This page shows what was measured, who it was measured in, and what that does not settle.
What Levoketoconazole does in the body
The fungus cannot finish its membrane and stops growing.
Fungal cell membranes are built from ergosterol, and one step in making it is done by an enzyme with an iron atom at its centre. Ketoconazole binds that iron and shuts the enzyme down. Human cells contain a family of enzymes built the same way — the ones that metabolise most medicines, and the ones that make cortisol and testosterone — and ketoconazole binds those too. On skin that barely matters. Swallowed, it is the whole story: it is why the tablets can cause liver failure and dangerous heart rhythms, and why the same molecule is now approved as a treatment for a hormone disease.
Why people take it. Dandruff and seborrhoeic dermatitis, and the pale or dark patches of tinea versicolor
What happened in people
Risk of failed clearance 31% lower than placebo at four weeks (RR 0.69, 95% CI 0.59 to 0.81) across eight trials
✎ 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.
Ketoconazole tablets United States prescribing information, boxed warning and Indications and Usage — ANDA 075912, retrieved from the openFDA label endpoint … · a recorded source, not a stored snapshot
RECORLEV (levoketoconazole) United States prescribing information, Indications and Usage with Limitations of Use, and boxed warning — NDA 214133 (https://api… · a recorded source, not a stored snapshot
The limit that matters most
That one topical antifungal in this class outperforms another — the pooled comparisons cannot separate them
Where it acts
The scalp and sebaceous skin, where Malassezia yeasts live in the oil, and the fungal cell membrane they build from ergosterol
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
Its recorded molecular formula is C26H28Cl2N4O4, weighing 531.43.
US prescribing information · a878a39d-6d26-4ede-9667-b3e201ffc337 · read 2026-08-30
Where each sentence above came from
A person wrote this explanation into the record, with the studies named in the path below.
The recorded use, written for a reader without medical training. Not signed off.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 149 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.
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.
Absolute difference
An absolute difference is how many more people in a hundred were affected.
A picture of it, and where the picture fails
It is like counting heads in two rooms of a hundred.
Where that stops being true. Heads are easy to count. Study results carry a margin of error too.
What people get wrong. It is confused with a percentage change, which can look far larger.
The arithmetic difference in event rates between arms.
Confidence interval
A confidence interval is the range the true answer is likely to sit in.
A picture of it, and where the picture fails
It is like a weather forecast giving a range rather than one number.
Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.
What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.
An interval estimate that would contain the true parameter in a stated proportion of repeated studies.
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.
Failed clearance of rash at four weeks against placebo or vehicle
✓ The study showed what it set out to show
Who was studied
Cochrane pooled ketoconazole 2% against placebo (CD008138)
How many people
3253
Study design
Systematic review and meta-analysis of randomised controlled trials
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
RR 0.69 (95% CI 0.59 to 0.81), eight studies, low-quality evidence, I² = 74%; median non-clearance in placebo groups 69%
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. Substantial heterogeneity between trials, 24 of the 51 trials in the review judged to carry a conflict of interest, and no study anywhere in the review assessed quality of life.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Topical shampoo, cream, gel and foam; oral tablets, restricted
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
Ketoconazole tablets United States prescribing information, boxed warning and Indications and Usage — ANDA 075912, retrieved from the openFDA label endpoint … · a recorded source, not a stored snapshot
RECORLEV (levoketoconazole) United States prescribing information, Indications and Usage with Limitations of Use, and boxed warning — NDA 214133 (https://api… · a recorded source, not a stored snapshot
openFDA Drugs@FDA record for NDA 214133 (RECORLEV levoketoconazole), original approval 30 December 2021, Strongbridge (https://api.fda.gov/drug/drugsfda.json… · a recorded source, not a stored snapshot
Remission rate and side effect occurrence against topical corticosteroids
✗ The study did not show it
Who was studied
Cochrane pooled ketoconazole against topical steroids (CD008138)
How many people
632
Study design
Pooled head-to-head comparison within the same systematic review
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Remission RR 1.17 (95% CI 0.95 to 1.44), six studies, low-quality evidence — no significant difference. Side effects RR 0.56 (95% CI 0.32 to 0.96), eight studies, moderate-quality evidence — 44% lower
