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
-

Study of the Therapeutic Effects of Naohuan Dan and Idebenone in Treating Mild Cognitive Impairment With Kidney Deficiency and Phlegm Stasis

First Posted Date
2023-07-05
Last Posted Date
2023-07-05
Lead Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Target Recruit Count
64
Registration Number
NCT05931029
Locations
🇨🇳

Sun Yat-sen Memorial Hospital,Sun Yat-sen University,Guangzhou 510300,China, Guangzhou, Guangdong, China

Safety and Efficacy of Oral Idebenone for Preventive Treatment of Migraine in Adult Migraine Patients

First Posted Date
2022-06-09
Last Posted Date
2022-06-23
Lead Sponsor
Beijing Tiantan Hospital
Target Recruit Count
900
Registration Number
NCT05411978
Locations
🇨🇳

Yonggang Wang, Beijing, China

Study of Oral Idebenone to Treat Non-Alcoholic Steatohepatitis

Phase 1
Active, not recruiting
Conditions
Interventions
First Posted Date
2020-12-16
Last Posted Date
2023-10-25
Lead Sponsor
Stanford University
Target Recruit Count
45
Registration Number
NCT04669158
Locations
🇺🇸

Digestive Health Center, Stanford University, Redwood City, California, United States

🇺🇸

Stanford University, Stanford, California, United States

A Clinical Study of the Efficacy of Idebenone in the Treatment of iRBD Into Synucleinopathies

First Posted Date
2020-09-01
Last Posted Date
2023-05-09
Lead Sponsor
Ruijin Hospital
Target Recruit Count
142
Registration Number
NCT04534023
Locations
🇨🇳

Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China

A Study of Efficacy and Safety of Idebenone vs. Placebo in Prodromal Parkinson Disease

First Posted Date
2019-11-05
Last Posted Date
2021-07-16
Lead Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Target Recruit Count
180
Registration Number
NCT04152655
Locations
🇨🇳

Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China

Symptomatic Therapy for Patients With Huntington's Disease

First Posted Date
2019-08-28
Last Posted Date
2021-04-02
Lead Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Target Recruit Count
60
Registration Number
NCT04071639
Locations
🇨🇳

Second Affiliated Hospital,Zhejiang University School of Medicine, Hangzhou, Zhejiang, China

Expanded Access Program for Idebenone in Participants With Duchenne Muscular Dystrophy (DMD)

First Posted Date
2018-02-15
Last Posted Date
2023-04-21
Lead Sponsor
Santhera Pharmaceuticals
Registration Number
NCT03433807
Locations
🇺🇸

Phoenix Children's Hospital, Phoenix, Arizona, United States

🇺🇸

Yale New Haven Hospital, New Haven, Connecticut, United States

🇺🇸

Lurie Children's Hospital of Chicago, Chicago, Illinois, United States

and more 9 locations

Study to Assess the Efficacy and Safety of Raxone in LHON Patients

Phase 4
Completed
Conditions
Interventions
First Posted Date
2016-05-16
Last Posted Date
2023-04-21
Lead Sponsor
Santhera Pharmaceuticals
Target Recruit Count
199
Registration Number
NCT02774005
Locations
🇬🇧

University Hospital of Wales, Cardiff, United Kingdom

🇪🇸

Institut Catala de Retina, Barcelona, Spain

🇪🇸

Hospital Universitario Ramon y Cajal, Madrid, Spain

and more 26 locations

Post Authorisation Safety Study With Raxone in LHON Patients

First Posted Date
2016-05-13
Last Posted Date
2021-07-16
Lead Sponsor
Santhera Pharmaceuticals
Target Recruit Count
229
Registration Number
NCT02771379
Locations
🇮🇹

Ospedale San Raffaele, Milano, Italy

🇩🇪

Universitaetsklinikum Essen, Essen, Germany

🇫🇷

CHU Amiens - Centre Saint Victor, Amiens, Somme, France

and more 23 locations

Idebenone for Primary Progressive Multiple Sclerosis

First Posted Date
2013-05-15
Last Posted Date
2021-05-19
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
61
Registration Number
NCT01854359
Locations
🇺🇸

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

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