This page shows what was measured, who it was measured in, and what that does not settle.
What Imiquimod does in the body
The topical treatment
From the FDA-approved label: The mechanism of action of Imiquimod Cream in treating AK, sBCC, and EGW lesions is unknown.
What happened in people
RNAWiki has not yet published a reviewed conclusion for this use.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
No reviewed claim names a result for any goal on this record.
No source is stored against this line.
The limit that matters most
Not recorded.
Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
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 · P1QW714R7M · read 2026-08-29
Its recorded molecular formula is C14H16N4, weighing 240.3.
US prescribing information · 59af8153-4cf8-4f22-9000-f239798d52d1 · read 2026-08-30
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.
No statement of the main limit is recorded.
The four opening statements run to 36 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.
Enzyme
An enzyme is a protein that speeds up one chemical change.
A picture of it, and where the picture fails
An enzyme is like a machine on a production line doing one cut.
Where that stops being true. A machine is switched on and off by a person. Enzymes are controlled by the cell.
What people get wrong. Enzymes are thought to be used up. They are not; they work again and again.
A catalytic protein that lowers the activation energy of a specific reaction.
Receptor
A receptor is a part of a cell that a signal fits into.
A picture of it, and where the picture fails
A receptor is like a lock waiting for one key.
Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.
What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.
A protein that binds a specific ligand and converts that binding into a cellular response.
Pathway
A pathway is a chain of steps inside a cell, each one setting off the next.
A picture of it, and where the picture fails
A pathway is like a row of dominoes.
Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.
What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.
An ordered series of molecular interactions producing a defined cellular change.
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.
Anal Cancer Incidence
✗ The study did not show it
Who was studied
NCT02135419
How many people
4446
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
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. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Topical
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Mortality
✗ The study did not show it
Who was studied
NCT04143451
How many people
4000
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
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. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Topical
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Proportion of participants with a new Basal Cell Carcinoma (BCC) on the face at 1 year
✗ The study did not show it
Who was studied
NCT05212246
How many people
1630
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
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. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Topical
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
treatment succes
✗ The study did not show it
Who was studied
NCT02281682
How many people
624
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
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. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Topical
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Number of Participants With Treatment Success/Failure at Visit 5/Week 14
✗ The study did not show it
Who was studied
NCT01686152
How many people
589
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
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. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Topical
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Number of Participants Who Experienced an Adverse Event
✗ The study did not show it
Who was studied
NCT00116649
How many people
551
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
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. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Topical
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 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 eventEvidence recorded. Death, a heart attack, a stroke, a hospital stay.3 registered measures of this kind. No reviewed result.
□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 healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.2 registered measures of this kind.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.1 registered measure inside human tissue.
■AnimalsEvidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse. A result in animals says what to test next. It does not say what happens in people.
■Cells in a dishEvidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
□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 would be like to take◇Read 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.
No registered study measured anything of this kind.
Measured
Things only a test, a scale or a device shows.
gene expression profiling of treated lesions
blood pressure
heart rate
Meaningful
Things that change how a life goes, not only a number.
overall survival
overall survival at 12 months
progression free survival
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 (34)
who experienced an adverse event
treatment emergent adverse events
efficacy
safety
adverse events
recuurence rate 24 weeks after ablative therapy
elevated myxa
disease control rate
safety assessment
lesion count
objective response
related serious adverse events
maximum tolerated dose
dose limiting toxicity
seroconversion rate
unacceptable toxicity
adverse events as a measure of safety and tolerability
treatment related adverse events
complete clinical response
rate of toxicity in study receiving protocol therapy
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
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.
Imiquimod Cream is indicated for the topical treatment of: • Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AK) on the face or scalp in immunocompetent adults. ( 1.1 ) • Biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults with a maximum tumor diameter of 2.0 cm on trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet),…
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 efficacy of Imiquimod Cream for AK or sBCC in patients less than 18 years of age have not been established.”
US prescribing information · 59af8153-4cf8-4f22-9000-f239798d52d1 · read 2026-08-30
On older people, the label states: “Of the 215 subjects treated with Imiquimod Cream in the AK clinical studies, 127 subjects (59%) were 65 years and older, while 60 subjects (28%) were 75 years and older.”