Repeated elsewhere
Replicated
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 efficacy comparison is a draw. The result that survives is about tolerability, and it carries a higher certainty grade than the efficacy result does.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Topical shampoo, cream, gel and foam; oral tablets, restricted
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
Ketoconazole tablets United States prescribing information, boxed warning and Indications and Usage — ANDA 075912, retrieved from the openFDA label endpoint … · a recorded source, not a stored snapshot
RECORLEV (levoketoconazole) United States prescribing information, Indications and Usage with Limitations of Use, and boxed warning — NDA 214133 (https://api… · a recorded source, not a stored snapshot
openFDA Drugs@FDA record for NDA 214133 (RECORLEV levoketoconazole), original approval 30 December 2021, Strongbridge (https://api.fda.gov/drug/drugsfda.json… · a recorded source, not a stored snapshot
Remission failure rate, ketoconazole against ciclopirox
✗ The study did not show it
Who was studied
Cochrane pooled ketoconazole against ciclopirox (CD008138)
How many people
3029
Study design
Pooled head-to-head comparison within the same systematic review
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
RR 1.09 (95% CI 0.95 to 1.26), three studies, low-quality evidence
Repeated elsewhere
Partially Replicated
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. Most comparisons between ketoconazole and other antifungals rested on single studies. The review concludes that limited evidence suggests any agent in the class is more effective than any other.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Topical shampoo, cream, gel and foam; oral tablets, restricted
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
Ketoconazole tablets United States prescribing information, boxed warning and Indications and Usage — ANDA 075912, retrieved from the openFDA label endpoint … · a recorded source, not a stored snapshot
RECORLEV (levoketoconazole) United States prescribing information, Indications and Usage with Limitations of Use, and boxed warning — NDA 214133 (https://api… · a recorded source, not a stored snapshot
openFDA Drugs@FDA record for NDA 214133 (RECORLEV levoketoconazole), original approval 30 December 2021, Strongbridge (https://api.fda.gov/drug/drugsfda.json… · a recorded source, not a stored snapshot
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 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.10 registered measures of this kind.
■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.
Where a source records it acting
Skin: Recorded as treating tinea (pityriasis) versicolor, a non-contagious infection of the skin caused by Pityrosporum orbiculare (Malassezia furfur), an organism that is part of the normal skin flora
US prescribing information · 00c1cac8-a865-4583-aaba-3a0f21fb31e6 · read 2026-08-28
Start
Levoketoconazole
What a person takes: Topical shampoo, cream, gel and foam; oral tablets, restricted.
The measurement behind this step
The topical forms sit in the sebaceous reservoir where Malassezia lives, with minimal systemic absorption. Contact time differs by an order of magnitude between a shampoo and a leave-on cream, and the Cochrane review found the evidence insufficient to conclude that mode of delivery influences outcome. The oral tablets are a different risk category entirely and their label says so in its first sentence.
Getting in
Applied to skin or scalp, and mostly staying there
As a shampoo, cream or foam the drug sits in the oily layer where the yeast lives. Almost none of it reaches the bloodstream, which is why the topical products carry none of the tablet’s warnings.
╌╌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
Ketoconazole is lipophilic and accumulates in the sebaceous reservoir where Malassezia species reside. Systemic absorption from topical application is minimal, so the CYP3A4 and steroidogenic inhibition that dominates the oral drug’s safety profile does not arise.
Ketoconazole tablets United States prescribing information, boxed warning and Indications and Usage — ANDA 075912, retrieved from the openFDA label endpoint … · a recorded source, not a stored snapshot
RECORLEV (levoketoconazole) United States prescribing information, Indications and Usage with Limitations of Use, and boxed warning — NDA 214133 (https://api… · a recorded source, not a stored snapshot
What it acts on
The imidazole ring grabs an iron atom
At the centre of the target enzyme is a single iron atom. One nitrogen on the drug latches onto it and will not let go, which stops the enzyme working.
╌╌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
The imidazole nitrogen coordinates the heme iron of fungal lanosterol 14-alpha-demethylase (CYP51/ERG11), blocking oxygen activation at the catalytic centre. This is the binding mode of the entire azole class; the rest of each molecule determines where it goes, not what it does.
