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Methylene Blue Cation

  • Prescription medicine
  • Given by a clinician
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Methylene Blue Cation does in the body

An antidote for a blood disorder, taken off-label in tiny doses as a nootropic

Methylene blue is a dye that moves electrons. In a red blood cell it takes electrons from NADPH and hands them to oxidised haemoglobin, turning it back into something that can carry oxygen — which is why it is the antidote for methaemoglobinaemia. In a mitochondrion it can do something similar, accepting electrons and passing them further down the chain, and that is the entire basis of the mitochondrial and nootropic claims. It also blocks monoamine oxidase A, the enzyme that breaks down serotonin, potently enough that giving it to someone on an antidepressant has caused fatal serotonin syndrome. Its behaviour depends sharply on concentration: at low concentrations it donates electrons and at high ones it takes them, so more is not a stronger version of the same effect.

What happened in people

A 598-patient phase 3 of a methylene blue derivative missed both co-primary endpoints at 52 weeks, with the investigators attributing the failure to symptomatic activity in the low-dose control arm

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.

The limit that matters most

ProvayBlue was approved on 8 April 2016 under NDA 204630 as the first FDA-approved methylene blue product, for acquired methaemoglobinaemia only

Where it acts
Erythrocyte cytosol, where methaemoglobin is reduced; mitochondrial electron transport chain; monoamine oxidase A throughout
Kind of result
The kind of result is not recorded
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

What the registries record it as

  • The substance registry classes this as chemical.

    FDA substance registry · T42P99266K · read 2026-08-29

Where each sentence above came from

No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.

Shown as the opening line on this page.

A limit recorded against this substance. Not signed off as a reviewed claim.

The four opening statements run to 174 words.

Words this page uses

Four words worth knowing first

Chosen from what this page shows, with each one explained before the word it depends on.

Stand-in result

A stand-in result is a number measured because the real result takes too long.

A picture of it, and where the picture fails

It is like judging a journey by the speedometer rather than by arriving.

Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.

What people get wrong. A stand-in result is often reported as the result itself.

A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.

Placebo

A placebo is a dummy treatment given so the real one can be compared with it.

A picture of it, and where the picture fails

A placebo is like a blank control in an experiment.

Where that stops being true. A blank does nothing. People given a placebo often do get better.

What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.

An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.

Comparator

A comparator is whatever the treatment was measured against.

A picture of it, and where the picture fails

It is like the other runner in a race.

Where that stops being true. A race has one winner. A study can show both arms improved.

What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.

The control condition against which the experimental intervention is assessed.

Randomisation

Randomisation means chance decides who gets which treatment.

A picture of it, and where the picture fails

It is like a coin toss deciding the groups.

Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.

What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.

Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.

What happened in peopleRead from sources, not yet reviewed

What was measured, goal by goal

One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.

Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.

There is no single score. A strong test result and a weak life result are different facts.

Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
GoalLife outcomeWhat a body can doHow a person feelsA test resultA step in the bodyHarmsHow longWho was studied
Healthy ageingWaiting for a reviewer2 registered study measure of this kind. No reviewed result yet.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Nothing in the sources checkedNo registered study lists a test result for this goal.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
FocusNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Nothing in the sources checkedNo registered study lists a test result for this goal.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
PainNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Waiting for a reviewer1 registered symptom measure.Nothing in the sources checkedNo registered study lists a test result for this goal.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Healthy ageing
mortality; mortality rate
Focus
wechsler memory scale third edition; wechsler memory scale iii logical memory subset
Pain
pain

Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.

What each mark on this table means
Waiting for a reviewer
2 registered study measure of this kind. No reviewed result yet.
Nothing in the sources checked
No registered study lists a performance measure for this goal.
Not recorded
Harms were not a registered measure for this goal.

What happened in peopleRead from sources, not yet reviewed

What happened in people

Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.

Co-primary: ADAS-cog11 and ADCS-ADL23 at 52 weeks

The study did not show it

Who was studied
LUCIDITY — phase 3 of hydromethylthionine mesylate in Alzheimer disease
How many people
598
Study design
Phase 3, randomised, modified delayed-start, 82 centres, 104 weeks
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
No significant difference on either co-primary endpoint at 52 weeks, attributed by the investigators to symptomatic activity in the 4 mg twice-weekly control arm. ADAS-cog13 separation in the MCI subgroup at 78 weeks (p = 0.0291) and 104 weeks (p = 0.0308) between early and delayed start
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. The control arm was methylthioninium chloride 4 mg twice weekly, chosen as an inactive urinary colourant. Its unexpected activity is the stated reason the trial could not demonstrate its primary result, and it is the same claim the nootropic market makes for low doses.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Slow intravenous injection (approved); oral stabilised leuco form in the Alzheimer programme; unregulated oral drops outside both

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

Functional MRI response during psychomotor vigilance and delayed match-to-sample tasks, with cerebrovascular reactivity

The study showed what it set out to show

Who was studied
Rodriguez 2016 randomised imaging trial in healthy adults
How many people
26
Study design
Randomised double-blinded placebo-controlled, single low oral dose
Compared against
A dummy treatment
Kind of result
What a body can do day to day
What was found
Bilateral insular response during vigilance Z = 2.9-3.4 (P = .01-.008); prefrontal, parietal and occipital response during memory task Z = 2.9-4.2 (P = .03-.0003); 7% increase in correct responses during memory retrieval (P = .01)
Repeated elsewhere
Unreplicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. Twenty-six participants, a single dose, and an age range spanning 22 to 62 years. No repeated-dose or dose-ranging data exist.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Slow intravenous injection (approved); oral stabilised leuco form in the Alzheimer programme; unregulated oral drops outside both