US prescribing information · 59af8153-4cf8-4f22-9000-f239798d52d1 · read 2026-08-30
On people who are pregnant, the label states: “Category C: Note: The Maximum Recommended Human Dose (MRHD) was set at 2 packets per treatment of Imiquimod Cream (25 mg imiquimod) for the animal multiple of human exposure ratios presented in this label.”
US prescribing information · 59af8153-4cf8-4f22-9000-f239798d52d1 · read 2026-08-30
On people who are breastfeeding, the label states: “It is not known whether imiquimod is excreted in human milk following use of Imiquimod Cream.”
US prescribing information · 59af8153-4cf8-4f22-9000-f239798d52d1 · read 2026-08-30
Where the result stopped carrying
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
Prescription only
❝ 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
Topical
✎ 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
Sold as cream, given by the topical route.
✎ 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 take∅Nothing found in the sources checked
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.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
Reports sent to a regulator
These are reports people sent to a regulator. They do not show the medicine caused the reaction.
Nobody counted how many people took the medicine and reported nothing.
The same event can be reported more than once, and many reports are incomplete.
News coverage, lawsuits and new warnings change how often people report.
A count is not a rate and not a risk.
Imiquimod appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 445 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
erythema — 103 reaction mentions
pain — 59 reaction mentions
influenza like illness — 50 reaction mentions
application site erythema — 49 reaction mentions
scab — 39 reaction mentions
oedema — 36 reaction mentions
chills — 30 reaction mentions
application site reaction — 27 reaction mentions
myalgia — 27 reaction mentions
erythema multiforme — 25 reaction mentions
open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot
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◇Read 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
Topical
✎ 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
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
25 products list this as an active ingredient in the United States drug directory. 25 of them contain it and nothing else.
FDA National Drug Code directory · 62147-0087 · read 2026-08-29
They are sold as cream and powder, taken topical.
FDA National Drug Code directory · 62147-0087 · read 2026-08-29
The regulator's established pharmacologic class for it is increased cytokine activity [pe], increased cytokine production [pe] and interferon inducers [moa].
FDA National Drug Code directory · 62147-0087 · read 2026-08-29
11 published labels name it as an active ingredient. 11 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 1505cf54-37da-4b2b-9812-6ffd6a01a7c7 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 1505cf54-37da-4b2b-9812-6ffd6a01a7c7 · read 2026-08-29
Imiquimod is topical at 3 DOSAGE FORMS AND STRENGTHS Imiquimod Cream USP, 5%, is supplied in single-use packets each of which contains 250 mg of the cream, equivalent to 12.5 mg of imiquimod., recorded as fda label in effect 2025-08-11 in the United States.
US prescribing information · 59af8153-4cf8-4f22-9000-f239798d52d1 · read 2026-08-30
Recorded price in US: 0.64453–36.21804 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 5 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..
Recorded source · 2026-08-26 · read 2026-08-28
Recorded price in US: 107.04272 USD per one gram, across 2 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..
Recorded source · 2026-08-26 · read 2026-08-28
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 Imiquimod 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
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 Imiquimod 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.
How many documents were read
11 documents were read for this substance.
RNAWiki source record
4 of them state the same tMax, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
P1QW714R7M
RxNorm concept
310982
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
✗ Not passed
Safety mode resolved
No register row and no identity class settled the question.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or unclear◇Read 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
12 approved applications cover products containing this substance. The earliest was NDA020723, approved 19970227 to BAUSCH.
This order is fixed in code and does not count clicks or time on the page.
What is not here
7 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 was measured, goal by goal — found nothing in the sources checked.
The path through the body — found nothing in the sources checked.
How long anything takes — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
Claims that go past the evidence — 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.
Recorded evidence blocks (11)
Q1
What did Imiquimod's largest trial (4446 people) and its longest (17 years) measure?
4446 people in Imiquimod's largest registered study, 17 years in its longest registered window, measuring Baseline biomarker profile predicting clinical response to imiquimod treatment. ClinicalTrials.gov · 2026-09-01
32 phase1, 32 phase2, 28 phase3, 17 phase4, 10 na, 6 early phase1, 5 na or unstated; NCT00799110; 2025-09; no ageing endpoint recorded. Last human test completed 2026, NCT06840470.
