idebenone

Orphan DrugEMA Approved

Description

Idebenone is a synthetic analog of coenzyme Q10 with antioxidant properties. It is approved in the European Union for the treatment of visual impairment in adolescent and adult patients with Leber's hereditary optic neuropathy (LHON). The drug has also been investigated for other mitochondrial and neurodegenerative conditions including certain forms of muscular dystrophy.

Indications & Therapeutic Use

Leber hereditary optic neuropathy, investigational: Duchenne muscular dystrophy, Friedreich ataxia

Global Availability (9 countries)

CountryAccess RouteRegulatory PathwayLead TimeStatus

Available Through

This drug is available for procurement through the following fulfilment partner.

Fulfilment Partner
idebenone
Generic Nameidebenone
Brands1 brand available
Active Ingredientidebenone
Drug ClassLeber hereditary optic neuropathy
ManufacturerSanthera Pharmaceuticals
Dosage Formsoral tablet, 150 mg
Medical CodeN06BX13
Orphan StatusYes — Orphan Drug
Cold ChainNot Required
Lead Time21 days
Reg. StatusEMA Approved
Clinical TrialNCT02774005
Countries9 countries
Authority Signals
Last Verified3/21/2026
Data ConfidenceHigh (AI + Pharmacist)
Source Citations10 Validated Nodes