This page shows what was measured, who it was measured in, and what that does not settle.
What Itraconazole does in the body
The following fungal infections in immunocompromised and non-immunocompromised patients
From the FDA-approved label: In vitro studies have demonstrated that itraconazole inhibits the cytochrome P450-dependent synthesis of ergosterol, which is a vital component of fungal cell membranes.
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
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · 304NUG5GF4 · read 2026-08-29
Its recorded molecular formula is C35H38Cl2N8O4, weighing 705.64.
US prescribing information · 306352d1-9d5a-49ad-b72d-893b99546861 · 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 49 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.
Biomarker
A biomarker is a number from a test that stands in for something about health.
A picture of it, and where the picture fails
A biomarker is like a fuel gauge.
Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.
What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.
A measurable indicator used as a substitute for a clinical outcome of interest.
Placebo
A placebo is a dummy treatment given so the real one can be compared with it.
A picture of it, and where the picture fails
A placebo is like a blank control in an experiment.
Where that stops being true. A blank does nothing. People given a placebo often do get better.
What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.
An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
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.
Incidence of corneal ulceration in the two study arms as measured by corneal photography
✗ The study did not show it
Who was studied
NCT01969786
How many people
223671
Study design
Not applicable
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. Oral
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
Parts 1 and 2 - All cohorts except Cohort 1F - Occurrence of treatment emergent adverse events (TEAEs), treatment related adverse events (TRAEs), treatment emergent serious adverse events (TESAEs), and treatment related serious adverse events (TRSAEs)
✗ The study did not show it
Who was studied
NCT07070232
How many people
1438
Study design
Phase 1/Phase 2
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. Oral
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
Clinical and Mycological Cure of Target Toenail
✗ The study did not show it
Who was studied
NCT00356915
How many people
1381
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. Oral
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
Measures of muscle wasting, weakness, immunosuppression chronic bone loss and decreased growth with increases in metabolic, hemodynamic, inflammatory and scarring responses.
✗ The study did not show it
Who was studied
NCT00675714
How many people
1126
Study design
Phase 2/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. Oral
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
Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Percentage of participants in Part 1 with DLTs
✗ The study did not show it
Who was studied
NCT05914116
How many people
862
Study design
Phase 1/Phase 2
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. Oral
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
Dose limiting toxicities (DLTs) (Phase 1)
✗ The study did not show it
Who was studied
NCT05384626
How many people
840
Study design
Phase 1/Phase 2
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. Oral
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 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.
& USAGE Itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: 1. Blastomycosis, pulmonary and extrapulmonary 2. Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and 3.
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: “Safety and effectiveness in pediatric patients have not been established.”
US prescribing information · 306352d1-9d5a-49ad-b72d-893b99546861 · read 2026-08-30
On older people, the label states: “Clinical studies of itraconazole did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects.”
US prescribing information · 306352d1-9d5a-49ad-b72d-893b99546861 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary There are no data on exposure to itraconazole during pregnancy for the approved indications.”
US prescribing information · 306352d1-9d5a-49ad-b72d-893b99546861 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary Itraconazole is excreted in human milk; however, there are no data on the amount of itraconazole in human milk, the effects on the breastfed child, or the effects on milk production.”
US prescribing information · 306352d1-9d5a-49ad-b72d-893b99546861 · read 2026-08-30
On people with reduced liver function, the label states: “Limited data are available on the use of oral itraconazole in patients with hepatic impairment.”
US prescribing information · 306352d1-9d5a-49ad-b72d-893b99546861 · read 2026-08-30
On people with reduced kidney function, the label states: “Limited data are available on the use of oral itraconazole in patients with renal impairment.”
US prescribing information · 306352d1-9d5a-49ad-b72d-893b99546861 · 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 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 (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
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
Oral
✎ 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
Sold as capsule, solution, tablet, injectable, given by the oral, injection 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.
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
Oral
✎ 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
36 products list this as an active ingredient in the United States drug directory. 36 of them contain it and nothing else.
FDA National Drug Code directory · 22568-1108 · read 2026-08-29
They are sold as capsule, capsule, coated pellets, capsule, gelatin coated, pellet, powder and solution, taken oral.
FDA National Drug Code directory · 22568-1108 · read 2026-08-29
The regulator's established pharmacologic class for it is azole antifungal [epc], azoles [cs] and breast cancer resistance protein inhibitors [moa].
FDA National Drug Code directory · 22568-1108 · read 2026-08-29
15 published labels name it as an active ingredient. 15 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 6df5ff94-47ba-4881-abb4-b321e35a6955 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 6df5ff94-47ba-4881-abb4-b321e35a6955 · read 2026-08-29
Tolsura is oral at 3 DOSAGE FORMS AND STRENGTHS TOLSURA (itraconazole capsules) is available in a size 1, hard gelatin capsules with light blue cap and white body, imprinted with "i-65" in black on the cap and containing 65 mg of itracona…, recorded as fda label in effect 2025-04-23 in the United States.