Ketoconazole tablets United States prescribing information, boxed warning and Indications and Usage — ANDA 075912, retrieved from the openFDA label endpoint … · a recorded source, not a stored snapshot
RECORLEV (levoketoconazole) United States prescribing information, Indications and Usage with Limitations of Use, and boxed warning — NDA 214133 (https://api… · a recorded source, not a stored snapshot
The change it makes
The fungus cannot finish its membrane
Without that step the fungus cannot convert its raw material into the sterol its membrane needs, and it stops growing.
╌╌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
Blocking 14-alpha-demethylation halts conversion of lanosterol to ergosterol and causes accumulation of 14-methylated sterol intermediates that disorder the membrane. The effect is largely fungistatic — a difference from terbinafine, which kills by a second mechanism.
Ketoconazole tablets United States prescribing information, boxed warning and Indications and Usage — ANDA 075912, retrieved from the openFDA label endpoint … · a recorded source, not a stored snapshot
RECORLEV (levoketoconazole) United States prescribing information, Indications and Usage with Limitations of Use, and boxed warning — NDA 214133 (https://api… · a recorded source, not a stored snapshot
Reaching the cell
The same chemistry works on human enzymes
Humans use enzymes built the same way to break down medicines and to make hormones. The drug binds those too. On skin this does not matter. Swallowed, it is the whole problem.
╌╌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
Ketoconazole is a potent CYP3A4 inhibitor and inhibits CYP17A1 and CYP11B1 in the adrenal steroid pathway. This produces the oral drug’s hepatotoxicity risk, its QT prolongation through raised concentrations of co-administered drugs, and — repurposed — the cortisol synthesis inhibition for which levoketoconazole was approved in 2021.
Ketoconazole tablets United States prescribing information, boxed warning and Indications and Usage — ANDA 075912, retrieved from the openFDA label endpoint … · a recorded source, not a stored snapshot
RECORLEV (levoketoconazole) United States prescribing information, Indications and Usage with Limitations of Use, and boxed warning — NDA 214133 (https://api… · a recorded source, not a stored snapshot
What that does for a person
The scale and redness settle
Fewer yeasts means less inflammation. About a third fewer people are left with unresolved rash than on a dummy shampoo, and it works about as well as a steroid with fewer side effects.
╌╌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
Against placebo, risk of failed clearance RR 0.69 (95% CI 0.59 to 0.81) at four weeks, eight studies, low-quality evidence, I² = 74%. Against topical steroids, remission RR 1.17 (95% CI 0.95 to 1.44) and side effects RR 0.56 (95% CI 0.32 to 0.96).
Ketoconazole tablets United States prescribing information, boxed warning and Indications and Usage — ANDA 075912, retrieved from the openFDA label endpoint … · a recorded source, not a stored snapshot
RECORLEV (levoketoconazole) United States prescribing information, Indications and Usage with Limitations of Use, and boxed warning — NDA 214133 (https://api… · a recorded source, not a stored snapshot
What that does for a person
What the endpoint does not measure
Forty-five of fifty-one trials stopped looking at five weeks or less. None of them measured whether patients felt better about their skin. And for tinea versicolor the label warns that clearing the yeast may not restore the colour.
╌╌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
No study in the 51-trial review assessed quality of life; one reported compliance; one measured maximum rash-free period and provided insufficient data to analyse. Twenty-four of the 51 trials were judged to carry some form of conflict of interest.
Ketoconazole tablets United States prescribing information, boxed warning and Indications and Usage — ANDA 075912, retrieved from the openFDA label endpoint … · a recorded source, not a stored snapshot
RECORLEV (levoketoconazole) United States prescribing information, Indications and Usage with Limitations of Use, and boxed warning — NDA 214133 (https://api… · a recorded source, not a stored snapshot
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 6 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 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.
plasma lapatinib levels
maximum plasma concentration
maximum observed plasma concentration
maximum concentration at steady state
time to maximum observed plasma concentration
apparent total plasma clearance
maximum measured concentration
maximum measured concentration of the analyte in plasma
pharmacokinetics area under the concentration time curve
pharmacokinetics maximum plasma concentration
Meaningful
Things that change how a life goes, not only a number.
overall survival from randomization
overall survival
phase 2 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 (27)
vary by protocol
time to progression
objective response rate for treatment arm
maximum tolerated dose of calcitriol
maximum tolerated dose
muscle protein synthesis
psa response rate
response
any adverse event
prostate specific antigen response
adverse events as a measure of safety and tolerability
lapatinib maximum tolerated dose
lapatinib dose limiting toxicity
pharmacokinetic parameters
cmax
auclast
incidence nature and severity of adverse events
tacrolimus bioavailability
tmax
overall response rate
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.