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

Resolution of acquired methaemoglobinaemia

The study showed what it set out to show

Who was studied
ProvayBlue registration programme in acquired methaemoglobinaemia
How many people
0
Study design
Regulatory submission supporting NDA 204630
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Approved 8 April 2016. The label instructs that alternative treatments be considered if there is no resolution after two doses
Repeated elsewhere
Replicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. Labelled risks include fatal serotonin syndrome with serotonergic co-medication, haemolytic anaemia requiring discontinuation and transfusion, contraindication in G6PD deficiency, and invalidation of pulse oximetry.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Slow intravenous injection (approved); oral stabilised leuco form in the Alzheimer programme; unregulated oral drops outside both

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

What we know
RNAWiki holds 3 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What happened in peopleRead from sources, not yet reviewed

How close this is to real life

The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.

  1. Living longer, or avoiding a major event Evidence recorded. Death, a heart attack, a stroke, a hospital stay.2 registered measures of this kind. No reviewed result.
  2. What a body can do day to day No evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
  3. Measured performance No evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
  4. Symptoms and quality of life Evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.1 registered measure of this kind.
  5. A number that stands in for health Evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.5 registered measures of this kind.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
  7. Animals No evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
  8. Cells in a dish No evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
  9. A guess from software No evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.

Higher on these steps means closer to something a person would feel. It does not mean better done.

What it changes in the bodyRead from sources, not yet reviewed

The path through the body

From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.

  1. Start

    Methylene Blue Cation

    What a person takes: Slow intravenous injection (approved); oral stabilised leuco form in the Alzheimer programme; unregulated oral drops outside both.

    The measurement behind this step

    The approved product is a sterile solution for slow intravenous administration. The Alzheimer derivative is an oral tablet of the stabilised reduced form, at 8 or 16 mg daily. What is taken as a nootropic is typically a dilute aqueous solution of dye-grade or reagent-grade methylene blue in drops, a presentation with no pharmacopoeial specification and no approved counterpart.

  2. Getting in

    Given by slow intravenous injection on label

    The approved product is an injection given slowly into a vein, not a tablet or a drop.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    ProvayBlue is a sterile solution for slow intravenous administration in acquired methaemoglobinaemia. There is no approved oral methylene blue product. The Alzheimer derivative is oral and is a stabilised reduced form, chosen because the leuco form is better absorbed than the oxidised dye.

  3. Reaching the cell

    Enters the red cell and the mitochondrion

    It crosses membranes easily and reaches both the inside of red blood cells and the energy machinery of other cells.

    Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.

    The measurement behind this step

    The cationic dye crosses plasma and mitochondrial membranes and accumulates in mitochondria down the membrane potential gradient. That accumulation is the basis of the mitochondrial claims and also of its use as a vital stain.

  4. What it acts on

    Shuttles electrons, in whichever direction the concentration dictates

    It picks up electrons from one carrier and hands them to another. At low concentration it gives; at high concentration it takes.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    NADPH-dependent methaemoglobin reductase reduces methylthioninium to leucomethylthioninium, which reduces ferric haem back to ferrous — the antidote reaction. In mitochondria it can accept electrons from complex I and donate them to cytochrome c, bypassing part of the chain. The behaviour is concentration-dependent and reverses at high concentration, which is why excess methylene blue causes the condition it treats.

  5. The change it makes

    And blocks monoamine oxidase A at the same time

    Independently of the electron chemistry, it shuts down the enzyme that breaks down serotonin.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Potent reversible inhibition of monoamine oxidase A. In a person taking a serotonergic antidepressant this produces serotonin syndrome, and the approved label records that some reported cases were fatal. This is the mechanism that makes an apparently innocuous dye a serious drug interaction, and it is unrelated to the redox activity that everything else about the compound is built on.

  6. What that does for a person

    A reliable antidote, an equivocal drug, an unmeasured supplement

    It works for the one thing it is approved for. In Alzheimer disease the phase 3 could not separate from a control that turned out to be active. As a nootropic there is one 26-person study.

    Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.

    The measurement behind this step

    Approved 2016 for acquired methaemoglobinaemia. The 598-patient tau phase 3 missed both co-primary endpoints at 52 weeks with the failure attributed to symptomatic activity in the low-dose control arm, while biomarkers of neurodegeneration and atrophy moved. The cognitive-enhancement evidence is a single-dose randomised imaging study in 26 healthy adults reporting a 7% improvement in memory retrieval.

No suggested links are held for this record, so nothing is hidden from this path.

What we know
The record describes 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.

What it would be like to takeRead from sources, not yet reviewed

Felt, measured, or meaningful

Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.

Felt

Things a person could notice without a test.

  • pain

Measured

Things only a test, a scale or a device shows.

  • maximum measured plasma concentration
  • time to maximum plasma concentration
  • haemoglobin compared to the baseline
  • systolic blood pressure
  • diastolic blood pressure

Meaningful

Things that change how a life goes, not only a number.

