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Last updated: 6 Oct 2015

Idebenone

Summary
Trade name: 
Avan (Takeda Chemical Industries, Japan)
(9)
Chemistry, toxicology, pharmacology and pharmacokinetics of idebenone: a review.
Zs -Nagy I
Arch Gerontol Geriatr. 1990 Nov-Dec; 11(3):177-86. PMID: 15374467. Abstract
Catena (Santhera Pharmaceuticals, Switzerland)
(13)
Raxone®/Catena® (idebenone)
Santhera Pharmaceuticals
Accessed on 2 Dec 2013 from http://www.santhera.com/index.php?mid=53&vid=&lang=en.
Cerestabon
(25)
New Drugs Online report for idebenone
UK Medicines Information
Accessed on 2 Dec 2013 from http://www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=4237.
Daruma
(25)
New Drugs Online report for idebenone
UK Medicines Information
Accessed on 2 Dec 2013 from http://www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=4237.
Mnesis
(25)
New Drugs Online report for idebenone
UK Medicines Information
Accessed on 2 Dec 2013 from http://www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=4237.
Raxone (Santhera Pharmaceuticals, Switzerland)
(13)
Raxone®/Catena® (idebenone)
Santhera Pharmaceuticals
Accessed on 2 Dec 2013 from http://www.santhera.com/index.php?mid=53&vid=&lang=en.
Sovrima (Santhera Pharmaceuticals, Switzerland)
(24)
CHMP assessment report for Sovrima (International nonproprietary name: idebenone)
European Medicines Agency, 20 Nov 2008
Accessed on 2 Dec 2013 from http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/000908/WC500070576.pdf.
Class: 
Neuroprotector
(4)
The antioxidant idebenone fails to prevent or attenuate chronic experimental autoimmune encephalomyelitis in the mouse.
Fiebiger SM, Bros H, Grobosch T, Janssen A, Chanvillard C, Paul F, Dörr J, Millward JM, Infante-Duarte C
J Neuroimmunol. 2013 Sep 15; 262(1-2):66-71. Epub 2013 Jul 18. PMID: 23871488. Abstract
(6)
Effects of idebenone (CV-2619) and its metabolites on respiratory activity and lipid peroxidation in brain mitochondria from rats and dogs.
Sugiyama Y, Fujita T, Matsumoto M, Okamoto K, Imada I
J Pharmacobiodyn. 1985 Dec; 8(12):1006-17. PMID: 2871147. Abstract
(26)
Mitochondrial approaches for neuroprotection.
Chaturvedi RK, Beal FM
Ann N Y Acad Sci. 2008 Dec; 1147:395-412. PMID: 19076459. Abstract
Target: 
Reactive oxygen species
(6)
Effects of idebenone (CV-2619) and its metabolites on respiratory activity and lipid peroxidation in brain mitochondria from rats and dogs.
Sugiyama Y, Fujita T, Matsumoto M, Okamoto K, Imada I
J Pharmacobiodyn. 1985 Dec; 8(12):1006-17. PMID: 2871147. Abstract
(12)
Inhibition of glycerophosphate-dependent H2O2 generation in brown fat mitochondria by idebenone.
Rauchová H, Vrbacký M, Bergamini C, Fato R, Lenaz G, Houstek J, Drahota Z
Biochem Biophys Res Commun. 2006 Jan 6; 339(1):362-6. Epub 2005 Nov 14. PMID: 16300743. Abstract
Status for MS: 
Phase I/II trial is recruiting as of November, 2013
(2)
Double blind placebo-controlled Phase I/II clinical trial of idebenone in patients with primary progressive multiple sclerosis (IPPoMS)
ClinicalTrials.gov, 22 Nov 2013
Accessed on 26 Nov 2013 from http://www.clinicaltrials.gov/ct2/show/NCT00950248.
Administration: 
Oral
(2)
Double blind placebo-controlled Phase I/II clinical trial of idebenone in patients with primary progressive multiple sclerosis (IPPoMS)
ClinicalTrials.gov, 22 Nov 2013
Accessed on 26 Nov 2013 from http://www.clinicaltrials.gov/ct2/show/NCT00950248.
Dose in clinical trial for PPMS is 2250 mg per day (750 mg dose, 3 times per day)
(2)
Double blind placebo-controlled Phase I/II clinical trial of idebenone in patients with primary progressive multiple sclerosis (IPPoMS)
ClinicalTrials.gov, 22 Nov 2013
Accessed on 26 Nov 2013 from http://www.clinicaltrials.gov/ct2/show/NCT00950248.
(15)
Santhera and NIH collaborate to evaluate Catena® in primary progressive multiple sclerosis
Santhera Pharmaceuticals, 24 Jun 2009
Accessed on 2 Dec 2013 from http://www.santhera.com/index.php?docid=212&vid=&lang=en&newsdate=200906&newsid=1324517&newslang=en.
Commercial: 
Initially developed in Japan, where it was licensed for treating Alzheimer's disease
(5)
Co-enzyme Q10 and idebenone use in Friedreich's ataxia.
Parkinson MH, Schulz JB, Giunti P
J Neurochem. 2013 Aug; 126 Suppl 1:125-41. PMID: 23859348. Abstract
Patented by Takeda Chemical Industries, Japan
(9)
Chemistry, toxicology, pharmacology and pharmacokinetics of idebenone: a review.
Zs -Nagy I
Arch Gerontol Geriatr. 1990 Nov-Dec; 11(3):177-86. PMID: 15374467. Abstract
Introduced into the Japanese market in 1986
(9)
Chemistry, toxicology, pharmacology and pharmacokinetics of idebenone: a review.
Zs -Nagy I
Arch Gerontol Geriatr. 1990 Nov-Dec; 11(3):177-86. PMID: 15374467. Abstract
Post-marketing data are available from over 8 million people
(5)
Co-enzyme Q10 and idebenone use in Friedreich's ataxia.
Parkinson MH, Schulz JB, Giunti P
J Neurochem. 2013 Aug; 126 Suppl 1:125-41. PMID: 23859348. Abstract
Withdrawn from the Japanese market in 1998 because of lack of proven efficacy in Alzheimer's disease
(24)
CHMP assessment report for Sovrima (International nonproprietary name: idebenone)
European Medicines Agency, 20 Nov 2008
Accessed on 2 Dec 2013 from http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/000908/WC500070576.pdf.