People with dandruff, seborrhoeic dermatitis or tinea versicolor use the shampoo, cream or foam. The tablets are now a last-resort drug for deep systemic fungal infection.
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 ketoconazole foam, 2% in pediatric patients less than 12 years of age have not been established.”
US prescribing information · a878a39d-6d26-4ede-9667-b3e201ffc337 · read 2026-08-30
On older people, the label states: “Clinical trials of ketoconazole foam, 2% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects.”
US prescribing information · a878a39d-6d26-4ede-9667-b3e201ffc337 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary There are no available data on ketoconazole foam, 2% use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.”
US prescribing information · a878a39d-6d26-4ede-9667-b3e201ffc337 · read 2026-08-30
On people who are breastfeeding, the label states: “8.3 Females and Males of Reproductive Potential Infertility In animal fertility studies in rats and dogs, administration of oral doses of ketoconazole between 3-day and 3-month periods resulted in infertility that was reversible [see Nonclinical Toxicology (13.1)] .”
US prescribing information · a878a39d-6d26-4ede-9667-b3e201ffc337 · read 2026-08-30
Where the result stopped carrying
Oral ketoconazole was de-indicated by its own boxed warning for onychomycosis, cutaneous dermatophyte infections and Candida infections
Serious hepatotoxicity with fatal outcome or requiring liver transplantation occurred in patients with no obvious risk factors
Nine drugs are contraindicated for co-administration because of QT prolongation through CYP3A4 inhibition
For tinea versicolor, the label states that treating the infection may not immediately normalise the pigment the patient came in about
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 shampoo, cream, gel and foam; oral tablets, restricted
✎ 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 topical forms sit in the sebaceous reservoir where Malassezia lives, with minimal systemic absorption.
✎ 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: Contact time differs by an order of magnitude between a shampoo and a leave-on cream, and the Cochrane review found the evidence insufficient to conclude that mode of delivery influences outcome. The oral tablets are a different risk category entirely and their label says so in its first sentence.
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
Topical use: local irritation, and side effects 44% less frequent than with topical corticosteroids in the pooled comparison, though the comparison against placebo was too uncertain to interpret. Oral use carries a boxed warning for serious hepatotoxicity including fatal cases and cases requiring liver transplantation, in some patients with no obvious risk factors, and for QT prolongation through CYP3A4 inhibition, with dofetilide, quinidine, pimozide, lurasidone, cisapride, methadone, disopyramide, dronedarone and ranolazine contraindicated for co-administration.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
Ketoconazole tablets United States prescribing information, boxed warning and Indications and Usage — ANDA 075912, retrieved from the openFDA label endpoint … · a recorded source, not a stored snapshot
RECORLEV (levoketoconazole) United States prescribing information, Indications and Usage with Limitations of Use, and boxed warning — NDA 214133 (https://api… · 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 shampoo, cream, gel and foam; oral tablets, restricted
✎ 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
A recorded note compares this form with the others that are sold. It is kept below, word for word.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
The recorded note, unchanged: Contact time differs by an order of magnitude between a shampoo and a leave-on cream, and the Cochrane review found the evidence insufficient to conclude that mode of delivery influences outcome. The oral tablets are a different risk category entirely and their label says so in its first sentence.
No source is stored against this line.
What is recorded as being sold
98 products list this as an active ingredient in the United States drug directory. 97 of them contain it and nothing else.
FDA National Drug Code directory · 87255-009 · read 2026-08-29
They are sold as aerosol, foam, cream, liquid, powder, shampoo and shampoo, suspension, taken cutaneous, oral and topical.