Interpretation These counts include studies where Imiquimod 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
32
phase2
32
phase3
28
phase4
17
na
10
early phase1
6
2 more recorded rows
na or unstated
5
Last recorded human testNCT06840470
2026-04-08
recorded 2026-09-01 · last checked 2026-09-04
Q2
From mouse to human: where has Imiquimod shown biomarker?
terminated; "Due to poor accrual. This decision was taken without any safety reasons. Since beginning of the study (June 2011) only six patients were enrolled."
NCT01663558
withdrawn; "funding not available"
NCT01795313
terminated; "Closed supratentorial arm prematurely secondary to lack of enrollment"
NCT01902771
terminated; "Lack of Accrual"
NCT02329171
terminated; "Insufficient number of participants."
NCT02689726
terminated; "Lack of efficacy in European Phase 2 study"
NCT03760250
terminated; "Investigator decision"
NCT04809662
terminated; "PI failed to submit the study for continuing review to IRB, failed to respond."
recorded 2026-09-01 · last checked 2026-09-04
Q4
Human studies of Imiquimod used Aldara® (imiquimod) cream 5% — over how long?
20 recorded entries; human; topical; also "Aldara (imiquimod 5% cream)", "Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser", "Imiquimod, 5% cream"
Show the evidence
human
NCT00116649
Aldara® (imiquimod) cream 5%
NCT00335179
Aldara (imiquimod 5% cream)
NCT00585247
Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser
NCT00638651
Imiquimod, 5% cream
NCT00674739
topical; imiquimod 2.5% topical creram
NCT00674739
3.75% imiquimod cream
14 more recorded rows
humanNCT00674739
topical; 3.75% imiquimod topical cream
humanNCT00774787
imiquimod 5% cream
humanNCT00849992
Imiquimod 5%
humanNCT01059110
Aldara® 5%
humanNCT01161888
Aldara 5% cream
humanNCT01203878
Zyclara (imiquimod 3.75% cream)
humanNCT01686152
Imiquimod Cream, 3.75%
humanNCT01926496
Imiquimod Cream, 5%
humanNCT02242929
Imiquimod 5% cream with prior curettage
humanNCT02276300
Aldara 5% Crème
humanNCT03071679
Omiganan 1% and Imiquimod
humanNCT03071679
Omiganan 2.5% and Imiquimod
humanNCT03233412
Imiquimod 5% cream
humanNCT04808245
Imiquimod (5%)
recorded 2026-09-01 · last checked 2026-09-04
Q5
Could one person measure Imiquimod's effect on overall survival?
Overall survival: measured in Imiquimod's trials.
Interpretation overall survival is the recorded endpoint.
Show the evidence
biomarkers
overall survival; 2026-09-01
who experienced an adverse event; 2026-09-01
treatment emergent adverse events; 2026-09-01
efficacy; 2026-09-01
safety; 2026-09-01
adverse events; 2026-09-01
14 more recorded rows
biomarkers
recuurence rate 24 weeks after ablative therapy; 2026-09-01
biomarkers
gene expression profiling of treated lesions; 2026-09-01
biomarkers
elevated myxa; 2026-09-01
biomarkers
disease control rate; 2026-09-01
biomarkers
safety assessment; 2026-09-01
biomarkers
lesion count; 2026-09-01
biomarkers
objective response; 2026-09-01
biomarkers
related serious adverse events; 2026-09-01
biomarkers
maximum tolerated dose; 2026-09-01
biomarkers
dose limiting toxicity; 2026-09-01
biomarkers
seroconversion rate; 2026-09-01
biomarkers
unacceptable toxicity; 2026-09-01
biomarkers
adverse events as a measure of safety and tolerability; 2026-09-01
biomarkers
treatment related adverse events; 2026-09-01
half life
2026-09-04; halfLife; 2026-01-21
human trials at or under30
52
smallest human trial
0; NCT01663558; PHASE4; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN
Q6
Which of adverse events, adverse events as a measure of safety and tolerability and blood pressure did Imiquimod's trials measure?
adverse events, adverse events as a measure of safety and tolerability and blood pressure lead 40 outcome terms across Imiquimod's trials. ClinicalTrials.gov · 2026-09-01
efficacy, safety, adverse events, recuurence rate 24 weeks after ablative therapy, gene expression profiling of treated lesions and elevated myxa follow.
