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
-
Clinical Trials
Related News

Study With Idebenone in Patients With Chronic Vision Loss Due to Leber's Hereditary Optic Neuropathy (LHON)

First Posted Date
2011-12-20
Last Posted Date
2014-08-22
Lead Sponsor
Santhera Pharmaceuticals
Registration Number
NCT01495715

Patient Reported Outcomes in Friedreich's Ataxia Patients After Withdrawal From Treatment With Idebenone (PROTI)

Phase 3
Completed
Conditions
Friedreich's Ataxia
Interventions
Drug: Placebo
Drug: Idebenone
First Posted Date
2011-02-24
Last Posted Date
2016-03-09
Lead Sponsor
Santhera Pharmaceuticals
Target Recruit Count
29
Registration Number
NCT01303406
Locations
🇬🇧

The National Hospital, University College London, London, United Kingdom

Phase III Study of Idebenone in Duchenne Muscular Dystrophy (DMD)

First Posted Date
2009-12-09
Last Posted Date
2015-10-19
Lead Sponsor
Santhera Pharmaceuticals
Target Recruit Count
65
Registration Number
NCT01027884
Locations
🇺🇸

University of California Davis Medical Center, Sacramento, California, United States

🇺🇸

Children's Hospital Colorado, Aurora, Colorado, United States

🇺🇸

Carolinas Medical Center, Neurosciences and Spine Institute, Charlotte, North Carolina, United States

and more 20 locations

Long-Term Safety and Tolerability of Idebenone in Friedreich's Ataxia Patients (MICONOS Extension)

Phase 3
Completed
Conditions
Freidreich's Ataxia
Interventions
Drug: idebenone
First Posted Date
2009-10-14
Last Posted Date
2018-03-05
Lead Sponsor
Santhera Pharmaceuticals
Target Recruit Count
200
Registration Number
NCT00993967
Locations
🇫🇷

Hôpital de la Salpétrière - INSERM U679, Neurologie et Thérapeutique expérimentale, Paris, France

🇩🇪

Zentrum für Neurologische Medizin, Göttingen, Germany

🇩🇪

HELIOS Klinikum Berlin, Berlin, Germany

and more 8 locations

Clinical Trial of Idebenone in Primary Progressive Multiple Sclerosis (IPPoMS)

First Posted Date
2009-07-31
Last Posted Date
2019-03-19
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
85
Registration Number
NCT00950248
Locations
🇺🇸

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

A Study of Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia (FRDA) Patients

Phase 3
Completed
Conditions
Friedreich's Ataxia
Interventions
Drug: idebenone
Drug: Placebo
First Posted Date
2009-05-20
Last Posted Date
2016-06-27
Lead Sponsor
Santhera Pharmaceuticals
Target Recruit Count
232
Registration Number
NCT00905268
Locations
🇫🇷

Hôpital de la Salpêtrière - INSERM U679, Neurologie et Thérapeutique expérimentale, Paris, France

🇩🇪

Neurologische Klinik- klinikum Grosshadern, München, Germany

🇬🇧

National Hospital for Neurology & Neurosurgery, London, United Kingdom

and more 10 locations

Study of Idebenone in the Treatment of Mitochondrial Encephalopathy Lactic Acidosis & Stroke-like Episodes

Phase 2
Completed
Conditions
MELAS Syndrome
Interventions
Other: Placebo
Drug: Idebenone
First Posted Date
2009-04-24
Last Posted Date
2016-10-26
Lead Sponsor
Michio Hirano
Target Recruit Count
27
Registration Number
NCT00887562
Locations
🇺🇸

Columbia University Medical Center, New York, New York, United States

Long-term Safety, Tolerability and Efficacy of Idebenone in Duchenne Muscular Dystrophy (DELPHI Extension)

Phase 2
Completed
Conditions
Duchenne Muscular Dystrophy
Interventions
Drug: Idebenone
First Posted Date
2008-09-25
Last Posted Date
2011-06-01
Lead Sponsor
Santhera Pharmaceuticals
Target Recruit Count
21
Registration Number
NCT00758225
Locations
🇧🇪

University Hospitals Leuven, Leuven, Belgium

Study to Assess Efficacy,Safety and Tolerability of Idebenone in the Treatment of Leber's Hereditary Optic Neuropathy

First Posted Date
2008-09-05
Last Posted Date
2013-05-27
Lead Sponsor
Santhera Pharmaceuticals
Target Recruit Count
85
Registration Number
NCT00747487
Locations
🇨🇦

Unité de recherche clinique Ophtalmologie- Hopital Notre-Dame, Montreal, Quebec, Canada

🇬🇧

Clinical Research Facility, 4th Floor Leazes Wing, Royal Victoria Infirmary, Newcastle Upon Tyne, United Kingdom

🇩🇪

Klinikum der Universität München - Grosshadern, Neurologische Klinik und Poliklinik, Munich, Germany

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

Phase 3
Completed
Conditions
Friedreich's Ataxia
Interventions
Drug: Idebenone
First Posted Date
2008-06-13
Last Posted Date
2023-07-11
Lead Sponsor
Santhera Pharmaceuticals
Target Recruit Count
68
Registration Number
NCT00697073
Locations
🇺🇸

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

🇺🇸

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

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