FDA National Drug Code directory · 87255-009 · read 2026-08-29
The regulator's established pharmacologic class for it is azole antifungal [epc], azoles [cs] and cytochrome p450 3a4 inhibitors [moa].
FDA National Drug Code directory · 87255-009 · read 2026-08-29
73 published labels name it as an active ingredient. 72 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 1d598696-c6f3-4b7c-ad73-949d2089df35 · read 2026-08-29
Those labels are classed as human otc drug and human prescription drug.
US prescribing information · 1d598696-c6f3-4b7c-ad73-949d2089df35 · read 2026-08-29
1 marketed supplement label lists this ingredient, classed as other combinations.
Those labels carry 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.
Ketoconazole is shampoo at 2%, recorded as recorded as a topical shampoo; fda label in effect 2026-01-29 (the fetched label states no prescription or over-the-counter framing) in the United States.
US prescribing information · 00c1cac8-a865-4583-aaba-3a0f21fb31e6 · read 2026-08-28
Recorded price in US: 0.07606 USD per one millilitre, across 6 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: 0.16285–5.69213 USD per one gram, across 19 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: 0.64846 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 6 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.
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 Levoketoconazole 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 one topical antifungal in this class outperforms another — the pooled comparisons cannot separate them
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 clearance of scale corresponds to a patient feeling better, an outcome no study in the 51-trial review measured
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 an oral azole with a broad historical spectrum is still a reasonable choice for skin or nail infection
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 the four-week trial horizon tells you anything about a relapsing lifelong condition, when 45 of 51 trials stopped at five weeks or less
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.
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 Levoketoconazole 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.
A 31% lower failure rate than placebo, on low-quality evidence
In plain words
Pooling eight trials, ketoconazole shampoo left about a third fewer people with unresolved rash than a dummy shampoo. The reviewers graded the evidence low quality, and the trials disagreed with each other substantially.
What was measured
Risk ratio for failed clearance of rash at four weeks against placebo, pooled across eight trials
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The 2015 Cochrane review included 51 studies with 9,052 participants, of which 45 assessed outcomes at five weeks or less. Topical ketoconazole 2% showed a 31% lower risk of failed clearance of rashes compared with placebo (RR 0.69, 95% CI 0.59 to 0.81; eight studies, low-quality evidence) at four weeks, with substantial heterogeneity between studies (I² = 74%). The median proportion who did not clear in the placebo groups was 69%. The effect on side effects against placebo was uncertain on very low-quality evidence (RR 0.97, 95% CI 0.58 to 1.64, six studies). The reviewers believe 24 of the 51 trials had some form of conflict of interest, such as pharmaceutical company funding.
Written into the record, not signed off as a reviewed claim
As good as a steroid, with 44% fewer side effects
In plain words
Head to head against topical steroids, remission rates were the same. Side effects were nearly half as common on the antifungal. That tolerability difference, not the clearance rate, is the strongest reason to choose it.
What was measured
Remission rate ratio and side effect rate ratio against topical corticosteroids, pooled
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Ketoconazole treatment resulted in a remission rate similar to that of steroids (RR 1.17, 95% CI 0.95 to 1.44; six studies, low-quality evidence), and occurrence of side effects was 44% lower in the ketoconazole group (RR 0.56, 95% CI 0.32 to 0.96; eight studies, moderate-quality evidence). The side effect comparison carries a higher certainty grade than the efficacy comparison, which is unusual and worth noticing: the better-supported claim about this drug is about what it does not do.
Written into the record, not signed off as a reviewed claim
Nothing in the class beats anything else, and nobody measured quality of life
In plain words
Ketoconazole, ciclopirox and the rest came out level with one another. Of fifty-one trials in nine thousand people, not one measured whether patients felt better. Only one recorded whether they used the treatment as intended.
What was measured
That one topical antifungal is better than another for seborrhoeic dermatitis, and that clearing scale is the same as the patient being better — neither was measured across 51 trials and 9,052 participants
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The reviewers’ conclusion is that ketoconazole and ciclopirox are more effective than placebo, but limited evidence suggests that either is more effective than any other agent within the same class. Ketoconazole yielded a similar remission failure rate to ciclopirox (RR 1.09, 95% CI 0.95 to 1.26, three studies, low-quality evidence), and most comparisons between ketoconazole and other antifungals rested on single studies showing comparability. Treatment effects on individual symptoms were less clear and inconsistent. Evidence was insufficient to conclude that dose or mode of delivery influenced outcome. Only one study reported on treatment compliance. No study assessed quality of life. One study assessed maximum rash-free period and provided insufficient data to analyse.