  • mortality
  • mortality rate

A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.

Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.

Measured, but not felt. A number moves. The person notices nothing. Both can be true.

Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.

Matters, but takes years. The result that counts may take longer than anyone would keep watching.

Names that fit none of the three (32)
  • sensitivity
  • young mania rating scale
  • pregnancy rate
  • study related serious adverse events
  • study related unanticipated adverse events
  • evidence of fat embolism
  • need for surgery to remove a broken optical fiber fragment
  • technically successful procedure
  • fmri measurement
  • wechsler memory scale third edition
  • fmri during fname
  • fname
  • fmri during psychomotor vigilance task
  • psychomotor vigilance task
  • wechsler memory scale iii logical memory subset
  • mini mental state exam
  • clox an executive clock drawing test
  • area under the curve
  • total body clearance
  • terminal elimination half life

These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.

What it would be like to takeRead from sources, not yet reviewed

How long anything takes

Nine different lengths of time that get confused with each other. None of them is worked out from another.

  1. Before anything is noticed. RNAWiki does not store this separately, and never works it out from another figure on this page.

  2. Before a test result moves. RNAWiki does not store this separately, and never works it out from another figure on this page.

  3. Before performance moves. RNAWiki does not store this separately, and never works it out from another figure on this page.

  4. How long the result was watched. No finished study window is recorded for a study that tested this substance.

  5. How long people took it. How long people actually took it is not stored. The study window is not the same thing.

  6. How long people were followed. Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.

  7. How fast the body clears it. 24 hours hours

    Read from the label, which states: “Elimination Methylene blue has a half-life of approximately 24 hours in humans.”

  8. How long effects linger. RNAWiki does not store this separately, and never works it out from another figure on this page.

  9. Beyond the studies. Nothing is recorded about the long term.

    The longest finished study sets the edge of what anyone measured.

A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • On label, patients with acquired methaemoglobinaemia, by slow intravenous injection. Off label, surgeons using it as a dye, intensivists in refractory vasoplegic shock, and people taking drops of aquarium-grade or reagent-grade dye for cognitive effect.

Who is missing from the studies

  • Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What the label states about particular groups

  • On pediatric, the label states: “The safety and effectiveness of methylene blue injection for the treatment of acquired methemoglobinemia have been established in pediatric patients.”

    US prescribing information · 67da2a69-8166-46c7-921c-d6ec47bfeac8 · read 2026-08-30

  • On older people, the label states: “Clinical studies of methylene blue injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.”

    US prescribing information · 67da2a69-8166-46c7-921c-d6ec47bfeac8 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Methylene blue injection may cause fetal harm when administered to a pregnant woman.”

    US prescribing information · 67da2a69-8166-46c7-921c-d6ec47bfeac8 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There is no information regarding the presence of methylene blue in human milk, the effects on the breastfed infant, or the effects on milk production.”

    US prescribing information · 67da2a69-8166-46c7-921c-d6ec47bfeac8 · read 2026-08-30

  • On people with reduced liver function, the label states: “Methylene blue is extensively metabolized in the liver.”

    US prescribing information · 67da2a69-8166-46c7-921c-d6ec47bfeac8 · read 2026-08-30

  • On people with reduced kidney function, the label states: “Methylene blue concentrations increased in subjects with renal impairment (eGFR 15 to 89 mL/min/1.73m 2 ) significantly [see Clinical Pharmacology (12.3) ] .”

    US prescribing information · 67da2a69-8166-46c7-921c-d6ec47bfeac8 · read 2026-08-30

Where the result stopped carrying

  • The phase 3 in Alzheimer disease did not demonstrate its co-primary endpoints, and the stated reason was that the control arm was not inert
  • Every use other than acquired methaemoglobinaemia remains off-label after more than a century of medical use
  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

What it would be like to takeRead from sources, not yet reviewed

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied for a different goal

The studies measured something else entirely.

On this record: Some registered studies measured things that match no goal on this page.

It was studied in different people

The people in the studies were not much like the reader.

On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

There was nothing to correct

Where a level is already normal, topping it up may change nothing.

On this record: Development of the tau-directed derivative continues on the strength of biomarker and delayed-start subgroup results rather than a met primary endpoint

The evidence may simply be wrong

Small early studies often do not hold up.

On this record: RNAWiki has not yet published a reviewed conclusion for this use.

Other reasons RNAWiki checked and found nothing for (9)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

What it would be like to takeRead from sources, not yet reviewed

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

Given by a clinician

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Read from the recorded approval status.

No source is stored against this line.

Form and route

Slow intravenous injection (approved); oral stabilised leuco form in the Alzheimer programme; unregulated oral drops outside both

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Suppression classes recorded: S6.

No source is stored against this line.

What is in the pack

The approved product is a sterile solution for slow intravenous administration. The Alzheimer derivative is an oral tablet of the stabilised reduced form, at 8 or 16 mg daily. What is taken as a nootropic is typically a dilute aqueous solution of dye-grade or reagent-grade methylene blue in drops, a presentation with no pharmacopoeial specification and no approved counterpart.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on how this is sold and what that means for what is in the pack.

No source is stored against this line.

Where it is registered

Regulatory records are listed in the technical disclosure at the foot of this page.

