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ClinicalTrials.gov public records Last synced Oct 21, 2026, 9:06 PM EDT

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Showing 1–23 of 23 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Omaveloxolone Clear all
Completed Phase 1 Interventional Accepts healthy volunteers

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

NCT07019064
View directory record Official record
Conditions
Healthy Volunteer
Interventions
Omaveloxolone
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years to 55 Years
Enrollment
52 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2025
U.S. locations
1
States / cities
Austin, Texas
Source: ClinicalTrials.gov public record
Updated Sep 22, 2025 · Synced Oct 21, 2026, 9:06 PM EDT
Recruiting No phase listed Observational

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

NCT06628687
View directory record Official record
Conditions
Friedreich Ataxia
Interventions
Omaveloxolone
Drug
Lead sponsor
Biogen
Industry
Eligibility
16 Years and older · Female only
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2035
U.S. locations
1
States / cities
Morrisville, North Carolina
Source: ClinicalTrials.gov public record
Updated Jul 10, 2026 · Synced Oct 21, 2026, 9:06 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

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

NCT07297199
View directory record Official record
Conditions
Healthy Volunteer
Interventions
Omaveloxolone
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years to 55 Years
Enrollment
70 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2025 – 2026
U.S. locations
1
States / cities
Austin, Texas
Source: ClinicalTrials.gov public record
Updated May 14, 2026 · Synced Oct 21, 2026, 9:06 PM EDT
Completed Phase 1Phase 2 Interventional Results available

RTA 408 Capsules in Patients With Melanoma - REVEAL

NCT02259231
View directory record Official record
Conditions
Melanoma, Unresectable (Stage III) Melanoma, Metastatic (Stage IV) Melanoma
Interventions
Omaveloxolone Capsules (2.5 mg/capsule), Ipilimumab (3 mg/kg), Nivolumab (240 mg), Omaveloxolone Capsules (10 mg/capsule), Omaveloxolone Capsules (50 mg/capsule)
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years and older
Enrollment
41 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2018
U.S. locations
10
States / cities
Mobile, Alabama • Fayetteville, Arkansas • Aurora, Colorado + 7 more
Source: ClinicalTrials.gov public record
Updated Jun 4, 2025 · Synced Oct 21, 2026, 9:06 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Human AME Study for Omaveloxolone

NCT03931590
View directory record Official record
Conditions
Healthy Male Subjects
Interventions
[14C]-Omaveloxolone
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years to 55 Years · Male only
Enrollment
8 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2019
U.S. locations
1
States / cities
Madison, Wisconsin
Source: ClinicalTrials.gov public record
Updated May 30, 2025 · Synced Oct 21, 2026, 9:06 PM EDT
Active, not recruiting Phase 1 Interventional

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

NCT06054893
View directory record Official record
Conditions
Friedreich Ataxia
Interventions
Omaveloxolone
Drug
Lead sponsor
Biogen
Industry
Eligibility
2 Years to 15 Years
Enrollment
33 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2030
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Sep 3, 2026 · Synced Oct 21, 2026, 9:06 PM EDT
Completed Phase 2 Interventional Results available

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

NCT02065375
View directory record Official record
Conditions
Inflammation and Pain Following Ocular Surgery
Interventions
Omaveloxolone Ophthalmic Suspension 1.0%, Omaveloxolone Opthalmic Suspension 0.5%, Placebo
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years and older
Enrollment
109 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014
U.S. locations
6
States / cities
Garden Grove, California • Fort Myers, Florida • Kansas City, Missouri + 3 more
Source: ClinicalTrials.gov public record
Updated Jun 3, 2025 · Synced Oct 21, 2026, 9:06 PM EDT
Active, not recruiting Phase 3 Interventional

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

NCT06953583
View directory record Official record
Conditions
Friedreich Ataxia
Interventions
Omaveloxolone, Placebo
Drug
Lead sponsor
Biogen
Industry
Eligibility
2 Years to 15 Years
Enrollment
255 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2029
U.S. locations
7
States / cities
Los Angeles, California • Gainesville, Florida • Tampa, Florida + 4 more
Source: ClinicalTrials.gov public record
Updated Oct 2, 2026 · Synced Oct 21, 2026, 9:06 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

