Drug

Idebenone

Approved · EMA

Emerging researchLate-stage developmentRising momentum

Also known as idebenona, 2,3-dimethoxy-5-methyl-6-(10'-hydroxydecyl)-1,4-benzoquinone, 2-(10-hydroxydecyl)-5,6-dimethoxy-3-methyl-1,4-benzoquinone, 2-(10-hydroxydecyl)-5,6-dimethoxy-3-methyl-p-benzoquinone+3 more

idebenona, 2,3-dimethoxy-5-methyl-6-(10'-hydroxydecyl)-1,4-benzoquinone, 2-(10-hydroxydecyl)-5,6-dimethoxy-3-methyl-1,4-benzoquinone, 2-(10-hydroxydecyl)-5,6-dimethoxy-3-methyl-p-benzoquinone, 2-(10-hydroxydecyl)-5,6-dimethoxy-3-methylcyclohexa-2,5-diene-1,4-dione, 6-(10-hydroxydecyl)-2,3-dimethoxy-5-methyl-1,4-benzoquinone, 6-(10-hydroxydecyl)-2,3-dimethoxy-5-methyl-p-benzoquinone.

RxNorm51296 ChEMBLCHEMBL252556UNIIHB6PN45W4J

Research papers

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Pilot Study to Treat Adults With Non-Alcoholic Steatohepatitis With Oral Idebenone

Clinical trial2026-04-24Results posted · ClinicalTrials.gov

LHON updates: Gene therapy progress; idebenone receives US CRL

Industry2026-04-02BioWorld Gene Therapy

A Randomized, Double-blinded, Placebo-controlled Trial of Idebenone in the Prevention of Episodic Migraine

Clinical trial2025-12-31Primary completion · ClinicalTrials.gov

A Randomized, Double-blind, Multi-center Clinical Study of the Efficacy of Idebenone in the Treatment of Primary Rapid Eye Movement Sleep Behavior Disorder Into Synucleinopathies

Clinical trial2025-11-25Results expected Q3 2026 · ClinicalTrials.gov

Non-randomized Control Clinical Trial to Evaluate the Efficacy and Safety of Symptomatic Drug Therapy for Mild to Moderate Huntington's Disease Patients

Clinical trial2024-12-31Primary completion · ClinicalTrials.gov

A Multi-center, Randomized, Double-blind, Placebo-controlled Parallel Pilot Study to Evaluate Safety and Efficacy of Oral Idebenone for Preventive Treatment of Migraine in Adult Migraine Patients

Clinical trial2024-06-20Primary completion · ClinicalTrials.gov

A Phase III Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia Patients

Clinical trial2023-07-11Results posted · ClinicalTrials.gov

A Phase III Open-Label, Single Group Extension Study of the Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia Patients

Clinical trial2023-07-11Results posted · ClinicalTrials.gov

Approval: Raxone (EMA)

Regulatory2015-09-08EMA

Efficacy of idebenone on respiratory function in patients with Duchenne muscular dystrophy not using glucocorticoids (DELOS): a double-blind randomised placebo-controlled phase 3 trial.

Research2015-04-20Lancet (London, England)

Assessment of neurological efficacy of idebenone in pediatric patients with Friedreich's ataxia: data from a 6-month controlled study followed by a 12-month open-label extension study.

Research2011-07-22Journal of neurology

Idebenone as a novel, therapeutic approach for Duchenne muscular dystrophy: results from a 12 month, double-blind, randomized placebo-controlled trial.

Research2011-03-23Neuromuscular disorders : NMD

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Idebenone

Aliases & brands

idebenona2,3-dimethoxy-5-methyl-6-(10'-hydroxydecyl)-1,4-benzoquinone2-(10-hydroxydecyl)-5,6-dimethoxy-3-methyl-1,4-benzoquinone2-(10-hydroxydecyl)-5,6-dimethoxy-3-methyl-p-benzoquinone2-(10-hydroxydecyl)-5,6-dimethoxy-3-methylcyclohexa-2,5-diene-1,4-dione6-(10-hydroxydecyl)-2,3-dimethoxy-5-methyl-1,4-benzoquinone6-(10-hydroxydecyl)-2,3-dimethoxy-5-methyl-p-benzoquinone

RxNorm CUI

51296

ChEMBL ID

CHEMBL252556

UNII

HB6PN45W4J

Regulatory jurisdictions

ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2015-09-08

Latest approval

2015-09-08

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2015-09-08Approval

Approval: Raxone (EMA)

Indication: Raxone is indicated for the treatment of visual impairment in adolescent and adult patients with Leber’s Hereditary Optic Neuropathy (LHON).

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.