Counted from records

Where this came from

A count of rows RNAWiki holds. It describes our records, not your body.

Register entries are stored per jurisdiction and shown with their dates.

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No record of why people stopped taking it is stored for this substance.

No source is stored against this line.

What it would be like to takeRead from sources, not yet reviewed

What can go wrong

Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.

Worth asking a clinician aboutWritten into the record from the studies named on this page

Labelled: contraindicated in severe hypersensitivity to thiazine dyes and in glucose-6-phosphate dehydrogenase deficiency because of haemolytic anaemia. Warnings for serotonin syndrome with serotonergic drugs and opioids, with some reported cases fatal; hypersensitivity; haemolytic anaemia requiring discontinuation and transfusion; interference with pulse oximetry so that other methods must be used to assess oxygen saturation; and neurological and visual symptoms affecting driving. In the oral Alzheimer programme at 8 to 16 mg daily the commonest adverse effects were headache at 1.5% and diarrhoea at 1.2%. Urine and other secretions turn blue-green, which is harmless and is the reason the phase 3 needed a colourant control at all.

Nobody counted how many people took this and were fine, so this cannot be turned into a rate.

Where this came from

Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.

Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.

The form that was studied

Slow intravenous injection (approved); oral stabilised leuco form in the Alzheimer programme; unregulated oral drops outside both

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form used in the studies cited on this page.

No source is stored against this line.

What is sold

The Alzheimer derivative is an oral tablet of the stabilised reduced form, at 8 or 16 mg daily. What is taken as a nootropic is typically a dilute aqueous solution of dye-grade or reagent-grade methylene blue in drops, a presentation with no pharmacopoeial specification and no approved counterpart.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on which forms are sold and how they compare.

No source is stored against this line.

What is recorded as being sold

  • 66 products list this as an active ingredient in the United States drug directory. 55 of them contain it and nothing else.

    FDA National Drug Code directory · 0517-0125 · read 2026-08-29

  • They are sold as capsule, injection, injection, solution, liquid, powder and solution, taken extracorporeal, intravenous and oral.

    FDA National Drug Code directory · 0517-0125 · read 2026-08-29

  • The regulator's established pharmacologic class for it is oxidation-reduction activity [moa] and oxidation-reduction agent [epc].

    FDA National Drug Code directory · 0517-0125 · read 2026-08-29

  • 27 published labels name it as an active ingredient. 16 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 1e1b0dee-1a3b-4846-a212-c9febb3fc17d · read 2026-08-29

  • Those labels are classed as human otc drug and human prescription drug.

    US prescribing information · 1e1b0dee-1a3b-4846-a212-c9febb3fc17d · read 2026-08-29

  • 1317 marketed supplement labels list this ingredient, classed as botanical and other combinations.

    NIH Dietary Supplement Label Database · 181047 · read 2026-08-29

  • Those labels carry all other, nutrient and structure/function claims. A claim of that kind is written by the manufacturer and is not assessed by any regulator, so its presence says nothing about whether it is true.

    NIH Dietary Supplement Label Database · 181047 · read 2026-08-29

  • Methylene blue is intravenous at 3 DOSAGE FORMS AND STRENGTHS Methylene blue injection, USP: 50 mg/10 mL (5 mg/mL) (0.5%) clear dark blue solution in single-dose ampules or single-dose prefilled syringes. 50 mg/10 mL (5 mg/mL) (0.5%) single-dose ampule., recorded as fda label in effect 2025-11-19 in the United States.

    US prescribing information · 67da2a69-8166-46c7-921c-d6ec47bfeac8 · read 2026-08-30

Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.

What it would be like to takeRead from sources, not yet reviewed

What you could measure

This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.

Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Methylene Blue Cation studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

Tracking can show whether something changed for you. It cannot show what caused it.

RNAWiki records evidence. It does not say whether this substance is right for you.

What is missing or unclearRead from sources, not yet reviewed

Claims that go past the evidence

Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.

Goes past the evidence

That a single-dose imaging study in 26 people establishes a repeated oral dose for cognitive enhancement

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That dye-grade or aquarium-grade material is equivalent to pharmacopoeial methylene blue, when the impurity specifications are written for different purposes

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That more is better, when the redox behaviour reverses at high concentration and excess causes the condition the drug treats

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That a compound most people meet as a surgical dye has no serious interactions, when it is a potent MAO-A inhibitor with fatal serotonin syndrome cases on the label

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

Missing populations

Which groups were under-represented in the studies has not been recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing long-term data

No completed tested study window is recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

No reviewed conclusion

RNAWiki has not yet published a reviewed conclusion for this use.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing interaction studies

No interaction was found in the registers checked. Not finding one is not the same as showing there is none.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Formulation uncertainty

Several salts, forms or products of Methylene Blue Cation are recorded. Results from one form may not transfer to another.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

Every line above can be traced to the study named beside it. Follow the link and read it.

