which is involved in the cellular response to oxidative stress.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: Skyclarys, BIIB141, RTA-408
Drug type: Small molecule
Targets: Nuclear factor (erythroid-derived 2)-like 2 (NFE2L2)
Mechanism: Activator of Nuclear factor (erythroid-derived 2)-like 2 (NFE2L2)
Pathways: oxidative stress response
Therapy area: Neurology
Developer: Biogen Us (BIIB)
FDA status: Approved as Skyclarys (February 28, 2023), NDA216718 · FDA label
UNII: G69Z98951Q

✅ FDA-approved uses

Friedreich's ataxia

From the indications section of the FDA label (version of Apr 6, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT06953583	Phase 3	Friedreich Ataxia	Active not recruiting	BIIB
NCT02255435	Phase 2	Friedreich Ataxia	Completed	BIIB

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Friedreich Ataxia

Other drugs acting on NFE2L2

Dimethyl Fumarate FDA approved Diroximel Fumarate FDA approved

More from Biogen Us

Dimethyl Fumarate FDA approved Diroximel Fumarate FDA approved Interferon Beta-1A FDA approved Natalizumab FDA approved Nusinersen FDA approved Tofersen FDA approved Zuranolone FDA approved BIIB115 Phase 1 BIIB122 Phase 3 BIIB144 Phase 1 BIIB147 Phase 1/2 Diranersen Phase 2

Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the BIIB page.

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z