Under development for orphan mitochondrial and neuromuscular conditions by Santhera Pharmaceuticals
(13)
Raxone®/Catena® (idebenone)
Santhera Pharmaceuticals
Accessed on 2 Dec 2013 from http://www.santhera.com/index.php?mid=53&vid=&lang=en.
Conditionally approved by Health Canada for the treatment of Friedreich's ataxia (24 July 2008)
(14)
Santhera receives first product approval: Health Canada approves Catena® for treatment of Friedreich's ataxia
Santhera Pharmaceuticals, 24 Jul 2008
Accessed on 2 Dec 2013 from http://www.santhera.com/index.php?docid=212&vid=&lang=en&newsdate=200807&newsid=1238090&newslang=en.
Can be obtained in some European countries on a "named patient" basis for treating Friedreich's ataxia as of November 2008
(24)
CHMP assessment report for Sovrima (International nonproprietary name: idebenone)
European Medicines Agency, 20 Nov 2008
Accessed on 2 Dec 2013 from http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/000908/WC500070576.pdf.
Clinical trial to assess use in PPMS involves a collaboration between the US National Institutes of Health (which is conducting the trial) and Santhera Pharmaceuticals (which is supplying idebenone) (24 June 2009)
(15)
Santhera and NIH collaborate to evaluate Catena® in primary progressive multiple sclerosis
Santhera Pharmaceuticals, 24 Jun 2009
Accessed on 2 Dec 2013 from http://www.santhera.com/index.php?docid=212&vid=&lang=en&newsdate=200906&newsid=1324517&newslang=en.
Sales in Canada for the treatment of Friedreich's ataxia were discontinued voluntarily by Santhera Pharmaceuticals after additional clinical studies (30 April 2013)
(16)
Santhera to discontinue sale of Catena® in Canada
Santhera Pharmaceuticals, 27 Feb 2013
Accessed on 2 Dec 2013 from http://www.santhera.com/index.php?docid=212&vid=&lang=en&newsdate=201302&newsid=1681302&newslang=en.
Marketing authorization for treating Leber's hereditary optic neuropathy has been recommended by the European Medicines Agency's Committee for Medicinal Products for Human Use (26 June 2015)
(29)
CHMP recommends granting a marketing authorization for Santhera's Raxone® for the treatment of Leber's Hereditary Optic Neuropathy (LHON)
Santhera Pharmaceuticals, 26 Jun 2015
Accessed on 30 Jun 2015 from http://www.santhera.com/index.php?docid=212&vid=&lang=en&newsdate=201506&newsid=1931735&newslang=en.
Marketing authorization for treating Leber's hereditary optic neuropathy has been granted by the European Commission (9 September 2015)
(30)
Santhera Receives European Marketing Authorization for Raxone® in Leber's Hereditary Optic Neuropathy (LHON)
Santhera, 9 Sep 2015
Accessed on 6 Oct 2015 from http://www.santhera.com/index.php?docid=212&vid=&lang=en&newsdate=201509&newsid=1950678&newslang=en.
Names
Name: 
Idebenone
Trade name: 
Avan (Takeda Chemical Industries, Japan)
(9)
Chemistry, toxicology, pharmacology and pharmacokinetics of idebenone: a review.
Zs -Nagy I
Arch Gerontol Geriatr. 1990 Nov-Dec; 11(3):177-86. PMID: 15374467. Abstract
Catena (Santhera Pharmaceuticals, Switzerland)
(13)
Raxone®/Catena® (idebenone)
Santhera Pharmaceuticals
Accessed on 2 Dec 2013 from http://www.santhera.com/index.php?mid=53&vid=&lang=en.
Cerestabon
(25)
New Drugs Online report for idebenone
UK Medicines Information
Accessed on 2 Dec 2013 from http://www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=4237.
Daruma
(25)
New Drugs Online report for idebenone
UK Medicines Information
Accessed on 2 Dec 2013 from http://www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=4237.
Mnesis
(25)
New Drugs Online report for idebenone
UK Medicines Information
Accessed on 2 Dec 2013 from http://www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=4237.
Raxone (Santhera Pharmaceuticals, Switzerland)
(13)
Raxone®/Catena® (idebenone)
Santhera Pharmaceuticals
Accessed on 2 Dec 2013 from http://www.santhera.com/index.php?mid=53&vid=&lang=en.
Sovrima (Santhera Pharmaceuticals, Switzerland)
(24)
CHMP assessment report for Sovrima (International nonproprietary name: idebenone)
European Medicines Agency, 20 Nov 2008
Accessed on 2 Dec 2013 from http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/000908/WC500070576.pdf.
Synonyms: 
6-(10-Hydroxydecyl)-2,3-dimethoxy-5-methyl-1,4-benzoquinone
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
BRN 2001459
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
CV 2619
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
Hydroxydecyl-ubiquinone
(12)
Inhibition of glycerophosphate-dependent H2O2 generation in brown fat mitochondria by idebenone.
Rauchová H, Vrbacký M, Bergamini C, Fato R, Lenaz G, Houstek J, Drahota Z
Biochem Biophys Res Commun. 2006 Jan 6; 339(1):362-6. Epub 2005 Nov 14. PMID: 16300743. Abstract
Idebenona
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
Idebenonum
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
SNT MC17
(25)
New Drugs Online report for idebenone
UK Medicines Information
Accessed on 2 Dec 2013 from http://www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=4237.
UNII-HB6PN45W4J
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
Systematic name: 
2,5-Cyclohexadiene-1,4-dione, 2-(10-hydroxydecyl)-5,6-dimethoxy-3-methyl-
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
2,5-Cyclohexadiene-1,4-dione, 5,6-dimethoxy-2-(10-hydroxydecyl)-3-methyl-
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
2-(10-Hydroxydecyl)-5,6-dimethoxy-3-methyl-p-benzoquinone
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
Physiology
Class: 
Neuroprotector
(4)
The antioxidant idebenone fails to prevent or attenuate chronic experimental autoimmune encephalomyelitis in the mouse.
Fiebiger SM, Bros H, Grobosch T, Janssen A, Chanvillard C, Paul F, Dörr J, Millward JM, Infante-Duarte C
J Neuroimmunol. 2013 Sep 15; 262(1-2):66-71. Epub 2013 Jul 18. PMID: 23871488. Abstract
(6)
Effects of idebenone (CV-2619) and its metabolites on respiratory activity and lipid peroxidation in brain mitochondria from rats and dogs.