Show the evidence
overall survival
1
who experienced an adverse event
1
treatment emergent adverse events
1
efficacy
1
safety
1
adverse events
1
14 more recorded rows
recuurence rate 24 weeks after ablative therapy
1
gene expression profiling of treated lesions
1
elevated myxa
1
disease control rate
1
safety assessment
1
lesion count
1
objective response
1
related serious adverse events
1
maximum tolerated dose
1
dose limiting toxicity
1
seroconversion rate
1
unacceptable toxicity
1
adverse events as a measure of safety and tolerability
1
treatment related adverse events
1
recorded 2026-09-01 · last checked 2026-09-04
Q7
Which of Imiquimod's 8 ongoing trials reports first?
Proportion of enrolled patients for whom a personalized vaccine is developed and ready to administer (cohorts A and B); Frequency of patients experiencing treatment emergent adverse events as assessed by CTCAE v5.0; latest 2028-12-31
Show the evidence
Trial
NCT02600949
"Personalized Peptide Vaccine in Treating Patients With Advanced Pancreatic Cancer or Colorectal Cancer"; n 300; "Proportion of enrolled patients for whom a personalized vaccine is developed and ready to administer (cohorts A and B)"; 2027-05-31
NCT03872947
"A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors"; n 138; "Frequency of patients experiencing treatment emergent adverse events as assessed by CTCAE v5.0"; 2026-06
NCT04808245
"A MultIceNTER Phase I Peptide VaCcine Trial for the Treatment of H3-Mutated Gliomas"; n 15; "Assessment of safety of repeated fixed dose vaccinations with the H3K27M peptide vaccine administered with radiotherapy and Atezolizumab in patients with H3K27M-mutant gliomas. Primary safety endpoint is the Regime Limiting Toxicity (RLT)."; 2026-11
NCT05405270
"Predicting Response In Cervical Intraepithelial Neoplasia to Topical Imiquimod Treatment"; n 410; "Confirm association of 'hot signature' immune infiltrates in cHSIL with complete clinical responses to imiquimod"; 2026-12
NCT05838599
"Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides"; n 25; "Efficacy of a combination local radiotherapy and topical imiquimod approach for the treatment of conventional (CD4+) MF as measured by mSWAT at week 8."; 2027-12-01
NCT06305910
"CD200AR-L and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent HGG and Newly Diagnosed DMG/DIPG in Children and Young Adults"; n 24; "Maximum Tolerated Dose (MTD) of CD200AR-L"; 2027-01-15
2 further recorded trials
NCT06356012
"Clinical Outcome and Biomarkers for Predicting Immunological Response in Patients Treated with Imiquimod"; n 96; "Number of participants with histological regression of High-grade squamous intraepithelial lesion (HSIL)"; 2028-12-31
NCT07210775
"Topical Imiquimod Treatment of Oral Dysplasia"; n 20; "Effectiveness by Clinical Response"; 2027-10-01
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which 48 trials of Imiquimod posted no result?
Posted no result
48 of 48 completed trials
Registrations
NCT00335179, NCT00079300, NCT00204555, NCT00175643, NCT00189254 and NCT00314756, and 42 more
Completion dates
oldest 2003-07; newest 2024-06-21
Show the evidence
Trial
NCT00335179
2003-07
NCT00079300
2005-08
NCT00204555
2005-09
NCT00175643
2005-11
NCT00189254
2005-11
NCT00314756
2005-11
14 further recorded trials
NCT00257530
2006-06
NCT00118313
2006-07-28
NCT00294320
2007-01
NCT00189241
2007-02
NCT00189280
2007-10
NCT00189293
2007-12
NCT00031759
2010-02
NCT00066872
2010-04
NCT00941811
2010-05
NCT00941252
2011-01
NCT01212562
2011-08
NCT01161888
2012-03
NCT01171469
2012-06
NCT01264731
2012-06
Q9
At the median, Imiquimod's trials enrolled 48 people — anything larger?
