This page shows what was measured, who it was measured in, and what that does not settle.
What Mebufotenin does in the body
Nothing approved. A synthetic inhaled version is in trials for depression that has not responded to other drugs; the substance itself is Schedule I
Inhaled as a vapour, the molecule reaches the brain in a few seconds because it goes straight from the lungs into arterial blood. It switches on serotonin receptors, with an unusually strong pull on the 5-HT1A subtype — a different balance from LSD or psilocybin, which favour 5-HT2A. The experience is overwhelming, very short, and often has no narrative content at all. Because monoamine oxidase destroys the molecule quickly, anything that inhibits that enzyme turns a 20-minute effect into a dangerous overdose; the one published death involved exactly that combination.
What happened in people
No change in cognition, mood or well-being measures in that same healthy-volunteer phase 1
✎ 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.
Harvesting Incilius alvarius secretion for ceremonial use is a conservation and animal-welfare pressure that the synthetic clinical formulation does not create
Where it acts
Cortical and limbic 5-HT1A and 5-HT2A receptors, reached within seconds of inhalation because the drug bypasses the gut and the liver entirely
Kind of result
Symptoms and quality of life
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · X0MKX3GWU9 · read 2026-08-29
Where each sentence above came from
The recorded explanation is written in label language rather than for a beginner. 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 129 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.
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 people◇Read 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.
Phase 2b randomised, double-blind, placebo-controlled with open-label extension
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
Least-squares mean difference -15.5 versus placebo, effect size -2.0; remission (MADRS ≤ 10) at day 8 in 57.5% versus 0% on placebo
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. A 0% placebo remission rate is far below the placebo response usual in depression trials and is consistent with complete functional unblinding, since the drug effect is unmistakable within seconds of inhalation. The trial was sponsored, designed and analysed by the manufacturer.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Vaporised inhalation, single supervised session, doses escalated within one day
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Remission at day 7 in 7/8 (87.5%) of the individualised-dosing group, p < 0.0001; 2/4 at 12 mg and 1/4 at 18 mg in the phase 1 part
Repeated elsewhere
Partially 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. Open-label, no control arm, 16 patients in total with four per single-dose group. Funder involved in study design, data analysis and manuscript preparation, as disclosed.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Vaporised inhalation, single supervised session, doses escalated within one day
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Significant increases over 2 mg on PES, MEQ, EDI and 5D-ASC at 6, 12 and 18 mg; no significant change on the Challenging Experience Questionnaire
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. Cognition, mood and well-being measures were not affected by the drug in healthy volunteers — a null result that sits uneasily beside the naturalistic survey literature.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Vaporised inhalation, single supervised session, doses escalated within one day
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
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 people◇Read 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.
□Living longer, or avoiding a major eventNo evidence recorded. Death, a heart attack, a stroke, a hospital stay.No registered study measures this.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
□Symptoms and quality of lifeNo evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
□A number that stands in for healthNo evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.No registered study measures this.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
□AnimalsNo evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
□Cells in a dishNo evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
□A guess from softwareNo 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 body◇Read 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.
Start
Mebufotenin
What a person takes: Vaporised inhalation, single supervised session, doses escalated within one day.
The measurement behind this step
The clinical formulation is vaporised and inhaled in a monitored session; the individualised regimen gives up to three increasing doses within a single day, which is possible only because the acute effect resolves in under half an hour. Naturalistic use is inhalation of vapour from synthetic freebase or from dried toad secretion of unknown composition.
Getting in
Inhaled as a vapour
The dose is vaporised and drawn into the lungs. Taken by mouth on its own it does almost nothing, because gut and liver enzymes destroy it before it reaches the brain.
╌╌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
Vaporised freebase, 6 to 18 mg in the clinical programme. Pulmonary absorption delivers the molecule into arterial blood without first-pass metabolism; oral bioavailability is negligible because monoamine oxidase A in gut wall and liver deaminates it, which is why oral preparations pair it with an MAO inhibitor.
Onset is faster than an intravenous injection because the blood goes lung to heart to brain. The full effect arrives before the person can put the device down.
