Idebenone dosage and evidence
Written by Aaron CuhaReviewed Sep 2026
The short answer
Approved in the European Union for one rare inherited eye disease that causes sudden vision loss. The approval came under special rules because the normal evidence bar was not met. The study behind it missed its main goal, and the studies in Alzheimer's disease and Friedreich ataxia found no benefit.
Evidence grade for Idebenone: Moderate. The rule: at least one finished study in people, and at least 100 people who took it. The sum on this page: 5 completed trials, 732 people given it. A grade counts how much has been done to people, not whether it works.
- People given it
- 732
- Human studies
- 5
- Found nothing
- 2
Dose
No human dose established
Amounts that were given in studies sit in Human evidence on this page. None of them is a personal dose.
5 completed trials, 732 people given it
No first-hand reports gathered yet. That is a gap in what we have collected, not a finding that nothing has been reported.
Goal pages: Brain, memory and mood, Skin, hair and appearance
In plain English
In plain English, from Aaron
This is how I would explain it to a friend. The evidence, with the numbers, is further down the page.
Idebenone is a lab-made cousin of CoQ10. In Europe it is a prescription drug for one rare inherited eye disease. It is also sold as a brain supplement and in skin creams. It is not FDA approved.
What people take it for
- Sharper thinking and more mental energy.
- Better mitochondria and general energy.
- Fewer wrinkles, as a skin cream.
What studies in people showed
The biggest study had 536 people with Alzheimer's disease. They took one of three doses or a dummy pill for a year. It did not slow their decline. In 70 young people with Friedreich ataxia, a movement disorder, it did not clearly help. In 85 people with the eye disease, it missed its main goal. Europe approved it anyway, under special rules for rare diseases. A skin cream study in 41 women had no plain cream to compare with.
What people report
Reports, not study results
The good
- In the studies on this page, it was safe and well tolerated at 900 mg a day.
The bad
- It did not slow Alzheimer's disease in the big study.
- In cells short of an enzyme called NQO1, it has been reported to kill cells instead of protecting them.
Where these come from: Both lines are from the studies on this page. We have not collected user reports on this one yet.
My bottom line
It was tested properly as a brain drug, and it failed. The one approval is for a rare eye disease. For energy, get blood work first and train.
An opinion, not a finding. I am a coach, not a doctor.
What it has been measured to do
Measured in people
Goals Idebenone has been tested for in people, biggest studies first. We count only what the studies on this page say, so the real numbers may be higher.
- Memory and thinking536 people · 1 study · 1 found nothing
- Eyes and vision85 people · 1 study
- Skin, wrinkles and elasticity41 people · 1 study
33 of the 36 indexed goals have no study of any kind behind Idebenone
No study in people, animals or cells on this page reports a result for these. That does not prove Idebenone does nothing for them. It does mean anything you have heard about Idebenone and one of these did not come from a study cited here.
Show full evidence
What is Idebenone?
Approved in the European Union for one rare inherited eye disease that causes sudden vision loss. The approval came under special rules because the normal evidence bar was not met. The study behind it missed its main goal, and the studies in Alzheimer's disease and Friedreich ataxia found no benefit.
Idebenone is three separate products wearing one name. They should not be read as backing each other up.
The brain pill. This is where the biggest study is. Idebenone was tested properly in Alzheimer's disease: 536 patients, one year, three doses against a dummy pill, at many clinics, with nobody knowing who got what. Neither main measure differed between the groups in the planned four-group comparison. The paper's title is the conclusion: idebenone treatment fails to slow cognitive decline in Alzheimer's disease. It was also taken through a large final-stage study of 70 young people with Friedreich ataxia, an inherited movement disorder. Their nerve function did not differ clearly from the dummy group at 24 weeks.