RTA 408 Lotion in Healthy Volunteers

NCT02029716
View directory record Official record
Conditions
Healthy
Interventions
RTA 408 Lotion 0.5%, 1%, 3%, Lotion vehicle/placebo
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years to 65 Years
Enrollment
109 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2013 – 2014
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated May 28, 2025 · Synced Oct 21, 2026, 9:06 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

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

NCT03902002
View directory record Official record
Conditions
Hepatic Impairment
Interventions
Omaveloxolone 50 mg capsules
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years to 70 Years
Enrollment
48 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2019 – 2020
U.S. locations
3
States / cities
Tustin, California • Miami, Florida • Orlando, Florida
Source: ClinicalTrials.gov public record
Updated May 30, 2025 · Synced Oct 21, 2026, 9:06 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

An Open-label DDI Study of Omaveloxolone in Healthy Subjects

NCT05909644
View directory record Official record
Conditions
Healthy Adult Subjects
Interventions
Omaveloxolone, Efavirenz
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years to 55 Years
Enrollment
20 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2023
U.S. locations
1
States / cities
Tempe, Arizona
Source: ClinicalTrials.gov public record
Updated May 30, 2025 · Synced Oct 21, 2026, 9:06 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

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

NCT04008186
View directory record Official record
Conditions
Healthy Adult Subjects
Interventions
Omaveloxolone, Midazolam oral solution, Repaglinide 1 MG, MetFORMIN 500 Mg Oral Tablet, Rosuvastatin, Digoxin tablet, Gemfibrozil Tablets, Itraconazole capsule, Verapamil Pill
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years to 55 Years
Enrollment
61 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2019
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated May 30, 2025 · Synced Oct 21, 2026, 9:06 PM EDT
Recruiting No phase listed Observational

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

NCT06623890
View directory record Official record
Conditions
Friedreich Ataxia
Interventions
Omaveloxolone
Drug
Lead sponsor
Biogen
Industry
Eligibility
16 Years and older
Enrollment
300 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2029
U.S. locations
4
States / cities
Los Angeles, California • Aurora, Colorado • Gainesville, Florida + 1 more
Source: ClinicalTrials.gov public record
Updated Apr 28, 2026 · Synced Oct 21, 2026, 9:06 PM EDT
Completed Phase 2 Interventional Results available

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

NCT02128113
View directory record Official record
Conditions
Corneal Endothelial Cell Loss, Ocular Pain, Ocular Inflammation, Cataract Surgery
Interventions
Vehicle Ophthalmic Solution, Omaveloxolone Ophthalmic Suspension 0.5%, Omaveloxolone Ophthalmic Suspension 1%
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years to 80 Years
Enrollment
307 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
15
States / cities
Laguna Hills, California • Lancaster, California • Cape Coral, Florida + 11 more
Source: ClinicalTrials.gov public record
Updated Jun 3, 2025 · Synced Oct 21, 2026, 9:06 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A TQTc Study for Omaveloxolone

NCT05927649
View directory record Official record
Conditions
Health Adult Subjects
Interventions
Omaveloxolone, Moxifloxacin
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years to 55 Years
Enrollment
30 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2023
U.S. locations
1
States / cities
Tempe, Arizona
Source: ClinicalTrials.gov public record
Updated May 30, 2025 · Synced Oct 21, 2026, 9:06 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

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

NCT07149415
View directory record Official record
Conditions
Healthy Volunteer
Interventions
Omaveloxolone, Omeprazole
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years to 55 Years
Enrollment
22 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2025
U.S. locations
1
States / cities
Austin, Texas
Source: ClinicalTrials.gov public record
Updated Oct 23, 2025 · Synced Oct 21, 2026, 9:06 PM EDT
Completed Phase 2 Interventional Results available