╌╌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
Lipophilic tryptamine crossing the blood-brain barrier without a transporter. Time to peak subjective effect is under a minute by inhalation and the acute experience is largely over within 15 to 30 minutes, which is what makes a three-dose escalation within a single day feasible.
It binds serotonin receptors, but with a different balance from LSD or psilocybin — pulling harder on the subtype that quietens neurons than on the one that excites them.
──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
Agonist at 5-HT1A with higher affinity than at 5-HT2A. 5-HT1A is Gi-coupled and inhibitory, 5-HT2A is Gq-coupled and excitatory; the inverted affinity ratio relative to the other classical psychedelics is the standard explanation for the qualitatively different, largely contentless experience, though no human study has separated the two receptors' contributions with an antagonist.
An enzyme in the body strips the molecule apart almost as fast as it arrives. That is why the experience is so short — and why blocking that enzyme is dangerous.
╌╌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
Oxidative deamination by MAO-A is the principal clearance route, with CYP2D6-mediated O-demethylation to bufotenin as a competing pathway. Harmaline and other MAO-A inhibitors raise and prolong exposure; the published fatality involved that combination.
Depression scores fall within hours, in the trials
In the phase 2b, more than half the treated group were in remission a week later, and most improvements were visible on day one. The drug itself was gone within the hour.
╌╌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
MADRS remission at day 8 in 57.5% versus 0% on placebo, with remissions observed from day 1 and, in the earlier phase 1/2, six of ten remissions apparent from two hours. No mechanism links a 20-minute receptor exposure to a week-long change in mood ratings; the persistence is an observation, not an explanation.
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 is missing or unclear◇Read 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.
In the trials: adults with treatment-resistant depression, dosed once in a single supervised day. Outside the trials it is taken as a vapour, either synthetic or from dried toad secretion, in unregulated group ceremonies.
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.
Where the result stopped carrying
Phase 2 trials in postpartum depression (NCT05804708) and bipolar II disorder (NCT05839509) were both terminated, at enrolments of 10 and 6
The healthy-volunteer phase 1 found no effect on the mood and well-being measures it collected, despite a clear dose-response on experience intensity
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 take◇Read 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.
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 (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. 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 take◇Read 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
Not available
❝ 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
Vaporised inhalation, single supervised session, doses escalated within one day
✎ 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
RNAWiki has not recorded a supervision or regulatory status for this substance.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
No register row and no identity class settled the question.
No source is stored against this line.
What is in the pack
The clinical formulation is vaporised and inhaled in a monitored session; the individualised regimen gives up to three increasing doses within a single day, which is possible only because the acute effect resolves in under half an hour.
✎ 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. The rest of the recorded wording: Naturalistic use is inhalation of vapour from synthetic freebase or from dried toad secretion of unknown composition.
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 take◇Read 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
Acute effects are intense, begin within seconds and are largely over in 15 to 30 minutes. In the phase 1, vital signs at 1 and 3 hours were unaffected and adverse events were generally mild and self-resolving. The dominant documented hazard is pharmacokinetic: monoamine oxidase inhibitors, including prescribed MAOIs and harmala alkaloids in ayahuasca-style preparations, prolong and raise exposure and are implicated in the published fatality. Toad secretion additionally contains cardioactive bufadienolides. Delayed re-emergence of the experience without redosing, described in the literature as reactivation, is reported in naturalistic settings; its incidence is not established.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
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 unclear∅Nothing found in the sources checked
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
Vaporised inhalation, single supervised session, doses escalated within one day
✎ 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
Naturalistic use is inhalation of vapour from synthetic freebase or from dried toad secretion of unknown composition.
✎ 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.
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 take◇Read 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.
RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.
Questions worth asking
Which of the trials of Mebufotenin 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 unclear◇Read 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 the phase 2b effect size of -2.0 is pharmacological, when the placebo arm produced zero remissions and the drug reveals its allocation within seconds
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 retrospective self-ratings from ceremony attendees estimate an antidepressant effect size
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 5-HT1A-weighted binding profile explains the qualitative difference from LSD or psilocybin — no human antagonist study has separated the receptors' contributions
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 toad-derived material and the synthetic clinical formulation are the same exposure; the secretion also contains bufotenin and cardioactive bufadienolides in undefined proportions
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 unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
How much did people take in the studies?
