Drug

Omaveloxolone

Approved · EMA

Late-stage development

Also known as Skyclarys, Propanamide, N-(2-cyano-3,12-dioxo-28-noroleana-1,9(11)-dien-17-yl)-2,2-difluoro-.

RxNorm2631931 ChEMBLCHEMBL4303525UNIIG69Z98951Q

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Omaveloxolone (BIIB141) in Participants With Friedreich's Ataxia Aged 2 to < 16 Years

Clinical trial2026-06-16Results expected Q4 2027 · ClinicalTrials.gov

A Phase 1, Randomized, Open-Label, Single-Dose, Crossover, Bioequivalence Study of Omaveloxolone Tablets for Oral Suspension Versus Capsules in Healthy Adult Participants

Clinical trial2026-05-01Completed · ClinicalTrials.gov

A Phase 2 Study of the Safety, Efficacy, and Pharmacodynamics of RTA 408 in the Treatment of Friedreich's Ataxia (MOXIe)

Clinical trial2026-01-23Results posted · ClinicalTrials.gov

A Phase 1, Open-Label, Single-Sequence, 2-Period, Drug-Drug Interaction Study in Healthy Participants Evaluating the Effect of Omaveloxolone on the Pharmacokinetics of CYP2C19 Substrate, Omeprazole

Clinical trial2025-10-16Completed · ClinicalTrials.gov

An Open-Label, Phase 1, Study to Evaluate the Pharmacokinetics, Safety, Tolerability, Pharmacodynamics, and Efficacy of Omaveloxolone in Participants ≥2 to <16 Years of Age With Friedreich's Ataxia

Clinical trial2025-09-30Primary completion · ClinicalTrials.gov

A Phase 1, Randomized, Open-label, Single-dose, Crossover, Relative Bioavailability Study of Omaveloxolone Intact Capsules Versus Capsule Contents Sprinkled Over Low-fat, Non-Greek Yogurt in Healthy Adult Subjects

Clinical trial2025-08-19Completed · ClinicalTrials.gov

A Phase 2 Study of the Safety, Efficacy, and Pharmacodynamics of RTA 408 in the Treatment of Mitochondrial Myopathy (MOTOR)

Clinical trial2025-06-05Results posted · ClinicalTrials.gov

An Open-Label, Single Dose Study to Assess the Breast Milk and Plasma Pharmacokinetics of Omaveloxolone (BIIB141) in Healthy Lactating Women

Clinical trial2025-04-08Completed · ClinicalTrials.gov

Approval: Skyclarys (EMA)

Regulatory2024-02-09EMA

A Randomized, Double-Blind, Placebo- and Active-Controlled, 3-Way Crossover Study in Healthy Subjects to Determine the Effect of Omaveloxolone on QTc Interval

Clinical trial2023-09-01Completed · ClinicalTrials.gov

A Single Sequence, 2-Period, Open-label Crossover Study in Healthy Subjects to Determine the Effect of a Moderate CYP3A4 Inducer on the Pharmacokinetics of Omaveloxolone

Clinical trial2023-08-30Completed · ClinicalTrials.gov

A Single Dose, Open Label Pharmacokinetic Study of Omaveloxolone in Subjects With Mild, Moderate, or Severe Hepatic Impairment, or With Normal Hepatic Function

Clinical trial2020-01-27Completed · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Omaveloxolone

Aliases & brands

SkyclarysPropanamide, N-(2-cyano-3,12-dioxo-28-noroleana-1,9(11)-dien-17-yl)-2,2-difluoro-

RxNorm CUI

2631931

ChEMBL ID

CHEMBL4303525

UNII

G69Z98951Q

Regulatory jurisdictions

ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2024-02-09

Latest approval

2024-02-09

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2024-02-09Approval

Approval: Skyclarys (EMA)

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

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

15 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

LATEST COMPLETION 2026

Active studies

Recruiting

Late-stage (III+)

Completed

PHASE DISTRIBUTIONn = 15

Phase 112Phase 22Phase 31

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Phase 3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Omaveloxolone (BIIB141) in Participants With Friedreich's Ataxia Aged 2 to < 16 Years

RecruitingPH IIIBiogenn=2552029

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 1, Randomized, Open-Label, Single-Dose, Crossover, Bioequivalence Study of Omaveloxolone Tablets for Oral Suspension Versus Capsules in Healthy Adult Participants

CompletedPH IBiogenn=702026

A Phase 2 Study of the Safety, Efficacy, and Pharmacodynamics of RTA 408 in the Treatment of Friedreich's Ataxia (MOXIe)

CompletedPH IIBiogenn=1722025

A Phase 1, Open-Label, Single-Sequence, 2-Period, Drug-Drug Interaction Study in Healthy Participants Evaluating the Effect of Omaveloxolone on the Pharmacokinetics of CYP2C19 Substrate, Omeprazole

CompletedPH IBiogenn=222025

CompletedPH IBiogenn=522025

An Open-Label, Single Dose Study to Assess the Breast Milk and Plasma Pharmacokinetics of Omaveloxolone (BIIB141) in Healthy Lactating Women

CompletedPH IBiogenn=122025

A Randomized, Double-Blind, Placebo- and Active-Controlled, 3-Way Crossover Study in Healthy Subjects to Determine the Effect of Omaveloxolone on QTc Interval

CompletedPH IBiogenn=302023

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.