About this data
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.
Omaveloxolone
- Company
- Biogen
- Mechanism
- Mechanism not yet reported
- Route
- Route not yet reported
- Recruiting trials
- 4 recruiting
Efficacy results: Not yet reported
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.
Trial details
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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 sitesOther conditions: Friedreich AtaxiaView 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 siteOther conditions: Friedreich AtaxiaView 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 siteOther conditions: Friedreich AtaxiaView 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-aloneOther conditions: Friedreich's AtaxiaView official trial listing → -
Completed NCT NCT02029716
RTA 408 Lotion in Healthy Volunteers
Not yet reported Biogen 109 participants Est. completion 2014-04-01 1 siteOther conditions: HealthyView 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-aloneOther conditions: Metastatic or Incurable Non-small Cell Lung Cancer, Relapsed, Refractory MelanomaView 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-aloneOther conditions: Inflammation and Pain Following Ocular SurgeryView 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-aloneOther conditions: Corneal Endothelial Cell Loss, Ocular Pain, Ocular Inflammation, Cataract SurgeryView 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-aloneOther conditions: Breast CancerView 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-aloneOther conditions: MItochondrial MyopathiesView 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-aloneOther conditions: Friedreich AtaxiaView 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-aloneOther conditions: Melanoma, Unresectable (Stage III) Melanoma, Metastatic (Stage IV) MelanomaView official trial listing → -
No Longer Available NCT NCT03593499
Expanded Access to Omaveloxolone for Melanoma for Patients Previously Enrolled in 408-C-1401
BiogenOther conditions: MelanomaView 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-aloneOther conditions: HealthyView 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-aloneOther conditions: Hepatic ImpairmentView 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-aloneOther conditions: Healthy Male SubjectsView 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-aloneOther conditions: Healthy Adult SubjectsView 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-aloneOther conditions: Healthy Adult SubjectsView 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-aloneOther conditions: Health Adult SubjectsView 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-aloneOther conditions: Friedreich AtaxiaView 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-aloneOther conditions: Healthy VolunteerView 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-aloneOther conditions: Friedreich AtaxiaView 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-aloneOther conditions: Healthy VolunteerView 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-aloneOther conditions: Healthy VolunteerView 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-aloneOther conditions: Healthy VolunteerView 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.