The sources RNAWiki checked hold nothing for this field.
Why it matters. A result belongs to an amount. Without the amount the result floats free.
What would answer it
A stored source that records 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.
How fast does the body clear it?
The sources RNAWiki checked hold nothing for this field.
Why it matters. Without this, nothing on this page can say how long anything lasts.
What would answer it
A stored source that records 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 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 Mebufotenin 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 people◇Read 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.
Phase 2b: 15.5-point MADRS advantage and 57.5% remission against 0% on placebo
In plain words
In a randomised placebo-controlled trial of 81 people whose depression had not responded to at least two other drugs, a single day of inhaled doses put more than half into remission within a week. Nobody on placebo remitted.
What was measured
MADRS change from baseline to day 7 and remission rate at day 8, n=81
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
NCT05800860 was a randomised, double-blind, placebo-controlled phase 2b with an open-label extension in 81 patients with treatment-resistant depression, completed March 2025. The primary endpoint was mean change in MADRS from baseline to day 7. A single-day individualised dosing regimen of GH001 produced a least-squares mean difference of -15.5 versus placebo, effect size -2.0, with 57.5% remission (MADRS ≤ 10) at day 8 against 0% on placebo. Forty patients received GH001 in the double-blind part. In the published post hoc analysis, remission at day 8 did not correlate with the number of prior antidepressant failures (r = -0.13, p = 0.44), and remission rates were 53.9% to 63.6% across subgroups defined by 2, 3, 4 or ≥5 prior failures. Three of the six authors of that analysis are employees of the sponsor.
Written into the record, not signed off as a reviewed claim
A 0% placebo remission rate is a signal about the blind, not only about the drug
In plain words
Not one person in the placebo group of the phase 2b reached remission. In depression trials, placebo response is normally large. A zero says the two groups could tell which one they were in.
What was measured
That a 15.5-point MADRS separation against a 0% placebo remission rate measures a drug effect rather than a drug effect plus a fully unblinded expectancy effect
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Across antidepressant trials, placebo remission at one week is routinely non-zero and placebo response rates in the 30% range are the usual reason drug-placebo separation is hard to demonstrate. A 0% placebo remission rate in a psychedelic trial is consistent with a group who knew they had received nothing: 5-MeO-DMT produces an unmistakable effect within seconds of inhalation, so allocation is revealed at the moment of dosing to participant and observer alike. The reported effect size of -2.0 therefore contains an expectancy component of unknown size that the design cannot isolate. This is a limitation shared by every trial in this file and is not a criticism of the conduct of this one; it is the reason the record does not treat -15.5 as a pharmacological effect size.
Written into the record, not signed off as a reviewed claim
Dose-ranging in 22 healthy volunteers established the escalating single-day regimen
In plain words
A phase 1 gave 2, 6, 12 or 18 milligrams to healthy people. Higher doses produced stronger experiences, vital signs were unaffected, and stepping the dose up within one day produced the strongest effect of all.
What was measured
Dose-related change in PES, MEQ, EDI and 5D-ASC ratings, plus vital signs and cognition, n=22
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
GH001-HV-101 gave single vaporised doses of 2 mg (n=4), 6 mg (n=6), 12 mg (n=4) and 18 mg (n=4), plus an individualised dose-escalation regimen (n=4), to 22 healthy volunteers. Doses of 6, 12 and 18 mg produced significant increases over 2 mg on the Peak Experience Scale, Mystical Experience Questionnaire, Ego Dissolution Inventory and 5D-ASC, but not on the Challenging Experience Questionnaire. Maximal ratings occurred with individualised escalation. Vital signs at 1 and 3 hours were unaffected and adverse events were generally mild and self-resolving. Measures of cognition, mood and well-being were not changed. That last finding is the one usually left out of summaries: the phase 1 found the experience scaled with dose and the psychological outcome measures did not move.