Median enrolment
48
Largest enrolment
4446
Registered trials counted
117
Q10
What do 445 spontaneous reports say about Imiquimod — and not say?
These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.
Imiquimod appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 445 reaction mentions were counted: erythema 103; pain 59; influenza like illness 50; application site erythema 49. open-targets-adr · CHEMBL1282 · 2026-06-24
Show the evidence
erythema
103
pain
59
influenza like illness
50
application site erythema
49
scab
39
oedema
36
4 more recorded rows
chills
30
application site reaction
27
myalgia
27
erythema multiforme
25
recorded 2026-06-24 · last checked 2026-09-04
Q11
What is recorded about Imiquimod and sirtuin?
"Our results found that CAG alleviated autophagy inhibition in the imiquimod-induced psoriasis-like mouse model and enhanced autophagy by upregulating SIRT1 expression." — where Imiquimod and sirtuin appear together. Europe PMC · pathway abstract search · 2026-04-14
"Our results found that CAG alleviated autophagy inhibition in the imiquimod-induced psoriasis-like mouse model and enhanced autophagy by upregulating SIRT1 expression."
autophagyPMID 41329560
"Our results found that CAG alleviated autophagy inhibition in the imiquimod-induced psoriasis-like mouse model and enhanced autophagy by upregulating SIRT1 expression."
mTORPMID 40862458
"Furthermore, the inhibition of autophagy and AMPK-mTOR pathway could be reversed by trifolirhizin in M5-induced HaCaT keratinocytes and skin lesions from imiquimod-mediated psoriasis-like mouse model."
AMPKPMID 40862458
"Furthermore, the inhibition of autophagy and AMPK-mTOR pathway could be reversed by trifolirhizin in M5-induced HaCaT keratinocytes and skin lesions from imiquimod-mediated psoriasis-like mouse model."
autophagy
PMID 40862458
"Furthermore, the inhibition of autophagy and AMPK-mTOR pathway could be reversed by trifolirhizin in M5-induced HaCaT keratinocytes and skin lesions from imiquimod-mediated psoriasis-like mouse model."
PMID 41080153
"Subsequently, paeoniflorin activated autophagy and upregulated autophagy flux-related protein levels in mice with SLE induced by the TLR-7 agonist imiquimod."
mTORPMID 41080153
"Paeoniflorin plays a critical neuroprotective role as demonstrated in the TLR-7 agonist imiquimod-induced murine lupus model, mediated through activation of autophagic flux via modulation of the PI3K/AKT/mTOR signaling axis."
sirtuinPMID 41985670
"Afterward, the effects of SIRT7 on psoriasis were investigated utilizing an imiquimod-induced psoriasis-like mouse model with KRT5<sup>cre</sup>; SIRT7<sup>fl/fl</sup> and cellular models involving siRNA transfection or overexpression through plasmid."
mTORPMID 40483360
"KEY MESSAGES: • Exosomes from human placental mesenchymal stem sells demonstrate therapeutic potential against psoriasis. • MicroRNA-100-5p plays a crucial role in mediating the therapeutic effects of mesenchymal stem cells exosomes in an imiquimod-induced murine psoriasis model, potentially by modulating the mammalian target of rapamycin/S6 kinase 1 pathway."
NAD+PMID 35991005
"Therefore, in this study, we investigated the effect of NAD<sup>+</sup>/NADH ratio modulation on imiquimod (IMQ)-induced, psoriasis-like skin inflammation in mice."
sirtuinPMID 35991005
"Moreover, we found that an increase in the NAD<sup>+</sup>/NADH ratio by dunnione restored SIRT1 activity, thereby reduced imiquimod-induced STAT3 acetylation, which modulates the expression of psoriasis-promoting inflammatory cytokines, such as IL-17, IL-22, and IL-23."
NAD+PMID 35991005
"Moreover, we found that an increase in the NAD<sup>+</sup>/NADH ratio by dunnione restored SIRT1 activity, thereby reduced imiquimod-induced STAT3 acetylation, which modulates the expression of psoriasis-promoting inflammatory cytokines, such as IL-17, IL-22, and IL-23."
recorded 2026-04-14 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
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