Sugiyama Y, Fujita T, Matsumoto M, Okamoto K, Imada I
J Pharmacobiodyn. 1985 Dec; 8(12):1006-17. PMID: 2871147. Abstract
(26)
Mitochondrial approaches for neuroprotection.
Chaturvedi RK, Beal FM
Ann N Y Acad Sci. 2008 Dec; 1147:395-412. PMID: 19076459. Abstract
Target: 
Reactive oxygen species
(6)
Effects of idebenone (CV-2619) and its metabolites on respiratory activity and lipid peroxidation in brain mitochondria from rats and dogs.
Sugiyama Y, Fujita T, Matsumoto M, Okamoto K, Imada I
J Pharmacobiodyn. 1985 Dec; 8(12):1006-17. PMID: 2871147. Abstract
(12)
Inhibition of glycerophosphate-dependent H2O2 generation in brown fat mitochondria by idebenone.
Rauchová H, Vrbacký M, Bergamini C, Fato R, Lenaz G, Houstek J, Drahota Z
Biochem Biophys Res Commun. 2006 Jan 6; 339(1):362-6. Epub 2005 Nov 14. PMID: 16300743. Abstract
Properties: 
Structural analog of coenzyme Q10, a molecule that transfers electrons between complexes in the electron transport chain in the inner mitochondrial membrane
(5)
Co-enzyme Q10 and idebenone use in Friedreich's ataxia.
Parkinson MH, Schulz JB, Giunti P
J Neurochem. 2013 Aug; 126 Suppl 1:125-41. PMID: 23859348. Abstract
Synthetic compound
(9)
Chemistry, toxicology, pharmacology and pharmacokinetics of idebenone: a review.
Zs -Nagy I
Arch Gerontol Geriatr. 1990 Nov-Dec; 11(3):177-86. PMID: 15374467. Abstract
Can act as an electron carrier in the mitochondrial electron transport chain
(6)
Effects of idebenone (CV-2619) and its metabolites on respiratory activity and lipid peroxidation in brain mitochondria from rats and dogs.
Sugiyama Y, Fujita T, Matsumoto M, Okamoto K, Imada I
J Pharmacobiodyn. 1985 Dec; 8(12):1006-17. PMID: 2871147. Abstract
Exists in reduced and oxidized forms
(9)
Chemistry, toxicology, pharmacology and pharmacokinetics of idebenone: a review.
Zs -Nagy I
Arch Gerontol Geriatr. 1990 Nov-Dec; 11(3):177-86. PMID: 15374467. Abstract
Antioxidant
(6)
Effects of idebenone (CV-2619) and its metabolites on respiratory activity and lipid peroxidation in brain mitochondria from rats and dogs.
Sugiyama Y, Fujita T, Matsumoto M, Okamoto K, Imada I
J Pharmacobiodyn. 1985 Dec; 8(12):1006-17. PMID: 2871147. Abstract
Almost insoluble in water; soluble in organic solvents
(9)
Chemistry, toxicology, pharmacology and pharmacokinetics of idebenone: a review.
Zs -Nagy I
Arch Gerontol Geriatr. 1990 Nov-Dec; 11(3):177-86. PMID: 15374467. Abstract
MW, 338.441
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
Has a reduced molecular weight and an increased solubility in water as compared with coenzyme Q10, suggesting that idebenone should be the more bioavailable of the two compounds
(5)
Co-enzyme Q10 and idebenone use in Friedreich's ataxia.
Parkinson MH, Schulz JB, Giunti P
J Neurochem. 2013 Aug; 126 Suppl 1:125-41. PMID: 23859348. Abstract
Only a small percentage is absorbed from the gastrointestinal tract in humans
(9)
Chemistry, toxicology, pharmacology and pharmacokinetics of idebenone: a review.
Zs -Nagy I
Arch Gerontol Geriatr. 1990 Nov-Dec; 11(3):177-86. PMID: 15374467. Abstract
Absorbed rapidly in humans, such that a peak concentration is reached 1 to 2 hours after a 10 to 100 mg dose
(9)
Chemistry, toxicology, pharmacology and pharmacokinetics of idebenone: a review.
Zs -Nagy I
Arch Gerontol Geriatr. 1990 Nov-Dec; 11(3):177-86. PMID: 15374467. Abstract
Serum levels are rapidly reduced by excretion in humans
(9)
Chemistry, toxicology, pharmacology and pharmacokinetics of idebenone: a review.
Zs -Nagy I
Arch Gerontol Geriatr. 1990 Nov-Dec; 11(3):177-86. PMID: 15374467. Abstract
Displays linear pharmacokinetics after both single and repeat doses in Phase I studies of healthy men
(17)
Pharmacokinetic properties and metabolism of idebenone.
Kutz K, Drewe J, Vankan P
J Neurol. 2009 Mar; 256 Suppl 1:31-5. PMID: 19283348. Abstract
Plasma concentrations increase about five-fold in fed versus fasting men
(17)
Pharmacokinetic properties and metabolism of idebenone.
Kutz K, Drewe J, Vankan P
J Neurol. 2009 Mar; 256 Suppl 1:31-5. PMID: 19283348. Abstract
Pharmacokinetics in plasma have been determined in rat and dog studies
(9)
Chemistry, toxicology, pharmacology and pharmacokinetics of idebenone: a review.
Zs -Nagy I
Arch Gerontol Geriatr. 1990 Nov-Dec; 11(3):177-86. PMID: 15374467. Abstract
Eliminated as metabolites within 48 hours after oral administration in rats and dogs
(9)
Chemistry, toxicology, pharmacology and pharmacokinetics of idebenone: a review.
Zs -Nagy I
Arch Gerontol Geriatr. 1990 Nov-Dec; 11(3):177-86. PMID: 15374467. Abstract
Can enter the brain, as shown by rat and dog studies
(9)
Chemistry, toxicology, pharmacology and pharmacokinetics of idebenone: a review.
Zs -Nagy I
Arch Gerontol Geriatr. 1990 Nov-Dec; 11(3):177-86. PMID: 15374467. Abstract
Some portion that enters the brain is recoverable in the mitochondrial fraction, as shown by rat and dog studies
(9)
Chemistry, toxicology, pharmacology and pharmacokinetics of idebenone: a review.
