Omaveloxolone

Generic Name: Omaveloxolone

Brand Names: Skyclarys

Drug Type: Small Molecule

Chemical Formula: C_₃₃H_₄₄F_₂N_₂O_₃

CAS Number: 1474034-05-3

Unique Ingredient Identifier: G69Z98951Q

Background: Omaveloxolone (RTA-408) is a semisynthetic oleanane triterpenoid with antioxidant and anti-inflammatory properties. Omaveloxolone acts as an activator of nuclear factor (erythroid-derived 2)-like 2 (Nrf2), a transcription factor that mitigates oxidative stress. In patients with Friedreich's ataxia, a genetic disease involving mitochondrial dysfunction, the N...

Indication: Omaveloxolone is indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older.

Associated Conditions: Friedreich's Ataxia

Associated Therapies: -

Clinical Trials

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

Recruiting

Conditions: Friedreich Ataxia

Interventions: Drug: Omaveloxolone

First Posted Date: 2024-10-08

Last Posted Date: 2024-12-20

Lead Sponsor: Biogen

Target Recruit Count: 20

Registration Number: NCT06628687

Locations: 🇺🇸
Evidera, Morrisville, North Carolina, United States

A Study to Learn More About the Long-Term Safety of BIIB141 (Omaveloxolone) in Participants With Friedreich's Ataxia Who Are Prescribed it for the First Time

Not yet recruiting

Conditions: Friedreich Ataxia

Interventions: Drug: Omaveloxolone

First Posted Date: 2024-10-02

Last Posted Date: 2024-10-02

Lead Sponsor: Reata, a wholly owned subsidiary of Biogen

Target Recruit Count: 300

Registration Number: NCT06623890

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

Phase 1

Recruiting

Conditions: Healthy Volunteer

Interventions: Drug: Omaveloxolone

First Posted Date: 2024-09-25

Last Posted Date: 2024-11-05

Lead Sponsor: Reata, a wholly owned subsidiary of Biogen

Target Recruit Count: 12

Registration Number: NCT06612879

Locations: 🇺🇸
Fortrea Madison WI, CRU, Madison, Wisconsin, United States

A Study of Omaveloxolone in Children With Friedreich's Ataxia

Phase 1

Recruiting

Conditions: Friedreich Ataxia

Interventions: Drug: Omaveloxolone

First Posted Date: 2023-09-26

Last Posted Date: 2024-07-08

Lead Sponsor: Reata, a wholly owned subsidiary of Biogen

Target Recruit Count: 20

Registration Number: NCT06054893

Locations: 🇺🇸
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

A TQTc Study for Omaveloxolone

Phase 1

Completed

Conditions: Health Adult Subjects

Interventions: Drug: Omaveloxolone
Drug: Moxifloxacin

First Posted Date: 2023-07-03

Last Posted Date: 2024-02-02

Lead Sponsor: Reata, a wholly owned subsidiary of Biogen

Target Recruit Count: 30

Registration Number: NCT05927649

Locations: 🇺🇸
Celerion, Inc., Tempe, Arizona, United States

An Open-label DDI Study of Omaveloxolone in Healthy Subjects

Phase 1

Completed

Conditions: Healthy Adult Subjects

Interventions: Drug: Omaveloxolone
Drug: Efavirenz

First Posted Date: 2023-06-18

Last Posted Date: 2024-02-02

Lead Sponsor: Reata, a wholly owned subsidiary of Biogen

Target Recruit Count: 20

Registration Number: NCT05909644

Locations: 🇺🇸
Celerion, Inc., Tempe, Arizona, United States

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

Phase 1

Completed

Conditions: Healthy Adult Subjects

Interventions: Drug: Omaveloxolone
Drug: Midazolam oral solution
Drug: Gemfibrozil Tablets
Drug: Itraconazole capsule
Drug: Verapamil Pill
Drug: Repaglinide 1 MG
Drug: MetFORMIN 500 Mg Oral Tablet
Drug: Rosuvastatin
Drug: Digoxin tablet

First Posted Date: 2019-07-05

Last Posted Date: 2024-02-02

Lead Sponsor: Reata, a wholly owned subsidiary of Biogen

Target Recruit Count: 61

Registration Number: NCT04008186

Locations: 🇺🇸
Covance Clinical Research Unit (CRU) Inc., Dallas, Texas, United States

A Pharmacokinetic Study of Omaveloxolone in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: omaveloxolone

First Posted Date: 2018-09-10

Last Posted Date: 2024-02-02

Lead Sponsor: Reata, a wholly owned subsidiary of Biogen

Target Recruit Count: 32

Registration Number: NCT03664453

Locations: 🇺🇸
Medpace Clinical Pharmacology Unit, Cincinnati, Ohio, United States

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

Conditions: Melanoma

First Posted Date: 2018-07-20

Last Posted Date: 2024-02-02

Lead Sponsor: Reata, a wholly owned subsidiary of Biogen

Registration Number: NCT03593499

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

Phase 1

Completed

Conditions: Metastatic or Incurable Non-small Cell Lung Cancer
Relapsed, Refractory Melanoma

Interventions: Drug: omaveloxolone

First Posted Date: 2014-01-08

Last Posted Date: 2024-02-02

Lead Sponsor: Reata, a wholly owned subsidiary of Biogen

Target Recruit Count: 11

Registration Number: NCT02029729

Locations: 🇺🇸
H. Lee Moffitt Cancer Center (NSCLC), Tampa, Florida, United States

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