The medicine. Raxone was approved in the European Union on 8 September 2015 for vision loss in teenagers and adults with Leber hereditary optic neuropathy (LHON), an inherited eye disease. It was approved under 'exceptional circumstances'. That label means the company could not provide full proof of benefit and safety, and was not expected to be able to. The study behind it, RHODOS, gave 85 patients 900 mg a day for 24 weeks. On its main goal, the best recovery in sharpness of vision, it did not show a clear win across everyone who started. A look back afterwards found the benefit was in patients whose two eyes had different sharpness at the start. A later study, LEROS, published in 2024, did not assign treatment by chance. It is the other main source of evidence. Idebenone is not FDA approved for anything.
The skin cream. Idebenone lotion at 0.5 and 1.0 percent was tested in 41 women with sun-damaged skin for six weeks. Roughness, moisture and fine lines improved. But no one used the same lotion without idebenone, so there is no way to tell the active ingredient apart from the lotion base.
How does Idebenone work?
Idebenone is a small, lab-made cousin of CoQ10. It can take electrons from an enzyme called NQO1 and hand them straight to a later step in the cell's energy chain, skipping a broken first step called complex I. That makes sense for a disease caused by complex I faults, which is what LHON is. It is why the drug found its use there, not as a general antioxidant. But it needs NQO1 to work. In cells short of NQO1, idebenone has been reported to kill cells instead of protecting them. So it only helps in tissues with the right enzyme.
What have studies in people found about Idebenone?
Idebenone has been through several proper studies against a dummy. Most found no benefit, and its one approval was granted on a study that missed its main goal.
- Alzheimer's disease, 536 patients, one year, three doses: no clear effect on either main measure.
- LEROS, published 2024: a study that did not assign treatment by chance, and the other evidence behind the EU approval.
- RHODOS, 85 patients with LHON, 900 mg a day, 24 weeks: the main goal was not clearly met across everyone who started. A look back afterwards found benefit in people whose two eyes started with different sharpness.
- Friedreich ataxia, 70 young patients, 24 weeks: 2.5 points better on the rating scale against 1.3 on the dummy, a gap that could be chance.
- Skin cream for sun damage, 41 women, six weeks: better graded roughness, wrinkles and moisture, with no plain-lotion comparison.
What this does not tell you: The approval rests on a study that missed its main goal, plus a follow-up that did not assign treatment by chance. That is exactly why the approval carries the 'exceptional circumstances' label. Nothing here supports idebenone for thinking in healthy people. The one study big enough to test thinking, in Alzheimer's disease, failed. The skin study was six weeks, small, used a company formula, and had no plain-lotion comparison, which is the weakest common setup in skin cream research. And no study has tested idebenone in healthy adults for energy, ageing or general mitochondrial support, which is what the supplement market sells it for.
The state of the research
Idebenone shows what happens when a mitochondrial antioxidant is actually put through the approval process.
It was tested in three serious diseases. In Alzheimer's disease, in a 536-patient one-year study, it failed. In Friedreich ataxia, in a large final-stage study, it failed on nerve function. In LHON, a disease caused directly by complex I faults, where the drug's skip-the-broken-step action fits best, it missed its main goal. It was approved in Europe anyway, under a label that exists because the evidence was known to be incomplete. A rare disease that blinds people and has no other treatment is the right place to accept that trade. A healthy adult buying a brain supplement is not in that position.
The way it works also argues against general use. Idebenone needs NQO1 to work, and in cells short of NQO1 it has been reported to kill cells instead of protecting them. That is not how a general antioxidant behaves. It is an electron carrier that only helps if the tissue has the right chemistry.
The skin claim should be judged on its own, not on the drug approval. One six-week study in 41 women, with no plain-lotion comparison, is not a strong reason to pay a premium price. The authors themselves say no one had done a clinical study of idebenone on skin before.
The evidence, in charts
Fig. 1a · how many people
732people, across 4 studies in people cited here
| Study | People | Share |
|---|---|---|
| Neurology 2003 | 536 | 73% |
| Brain 2011 | 85 | 12% |
| Archives of Neurology 2010 | 70 | 10% |
| Journal of Cosmetic Dermatology 2005 | 41 | 6% |
One study holds 73% of these people, so the total rests more on one study than its size suggests. Counts are the number of people each study on this page says it signed up. That includes studies that only watched people and gave nobody the compound. 1 more study in people gives no headcount and is not counted here. Studies still signing people up are left out, and only studies cited on this page are counted.