Written into the record, not signed off as a reviewed claim
The tablets were de-indicated for the infections that made them famous
In plain words
Ketoconazole was the first azole that could be swallowed, and it treated fungal nail and skin infections for two decades. Its label now opens by saying it is not indicated for any of those, and that it should only be used when nothing else works.
What was measured
That an early, broadly effective antifungal remains a reasonable oral option for skin and nail infection — its own label removes it from all three indications and confines it to deep mycoses of last resort
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The current oral ketoconazole label opens: "Because ketoconazole tablets have been associated with serious adverse reactions, ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections. Ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated." It records serious hepatotoxicity including cases with a fatal outcome or requiring liver transplantation, in some patients with no obvious risk factors. It contraindicates co-administration with dofetilide, quinidine, pimozide, lurasidone, cisapride, methadone, disopyramide, dronedarone and ranolazine because ketoconazole raises their plasma concentrations and may prolong the QT interval, sometimes causing torsades de pointes. The remaining indications are blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis and paracoccidioidomycosis in patients who have failed or cannot tolerate other therapies, and it is excluded from fungal meningitis because it penetrates cerebrospinal fluid poorly.
Source
Ketoconazole tablets United States prescribing information, boxed warning and Indications and Usage (ANDA 075912, openFDA label endpoint)
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 side effect became the indication, and the indication became a disclaimer
In plain words
Ketoconazole blocks the human enzymes that make cortisol — an unwanted effect for an antifungal. In 2021 half the molecule was approved as a treatment for a disease of too much cortisol, on a label that states it is not approved for fungal infections.
What was measured
That off-target activity is a defect — here the off-target inhibition of human steroidogenic cytochromes outlived the on-target antifungal indication and became a separately approved medicine
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Levoketoconazole, the 2S,4R enantiomer of ketoconazole, was approved as Recorlev under NDA 214133 on 30 December 2021 for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative. Its Limitations of Use state: "RECORLEV is not approved for the treatment of fungal infections. The safety and effectiveness of RECORLEV for the treatment of fungal infections have not been established." It is described in its own label as a cortisol synthesis inhibitor. It carries the same boxed warning for hepatotoxicity and QT prolongation as the racemic antifungal, with contraindications in cirrhosis, acute or poorly controlled chronic liver disease, recurrent symptomatic cholelithiasis, prior azole-induced liver injury requiring discontinuation, and extensive metastatic liver disease.
Source
RECORLEV (levoketoconazole) United States prescribing information, Indications and Usage and boxed warning (NDA 214133, approved 30 December 2021)
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
Curing the infection does not fix what the patient came in about
In plain words
Tinea versicolor shows up as pale or dark patches. The shampoo label says, in the Indications section itself, that treating the infection may not immediately normalise the colour of the skin.
What was measured
Regulatory label text — clearance of the organism stated not to imply resolution of the visible sign
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
The ketoconazole shampoo 2% label states the indication as treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by Pityrosporum orbiculare, also known as Malassezia furfur, and then adds: "Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. Treatment of the infection may not immediately result in normalization of pigment to the affected sites." The measured endpoint is mycological, the presenting complaint is cosmetic, and the label is unusually explicit that the two come apart — the same structure as terbinafine’s 70% mycological cure against 38% normal nails.
Source
Ketoconazole shampoo 2% United States prescribing information, Indications and Usage, as held on the record
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
How many documents were read
59 documents were read for this substance.
RNAWiki source record
12 of them state the same halfLife, and they agree.
RNAWiki source record
12 of them state the same bioavailability, and they agree.
RNAWiki source record
12 of them state the same tMax, and they agree.
RNAWiki source record
12 of them state the same proteinBinding, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
R9400W927I
CAS registry number
65277-42-1
PubChem compound
47576
RxNorm concept
6135
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 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
28 approved applications cover products containing this substance. The earliest was NDA018533, approved 19810612 to JANSSEN PHARMS.