Zs -Nagy I
Arch Gerontol Geriatr. 1990 Nov-Dec; 11(3):177-86. PMID: 15374467. Abstract

Mechanisms/Effects

Human: 
Undergoes reduction by nicotinamide adenine dinucleotide (phosphate) (NAD(P)H):quinone oxidoreductase enzymes, allowing electron transfer to the mitochondrial respiratory chain from cytosolic NAD(P)H in hepatoma cells
(22)
NQO1-dependent redox cycling of idebenone: effects on cellular redox potential and energy levels.
Haefeli RH, Erb M, Gemperli AC, Robay D, Courdier Fruh I, Anklin C, Dallmann R, Gueven N
PLoS One. 2011; 6(3):e17963. Epub 2011 Mar 31. PMID: 21483849. Abstract
Partially restores ATP levels in hepatocytes in which mitochondrial complex I is repressed
(22)
NQO1-dependent redox cycling of idebenone: effects on cellular redox potential and energy levels.
Haefeli RH, Erb M, Gemperli AC, Robay D, Courdier Fruh I, Anklin C, Dallmann R, Gueven N
PLoS One. 2011; 6(3):e17963. Epub 2011 Mar 31. PMID: 21483849. Abstract
Reduces levels of nicotinamide adenine dinucleotide (NADH) in lymphoblastoid cells in a dose-dependent manner
(22)
NQO1-dependent redox cycling of idebenone: effects on cellular redox potential and energy levels.
Haefeli RH, Erb M, Gemperli AC, Robay D, Courdier Fruh I, Anklin C, Dallmann R, Gueven N
PLoS One. 2011; 6(3):e17963. Epub 2011 Mar 31. PMID: 21483849. Abstract
Reduces lactate production from cybrid cells derived from individuals with MELAS (mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes)
(22)
NQO1-dependent redox cycling of idebenone: effects on cellular redox potential and energy levels.
Haefeli RH, Erb M, Gemperli AC, Robay D, Courdier Fruh I, Anklin C, Dallmann R, Gueven N
PLoS One. 2011; 6(3):e17963. Epub 2011 Mar 31. PMID: 21483849. Abstract
Improves cognitive and psychoneurological problems associated with cerebrovascular disease in some clinical studies
(9)
Chemistry, toxicology, pharmacology and pharmacokinetics of idebenone: a review.
Zs -Nagy I
Arch Gerontol Geriatr. 1990 Nov-Dec; 11(3):177-86. PMID: 15374467. Abstract
Has shown positive effects on memory and cognition in some but not all clinical studies of Alzheimer's disease
(26)
Mitochondrial approaches for neuroprotection.
Chaturvedi RK, Beal FM
Ann N Y Acad Sci. 2008 Dec; 1147:395-412. PMID: 19076459. Abstract
Animal: 
Can act as an electron carrier in the mitochondrial electron chain in isolated mitochondria from dogs
(6)
Effects of idebenone (CV-2619) and its metabolites on respiratory activity and lipid peroxidation in brain mitochondria from rats and dogs.
Sugiyama Y, Fujita T, Matsumoto M, Okamoto K, Imada I
J Pharmacobiodyn. 1985 Dec; 8(12):1006-17. PMID: 2871147. Abstract
Action site is likely nicotinamide adenine dinucleotide (NADH)-linked complex I from the mitochondrial electron transport chain, as shown by experiments on isolated mitochondria from dogs and rats
(6)
Effects of idebenone (CV-2619) and its metabolites on respiratory activity and lipid peroxidation in brain mitochondria from rats and dogs.
Sugiyama Y, Fujita T, Matsumoto M, Okamoto K, Imada I
J Pharmacobiodyn. 1985 Dec; 8(12):1006-17. PMID: 2871147. Abstract
Is an efficient substrate for succinate:Q reductase and ubiquinol:cytochrome c reductase, complex II and III of the electron transport chain, respectively, as shown by experiments with beef heart mitochondria
(7)
The interaction of Q analogs, particularly hydroxydecyl benzoquinone (idebenone), with the respiratory complexes of heart mitochondria.
Esposti MD, Ngo A, Ghelli A, Benelli B, Carelli V, McLennan H, Linnane AW
Arch Biochem Biophys. 1996 Jun 15; 330(2):395-400. PMID: 8660670. Abstract
Is a relatively poor substrate (as an electron acceptor) for nicotinamide adenine dinucleotide (NADH):Q reductase (complex I of the electron transport chain), as compared with other coenzyme Q analogs, as shown by experiments with beef heart mitochondria
(7)
The interaction of Q analogs, particularly hydroxydecyl benzoquinone (idebenone), with the respiratory complexes of heart mitochondria.
Esposti MD, Ngo A, Ghelli A, Benelli B, Carelli V, McLennan H, Linnane AW
Arch Biochem Biophys. 1996 Jun 15; 330(2):395-400. PMID: 8660670. Abstract
Strongly inhibits both redox and proton pumping activities of complex I from the mitochondrial electron transport chain, as shown by experiments with beef heart mitochondria
(7)
The interaction of Q analogs, particularly hydroxydecyl benzoquinone (idebenone), with the respiratory complexes of heart mitochondria.
Esposti MD, Ngo A, Ghelli A, Benelli B, Carelli V, McLennan H, Linnane AW
Arch Biochem Biophys. 1996 Jun 15; 330(2):395-400. PMID: 8660670. Abstract
Inhibits lipid peroxidation reactions in isolated mitochondria from dogs
(6)
Effects of idebenone (CV-2619) and its metabolites on respiratory activity and lipid peroxidation in brain mitochondria from rats and dogs.
Sugiyama Y, Fujita T, Matsumoto M, Okamoto K, Imada I
J Pharmacobiodyn. 1985 Dec; 8(12):1006-17. PMID: 2871147. Abstract
Inhibits both glycerophosphate- and succinate-dependent production of reactive oxygen species, as shown by experiments with mitochondria from brown adipose tissue from hamsters
(12)
Inhibition of glycerophosphate-dependent H2O2 generation in brown fat mitochondria by idebenone.
Rauchová H, Vrbacký M, Bergamini C, Fato R, Lenaz G, Houstek J, Drahota Z
Biochem Biophys Res Commun. 2006 Jan 6; 339(1):362-6. Epub 2005 Nov 14. PMID: 16300743. Abstract
Promotes superoxide radical formation, probably by mediating electron transfer from an Fe-S cluster in complex I of the electron transport chain to oxygen, as shown by experiments with submitochondrial particles from bovine heart
(10)
The site of production of superoxide radical in mitochondrial Complex I is not a bound ubisemiquinone but presumably iron-sulfur cluster N2.