The Alzheimer phase 3 failed because its placebo was not inert
In plain words
A 598-patient trial compared two doses of a methylene blue derivative against a very low dose meant only to colour the urine so nobody could tell who was on drug. The low dose turned out to be active, and the trial could not separate its arms.
What was measured
That 4 mg of methylthioninium twice weekly is pharmacologically inert — the assumption the trial control arm was built on, and which its own result contradicts
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Wischik et al. reported the phase 3 of hydromethylthionine mesylate in 598 amyloid-beta-PET-positive participants — 44% with mild cognitive impairment due to Alzheimer disease and 56% with mild to moderate dementia — across 82 centres in Canada, the European Union, the United Kingdom and the United States. Active arms received 16 mg/day or 8 mg/day; the control arm received methylthioninium chloride 4 mg twice weekly, intended as an inactive urinary colourant to preserve blinding against the urine discolouration the drug causes. The result, in the authors own words: it was not possible to demonstrate significant differences on the co-primary clinical endpoints ADAS-cog11 and ADCS-ADL23 at 52 weeks due to symptomatic activity in the control arm. Differences in ADAS-cog13 in the mild cognitive impairment subgroup emerged only at 78 weeks (p = 0.0291) and 104 weeks (p = 0.0308) between early-start and delayed-start 16 mg/day, in a modified delayed-start design. Biomarkers moved: neurofilament light chain (p = 0.0291) and grey matter atrophy at 52 and 104 weeks, and pTau217 in mild cognitive impairment (p = 0.0165).
Source
Wischik CM et al., J Prev Alzheimers Dis 2026;13:100480 (LUCIDITY)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
A low oral dose raised fMRI response and memory retrieval by 7%
In plain words
In 26 healthy adults, a single low dose of methylene blue increased brain activity during attention and memory tasks and improved correct responses on memory retrieval by 7%.
What was measured
Blood-oxygen-level-dependent response during sustained attention and short-term memory tasks, and correct responses during memory retrieval, after a single low dose
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Rodriguez et al. ran a prospective randomised double-blinded placebo-controlled trial in 26 subjects aged 22 to 62. Functional MRI was performed with a psychomotor vigilance task for sustained attention and delayed match-to-sample tasks for short-term memory, before and one hour after a single low oral dose of methylene blue or placebo, with a carbon dioxide challenge to measure cerebrovascular reactivity and a two-by-two repeated-measures analysis of variance for drug-by-time interaction, cluster-corrected at P < .05. Methylene blue increased response in bilateral insular cortex during the vigilance task (Z = 2.9-3.4, P = .01-.008) and in prefrontal, parietal and occipital cortex during the memory task (Z = 2.9-4.2, P = .03-.0003), and was associated with a 7% increase in correct responses during memory retrieval (P = .01). A companion paper reported modulation of functional connectivity. This is 26 people, a single dose, and one behavioural endpoint alongside the imaging.
Source
Rodriguez P et al., Radiology 2016;281:516-526; Rodriguez P et al., Brain Imaging Behav 2017;11:640-648
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
Serotonin syndrome, with fatal cases, in the approved label
In plain words
The prescribing information warns that methylene blue has caused serotonin syndrome in people taking antidepressants, and that some of those cases were fatal.
What was measured
Labelled contraindications and warnings, including fatal serotonin syndrome cases and G6PD contraindication
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The ProvayBlue label, section 5.1, states that serotonin syndrome has been reported with methylene blue class products, most reports associated with concomitant serotonergic drugs — SSRIs, SNRIs and monoamine oxidase inhibitors — with opioids and dextromethorphan increasing the risk, and that some of the reported cases were fatal. The mechanism is that methylene blue is itself a potent monoamine oxidase A inhibitor, which is not obvious from a compound most people encounter as a surgical dye. The label further contraindicates it in glucose-6-phosphate dehydrogenase deficiency because of haemolytic anaemia risk, warns to discontinue and transfuse if haemolytic anaemia occurs, warns that pulse oximetry is invalid in its presence and other methods must be used, warns of hypersensitivity, and advises patients not to drive until neurological and visual symptoms resolve. A cross-sectional study found a substantial proportion of patients receiving perioperative methylene blue were also on serotonergic drugs.
Source
ProvayBlue (methylene blue) injection prescribing information, NDA 204630, sections 4 and 5; McMillan E et al., Cureus 2025;17:e81090
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
An approved antidote with one approved indication
In plain words
The only FDA-approved use is treating acquired methaemoglobinaemia. Everything else it is used for is off-label.
What was measured
Approved indication, approval date and application number for the only FDA-approved methylene blue product
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
ProvayBlue (methylene blue injection) was approved on 8 April 2016 under NDA 204630 for the treatment of paediatric and adult patients with acquired methaemoglobinaemia, described in the label as an oxidation-reduction agent. Methylene blue had been in medical use for well over a century before that approval, which was granted under the FDA unapproved drugs initiative to bring a long-marketed agent into the modern regulatory framework. The label instructs that alternative treatments be considered if methaemoglobinaemia has not resolved after two doses. Widely used off-label applications — vasoplegic and septic shock, ifosfamide-induced encephalopathy, surgical and lymphatic mapping dye, and cognitive enhancement — are outside that indication and outside the evidence the approval rests on.
Source
ProvayBlue (methylene blue) injection prescribing information and Drugs@FDA record, NDA 204630, original approval 8 April 2016
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
The nootropic dose has no source and no product
In plain words
People take drops of methylene blue for cognition. The doses circulate as folklore, and the material is often manufactured to a dye specification rather than a drug one.
What was measured
That a single-dose imaging result in 26 people establishes a safe and effective repeated oral dose of an unregulated dye
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The only controlled human cognitive study of methylene blue is a single-dose imaging trial in 26 people. There is no dose-ranging study, no repeated-dose study, no study in any clinical cognitive population outside the tau programme, and no approved oral product. The material used is frequently sold as an aquarium or laboratory reagent, manufactured to a colour specification with impurity limits set for staining rather than for ingestion. Pharmacopoeial methylene blue carries limits for arsenic, lead, zinc and related thiazine dyes; dye-grade material need not. The redox behaviour is also biphasic — an electron donor at low concentration and an acceptor at high — so a dosing error does not produce more of the intended effect but can produce the opposite one, including methaemoglobinaemia caused by the drug used to treat it.
Source
Rodriguez P et al., Radiology 2016;281:516-526 as the only controlled human cognitive study; ProvayBlue label for the approved product and route; absence of any approved oral methylene blue product in Drugs@FDA
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
The tau programme did move biomarkers, and the field is watching
In plain words
Even though the trial missed its main endpoints, brain atrophy, a marker of nerve damage and a tau blood marker all moved in the treated groups.
What was measured
Plasma neurofilament light chain, plasma pTau217 and MRI grey matter atrophy change at 52 and 104 weeks
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
In the same phase 3, hydromethylthionine mesylate 16 mg/day produced a significant reduction in progression of neurodegeneration measured by plasma neurofilament light chain change at 52 weeks in the whole population (p = 0.0291), consistent with significant reductions in progression of grey matter atrophy at 52 and 104 weeks and a reduction in progression of tau pathology measured by plasma pTau217 in the mild cognitive impairment group (p = 0.0165). Headache (1.5%) and diarrhoea (1.2%) were the most frequent adverse effects. Earlier analyses had reported concentration-dependent activity on clinical decline and brain atrophy, and mechanistic work has reported that anticholinesterase and memantine co-treatment interferes with the compound activity — which is a specific and unusual interaction claim. The programme is run and largely authored by the sponsor, TauRx Therapeutics, and the conflict of interest disclosures on the phase 3 report are extensive.
Source
Wischik CM et al., J Prev Alzheimers Dis 2026;13:100480; Shiells H et al., J Alzheimers Dis 2020;75:501-519; Kondak C et al., J Neurochem 2022;160:172-184
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
contested
Review state
Written into the record, not signed off as a reviewed claim