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

NCT02142959
View directory record Official record
Conditions
Breast Cancer
Interventions
Omaveloxolone Lotion 0.5%, Omaveloxolone Lotion 3%, Vehicle Lotion, 3D conformal radiation therapy
Drug · Radiation
Lead sponsor
Biogen
Industry
Eligibility
18 Years to 75 Years · Female only
Enrollment
187 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
27
States / cities
Mesa, Arizona • Phoenix, Arizona • Scottsdale, Arizona + 23 more
Source: ClinicalTrials.gov public record
Updated Jun 3, 2025 · Synced Oct 21, 2026, 9:06 PM EDT
Completed Phase 2 Interventional Results available

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

NCT02255435
View directory record Official record
Conditions
Friedreich Ataxia
Interventions
Omaveloxolone Capsules, 2.5 mg, Omaveloxolone Capsules, 5 mg, Omaveloxolone Capsules, 10 mg, Placebo, Omaveloxolone Capsules, 20 mg, Omaveloxolone Capsules, 40 mg, Omaveloxolone Capsules, 80 mg, Omaveloxolone Capsules, 160 mg, Omaveloxolone Capsules, 300 mg, Omaveloxolone Capsules, 150 mg
Drug
Lead sponsor
Biogen
Industry
Eligibility
16 Years to 40 Years
Enrollment
172 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2025
U.S. locations
7
States / cities
Los Angeles, California • Gainesville, Florida • Tampa, Florida + 4 more
Source: ClinicalTrials.gov public record
Updated Sep 3, 2026 · Synced Oct 21, 2026, 9:06 PM EDT
Recruiting Not applicable Interventional

Cardiac Output and Fatigue in Friedreich's Ataxia

NCT07444333
View directory record Official record
Conditions
Friedreich's Ataxia
Interventions
Aerobic Exercise
Behavioral
Lead sponsor
Scott Barbuto
Other
Eligibility
Not listed
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Sep 22, 2026 · Synced Oct 21, 2026, 9:06 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

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

NCT06612879
View directory record Official record
Conditions
Healthy Volunteer
Interventions
Omaveloxolone
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years to 45 Years · Female only
Enrollment
12 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024 – 2025
U.S. locations
1
States / cities
Madison, Wisconsin
Source: ClinicalTrials.gov public record
Updated Apr 22, 2025 · Synced Oct 21, 2026, 9:06 PM EDT
Completed Phase 1 Interventional

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

NCT02029729
View directory record Official record
Conditions
Metastatic or Incurable Non-small Cell Lung Cancer, Relapsed, Refractory Melanoma
Interventions
omaveloxolone
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years to 75 Years
Enrollment
11 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
1
States / cities
Tampa, Florida
Source: ClinicalTrials.gov public record
Updated May 29, 2025 · Synced Oct 21, 2026, 9:06 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Pharmacokinetic Study of Omaveloxolone in Healthy Volunteers

NCT03664453
View directory record Official record
Conditions
Healthy
Interventions
omaveloxolone
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years to 55 Years
Enrollment
32 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated May 30, 2025 · Synced Oct 21, 2026, 9:06 PM EDT
Completed Phase 2 Interventional Results available

RTA 408 Capsules in Patients With Mitochondrial Myopathy - MOTOR

NCT02255422
View directory record Official record
Conditions
MItochondrial Myopathies
Interventions
Omaveloxolone capsules, 2.5 mg, omaveloxolone capsules, 5 mg, omaveloxolone capsules, 10 mg, Placebo capsules, omaveloxolone capsules, 20 mg, omaveloxolone capsules, 40 mg, omaveloxolone capsules, 80 mg, omaveloxolone capsules, 160 mg
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years to 75 Years
Enrollment
53 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2017
U.S. locations
8
States / cities
Los Angeles, California • Boston, Massachusetts • Akron, Ohio + 4 more
Source: ClinicalTrials.gov public record
Updated Jun 5, 2025 · Synced Oct 21, 2026, 9:06 PM EDT