Genova ML, Ventura B, Giuliano G, Bovina C, Formiggini G, Parenti Castelli G, Lenaz G
FEBS Lett. 2001 Sep 21; 505(3):364-8. PMID: 11576529. Abstract
Protects HT22 (mouse hippocampal neuronal cell line) cells from cell death induced by glutamate in vitro
(4)
The antioxidant idebenone fails to prevent or attenuate chronic experimental autoimmune encephalomyelitis in the mouse.
Fiebiger SM, Bros H, Grobosch T, Janssen A, Chanvillard C, Paul F, Dörr J, Millward JM, Infante-Duarte C
J Neuroimmunol. 2013 Sep 15; 262(1-2):66-71. Epub 2013 Jul 18. PMID: 23871488. Abstract
Improves cerebral energy metabolism (probably by enhancing glucose use, the formation of cyclic AMP, and serotonin turnover) and thus protects against neurological problems caused by cerebral ischemia in rat models
(9)
Chemistry, toxicology, pharmacology and pharmacokinetics of idebenone: a review.
Zs -Nagy I
Arch Gerontol Geriatr. 1990 Nov-Dec; 11(3):177-86. PMID: 15374467. Abstract
Stimulates the release of serotonin and norepinephrine, but does not affect the release of dopamine, in rat models
(9)
Chemistry, toxicology, pharmacology and pharmacokinetics of idebenone: a review.
Zs -Nagy I
Arch Gerontol Geriatr. 1990 Nov-Dec; 11(3):177-86. PMID: 15374467. Abstract
Has positive effects on memory impairment in rat models
(9)
Chemistry, toxicology, pharmacology and pharmacokinetics of idebenone: a review.
Zs -Nagy I
Arch Gerontol Geriatr. 1990 Nov-Dec; 11(3):177-86. PMID: 15374467. Abstract
Partly restores nerve growth factor (NGF) levels in the frontal and parietal cortices in rats that display age-associated decreases in NGF levels
(23)
Orally active NGF synthesis stimulators: potential therapeutic agents in Alzheimer's disease.
Yamada K, Nitta A, Hasegawa T, Fuji K, Hiramatsu M, Kameyama T, Furukawa Y, Hayashi K, Nabeshima T
Behav Brain Res. 1997 Feb; 83(1-2):117-22. PMID: 9062669. Abstract
Improves performance in different tasks in rats with bilateral forebrain lesions
(23)
Orally active NGF synthesis stimulators: potential therapeutic agents in Alzheimer's disease.
Yamada K, Nitta A, Hasegawa T, Fuji K, Hiramatsu M, Kameyama T, Furukawa Y, Hayashi K, Nabeshima T
Behav Brain Res. 1997 Feb; 83(1-2):117-22. PMID: 9062669. Abstract
Provides protection against amyloid beta peptide-induced defects in energy metabolism (which include an accumulation of reactive oxygen species, a reduction in cellular redox activity, and reduced ATP levels) in rat PC12 cells
(27)
Involvement of oxidative stress on the impairment of energy metabolism induced by A beta peptides on PC12 cells: protection by antioxidants.
Pereira C, Santos MS, Oliveira C
Neurobiol Dis. 1999 Jun; 6(3):209-19. PMID: 10408810. Abstract
Is cardioprotective in a mouse model of Friedreich ataxia, a neurodegenerative condition that is linked with cardiomyopathy and is caused by reductions in the mitochondrial protein frataxin
(11)
Idebenone delays the onset of cardiac functional alteration without correction of Fe-S enzymes deficit in a mouse model for Friedreich ataxia.
Seznec H, Simon D, Monassier L, Criqui-Filipe P, Gansmuller A, Rustin P, Koenig M, Puccio H
Hum Mol Genet. 2004 May 15; 13(10):1017-24. Epub 2004 Mar 17. PMID: 15028670. Abstract
When applied preventively, does not affect the incidence or onset of experimental autoimmune encephalomyelitis in mice
(4)
The antioxidant idebenone fails to prevent or attenuate chronic experimental autoimmune encephalomyelitis in the mouse.
Fiebiger SM, Bros H, Grobosch T, Janssen A, Chanvillard C, Paul F, Dörr J, Millward JM, Infante-Duarte C
J Neuroimmunol. 2013 Sep 15; 262(1-2):66-71. Epub 2013 Jul 18. PMID: 23871488. Abstract
When applied therapeutically, does not decrease the severity of experimental autoimmune encephalomyelitis in mice
(4)
The antioxidant idebenone fails to prevent or attenuate chronic experimental autoimmune encephalomyelitis in the mouse.
Fiebiger SM, Bros H, Grobosch T, Janssen A, Chanvillard C, Paul F, Dörr J, Millward JM, Infante-Duarte C
J Neuroimmunol. 2013 Sep 15; 262(1-2):66-71. Epub 2013 Jul 18. PMID: 23871488. Abstract
Does not reduce inflammation, axonal damage, or demyelination in the central nervous system in mice with experimental autoimmune encephalomyelitis
(4)
The antioxidant idebenone fails to prevent or attenuate chronic experimental autoimmune encephalomyelitis in the mouse.
Fiebiger SM, Bros H, Grobosch T, Janssen A, Chanvillard C, Paul F, Dörr J, Millward JM, Infante-Duarte C
J Neuroimmunol. 2013 Sep 15; 262(1-2):66-71. Epub 2013 Jul 18. PMID: 23871488. Abstract
Regulatory and Commercial Status
Status for MS: 
Phase I/II trial is recruiting as of November, 2013
(2)
Double blind placebo-controlled Phase I/II clinical trial of idebenone in patients with primary progressive multiple sclerosis (IPPoMS)
ClinicalTrials.gov, 22 Nov 2013
Accessed on 26 Nov 2013 from http://www.clinicaltrials.gov/ct2/show/NCT00950248.
Highest status achieved (for any condition): 
Approved for treating Leber's hereditary optic neuropathy in the EU
(30)
Santhera Receives European Marketing Authorization for Raxone® in Leber's Hereditary Optic Neuropathy (LHON)
Santhera, 9 Sep 2015
Accessed on 6 Oct 2015 from http://www.santhera.com/index.php?docid=212&vid=&lang=en&newsdate=201509&newsid=1950678&newslang=en.