Fig. 1b · evidence mix
5 of 6 sources here are studies in people. The rest is not.
- Study in people · done in people583%
- Review of studies · sums up other studies117%
Counted from the list of sources on this page. It counts only what we cite, so there may be more studies out there. A review counts once, however many studies it sums up.
Fig. 2 · evidence over time
The studies cover 6 different years, 2003 to 2024, counted from the list of sources on this page.
Fig. 3 · legal status at a glance
US
Not approved
UK
Prescription
AU
Not approved
CA
Not approved
Approved in 0 of 4, by prescription in 1, not approved in 3. This is what the law says, not a verdict on the science. See Legal status below for the full text and any notes.
Fig. 4 · how much does what
Nobody has tested different amounts in people
This chart would show how the effect changes as the amount goes up. For this compound, nobody has measured that in people. So we leave it empty. We will not borrow an animal chart and pretend it works the same in people.
Fig. 5 · what the molecule is
- Kind of compound
- Supplement
- Molecule weight
- 338.4 Da
- Half-life
- Stated in words, not a numbersee the exact wording below
- Chain length
- None on file
Half-life as stated on file: Short in plasma, a matter of hours, with extensive first-pass metabolism to conjugated metabolites.
No amino acid sequence is on file for Idebenone, which is expected: a supplement is not built from amino acids.
The studies we cite
- Study in people2011A randomized placebo-controlled trial of idebenone in Leber's hereditary optic neuropathy
Idebenone failed the main question in this trial, and the approval rests on what came afterwards. 85 people with an inherited cause of sudden blindness took a high daily dose or a dummy for 24 weeks, and nobody involved knew which. Best recovery of vision, the thing the trial was built to measure, was not clearly better on the drug. A later reanalysis found differences in people whose two eyes were affected unequally, but that analysis was devised after the results were in. The drug was tolerated well.
RHODOS. 85 patients with m.3460G>A, m.11778G>A or m.14484T>C mutations, idebenone 900 mg a day for 24 weeks, multicentre, double blind, placebo controlled. The primary endpoint, best recovery in visual acuity, did not reach statistical significance in the intention to treat population. A post hoc interaction analysis found significant secondary endpoint differences in patients with discordant visual acuities at baseline. Idebenone was safe and well tolerated.
- Study in people2024Therapeutic benefit of idebenone in patients with Leber hereditary optic neuropathy: The LEROS nonrandomized controlled trial
The other study behind the approval did not assign treatment by chance, and it did meet its target. 199 people with this inherited blindness took idebenone for two years. They were compared against 372 similar untreated patients pulled from past records and matched on how long they had been ill. That comparison group was never part of the study. Vision results favoured idebenone, more in some disease stages and some gene types than others. The makers paid for it and employ some authors.
The other main efficacy dataset for the approved indication. Note the word nonrandomized in the title: it is a controlled trial against an external natural history comparison, not a randomised one.
- Study in people2003Idebenone treatment fails to slow cognitive decline in Alzheimer's disease
Idebenone was tested properly as a brain drug and it did nothing. 536 people with probable Alzheimer's disease took one of three doses or a dummy pill for a year, and nobody involved knew which. Neither of the two main measures, thinking ability and overall clinical change, separated the groups. Nothing else measured separated them either. This is the trial behind the nootropic claim, and the answer was no.
536 patients with probable Alzheimer's disease, one year, multicentre, double blind, randomised, idebenone 120, 240 or 360 mg three times daily versus placebo. No significant differences between groups on either primary outcome, ADAS-Cog and Clinical Global Impression of Change, in the prespecified four-group design, and no differences on any secondary outcome. This is the trial that tests the nootropic claim, and it is negative.
- Study in people2010A phase 3, double-blind, placebo-controlled trial of idebenone in friedreich ataxia
The drug did not clearly help children with this inherited movement disorder. 70 patients aged 8 to 18 who could still walk took one of two doses or a dummy for 24 weeks, and nobody involved knew which. The main rating scale improved by 2.5 points on the drug and 1.3 on the dummy, a gap too small to separate from chance. The backup scale showed the same pattern. Neurological function was not meaningfully changed.
