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About this data Sourced primarily from ClinicalTrials.gov — a listing isn't proof of safety or FDA approval.

Pipeline and clinical trial information here comes primarily from ClinicalTrials.gov. A listing on ClinicalTrials.gov means a study has been registered — not that a treatment is proven safe, effective, or FDA-approved. Investigational treatments may never be approved. Who can join a trial is decided only by that trial's own study team.

Not yet reported

Omaveloxolone

Company
Biogen
Mechanism
Mechanism not yet reported
Route
Route not yet reported
Recruiting trials
4 recruiting

Efficacy results: Not yet reported

Find a Clinical Trial Near Me

4 recruiting studies currently listed on ClinicalTrials.gov.

Data source: ClinicalTrials.gov · trial data as of Oct 23, 2026

Find a Clinical Trial Near Me

See recruiting studies for Omaveloxolone and check eligibility with the study team.

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Treatment type

"Added to GLP-1" means the investigational treatment is being studied on top of an existing GLP-1-based therapy.

Your ZIP code is only used to calculate distance to trial sites — it isn't stored.

Trial details
  • Recruiting NCT NCT06623890

    A 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 300 participants Est. completion 2029-10-01 14 sites
    Other conditions: Friedreich Ataxia
    View official trial listing →
  • Recruiting NCT NCT06628687

    A 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 10 participants Est. completion 2035-04-30 1 site
    Other conditions: Friedreich Ataxia
    View official trial listing →
  • Recruiting NCT NCT07013292

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

    Centre Hospitalier Universitaire de Nice 40 participants Est. completion 2026-06-30 1 site
    Other conditions: Friedreich Ataxia
    View official trial listing →
  • Recruiting NCT NCT07444333

    Cardiac Output and Fatigue in Friedreich's Ataxia

    Not yet reported Scott Barbuto 30 participants Est. completion 2028-04-01 1 site Stand-alone
    Other conditions: Friedreich's Ataxia
    View official trial listing →
  • Completed NCT NCT02029716

    RTA 408 Lotion in Healthy Volunteers

    Not yet reported Biogen 109 participants Est. completion 2014-04-01 1 site
    Other conditions: Healthy
    View official trial listing →
  • Completed NCT NCT02029729

    RTA 408 in the Treatment of Advanced Solid Tumors (NSCLC & Melanoma) - DISCOVER

    Not yet reported Biogen 11 participants Est. completion 2015-10-01 1 site Stand-alone
    Other conditions: Metastatic or Incurable Non-small Cell Lung Cancer, Relapsed, Refractory Melanoma
    View official trial listing →
  • Completed NCT NCT02065375

    RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular Surgery

    Not yet reported Biogen 109 participants Est. completion 2014-09-30 6 sites Stand-alone
    Other conditions: Inflammation and Pain Following Ocular Surgery
    View official trial listing →
  • Completed NCT NCT02128113

    RTA 408 Ophthalmic Suspension for the Prevention of Corneal Endothelial Cell Loss Following Cataract Surgery - GUARD

    Not yet reported Biogen 307 participants Est. completion 2015-04-30 15 sites Stand-alone
    Other conditions: Corneal Endothelial Cell Loss, Ocular Pain, Ocular Inflammation, Cataract Surgery
    View official trial listing →
  • Completed NCT NCT02142959

    RTA 408 Lotion in Patients at Risk for Radiation Dermatitis - PRIMROSE

    Not yet reported Biogen 187 participants Est. completion 2015-04-30 27 sites Stand-alone
    Other conditions: Breast Cancer
    View official trial listing →
  • Completed NCT NCT02255422

    RTA 408 Capsules in Patients With Mitochondrial Myopathy - MOTOR

    Not yet reported Biogen 53 participants Est. completion 2017-11-30 9 sites Stand-alone
    Other conditions: MItochondrial Myopathies
    View official trial listing →
  • Completed NCT NCT02255435

    A Study to Learn About the Effects and Safety of RTA 408 (Omaveloxolone) in People Aged 16 to 40 With Friedreich's Ataxia

    Not yet reported Biogen 172 participants Est. completion 2025-12-19 11 sites Stand-alone
    Other conditions: Friedreich Ataxia
    View official trial listing →
  • Completed NCT NCT02259231

    RTA 408 Capsules in Patients With Melanoma - REVEAL

    Not yet reported, Not yet reported Biogen 41 participants Est. completion 2018-07-23 10 sites Stand-alone
    Other conditions: Melanoma, Unresectable (Stage III) Melanoma, Metastatic (Stage IV) Melanoma
    View official trial listing →
  • No Longer Available NCT NCT03593499