Other uses: 
Approved in the EU for treating Leber's hereditary optic neuropathy (a mitochondrial disorder)
(30)
Santhera Receives European Marketing Authorization for Raxone® in Leber's Hereditary Optic Neuropathy (LHON)
Santhera, 9 Sep 2015
Accessed on 6 Oct 2015 from http://www.santhera.com/index.php?docid=212&vid=&lang=en&newsdate=201509&newsid=1950678&newslang=en.
Has been studied in clinical trials for use in Alzheimer's disease; in some studies, the drug was associated with clinical improvement, but in another large study, no benefits were observed
(26)
Mitochondrial approaches for neuroprotection.
Chaturvedi RK, Beal FM
Ann N Y Acad Sci. 2008 Dec; 1147:395-412. PMID: 19076459. Abstract
Phase III trial for use in Duchenne muscular dystrophy is underway (November, 2013)
(20)
Santhera's Phase III program with Catena®/Raxone® in Duchenne muscular dystrophy on track to deliver pivotal data early in 2Q 2014
Santhera Pharmaceuticals, 26 Nov 2013
Accessed on 2 Dec 2013 from http://www.santhera.com/index.php?docid=212&vid=&lang=en&newsdate=201311&newsid=1745645&newslang=en.
Found to delay loss of respiratory function in Duchenne muscular dystrophy in a Phase III clinical trial (press release, May 2014)
(28)
Santhera Announces Successful Outcome of Phase III Study with Catena®/Raxone® in Duchenne Muscular Dystrophy
Santhera Pharmaceuticals, 13 May 2014
Accessed on 17 May 2014 from http://www.santhera.com/index.php?docid=212&vid=&lang=en&newsdate=201405&newsid=1784768&newslang=en.
Phase III trials for use in the neurodegenerative disease Friedreich's ataxia have been undertaken in North America and Europe
(5)
Co-enzyme Q10 and idebenone use in Friedreich's ataxia.
Parkinson MH, Schulz JB, Giunti P
J Neurochem. 2013 Aug; 126 Suppl 1:125-41. PMID: 23859348. Abstract
Has been successfully used to treat respiratory failure in an individual with Leigh syndrome, a neurometabolic condition that is caused defects in mitochondrial function
(18)
Efficacy of idebenone for respiratory failure in a patient with Leigh syndrome: a long-term follow-up study.
Haginoya K, Miyabayashi S, Kikuchi M, Kojima A, Yamamoto K, Omura K, Uematsu M, Hino-Fukuyo N, Tanaka S, Tsuchiya S
J Neurol Sci. 2009 Mar 15; 278(1-2):112-4. Epub 2008 Dec 20. PMID: 19101701. Abstract
Phase II trial for use in MELAS (mitochondrial encephalopathy, lactic acidosis, and stroke-like episodes, which is caused by a mitochondrial mutation) has been initiated
(19)
Santhera enters agreement with Columbia University to investigate additional potential of Catena® in MELAS
Santhera Pharmaceuticals, 26 Jun 2009
Accessed on 2 Dec 2013 from http://www.santhera.com/index.php?docid=212&vid=&lang=en&newsdate=200906&newsid=1325199&newslang=en.
Has been tested in topical skincare formulations for treating photodamaged skin
(8)
Clinical efficacy assessment in photodamaged skin of 0.5% and 1.0% idebenone.
McDaniel DH, Neudecker BA, DiNardo JC, Lewis JA, Maibach HI
J Cosmet Dermatol. 2005 Sep; 4(3):167-73. PMID: 17129261. Abstract
Administration: 
Oral
(2)
Double blind placebo-controlled Phase I/II clinical trial of idebenone in patients with primary progressive multiple sclerosis (IPPoMS)
ClinicalTrials.gov, 22 Nov 2013
Accessed on 26 Nov 2013 from http://www.clinicaltrials.gov/ct2/show/NCT00950248.
Dose in clinical trial for PPMS is 2250 mg per day (750 mg dose, 3 times per day)
(2)
Double blind placebo-controlled Phase I/II clinical trial of idebenone in patients with primary progressive multiple sclerosis (IPPoMS)
ClinicalTrials.gov, 22 Nov 2013
Accessed on 26 Nov 2013 from http://www.clinicaltrials.gov/ct2/show/NCT00950248.
(15)
Santhera and NIH collaborate to evaluate Catena® in primary progressive multiple sclerosis
Santhera Pharmaceuticals, 24 Jun 2009
Accessed on 2 Dec 2013 from http://www.santhera.com/index.php?docid=212&vid=&lang=en&newsdate=200906&newsid=1324517&newslang=en.
Negative effects: 
Long-term (2 year) treatment (60 or 300 mg per day) was not associated with any remarkable side effects in a study of elderly people with cerebral arteriosclerosis
(9)
Chemistry, toxicology, pharmacology and pharmacokinetics of idebenone: a review.
Zs -Nagy I
Arch Gerontol Geriatr. 1990 Nov-Dec; 11(3):177-86. PMID: 15374467. Abstract
Attention disturbances
(17)
Pharmacokinetic properties and metabolism of idebenone.
Kutz K, Drewe J, Vankan P
J Neurol. 2009 Mar; 256 Suppl 1:31-5. PMID: 19283348. Abstract
Fatigue
(17)
Pharmacokinetic properties and metabolism of idebenone.
Kutz K, Drewe J, Vankan P
J Neurol. 2009 Mar; 256 Suppl 1:31-5. PMID: 19283348. Abstract
Headache
(17)
Pharmacokinetic properties and metabolism of idebenone.
Kutz K, Drewe J, Vankan P
J Neurol. 2009 Mar; 256 Suppl 1:31-5. PMID: 19283348. Abstract
Loose stool
(17)
Pharmacokinetic properties and metabolism of idebenone.
Kutz K, Drewe J, Vankan P
J Neurol. 2009 Mar; 256 Suppl 1:31-5. PMID: 19283348. Abstract
Commercial: 
Initially developed in Japan, where it was licensed for treating Alzheimer's disease
(5)
Co-enzyme Q10 and idebenone use in Friedreich's ataxia.
Parkinson MH, Schulz JB, Giunti P
J Neurochem. 2013 Aug; 126 Suppl 1:125-41. PMID: 23859348. Abstract
Patented by Takeda Chemical Industries, Japan
(9)
Chemistry, toxicology, pharmacology and pharmacokinetics of idebenone: a review.
