omaveloxolone: Clinical Trials

14 completed, 3 recruiting, 2 active not recruiting, 1 no longer available. 12 Phase 1, 4 Phase 2, 1 Phase 3.

By phase and status

Phase	Trials	Status
Phase 1	12	Completed 11, Active not recruiting 1
Phase 2	4	Completed 4
Phase 3	1	Active not recruiting 1

Follow omaveloxolone: new trials by email Literature Review of omaveloxolone trials Research Report on omaveloxolone

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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

Trial	Phase	Status	Sponsor	Enrollment	Start	Updated
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 Omaveloxolone - Friedreich Ataxia		Recruiting	Biogen	10	2026-10-26	2026-07-10
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 Omaveloxolone - Healthy Volunteer	Phase 1	Completed	Biogen	70	2025-12-12	2026-05-14
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 Omaveloxolone, Omeprazole - Healthy Volunteer	Phase 1	Completed	Biogen	22	2025-09-02	2025-10-23
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 Omaveloxolone - Healthy Volunteer	Phase 1	Completed	Biogen	52	2025-06-11	2025-09-22
A Study to Learn More About the Effects and Long-Term Safety of Omaveloxolone (BIIB141) in Children and Teens With Friedreich's Ataxia Omaveloxolone, Placebo - Friedreich Ataxia	Phase 3	Active not recruiting	Biogen	255	2025-06-09	2026-10-02
Efficacy of Omaveloxolone Treatment for Dysphagia in French Patients With Friedreich's Ataxia SKYCLARYS (omaveloxolone) - Friedreich Ataxia		Recruiting	Centre Hospitalier Universitaire de Nice	40	2025-06-01	2026-04-29
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 Omaveloxolone - Friedreich Ataxia		Recruiting	Biogen	300	2024-12-12	2026-04-28
A Study to Find Out How BIIB141 (Omaveloxolone) Moves From the Blood Into the Breastmilk of Healthy Women Who Are Breastfeeding or Pumping Milk Omaveloxolone - Healthy Volunteer	Phase 1	Completed	Biogen	12	2024-10-18	2025-04-22
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 Omaveloxolone - Friedreich Ataxia	Phase 1	Active not recruiting	Biogen	33	2024-07-01	2026-09-03
A TQTc Study for Omaveloxolone Omaveloxolone, Moxifloxacin - Health Adult Subjects	Phase 1	Completed	Biogen	30	2023-07-11	2025-05-30
An Open-label DDI Study of Omaveloxolone in Healthy Subjects Omaveloxolone, Efavirenz - Healthy Adult Subjects	Phase 1	Completed	Biogen	20	2023-07-05	2025-05-30
A Pharmacokinetic Study of Omaveloxolone in Subjects With Hepatic Impairment and Normal Hepatic Function Omaveloxolone 50 mg capsules - Hepatic Impairment	Phase 1	Completed	Biogen	48	2019-07-19	2025-05-30
A Clinical Drug-Drug Interaction (DDI) Study With Omaveloxolone Omaveloxolone, Midazolam oral solution, Repaglinide 1 MG - Healthy Adult Subjects	Phase 1	Completed	Biogen	61	2019-06-14	2025-05-30
A Pharmacokinetic Study of Omaveloxolone in Healthy Volunteers omaveloxolone - Healthy	Phase 1	Completed	Biogen	32	2018-10-29	2025-05-30
RTA 408 Capsules in Patients With Mitochondrial Myopathy - MOTOR Omaveloxolone capsules, 2.5 mg, omaveloxolone capsules, 5 mg, omaveloxolone capsules, 10 mg - MItochondrial Myopathies	Phase 2	Completed	Biogen	53	2015-05-05	2025-06-05
A Study to Learn About the Effects and Safety of RTA 408 (Omaveloxolone) in People Aged 16 to 40 With Friedreich's Ataxia Omaveloxolone Capsules, 2.5 mg, Omaveloxolone Capsules, 5 mg, Omaveloxolone Capsules, 10 mg - Friedreich Ataxia	Phase 2	Completed	Biogen	172	2015-01-31	2026-09-03
RTA 408 Capsules in Patients With Melanoma - REVEAL Omaveloxolone Capsules (2.5 mg/capsule), Ipilimumab (3 mg/kg), Nivolumab (240 mg) - Melanoma, Unresectable (Stage III) Melanoma	Phase 1 / Phase 2	Completed	Biogen	41	2014-10-31	2025-06-04
RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular Surgery Omaveloxolone Ophthalmic Suspension 1.0%, Omaveloxolone Opthalmic Suspension 0.5%, Placebo - Inflammation and Pain Following Ocular Surgery	Phase 2	Completed	Biogen	109	2014-02-28	2025-06-03
RTA 408 in the Treatment of Advanced Solid Tumors (NSCLC & Melanoma) - DISCOVER omaveloxolone - Metastatic or Incurable Non-small Cell Lung Cancer, Relapsed, Refractory Melanoma	Phase 1	Completed	Biogen	11	2013-12-31	2025-05-29
Expanded Access to Omaveloxolone for Melanoma for Patients Previously Enrolled in 408-C-1401 omaveloxolone - Melanoma		No longer available	Biogen			2025-05-31

Conditions studied

Friedreich Ataxia (6)  ·  Melanoma (3)  ·  Neoplasm Metastasis (2)  ·  Carcinoma, Non-Small-Cell Lung (1)  ·  Endophthalmitis (1)  ·  Eye Pain (1)  ·  Inflammation (1)  ·  Mitochondrial Diseases (1)  ·  Mitochondrial Myopathies (1)  ·  Recurrence (1)

Sponsors

Biogen (19)  ·  Centre Hospitalier Universitaire de Nice (1)

Countries

United States (18)  ·  Austria (3)  ·  Italy (3)  ·  Australia (2)  ·  Denmark (2)  ·  France (2)  ·  Germany (2)  ·  Netherlands (2)  ·  United Kingdom (2)  ·  Belgium (1)  ·  Brazil (1)  ·  Canada (1)  ·  Czechia (1)  ·  India (1)  ·  Ireland (1)

Top investigators

Michelle Valentine, DO (2)  ·  Jennifer Zon, MD (1)

Results publications

PMID 30656180, PMID 31896620, PMID 33068037, PMID 39976332, PMID 40614535

NIH funding

2025 (1)