This order is fixed in code and does not count clicks or time on the page.
What is not here
5 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.
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.
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 imidazole that blocks the fungal enzyme converting lanosterol into ergosterol, and blocks the structurally similar human enzymes too — a 31% lower risk of failed clearance in seborrhoeic dermatitis against placebo across eight trials, indistinguishable from a topical steroid but with 44% fewer side effects, and carrying a boxed warning that removes the tablets from every infection they were famous for treating.
Recorded evidence blocks (9)
Q2
What did Levoketoconazole's largest trial (1126 people) and its longest (17 years) measure?
1126 people in Levoketoconazole's largest registered study, 17 years in its longest registered window, measuring Plasma levels will be measured for casopitant at Period 1: Day 1, 2 & 3. ClinicalTrials.gov · 2026-09-01
79 phase1, 30 phase2, 17 phase3, 7 early phase1, 6 na, 3 phase4, 1 na or unstated; NCT00859781; 2026-09; no ageing endpoint recorded. Last human test completed 2024, NCT03471364.
Interpretation These counts include studies where Levoketoconazole 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
79
phase2
30
phase3
17
early phase1
7
na
6
phase4
3
2 more recorded rows
na or unstated
1
Last recorded human testNCT03471364
2024-09-15
recorded 2026-09-01 · last checked 2026-09-04
Q3
Levoketoconazole was tested only in human — what did it show?
terminated; "At the request of the study site, this study has been closed and access to study-related data is unavailable. We are unable to submit the results-data."
NCT00953576
terminated; "The study terminated early due to concerns about drug toxicity."
NCT01110330
terminated; "Unexpected discordant results between the KOH microscopy and mycological culture tests at three study sites in the UK."
NCT01535157
terminated; "drug combination not providing any efficacy. Will use this data in opening new trial"
NCT01584297
terminated; "Insufficient recruitment rate"
NCT02147964
withdrawn; "No funding was obtained for this study."
terminated; "Enrollment was stopped due to direction from the scientific review committee of the Penn State Cancer Institute. The instruction came due to slow accrual."
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Levoketoconazole used Ketoconazole (NIZORAL) oral tablets (200 mg) — over how long?
Which of adverse events as a measure of safety and tolerability, any adverse event and apparent total plasma clearance did Levoketoconazole's trials measure?
adverse events as a measure of safety and tolerability, any adverse event and apparent total plasma clearance lead 40 outcome terms across Levoketoconazole's trials. ClinicalTrials.gov · 2026-09-01
Interpretation overall survival from randomization, overall survival, maximum tolerated dose of calcitriol, maximum tolerated dose, muscle protein synthesis and psa response rate follow.
Show the evidence
vary by protocol
1
time to progression
1
objective response rate for treatment arm
1
overall survival from randomization
1
overall survival
1
maximum tolerated dose of calcitriol
1
14 more recorded rows
maximum tolerated dose
1
muscle protein synthesis
1
psa response rate
1
response
1
any adverse event
1
prostate specific antigen response
1
adverse events as a measure of safety and tolerability
1
lapatinib maximum tolerated dose
1
lapatinib dose limiting toxicity
1
plasma lapatinib levels
1
pharmacokinetic parameters
1
maximum plasma concentration
1
maximum observed plasma concentration
1
maximum concentration at steady state
1
recorded 2026-09-01 · last checked 2026-09-04
Q7
Which of Levoketoconazole's 7 ongoing trials reports first?