Zs -Nagy I
Arch Gerontol Geriatr. 1990 Nov-Dec; 11(3):177-86. PMID: 15374467. Abstract
Introduced into the Japanese market in 1986
(9)
Chemistry, toxicology, pharmacology and pharmacokinetics of idebenone: a review.
Zs -Nagy I
Arch Gerontol Geriatr. 1990 Nov-Dec; 11(3):177-86. PMID: 15374467. Abstract
Post-marketing data are available from over 8 million people
(5)
Co-enzyme Q10 and idebenone use in Friedreich's ataxia.
Parkinson MH, Schulz JB, Giunti P
J Neurochem. 2013 Aug; 126 Suppl 1:125-41. PMID: 23859348. Abstract
Withdrawn from the Japanese market in 1998 because of lack of proven efficacy in Alzheimer's disease
(24)
CHMP assessment report for Sovrima (International nonproprietary name: idebenone)
European Medicines Agency, 20 Nov 2008
Accessed on 2 Dec 2013 from http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/000908/WC500070576.pdf.
Under development for orphan mitochondrial and neuromuscular conditions by Santhera Pharmaceuticals
(13)
Raxone®/Catena® (idebenone)
Santhera Pharmaceuticals
Accessed on 2 Dec 2013 from http://www.santhera.com/index.php?mid=53&vid=&lang=en.
Conditionally approved by Health Canada for the treatment of Friedreich's ataxia (24 July 2008)
(14)
Santhera receives first product approval: Health Canada approves Catena® for treatment of Friedreich's ataxia
Santhera Pharmaceuticals, 24 Jul 2008
Accessed on 2 Dec 2013 from http://www.santhera.com/index.php?docid=212&vid=&lang=en&newsdate=200807&newsid=1238090&newslang=en.
Can be obtained in some European countries on a "named patient" basis for treating Friedreich's ataxia as of November 2008
(24)
CHMP assessment report for Sovrima (International nonproprietary name: idebenone)
European Medicines Agency, 20 Nov 2008
Accessed on 2 Dec 2013 from http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/000908/WC500070576.pdf.
Clinical trial to assess use in PPMS involves a collaboration between the US National Institutes of Health (which is conducting the trial) and Santhera Pharmaceuticals (which is supplying idebenone) (24 June 2009)
(15)
Santhera and NIH collaborate to evaluate Catena® in primary progressive multiple sclerosis
Santhera Pharmaceuticals, 24 Jun 2009
Accessed on 2 Dec 2013 from http://www.santhera.com/index.php?docid=212&vid=&lang=en&newsdate=200906&newsid=1324517&newslang=en.
Sales in Canada for the treatment of Friedreich's ataxia were discontinued voluntarily by Santhera Pharmaceuticals after additional clinical studies (30 April 2013)
(16)
Santhera to discontinue sale of Catena® in Canada
Santhera Pharmaceuticals, 27 Feb 2013
Accessed on 2 Dec 2013 from http://www.santhera.com/index.php?docid=212&vid=&lang=en&newsdate=201302&newsid=1681302&newslang=en.
Marketing authorization for treating Leber's hereditary optic neuropathy has been recommended by the European Medicines Agency's Committee for Medicinal Products for Human Use (26 June 2015)
(29)
CHMP recommends granting a marketing authorization for Santhera's Raxone® for the treatment of Leber's Hereditary Optic Neuropathy (LHON)
Santhera Pharmaceuticals, 26 Jun 2015
Accessed on 30 Jun 2015 from http://www.santhera.com/index.php?docid=212&vid=&lang=en&newsdate=201506&newsid=1931735&newslang=en.
Marketing authorization for treating Leber's hereditary optic neuropathy has been granted by the European Commission (9 September 2015)
(30)
Santhera Receives European Marketing Authorization for Raxone® in Leber's Hereditary Optic Neuropathy (LHON)
Santhera, 9 Sep 2015
Accessed on 6 Oct 2015 from http://www.santhera.com/index.php?docid=212&vid=&lang=en&newsdate=201509&newsid=1950678&newslang=en.
Key Clinical Trials
Placebo-controlled Trials: 
Trial name: 
Idebenone in Patients With Primary Progressive Multiple Sclerosis (IPPoMS)
(2)
Double blind placebo-controlled Phase I/II clinical trial of idebenone in patients with primary progressive multiple sclerosis (IPPoMS)
ClinicalTrials.gov, 22 Nov 2013
Accessed on 26 Nov 2013 from http://www.clinicaltrials.gov/ct2/show/NCT00950248.
Phase: 
Phase I/II trial
(2)
Double blind placebo-controlled Phase I/II clinical trial of idebenone in patients with primary progressive multiple sclerosis (IPPoMS)
ClinicalTrials.gov, 22 Nov 2013
Accessed on 26 Nov 2013 from http://www.clinicaltrials.gov/ct2/show/NCT00950248.
Study Design: 
Government institute-sponsored (with industry-supplied drug), randomized, double-blind, placebo-controlled trial to assess the safety and effectiveness of idebenone [2250 mg orally per day (750 mg dose, 3 times per day)]; the primary outcome measure is an inhibition on the development of brain atrophy
(2)
Double blind placebo-controlled Phase I/II clinical trial of idebenone in patients with primary progressive multiple sclerosis (IPPoMS)
ClinicalTrials.gov, 22 Nov 2013
Accessed on 26 Nov 2013 from http://www.clinicaltrials.gov/ct2/show/NCT00950248.
(15)
Santhera and NIH collaborate to evaluate Catena® in primary progressive multiple sclerosis
Santhera Pharmaceuticals, 24 Jun 2009
Accessed on 2 Dec 2013 from http://www.santhera.com/index.php?docid=212&vid=&lang=en&newsdate=200906&newsid=1324517&newslang=en.
Disease Stage: 
PPMS
(2)
Double blind placebo-controlled Phase I/II clinical trial of idebenone in patients with primary progressive multiple sclerosis (IPPoMS)
ClinicalTrials.gov, 22 Nov 2013
Accessed on 26 Nov 2013 from http://www.clinicaltrials.gov/ct2/show/NCT00950248.