How many documents were read

  • 15 documents were read for this substance.

    RNAWiki source record

  • 11 of them state the same halfLife, and they agree.

    RNAWiki source record

  • 11 of them state the same proteinBinding, and they agree.

    RNAWiki source record

  • 11 of them state the same volumeOfDistribution, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
T42P99266K
RxNorm concept
1788984

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Written into the record, not signed off.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S6.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

What the approval register records

  • 8 approved applications cover products containing this substance. The earliest was NDA204630, approved 20160408 to PROVEPHARM SAS.

    Drugs@FDA application register · NDA204630 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · NDA204630 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20060523.

    FDA National Drug Code directory · 0517-0125 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

3 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • What changed on this page — found nothing in the sources checked.

The record as stored

The full record, for auditing

Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

The older medicine-wide conclusion held in this record

Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.

An approved antidote and potent MAO-A inhibitor whose 598-patient Alzheimer phase 3 failed to separate on both co-primary endpoints — because the low-dose arm intended as an inactive colourant turned out to have symptomatic activity of its own, which is the same claim the nootropic market makes for microdosing.

Recorded evidence blocks (12)

What did Methylene Blue Cation's largest trial (314 people) and its longest (12 years) measure?


314 people in Methylene Blue Cation's largest registered study, 12 years in its longest registered window, measuring Mortality. ClinicalTrials.gov · 2026-09-01

23 phase2, 20 na, 11 phase3, 6 phase1, 6 phase4, 4 early phase1, 4 na or unstated; NCT01847612; 2025-07-03. Last human test completed 2026, NCT06900140.

Interpretation These counts include studies where Methylene Blue Cation was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.

Show the evidence
  • phase2
    23
  • na
    20
  • phase3
    11
  • phase1
    6
  • phase4
    6
  • early phase1
    4
2 more recorded rows
  • na or unstated
    4
  • Last recorded human test NCT06900140
    2026-03-06

recorded 2026-09-01 · last checked 2026-09-04

Methylene Blue Cation was tested only in human — what did it show?


human: lifespan (70): the rungs where Methylene Blue Cation has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation Mortality — the recorded outcome words.

Yeast C. elegans Drosophila Mouse Rat Dog Non-human primate Human lifespan
Show the evidence
  • human NCT00159510
    lifespan; Mortality; 70

recorded 2026-09-01 · last checked 2026-09-04

The NIA ITP gave Methylene Blue Cation at 28 ppm from 4 months — did both sexes live longer?


