Product
Omaveloxolone
Aliases
Omaveloxolone 50 mg capsules, omaveloxolone capsules, 10 mg, Omaveloxolone Capsules, 10 mg, Omaveloxolone Capsules (10 mg/capsule) (36 other aliases)
Name
SKYCLARYS
INN Name
omaveloxolone
FDA Approved
Yes
10 clinical trials
1 organization
12 indications
1 document
Indication
Adult HealthIndication
Mitochondrial MyopathiesIndication
MelanomaIndication
Unresectable MelanomaIndication
Liver ImpairmentIndication
Friedreich AtaxiaIndication
Ocular SurgeryIndication
Adult Health SubjectsIndication
Corneal Endothelial Cell LossIndication
Eye PainIndication
Ocular InflammationIndication
Cataract SurgeryClinical trial
A Single Sequence, 2-Period, Open-label Crossover Study in Healthy Subjects to Determine the Effect of a Moderate CYP3A4 Inducer on the Pharmacokinetics of OmaveloxoloneStatus: Completed, Estimated PCD: 2023-08-30
Clinical trial
A Phase 2 Study of the Safety, Efficacy, and Pharmacodynamics of RTA 408 in the Treatment of Mitochondrial Myopathy (MOTOR)Status: Completed, Estimated PCD: 2017-11-02
Clinical trial
An Open-label, Multicenter, Dose-escalation, Phase 1b/2 Study of the Safety, Efficacy, Pharmacodynamics, and Pharmacokinetics of RTA 408 in Combination With Ipilimumab or Nivolumab in the Treatment of Patients With Unresectable or Metastatic MelanomaStatus: Completed, Estimated PCD: 2018-05-09
Clinical trial
A Single Dose, Open Label Pharmacokinetic Study of Omaveloxolone in Subjects With Mild, Moderate, or Severe Hepatic Impairment, or With Normal Hepatic FunctionStatus: Completed, Estimated PCD: 2020-01-27
Clinical trial
A Phase 2 Study of the Safety, Efficacy, and Pharmacodynamics of RTA 408 in the Treatment of Friedreich's Ataxia (MOXIe)Status: Active (not recruiting), Estimated PCD: 2019-10-31
Clinical trial
A Multicenter, Randomized, Dose-Ranging, Double-Masked, Placebo-Controlled Phase 2 Study Evaluating the Safety and Efficacy of RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular SurgeryStatus: Completed, Estimated PCD: 2014-09-30
Clinical trial
A Randomized, Double-Blind, Placebo- and Active-Controlled, 3-Way Crossover Study in Healthy Subjects to Determine the Effect of Omaveloxolone on QTc IntervalStatus: Completed, Estimated PCD: 2023-09-01
Clinical trial
A Phase 1, Open-Label, 4-Part, Drug-Drug Interaction Study With Omaveloxolone in Healthy SubjectsStatus: Completed, Estimated PCD: 2019-08-18
Clinical trial
A Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group, Phase 2 Study of the Efficacy and Safety of RTA 408 For the Prevention of Corneal Endothelial Cell Loss in Patients Undergoing Cataract SurgeryStatus: Completed, Estimated PCD: 2015-02-28
Clinical trial
An Open-Label, Phase 1 Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of A Single-Dose Of Omaveloxolone In Children ≥2 To <16 Years Of Age With Friedreich's AtaxiaStatus: Not yet recruiting, Estimated PCD: 2024-02-01
Document
DailyMed Label: SKYCLARYSOrganization
Reata Pharmaceuticals, Inc.