    Expanded Access to Omaveloxolone for Melanoma for Patients Previously Enrolled in 408-C-1401

    Biogen
    Other conditions: Melanoma
    View official trial listing →
  • Completed NCT NCT03664453

    A Pharmacokinetic Study of Omaveloxolone in Healthy Volunteers

    Not yet reported Biogen 32 participants Est. completion 2018-11-20 1 site Stand-alone
    Other conditions: Healthy
    View official trial listing →
  • Completed NCT NCT03902002

    A Pharmacokinetic Study of Omaveloxolone in Subjects With Hepatic Impairment and Normal Hepatic Function

    Not yet reported Biogen 48 participants Est. completion 2020-01-27 3 sites Stand-alone
    Other conditions: Hepatic Impairment
    View official trial listing →
  • Completed NCT NCT03931590

    A Human AME Study for Omaveloxolone

    Not yet reported Biogen 8 participants Est. completion 2019-05-31 1 site Stand-alone
    Other conditions: Healthy Male Subjects
    View official trial listing →
  • Completed NCT NCT04008186

    A Clinical Drug-Drug Interaction (DDI) Study With Omaveloxolone

    Not yet reported Biogen 61 participants Est. completion 2019-08-28 1 site Stand-alone
    Other conditions: Healthy Adult Subjects
    View official trial listing →
  • Completed NCT NCT05909644

    An Open-label DDI Study of Omaveloxolone in Healthy Subjects

    Not yet reported Biogen 20 participants Est. completion 2023-08-30 1 site Stand-alone
    Other conditions: Healthy Adult Subjects
    View official trial listing →
  • Completed NCT NCT05927649

    A TQTc Study for Omaveloxolone

    Not yet reported Biogen 30 participants Est. completion 2023-09-01 1 site Stand-alone
    Other conditions: Health Adult Subjects
    View official trial listing →
  • Active, not recruiting NCT NCT06054893

    A Study to Find Out How BIIB141 (Omaveloxolone) is Processed in the Body and to Learn More About Its Safety in Participants With Friedreich's Ataxia Aged 2 to 15 Years Old

    Not yet reported Biogen 33 participants Est. completion 2030-06-04 1 site Stand-alone
    Other conditions: Friedreich Ataxia
    View official trial listing →
  • Completed NCT NCT06612879

    A Study to Find Out How BIIB141 (Omaveloxolone) Moves From the Blood Into the Breastmilk of Healthy Women Who Are Breastfeeding or Pumping Milk

    Not yet reported Biogen 12 participants Est. completion 2025-04-08 1 site Stand-alone
    Other conditions: Healthy Volunteer
    View official trial listing →
  • Active, not recruiting NCT NCT06953583

    A Study to Learn More About the Effects and Long-Term Safety of Omaveloxolone (BIIB141) in Children and Teens With Friedreich's Ataxia

    Not yet reported Biogen 255 participants Est. completion 2029-11-22 34 sites Stand-alone
    Other conditions: Friedreich Ataxia
    View official trial listing →
  • Completed NCT NCT07019064

    A Study to Learn How BIIB141 (Omaveloxolone) is Processed in the Body When Taken as Capsules Compared to Sprinkled on Yogurt in Healthy Adults Aged 18 to 55

    Not yet reported Biogen 52 participants Est. completion 2025-08-19 1 site Stand-alone
    Other conditions: Healthy Volunteer
    View official trial listing →
  • Completed NCT NCT07149415

    A Study to Learn if Taking BIIB141 (Omaveloxolone) Affects How Omeprazole is Processed in the Body and About BIIB141's Safety in Healthy Adults Aged 18 to 55

    Not yet reported Biogen 22 participants Est. completion 2025-10-16 1 site Stand-alone
    Other conditions: Healthy Volunteer
    View official trial listing →
  • Completed NCT NCT07297199

    A Study to Learn How the Body Processes BIIB141 (Omaveloxolone) When Taken as a Capsule or as a Tablet Dissolved in Liquid, and to Learn About Its Safety in Healthy Adults Ages 18 to 55

    Not yet reported Biogen 70 participants Est. completion 2026-05-01 1 site Stand-alone
    Other conditions: Healthy Volunteer
    View official trial listing →
Efficacy history

Not yet reported.

Safety

Not yet reported.

Sources

Also known as: Omaveloxolone, SKYCLARYS

Related On The Pen coverage

No related coverage yet.

This drug may be investigational and not yet approved for any use. Whether someone can join a clinical trial is determined only by that trial's own study team — On The Pen does not determine eligibility. Information here can change; always confirm current details on the official ClinicalTrials.gov listing or with the sponsor.