28 ppm, from 4 months: the NIA Interventions Testing Program workbook rows for Methylene Blue Cation. jax-mpd-itp · ITP_C2009_Lifespan.xlsx · 2026-09-04

292 mice; cohorts C2009; cohort rows are the workbook's own printed values; no median, percent change or survival statistic is derived from the per-animal data

Show the evidence
  • ITP cohort C2009
    methylene blue; 28.0; 4.0 months; f, m; ITP_C2009_Lifespan.xlsx

recorded 2026-09-04 · last checked 2026-09-04

5 of Methylene Blue Cation's trials stopped: accrual/recruitment, funding/business, other?


accrual/recruitment (2), funding/business (2) and other (1): Methylene Blue Cation's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"Inability to recruit the patients due to the short supply and changed local hospital protocol"; 5 of 70 registered studies

Show the evidence

Trial

  • NCT00159510
    terminated; "Inability to recruit the patients due to the short supply and changed local hospital protocol"
  • NCT00486174
    withdrawn; "primary site withdrew due to competing study: never enrolled any subjects."
  • NCT01276054
    terminated; "P.I. left"
  • NCT01386879
    terminated; "The study was terminated because of slower than anticipated enrollment"
  • NCT03446599
    withdrawn; "Lack of funding"

recorded 2026-09-01 · last checked 2026-09-04

Mouse studies of Methylene Blue Cation used 28 ppm — over how long?


studies of Methylene Blue Cation used the recorded amount. clinicaltrials.gov+jax-mpd-itp · 2026-09-04

6 recorded entries; mouse, human; oral; also "28 ppm", "Methylene blue (1%)", "Methylene Blue (USP grade, 280mg oral)"

Show the evidence
  • mouse methylene blue C2009
    28 ppm

human

  • NCT00314405
    Methylene blue (1%)
  • NCT01836094
    oral; Methylene Blue (USP grade, 280mg oral)
  • NCT02240498
    Methylene Blue Injection, USP 1%
  • NCT06052956
    Methylene Blue Injection, 1%
  • NCT07435415
    Methylene Blue (50 mg/10ml)

recorded 2026-09-04 · last checked 2026-09-04

Methylene Blue Cation's half-life is 24 hours — which schedules were studied?


24 hours, the half-life Methylene Blue Cation's label states. openfda-label · 691a6872-bc2f-d492-11c6-c3eec25aa3d3 · 2026-08-30

Show the evidence
  • half life
    24 hours hours; Elimination Methylene blue has a half-life of approximately 24 hours in humans.

recorded 2026-08-30 · last checked 2026-09-04

Which of apache, area under the curve and arterial pressure did Methylene Blue Cation's trials measure?


apache, area under the curve and arterial pressure lead 40 outcome terms across Methylene Blue Cation's trials. ClinicalTrials.gov · 2026-09-01

Interpretation pregnancy rate, study related serious adverse events, study related unanticipated adverse events, evidence of fat embolism, need for surgery to remove a broken optical fiber fragment and technically successful procedure follow.

Show the evidence
  • sensitivity
    1
  • mortality
    1
  • young mania rating scale
    1
  • pregnancy rate
    1
  • study related serious adverse events
    1
  • study related unanticipated adverse events
    1
14 more recorded rows
  • evidence of fat embolism
    1
  • need for surgery to remove a broken optical fiber fragment
    1
  • technically successful procedure
    1
  • pain
    1
  • fmri measurement
    1
  • wechsler memory scale third edition
    1
  • fmri during fname
    1
  • fname
    1
  • fmri during psychomotor vigilance task
    1
  • psychomotor vigilance task
    1
  • wechsler memory scale iii logical memory subset
    1
  • mini mental state exam
    1
  • clox an executive clock drawing test
    1
  • area under the curve
    1

recorded 2026-09-01 · last checked 2026-09-04

Which of Methylene Blue Cation's 9 ongoing trials reports first?


9 registered trials of Methylene Blue Cation are open; earliest completion 2025-10-01. ClinicalTrials.gov · 2026-09-01

Time to removal of the drainage catheter; All-cause mortality within 7 days after randomization; latest 2032-06

Show the evidence

Trial

  • NCT06052956
    "Efficacy of Methylene Blue Photodynamic Therapy for Treatment of Deep Tissue Abscesses"; n 120; "Time to removal of the drainage catheter"; 2031-06-30
  • NCT06306001
    "Intravenous Methylene Blue for Treating Refractory Neonatal Septic Shock"; n 130; "All-cause mortality within 7 days after randomization"; 2027-02
  • NCT06660680
    "The Effect of Methylene Blue Infiltrating Injection on Anal Pain After Milligan-Morgan Surgery: A Randomized Controlled Clinical Study"; n 60; "Pain"; 2025-10-01
  • NCT06887036
    "Methylene Blue Treatment of Chronic Hepatitis B Virus Infection"; n 10; "Reduction >1 log10 in the starting HBsAg level and > 2 log10 in the starting HBV DNA PCR level"; 2027-05-31
  • NCT07169487
    "Adjunctive Methylene Blue for Immunotherapy-related CRS and ICANS: Phase I Study"; n 18; "Incidence and type of methylene blue-related serious adverse events (SAEs)"; 2030-06-28
  • NCT07179003
    "A Phase 2 Study of Methylene Blue Photodynamic Therapy for Treatment of Breast Abscesses"; n 50; "Time to resolution of clinical symptoms"; 2032-06
3 further recorded trials
  • NCT07264543
    "Early Methylene Blue in the Microhemodynamics of Septic Patients"; n 50; "To evaluate the feasibility of the study protocol."; 2026-12-31
  • NCT07435415
    "Local Injection Methylene Blue Combined With Radiation in HNSCC Patients"; n 10; "Any unexpected severe adverse event resulting from the combination treatment."; 2027-06-30
  • NCT07494773
    "Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection"; n 50; "Wound Healing Trajectory Measured by Digital Planimetry"; 2028-05-31

recorded 2026-09-01 · last checked 2026-09-04

Which running trial of Methylene Blue Cation could settle lifespan?