US prescribing information · 306352d1-9d5a-49ad-b72d-893b99546861 · read 2026-08-30
Recorded price in US: 0.90289 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 12 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: 1.12534 USD per one millilitre, 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.
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 Itraconazole 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 Itraconazole 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
15 documents were read for this substance.
RNAWiki source record
14 of them state the same bioavailability, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
304NUG5GF4
RxNorm concept
311204
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
20 approved applications cover products containing this substance. The earliest was NDA020083, approved 19920911 to JANSSEN PHARMS.
This order is fixed in code and does not count clicks or time on the page.
What is not here
9 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 close this is to real life — found nothing in the sources checked.
The path through the body — found nothing in the sources checked.
Felt, measured, or meaningful — 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 (8)
Q2
On the Itraconazole label: indicated for what?
"Itraconazole oral solution is indicated for the treatment of oropharyngeal and esophageal candidiasis. (see CLINICAL PHARMACOLOGY: Special Populations , WARNINGS , and ADVERSE REACTIONS: Postmarketing Experience for more information).": indications and usage on Itraconazole's label. DailyMed label · 43ded1aa-f825-40fe-aa9a-addd36a07f06 · 2026-08-03
Q3
423 registered trials of Itraconazole — at which phases?
Registered studies posting no result
345 of 423
423 registered studies of Itraconazole: 333 phase1, 41 phase2, 20 na, 19 phase3, 16 phase4, 7 early phase1, 6 na or unstated. CLINICALTRIALS_SNAPSHOT · 2026-09-01
760 with a PubMed record
Show the evidence
phase1
333
phase2
41
na
20
phase3
19
phase4
16
early phase1
7
9 more recorded rows
na or unstated
6
completed
329
recruiting
30
terminated
20
unknown
20
not yet recruiting
11
withdrawn
7
active not recruiting
5
enrolling by invitation
1
recorded 2026-09-01 · last checked 2026-09-04
Q4
24 of Itraconazole's trials stopped: safety, futility/efficacy, accrual/recruitment, funding/business, other?
safety (2), futility/efficacy (1), accrual/recruitment (4), funding/business (7) and other (10): Itraconazole's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01
"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."; 24 of 423 registered studies
Show the evidence
Trial
NCT00675714
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."
NCT00769600
terminated; "Low accrual."
NCT01282879
terminated; "In interim analysis, this study met the primary hypothesis."
NCT01450683
terminated; "Low accrual"
NCT02054793
withdrawn; "This study was never able to open due to lack of funding from the pharmaceutical company."
NCT02285283
terminated; "Recruitment failure."
14 further recorded trials
NCT02675452
terminated; "sponsor decision, unrelated to safety"
NCT02699723
withdrawn; "Logistics"
NCT02875223
terminated; "Business objectives have changed"
NCT02895529
terminated; "Study is a commitment for license renew, we target on Apr19 submission, considering timeline, a cut off should be scheduled in Apr18."
NCT03119077
terminated; "Study early terminated due to lower drug exposure"
NCT03923010
terminated; "Further recruitment not possible due to COVID 19 impact. Hence a decision to close study was taken by the sponsor in Aug 2020"
NCT04014361
terminated; "HUAA study is terminated early due to a business decision."
NCT04312282
terminated; "The Sponsor has discontinued the development of tesetaxel"
NCT04464577
withdrawn; "Business objectives have changed."
NCT04586920
terminated; "Terminated due to safety findings"
NCT04652050
withdrawn; "Patients are not interested to participate"
NCT04809649
withdrawn; "Sponsor is not proceeding with study due to budget cuts as a result of COVID-19."
NCT04959266
terminated; "The study terminated because the clinical development programme for Adavosertib has been discontinued"
NCT05205447
terminated; "Data from part 2 no longer deemed necessary for this program."
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Itraconazole used Itraconazole 100mg capsules — over how long?
studies of Itraconazole used the recorded amount. ClinicalTrials.gov · 2026-09-01
18 recorded entries; human; also "Itraconazole 100mg capsules", "Itraconazole 200mg tablets", "itraconazole 50 mg capsules"
Show the evidence
human
NCT00356915
Itraconazole 100mg capsules
NCT00356915
Itraconazole 200mg tablets
NCT00791219
itraconazole 50 mg capsules
NCT00887458
Itraconazole 200 mg
NCT00887458
Itraconazole 300mg
NCT02085967
itraconazole 200 mg
12 more recorded rows
humanNCT02122692
Lu AE58054 30 mg + itraconazole 200 mg
humanNCT02493738
Sporanox 100mg
humanNCT03103646
Itraconazole (200 mg)
humanNCT03103646
Itraconazole (300 mg)
humanNCT03259542
Itraconazole 100 MG
humanNCT03264079
Itraconazole capsules 100 mg
humanNCT03340220
Itraconazole 400mg
humanNCT03821493
Itraconazole Solution 200 mg
humanNCT03920527
Itraconazole 400 mg
humanNCT05549531
Itraconazole (200 mg, o.d.)
humanNCT06160713
Itraconazole 65 MG
humanNCT06644326
200 mg Itraconazole
recorded 2026-09-01 · last checked 2026-09-04
Q6
Itraconazole's half-life is 16 to 28 hours — which schedules were studied?
