Idebenone

Generic Name
Idebenone
Brand Names
Raxone
Drug Type
Small Molecule
Chemical Formula
C19H30O5
CAS Number
58186-27-9
Unique Ingredient Identifier
HB6PN45W4J
Background

Idebenone is a synthetic analogue of ubiquinone (also known as Coenzyme Q10), a vital cell antioxidant and essential component of the Electron Transport Chain (ETC). It has been proposed that by interacting with the ETC, idebenone increases ATP production required for mitochondrial function, reduces free radicals, inhibits lipid peroxidation, and consequentl...

Indication

Idebenone is indicated for use by the European Medicines Agency (EMA) for the treatment of visual impairment in adolescent and adult patients with

Leber’s Hereditary Optic Neuropathy (LHON). It is not currently approved for use by either the Food and Drug Administration (USA) or Health Canada .

Associated Conditions
Alzheimer's Disease (AD), Leber’s hereditary optic neuropathy
Associated Therapies
-

Efficacy and Tolerability of Idebenone in Boys With Cardiac Dysfunction Associated With Duchenne Muscular Dystrophy

First Posted Date
2008-04-09
Last Posted Date
2011-08-01
Lead Sponsor
Santhera Pharmaceuticals
Target Recruit Count
21
Registration Number
NCT00654784
Locations
🇧🇪

Children's Hospital, University Hospital, Leuven, Belgium

Study to Assess the Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia

Phase 3
Completed
Conditions
Interventions
First Posted Date
2007-10-01
Last Posted Date
2023-07-11
Lead Sponsor
Santhera Pharmaceuticals
Target Recruit Count
70
Registration Number
NCT00537680
Locations
🇺🇸

David Geffen School of Medicine, UCLA, Los Angeles, California, United States

🇺🇸

The Children's Hopsital of Philadelphia, Philadelphia, Pennsylvania, United States

Idebenone to Treat Friedreich's Ataxia

Phase 2
Completed
Conditions
First Posted Date
2005-09-29
Last Posted Date
2019-03-18
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Target Recruit Count
51
Registration Number
NCT00229632
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Phase 1 Trial of Idebenone to Treat Patients With Friedreich's Ataxia

Phase 1
Completed
Conditions
First Posted Date
2004-03-01
Last Posted Date
2008-03-04
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Target Recruit Count
16
Registration Number
NCT00078481
Locations
🇺🇸

National Institute of Neurological Disorders and Stroke (NINDS), Bethesda, Maryland, United States

Safety Study of Idebenone to Treat Friedreich's Ataxia

Phase 1
Completed
Conditions
First Posted Date
2001-05-07
Last Posted Date
2006-07-12
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Target Recruit Count
100
Registration Number
NCT00015808
Locations
🇺🇸

National Institute of Neurological Disorders and Stroke (NINDS), Bethesda, Maryland, United States

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