Enrollment/Number of Patients: 
80 (estimated)
(2)
Double blind placebo-controlled Phase I/II clinical trial of idebenone in patients with primary progressive multiple sclerosis (IPPoMS)
ClinicalTrials.gov, 22 Nov 2013
Accessed on 26 Nov 2013 from http://www.clinicaltrials.gov/ct2/show/NCT00950248.
Duration: 
3 years (1 year to establish the pretreatment baseline and 2 years of treatment)
(2)
Double blind placebo-controlled Phase I/II clinical trial of idebenone in patients with primary progressive multiple sclerosis (IPPoMS)
ClinicalTrials.gov, 22 Nov 2013
Accessed on 26 Nov 2013 from http://www.clinicaltrials.gov/ct2/show/NCT00950248.
Status/Outcome: 
Recruiting as of November 2013; estimated study completion date, September 2016
(2)
Double blind placebo-controlled Phase I/II clinical trial of idebenone in patients with primary progressive multiple sclerosis (IPPoMS)
ClinicalTrials.gov, 22 Nov 2013
Accessed on 26 Nov 2013 from http://www.clinicaltrials.gov/ct2/show/NCT00950248.
Head-to-Head Trials: 
Other Trials: 
Trial name: 
Open Label Extension Trial of Idebenone for Primary Progressive Multiple Sclerosis
(3)
Idebenone for primary progressive multiple sclerosis
ClinicalTrials.gov, 22 May 2013
Accessed on 26 Nov 2013 from http://www.clinicaltrials.gov/ct2/show/NCT01854359.
Phase: 
Extension of Phase I/II trial
(2)
Double blind placebo-controlled Phase I/II clinical trial of idebenone in patients with primary progressive multiple sclerosis (IPPoMS)
ClinicalTrials.gov, 22 Nov 2013
Accessed on 26 Nov 2013 from http://www.clinicaltrials.gov/ct2/show/NCT00950248.
(3)
Idebenone for primary progressive multiple sclerosis
ClinicalTrials.gov, 22 May 2013
Accessed on 26 Nov 2013 from http://www.clinicaltrials.gov/ct2/show/NCT01854359.
Study Design: 
Government institute-sponsored, open-label extension of the IPPoMS trial
(2)
Double blind placebo-controlled Phase I/II clinical trial of idebenone in patients with primary progressive multiple sclerosis (IPPoMS)
ClinicalTrials.gov, 22 Nov 2013
Accessed on 26 Nov 2013 from http://www.clinicaltrials.gov/ct2/show/NCT00950248.
, in which eligible participants from that trial who wish to continue will receive idebenone (but remain blinded to whether they received drug or placebo in the placebo-controlled trial), to provide further data about the safety and effectiveness of this drug
(3)
Idebenone for primary progressive multiple sclerosis
ClinicalTrials.gov, 22 May 2013
Accessed on 26 Nov 2013 from http://www.clinicaltrials.gov/ct2/show/NCT01854359.
Disease Stage: 
PPMS
(3)
Idebenone for primary progressive multiple sclerosis
ClinicalTrials.gov, 22 May 2013
Accessed on 26 Nov 2013 from http://www.clinicaltrials.gov/ct2/show/NCT01854359.
Enrollment/Number of Patients: 
80 (estimated)
(3)
Idebenone for primary progressive multiple sclerosis
ClinicalTrials.gov, 22 May 2013
Accessed on 26 Nov 2013 from http://www.clinicaltrials.gov/ct2/show/NCT01854359.
Duration: 
1 year
(3)
Idebenone for primary progressive multiple sclerosis
ClinicalTrials.gov, 22 May 2013
Accessed on 26 Nov 2013 from http://www.clinicaltrials.gov/ct2/show/NCT01854359.
Status/Outcome: 
Recruiting as of February 2013; estimated study completion date, October 2018
(3)
Idebenone for primary progressive multiple sclerosis
ClinicalTrials.gov, 22 May 2013
Accessed on 26 Nov 2013 from http://www.clinicaltrials.gov/ct2/show/NCT01854359.
Trial name: 
Kutz et al., J. Neurol., March 2009 studies
(17)
Pharmacokinetic properties and metabolism of idebenone.
Kutz K, Drewe J, Vankan P
J Neurol. 2009 Mar; 256 Suppl 1:31-5. PMID: 19283348. Abstract
Phase: 
Phase I studies
(17)
Pharmacokinetic properties and metabolism of idebenone.
Kutz K, Drewe J, Vankan P
J Neurol. 2009 Mar; 256 Suppl 1:31-5. PMID: 19283348. Abstract
Study Design: 
Four industry-sponsored studies to examine the pharmacokinetics, metabolism, and safety of idebenone (with oral doses of 150 mg, 750 mg, or 1050 mg given once or doses of 150 mg or 750 mg given every 8 hours for 14 days)
(17)
Pharmacokinetic properties and metabolism of idebenone.
Kutz K, Drewe J, Vankan P
J Neurol. 2009 Mar; 256 Suppl 1:31-5. PMID: 19283348. Abstract
Disease Stage: 
Healthy adult men
(17)
Pharmacokinetic properties and metabolism of idebenone.
Kutz K, Drewe J, Vankan P
J Neurol. 2009 Mar; 256 Suppl 1:31-5. PMID: 19283348. Abstract
Enrollment/Number of Patients: 
69
(17)
Pharmacokinetic properties and metabolism of idebenone.
Kutz K, Drewe J, Vankan P
J Neurol. 2009 Mar; 256 Suppl 1:31-5. PMID: 19283348. Abstract
Duration: 
Up to 14 days
(17)
Pharmacokinetic properties and metabolism of idebenone.
Kutz K, Drewe J, Vankan P
J Neurol. 2009 Mar; 256 Suppl 1:31-5. PMID: 19283348. Abstract
Status/Outcome: 
Plasma concentrations of idebenone were low but increased in a dose-dependent manner and were five-fold higher in fed versus fasting individuals; the drug was well tolerated in single doses as high as 1050 mg and as repeated daily doses as high as 2250 mg; the main metabolite in plasma and urine was QS4
(17)
Pharmacokinetic properties and metabolism of idebenone.
Kutz K, Drewe J, Vankan P
J Neurol. 2009 Mar; 256 Suppl 1:31-5. PMID: 19283348. Abstract
References
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.

Note: Compound name must be entered under "Substance Identification" and then "Names and Synonyms" selected to view synonyms.

DOI: 
doi/10.7493/msdf.10.8692.1