Idebenone: EU-Approved Raxone, Trials and Safety
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Idebenone: half-life, strengths and approval status

Label and trial amounts · Approval status · Half-life notes

What is idebenone?

Idebenone is a synthetic antioxidant that acts on mitochondria, the parts of cells that make energy. In the EU it is a prescription medicine (Raxone) for vision loss in Leber's hereditary optic neuropathy (LHON), a rare inherited eye disease.

Also known as: Raxone.

Label and trial amounts

Raxone comes as 150 mg tablets; the EU label dose is two tablets three times a day with food (EMA). A Duchenne muscular dystrophy trial used 300 mg three times a day for 52 weeks (Buyse 2015). These are prescription and trial amounts, not a recommendation.

Approval status and how it is used

Approval: EMA authorized Raxone in September 2015 for visual impairment in people aged 12 and older with LHON, as an orphan medicine under "exceptional circumstances" because the disease is rare and full data could not be obtained. It is prescription-only and should be started by a doctor experienced with LHON. Drugs@FDA lists no approved idebenone product, so it is not an FDA-approved drug.

What studies show: in the main LHON trial, 85 patients took 900 mg a day or placebo for 24 weeks. The main goal was not met, but post hoc analysis suggested benefit in patients whose eyes differed in vision at the start (Klopstock 2011). EMA says patients on Raxone could read 3 to 6 more letters than on placebo, and 30% (16 of 53) had a clinically relevant recovery in at least one eye versus 10% (3 of 29). In a 52-week trial in 64 young people aged 10 to 18 with Duchenne muscular dystrophy not taking steroids, idebenone slowed the decline in breathing (peak expiratory flow) compared with placebo; the trial was funded by Santhera Pharmaceuticals (Buyse 2015).

Safety: EMA lists nasopharyngitis (cold symptoms) and cough as very common, and mild to moderate diarrhea and back pain as common, with Raxone. In the Duchenne trial, mild, short-lived diarrhea was more common with idebenone (25% versus 12%) (Buyse 2015). The sources here do not describe drug interactions.

Idebenone half-life and time to peak

  • Half-lifeNot listed
  • Time to peak (Tmax)Not listed

We do not list a half-life or time to peak for idebenone because we could not confirm one from a source we read.

How to track idebenone in Dose Track

  1. Add idebenone as a custom compound. Start typing its name and Dose Track fills in the details from its research library for you to check, and it sits next to everything else you take.
  2. Log each dose when you take it so your history shows exactly what you took and when.
  3. Set reminders on your own schedule, whether that is daily, weekly or every few days.
  4. Your log is stored on your phone and no account is needed. Data only leaves it for features you choose, like AI answers and lab reading.

How Dose Track handles peptides · Reconstitution calculator · Half-life calculator

Coenzyme Q10 (CoQ10)coenzyme Q10, ubiquinone · half-life about 33 hours MitoQ (Mitoquinone)mitoquinone, mitoquinol mesylate PQQ (Pyrroloquinoline Quinone)pyrroloquinoline quinone, PQQ disodium salt

Frequently asked questions

What is the half-life of idebenone?+
We do not list a half-life or time to peak for idebenone because we could not confirm one from a source we read.
Is idebenone FDA-approved?+
No. Drugs@FDA lists no approved idebenone product. In the EU it is approved as the prescription medicine Raxone for vision loss in Leber's hereditary optic neuropathy.
Is idebenone the same as CoQ10?+
No. Idebenone is a synthetic antioxidant that acts on mitochondria, approved in the EU for one rare eye disease. CoQ10 is a different compound sold as a supplement.
Can I track idebenone in Dose Track?+
Yes. Idebenone is in Dose Track's research library, so when you add it as a custom compound its details are filled in for you to check. You can then log each dose next to your other compounds, set reminders on your own schedule, and see your history next to your lab results. Your log is stored on your phone and no account is needed. Data only leaves it for features you choose, like AI answers and lab reading.

Sources

  1. European Medicines Agency. Raxone (idebenone): EPAR summary for the public and product details.
  2. Klopstock T, et al. A randomized placebo-controlled trial of idebenone in Leber's hereditary optic neuropathy. Brain. 2011;134(Pt 9):2677-2686.
  3. Buyse GM, et al. 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. Lancet. 2015.
  4. FDA. Drugs@FDA database of approved drugs (searched October 28, 2026).
  5. FDA. Questions and answers on dietary supplements.

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