NCT06306001 measures All-cause mortality within 7 days after randomization, reading out 2027-02.

1 open trial; n 130; "Intravenous Methylene Blue for Treating Refractory Neonatal Septic Shock"

Show the evidence
  • Trial NCT06306001
    "Intravenous Methylene Blue for Treating Refractory Neonatal Septic Shock"; n 130; "All-cause mortality within 7 days after randomization"; 2027-02

Which 27 trials of Methylene Blue Cation posted no result?


Posted no result
27 of 27 completed trials
Registrations
NCT00354380, NCT00513032, NCT00214877, NCT00314405, NCT02303886 and NCT01725477, and 21 more
Completion dates
oldest 2006-11; newest 2024-03-16
Show the evidence

Trial

  • NCT00354380
    2006-11
  • NCT00513032
    2007-04
  • NCT00214877
    2007-10
  • NCT00314405
    2008-04
  • NCT02303886
    2014-11
  • NCT01725477
    2015-03-09
14 further recorded trials
  • NCT02084784
    2015-09
  • NCT01836094
    2016-03
  • NCT02089542
    2016-10
  • NCT02831023
    2017-01
  • NCT03177070
    2017-05-02
  • NCT03262077
    2017-06-26
  • NCT03120637
    2018-01-10
  • NCT04056923
    2018-07-01
  • NCT03098342
    2019-01-31
  • NCT04341844
    2020-07-30
  • NCT03579979
    2020-08-19
  • NCT04446871
    2021-01-25
  • NCT04635605
    2021-08-13
  • NCT03542760
    2021-08-31

At the median, Methylene Blue Cation's trials enrolled 50 people — anything larger?


Median enrolment
50
Largest enrolment
314
Registered trials counted
69

Methylene Blue Cation and BCRP, OCT2 and CYP3A4: shared by which compounds?


BCRP, OCT2 and CYP3A4 appear in Methylene Blue Cation's recorded interaction sentences, 6 in all. openfda-label+europepmc · 2026-08-30

Interpretation pharmacokinetics

Show the evidence
  • CYP1A2 pharmacokinetics
    Methylene blue induces CYP1A2 but does not induce CYP2B6 or CYP3A4.
  • CYP2B6 pharmacokinetics
    Methylene blue induces CYP1A2 but does not induce CYP2B6 or CYP3A4.
  • CYP2C9 pharmacokinetics
    Possible time-dependent inhibition of CYP2C9, CYP2D6 and CYP3A4/5 (testosterone as substrate) was also observed.
  • CYP2D6 pharmacokinetics
    Possible time-dependent inhibition of CYP2C9, CYP2D6 and CYP3A4/5 (testosterone as substrate) was also observed.

CYP3A4

  • pharmacokinetics
    Possible time-dependent inhibition of CYP2C9, CYP2D6 and CYP3A4/5 (testosterone as substrate) was also observed.
  • pharmacokinetics
    Methylene blue induces CYP1A2 but does not induce CYP2B6 or CYP3A4.

recorded 2026-08-30 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL191083
PubChem CID
4139
CAS number
7060-82-4
RxCUI
1546414
InChIKey
RBTBFTRPCNLSDE-UHFFFAOYSA-N
Also called
Basic blue 9, Dndi1417128, METHYLENE BLUE ANHYDROUS, Chlorure de methylthioninium, Cloruro de metiltioninio, Trx-0014, Trx0014, METHYLENE BLUE, C.i. basic blue 9, Lowacryl blue 9, Methylenium ceruleum, mb
Also called
Methylthioninium chloride
Trade name
Lumeblue (previously known as methylthioninium chloride cosmo), Methylthioninium chloride proveblue, Urolene blue, Provayblue, Arthcal 1% Methylene Blue, Ozipco 1% Methylene Blue
Development code
NSC-215213, NSC-617593, C.I. 52015, CI 52015, NSC-759135
Salt form
Basic blue 9 trihydrate, C.i. basic blue 9 trihydrate, Methylene blue trihydrate, usp methylene blue, ProvayBlue (injection); methylthioninium chloride. The Alzheimer derivative is hydromethylthionine mesylate, formerly TRx0237 and LMTM
Component
Methylthioninium chloride
Sources (9)

Sources

  • ClinicalTrials.gov ClinicalTrials.gov API v2 snapshot 2026-09-01T09:00:05 ·
  • clinicaltrials.gov+jax-mpd-itp clinicaltrials.gov+jax-mpd-itp ·
  • this record's own fields 2,3,5 ·
  • Europe PMC dose-response search ·
  • Europe PMC and ClinicalTrials.gov organism ladder ·
  • jax-mpd-itp ITP_C2009_Lifespan.xlsx ·
3 more sources
  • openfda-label 691a6872-bc2f-d492-11c6-c3eec25aa3d3 ·
  • openfda-label+europepmc K1:ZMZ79891ZH ·
  • national registers US, EU, CA ·

ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · NIA ITP via the JAX Mouse Phenome Database · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 9 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

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