70 ambulatory patients aged 8 to 18, randomised to lower dose idebenone, higher dose idebenone or placebo for 24 weeks. Idebenone improved the ataxia rating scale by 2.5 points against 1.3 on placebo, a difference that was not statistically significant, and the secondary scale showed the same pattern. Idebenone did not significantly alter neurological function.
- Study in people2005Clinical efficacy assessment in photodamaged skin of 0.5% and 1.0% idebenone
A skin cream study with no honest comparison. 41 women aged 30 to 65 with sun damaged skin used an idebenone lotion twice a day for six weeks. Graders scored the stronger version as cutting roughness and dryness by about a quarter, cutting fine lines by about a third, and raising hydration by a third. Nobody used the same lotion base without idebenone in it. Any moisturiser improves these scores, so there is no way to know what the active ingredient did.
41 women aged 30 to 65 with moderate photodamage used 0.5 or 1.0 percent idebenone lotion twice daily for six weeks. With the 1.0 percent formula, graders scored a 26 percent reduction in roughness and dryness, 29 percent reduction in fine lines and wrinkles, 37 percent increase in hydration and 33 percent global improvement. The paper describes itself as a nonvehicle control study, so the lotion base itself was never controlled for.
- Review of studies2015Raxone (idebenone): EU marketing authorisation under exceptional circumstances
The European medicines agency page. Raxone was approved on 8 September 2015 for vision loss in teenagers and adults with LHON, under 'exceptional circumstances'. That label is used when full proof of benefit and safety cannot be provided.
Authorised 8 September 2015 for visual impairment in adolescent and adult patients with Leber hereditary optic neuropathy, under exceptional circumstances, a category used when comprehensive efficacy and safety data cannot be provided under normal conditions of use.
Common questions
Has Idebenone been tested in people?
Yes. 732 people given it across 5 completed trials cited here, 2 of which found nothing. Approved in the European Union for one rare inherited eye disease that causes sudden vision loss. The approval came under special rules because the normal evidence bar was not met. The study behind it missed its main goal, and the studies in Alzheimer's disease and Friedreich ataxia found no benefit.
What is the Idebenone dosage?
No human dose established. Amounts that were given in studies sit in Human evidence on this page. None of them is a personal dose. 5 completed trials, 732 people given it
Is Idebenone FDA-approved?
Not FDA approved for any use. Approved in the European Union as Raxone since September 2015, under exceptional circumstances, a special route used when a disease is too rare to collect full data. It treats Leber hereditary optic neuropathy, an inherited disease that causes sudden vision loss. It is also sold in skin care and in brain-boosting supplements. Neither of those is an approved use.
Is idebenone FDA approved?
No. The FDA has not approved it for anything. It holds a European approval as Raxone for LHON, an inherited eye disease, under 'exceptional circumstances'. That label means full proof of benefit and safety could not be provided.
Does idebenone work as a nootropic?
The only study big enough to test thinking, in 536 people with Alzheimer's disease over a year, found no clear effect on either main measure. There is no study of idebenone for thinking in healthy adults at all.
Is idebenone better than CoQ10?
It is a shorter, lab-made cousin of CoQ10. It is absorbed differently and works a different way, taking electrons from NQO1 to skip a broken step in the energy chain. For the one disease where that fits, it got a European approval, which CoQ10 has not. That does not make it a better general supplement, and no study has compared them head to head in healthy people.
Does idebenone cream reduce wrinkles?
One six-week study in 41 women reported graded improvements in fine lines, roughness and moisture at 0.5 and 1.0 percent. It had no plain-lotion comparison, so the lotion base was never separated from the ingredient. Treat it as a hint, not a fact.
Is idebenone safe?
In studies at 900 mg a day it was described as safe and well tolerated, and much higher doses have been used in Friedreich ataxia. The main caution comes from how it works, not from harm seen in patients: it needs NQO1, and in cells short of NQO1 it has been reported to kill cells.