Written into the record, not signed off as a reviewed claim
The one published death was a monoamine-oxidase interaction
In plain words
A man died after drinking a brew that combined 5-MeO-DMT with harmala alkaloids. The alkaloids block the enzyme that normally destroys the tryptamine within minutes, so a short experience became a lethal exposure.
What was measured
Postmortem 5-MeO-DMT and harmala alkaloid concentrations in a fatal case, with the pharmacokinetic interaction quantified separately
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Sklerov et al. reported a fatal intoxication following ingestion of 5-MeO-DMT in an ayahuasca-style preparation, with harmala alkaloids identified in the material and in postmortem specimens. The mechanism is pharmacokinetic and reproducible: 5-MeO-DMT is deaminated by monoamine oxidase A, and Shen et al. demonstrated in a controlled system that the reversible MAO-A inhibitor harmaline raises and prolongs 5-MeO-DMT exposure, with CYP2D6 status modifying the effect through the competing O-demethylation pathway to bufotenin. This is the interaction that matters clinically, and it extends to prescribed MAO inhibitors. Inhalation without an MAO inhibitor gives an exposure lasting minutes; the same amount with one does not.
Written into the record, not signed off as a reviewed claim
The naturalistic survey results describe who answered the survey
In plain words
Surveys of people who had used it in ceremonies report large improvements in depression and anxiety. Everyone in those samples chose to attend, chose to answer afterwards, and rated their own symptoms from memory.
What was measured
That retrospective self-ratings from self-selected ceremony attendees estimate an antidepressant or anxiolytic effect size
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Davis et al. surveyed 362 adults who had used 5-MeO-DMT in a naturalistic group setting and found self-reported improvement in depression and anxiety among those who reported having had those conditions, with improvement associated with the intensity of the mystical experience. Uthaug et al. followed participants at a single retreat and found reductions in self-rated depression, anxiety and stress alongside increased satisfaction with life. Neither has a control group, both recruit from people who sought the experience out, and the outcome is a retrospective self-rating collected in the setting that produced the experience. These studies establish that the effect is reported and that it is common enough to be worth a trial; they do not estimate its size, and the phase 1 in healthy volunteers found no change in mood or well-being measures at all.
Written into the record, not signed off as a reviewed claim
Scheduled in 2010 as having no medical use, in randomised trials by 2023
In plain words
The DEA put 5-MeO-DMT in Schedule I in December 2010. Thirteen years later a synthetic version of the same molecule was running placebo-controlled trials in depression under a name assigned by the WHO.
What was measured
Date of Schedule I placement versus registered trial phase for the same molecule
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
DEA published the final rule placing 5-methoxy-N,N-dimethyltryptamine into Schedule I on 20 December 2010 (75 FR 79296), after proposed rules in August and October 2009. Schedule I requires a finding of no currently accepted medical use in the United States. GH Research began registered clinical trials of a vaporised synthetic formulation in 2020, completed a phase 1/2 in treatment-resistant depression in 2023 and a randomised placebo-controlled phase 2b in 2025, and the molecule now carries the international nonproprietary name mebufotenin. Two of the company's phase 2 trials, in postpartum depression (NCT05804708, n=10) and bipolar II disorder (NCT05839509, n=6), were terminated. The scheduling finding and the development programme coexist because they are made by different bodies against different standards.
Source
DEA final rule 75 FR 79296 (20 December 2010); ClinicalTrials.gov NCT05800860, NCT05804708, NCT05839509
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
Two phase 2 trials in other indications were terminated
In plain words
The same company ran trials in postpartum depression and bipolar II depression. Both stopped early, with ten and six patients enrolled.
What was measured
Registered trial status and actual enrolment
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
NCT05804708, a phase 2 trial of GH001 in postpartum depression, is recorded on ClinicalTrials.gov as terminated with an actual enrolment of 10. NCT05839509, a phase 2 trial in bipolar II disorder, is recorded as terminated with an actual enrolment of 6. Neither has posted results. A terminated trial with single-digit enrolment produces no efficacy information in either direction, and the record notes them because a development programme summarised only by its completed trials is a filtered one.
