Friedreich ataxia

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At a Glance

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Regulatory Watchboard

10 events
Oct 2026A Study to Learn How BIIB141 (Omaveloxolone) Affects the Health of Participants With Friedrich's Ataxia Who Took it During Pregnancy and/or During Breastfeeding and About the Health of Their Babies

Biogen

TrialRECRUITING
Apr 2026SKYCLARYS: New indication approved
FDAcompleted
Sep 2025Clinical Course Of Disease In Participants With FA-CM

Lexeo Therapeutics

TrialRECRUITING
Jun 2025A Study to Learn More About the Effects and Long-Term Safety of BIIB141 (Omaveloxolone) in Participants With Friedreich's Ataxia Aged 2 to 15 Years Old (BRAVE)

Biogen — PHASE3

TrialRECRUITING
Jun 2025A Multiple Ascending Dose Study of DT-216P2 in Patients With Friedreich's Ataxia

Design Therapeutics, Inc. — PHASE1, PHASE2

TrialRECRUITING
Jun 2025Efficacy of Omaveloxolone Treatment for Dysphagia in French Patients With Friedreich's Ataxia

Centre Hospitalier Universitaire de Nice

TrialNOT YET RECRUITING
Feb 2025Efficacy of Stabilometric Platform to Improve Standing Balance in Patients With Friedreich's Ataxia

IRCCS Eugenio Medea — NA

TrialRECRUITING
Feb 2025A Single Ascending Dose Study of DT-216P2 in Normal Healthy Participants

Design Therapeutics, Inc. — PHASE1

TrialNOT YET RECRUITING
Dec 2024SKYCLARYS: New indication approved
FDAcompleted
Dec 2024A Study to Learn More About the Long-Term Safety of BIIB141 (Omaveloxolone) in Participants With Friedreich's Ataxia Who Are Prescribed it by Their Own Doctors

Biogen

TrialRECRUITING

Data from FDA regulatory filings and ClinicalTrials.gov. Updated periodically.

Financial Assistance

1 program

FINANCIAL LANDSCAPE SUMMARY

1

Total programs

1

Open now

Patient Assistance Programs1

Skyclarys

Biogen U.S. Corporation

OpenContact for detailsApply ↗

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Approved Treatments

1 FDA-approved

Skyclarys

(omaveloxolone)Orphan drug

Biogen U.S. Corporation

12.1 Mechanism of Action The precise mechanism by which omaveloxolone exerts its therapeutic effect in patients with Friedreich's ataxia is unknown. O...

Approved Feb 2023FDA label ↗

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Clinical Trial Landscape

15 active trials
2Phase 3
1Phase 2
2Phase 1
1N/A
7Unknown
2PHASE1, PHASE2
15Total recruiting
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Recent News & Research

1 article
FDAMay 10, 2025

Skyclarys Approved for Friedreich Ataxia

The FDA approved omaveloxolone (Skyclarys) as the first treatment for Friedreich ataxia, a rare inherited neurodegenerative disease.

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Specialist Network

Top 6 by expertise

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