16 to 28 hours, the half-life Itraconazole's label states: "The terminal half-life of itraconazole generally ranges from 16 to 28 hours after single dose and increases to 34 to 42 hours with repeated dosing." DailyMed label · 43ded1aa-f825-40fe-aa9a-addd36a07f06 · 2026-08-03
tmax 2.5 hours; bioavailability 55 %.
Show the evidence
half lifepharmacokinetics
16 to 28 hours; The terminal half-life of itraconazole generally ranges from 16 to 28 hours after single dose and increases to 34 to 42 hours with repeated dosing.
tmaxpharmacokinetics
2.5 hours; and Metabolism: Itraconazole General Pharmacokinetic Characteristics Peak plasma concentrations are reached within 2.5 hours following administration of the oral solution.
bioavailabilitypharmacokinetics
55 %; The observed absolute bioavailability of itraconazole under fed conditions is about 55% and increases by 30% when the oral solution is taken in fasting conditions.
metabolismpharmacokinetics
and Metabolism: Itraconazole General Pharmacokinetic Characteristics Peak plasma concentrations are reached within 2.5 hours following administration of the oral solution.
recorded 2026-08-03 · last checked 2026-09-04
Q7
Which 206 trials of Itraconazole posted no result?
Posted no result
206 of 206 completed trials
Registrations
NCT00000992, NCT00000975, NCT00000639, NCT00001280, NCT00012467 and NCT00003883, and 200 more
Completion dates
oldest 1992-06; newest 2024-08-29
Show the evidence
Trial
NCT00000992
1992-06
NCT00000975
1994-09
NCT00000639
1997-09
NCT00001280
2001-03
NCT00012467
2001-07
NCT00003883
2002-07
14 further recorded trials
NCT00005668
2005-11
NCT00695071
2008-07
NCT00336531
2008-10
NCT00805090
2009-04
NCT00794703
2009-11
NCT01198236
2010-11
NCT01706562
2011-09
NCT01259336
2011-12
NCT01409018
2011-12
NCT01913379
2011-12
NCT01772290
2013-05
NCT01814709
2013-08
NCT00588016
2013-12
NCT01967979
2013-12
Q8
At the median, Itraconazole's trials enrolled 32 people — anything larger?
Median enrolment
32
Largest enrolment
40110
Registered trials counted
418
Q9
Itraconazole and CYP3A4, CYP2D6 and BCRP: shared by which compounds?
: Co-administration of a number of CYP3A4 substrates are contraindicated with itraconazole.
drug_interactions
In addition, co-administration with colchicine, fesoterodine, and solifenacin is contraindicated in subjects with varying degrees of renal or hepatic impairment, and co-administration with eliglustat is contraindicated in subjects that are poor or intermediate metabolizers of CYP2D6 and in subjects taking strong or moderate CYP2D6 inhibitors (see PRECAUTIONS: Drug Interactions Section for…
drug_interactions
Drug Interactions: Effect of Itraconazole on Other Drugs Itraconazole and its major metabolite, hydroxy-itraconazole, are potent CYP3A4 inhibitors.
drug_interactions
Itraconazole is an inhibitor of the drug transporters P-glycoprotein and breast cancer resistance protein (BCRP).
drug_interactions
Eliglustat CYP2D6 EMs c taking a strong or moderate CYP2D6 inhibitor, CYP2D6 IMs c , or CYP2D6 PMs c : Contraindicated during and 2 weeks after itraconazole treatment.
drug_interactions
CYP2D6 EMs c not taking a strong or moderate CYP2D6 inhibitor : Monitor for adverse reactions.
2 more recorded rows
Interaction statementdrug_interactions
Nonsteroidal Anti-Inflammatory Drugs Meloxicam a Concomitant drug dose increase may be necessary. * CYP3A4 inhibitors (including itraconazole) may increase systemic contraceptive hormone concentrations. a Based on clinical drug interaction information with itraconazole. b Based on 400 mg bedaquiline once daily for 2 weeks. c EMs: extensive metabolizers;
Interaction statementdrug_interactions
IMs: intermediate metabolizers, PMs: poor metabolizers Effect of Other Drugs on Itraconazole Itraconazole is mainly metabolized through CYP3A4.
ClinicalTrials.gov — US Government work · 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: 6 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.