Source
ClinicalTrials.gov NCT05804708 and NCT05839509, registry status records
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
Where else this substance is registered
FDA substance identifier (UNII)
X0MKX3GWU9
CAS registry number
1019-45-0
PubChem compound
1832
ChEBI
2086
WHO international nonproprietary name list entry
12325
EMA substance identifier
300000033352
European Chemicals Agency number
213-813-2
DrugBank
DB14010
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What to learn next
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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.
The fastest and shortest-acting classical psychedelic — effects begin in seconds and are over in half an hour — and a randomised placebo-controlled phase 2b in 81 patients reported a 15.5-point MADRS advantage and 57.5% remission at day 8 against 0% on placebo, in a trial that could not be blinded and was designed and analysed by the sponsor.
Recorded evidence blocks (7)
Q1
What did Mebufotenin's largest trial (81 people) and its longest (2.2 years) measure?
81 people in Mebufotenin's largest registered study, 2.2 years in its longest registered window, measuring Maximum Plasma Concentration (Cmax) following sublingual administration of 5-MeO-DMT. ClinicalTrials.gov · 2026-09-01
8 phase1, 6 phase2; NCT06810765; 2027-12; no ageing endpoint recorded. Last human test completed 2025, NCT05800860.
Interpretation These counts include studies where Mebufotenin 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
phase1
8
phase2
6
Last recorded human testNCT05800860
2025-03-11
recorded 2026-09-01 · last checked 2026-09-04
Q2
Mebufotenin was tested only in human — what did it show?
"Recruitment of this patient population was more challenging than anticipated. The sponsor concluded that a sufficient amount of patients have completed the trial to demonstrate proof of concept in this patient population."; 3 of 12 registered studies
Show the evidence
Trial
NCT05804708
terminated; "Recruitment of this patient population was more challenging than anticipated. The sponsor concluded that a sufficient amount of patients have completed the trial to demonstrate proof of concept in this patient population."
NCT05839509
terminated; "Recruitment of this patient population was more challenging than anticipated. The sponsor concluded that a sufficient amount of patients have completed the trial to demonstrate proof of concept in this patient population."
NCT06810765
withdrawn; "Study is being conducted externally."
recorded 2026-09-01 · last checked 2026-09-04
Q4
Could one person measure Mebufotenin's effect on treatment emergent aes?
Treatment emergent aes: measured in Mebufotenin's trials.
Interpretation treatment emergent aes is the recorded endpoint.
Show the evidence
biomarkers
treatment emergent aes; 2026-09-01
incidence of adverse events; 2026-09-01
human trials at or under30
6
Not recorded for this substance
a recorded half-life
smallest human trial
0; NCT06810765; PHASE2; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN
Q5
What will the one ongoing trial of Mebufotenin report, and when?
Interpretation Serum PK parameters of mebufotenin - maximum observed concentration (Cmax)
Show the evidence
TrialNCT07540494
"Pharmacokinetics and Safety of GH001 Delivered Via a GH001 Aerosol Delivery System in Healthy Subjects"; n 12; "Serum PK parameters of mebufotenin - maximum observed concentration (Cmax)"; 2026-05
recorded 2026-09-01 · last checked 2026-09-04
Q6
Which 6 trials of Mebufotenin posted no result?
Posted no result
6 of 6 completed trials
Registrations
NCT04640831, NCT04698603, NCT05163691, NCT05032833, NCT05698095 and NCT05753956
Completion dates
oldest 2019-10-04; newest 2023-11-29
Show the evidence
Trial
NCT04640831
2019-10-04
NCT04698603
2021-11-06
NCT05163691
2021-11-22
NCT05032833
2022-07-07
NCT05698095
2023-09-07
NCT05753956
2023-11-29
Q7
At the median, Mebufotenin's trials enrolled 29 people — anything larger?
Median enrolment
29
Largest enrolment
81
Registered trials counted
12
Where it is registeredIdentifiers, relations and other names
ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · derived from this page's own recorded fields; no external licence
✗ required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
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✓ source coverage passed: 3 source rows
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This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.