Proportion of Participants Free of Radiographically Evident Metastases From Baseline to 18 Months After Study Drug Administration; Average Blood Cortisol Concentration; latest 2027-12-31
Show the evidence
Trial
NCT00859781
"177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer"; n 55; "Proportion of Participants Free of Radiographically Evident Metastases From Baseline to 18 Months After Study Drug Administration"; 2026-09
NCT03142893
"Hormonal Mechanisms of Sleep Restriction - Axis Study"; n 80; "Average Blood Cortisol Concentration"; 2026-06-30
NCT03437005
"Alternation in the Human Microbiome With Commonly Used Topical Medications"; n 24; "Number of bacteria per each species"; 2026-09-28
NCT03763396
"Azoles Targeting Recurrent High Grade Gliomas"; n 30; "Intratumoral concentrations of KCZ or PCZ"; 2027-06
NCT07585851
"Administration of Repurposed Ketoconazole in Glioma Patients"; n 80; "Difference in Ketoconazole Concentrations Between Tumor Tissue and Plasma in Primary All-Grade Gliomas"; 2026-08
NCT07649317
"Ketoconazole Effects on the Daily Cortisol Rhythm in Mild Autonomous Cortisol Secretion"; n 36; "To assess the circadian rhythm of serum cortisol in participants with MACS compared to that in matched healthy volunteers (HV)."; 2027-12-31
1 further recorded trialNCT07734441
"The Effectiveness of Itraconazole Pulse Therapy vs Topical 2% Ketoconazole in the Treatment of Moderate to Severe Seborrheic Dermatitis of Scalp."; n 80; "Change in Seborrheic Dermatitis Severity Score from Baseline"; 2026-09-07
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which 63 trials of Levoketoconazole posted no result?
Posted no result
63 of 63 completed trials
Registrations
NCT00003084, NCT00000579, NCT00030654, NCT00002855, NCT00096317 and NCT00384917, and 57 more
Completion dates
oldest 2002-11; newest 2023-10
Show the evidence
Trial
NCT00003084
2002-11
NCT00000579
2004-07
NCT00030654
2005-02-04
NCT00002855
2005-06
NCT00096317
2005-12-05
NCT00384917
2006-09
14 further recorded trials
NCT01476800
2006-11
NCT00404378
2007-01-05
NCT00392457
2007-02
NCT00468689
2007-08
NCT00460707
2007-08-27
NCT00411866
2007-10-10
NCT00309894
2007-12
NCT00211393
2008-04
NCT00707551
2008-11
NCT00708591
2008-12
NCT00770042
2008-12
NCT00812344
2009-03
NCT00002760
2009-04
NCT00860275
2009-06
Q9
At the median, Levoketoconazole's trials enrolled 28 people — anything larger?
Median enrolment
28
Largest enrolment
1126
Registered trials counted
131
Q10
Levoketoconazole and CYP3A4, P-GP and CYP1A2: shared by which compounds?
CYP3A4, P-GP and CYP1A2 appear in Levoketoconazole's recorded interaction sentences, 7 in all. openfda-label+europepmc · 2026-08-30
Interpretation clinical_pharmacology
Show the evidence
CYP1A2clinical_pharmacology
Levoketoconazole does not inhibit CYP1A2, CYP2C9, CYP2C19, or CYP2D6, does not induce CYP2B6, and does not inhibit the OATP1B3, OAT1, OAT3, or MATE2-K transporters.
CYP2B6clinical_pharmacology
Levoketoconazole does not inhibit CYP1A2, CYP2C9, CYP2C19, or CYP2D6, does not induce CYP2B6, and does not inhibit the OATP1B3, OAT1, OAT3, or MATE2-K transporters.
CYP2C19clinical_pharmacology
Levoketoconazole does not inhibit CYP1A2, CYP2C9, CYP2C19, or CYP2D6, does not induce CYP2B6, and does not inhibit the OATP1B3, OAT1, OAT3, or MATE2-K transporters.
CYP2C9clinical_pharmacology
Levoketoconazole does not inhibit CYP1A2, CYP2C9, CYP2C19, or CYP2D6, does not induce CYP2B6, and does not inhibit the OATP1B3, OAT1, OAT3, or MATE2-K transporters.
CYP2D6clinical_pharmacology
Levoketoconazole does not inhibit CYP1A2, CYP2C9, CYP2C19, or CYP2D6, does not induce CYP2B6, and does not inhibit the OATP1B3, OAT1, OAT3, or MATE2-K transporters.
CYP3A4
clinical_pharmacology
CYP3A4 is the major enzyme involved in the metabolism of ketoconazole.
clinical_pharmacology
Drug Interaction Studies Levoketoconazole is a strong CYP3A4 inhibitor, as well as an inhibitor of the drug transporters P-gp, OCT2, and MATE1 in vivo.
recorded 2026-08-30 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ChEMBL ATC CC BY-SA · 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 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
✗ 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: 7 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
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.