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Posaconazole

  • Prescription medicine
  • Prescription only
  • Identity checked
  • Sources last checked 2026-09-04

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

What Posaconazole does in the body

Invasive Aspergillus and Candida infections

4) ] . Mechanism of Action Posaconazole blocks the synthesis of ergosterol, a key component of the fungal cell membrane, through the inhibition of cytochrome P-450 dependent enzyme lanosterol 14α-demethylase responsible for the conversion of lanosterol to ergosterol in the fungal cell membrane. This results in an accumulation of methylated sterol precursors and a depletion of ergosterol within the cell membrane thus weakening the structure and function of the fungal cell membrane. This may be responsible for the antifungal activity of posaconazole.

What happened in people

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

A fixed RNAWiki sentence

Where this came from

Wording RNAWiki always uses, not a finding about this substance.

No reviewed claim names a result for any goal on this record.

No source is stored against this line.

The limit that matters most

Not recorded.

Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.

What the registries record it as

  • The substance registry classes this as chemical.

    FDA substance registry · 6TK1G07BHZ · read 2026-08-29

  • Its recorded molecular formula is C37H42F2N8O4, weighing 700.79.

    US prescribing information · c551e121-d5fc-4b35-ba9f-72ce3a314fdc · 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 98 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 peopleRead from sources, not yet reviewed

What happened in people

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

Proportion of patients for whom molecular, immunophenotypic, and/or biochemical studies are completed in < 7 calendar days for assignment of treatment

The study did not show it

Who was studied
NCT03013998
How many people
3000
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

Mortality at 2 weeks

The study did not show it

Who was studied
NCT07261150
How many people
664
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. 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

Number of patients with adverse events and serious adverse events in Phase 1

The study did not show it

Who was studied
NCT04988555
How many people
606
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

Noninferior Fungal-Free Survival (US FDA)

The study did not show it

Who was studied
NCT04368559
How many people
602
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. 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

Prophylaxis Trial of Posaconazole Versus Standard Azole Therapy for Neutropenic Patients (Study P01899)

The study did not show it

Who was studied
NCT00044486
How many people
602
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

Prophylaxis Trial in High Risk Allogenic Stem Cell Transplant Recipients With Graft vs. Host Disease

The study did not show it

Who was studied
NCT00034645
How many people
600
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
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 unclearRead from sources, not yet reviewed

Were people like you studied?

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

Who was studied

People similar to this profile were included.

  • Posaconazole is an azole antifungal indicated as follows: Posaconazole is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus- host disease (GVHD) or those with hematologic malignancies with prolonged…

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 posaconazole have not been established in pediatric patients younger than 2 years of age.”

    US prescribing information · c551e121-d5fc-4b35-ba9f-72ce3a314fdc · read 2026-08-30

  • On older people, the label states: “No overall differences in the safety of posaconazole injection was observed between geriatric patients and younger adult patients in the clinical trials; therefore, no dosage adjustment is recommended for any formulation of posaconazole in geriatric patients.”

    US prescribing information · c551e121-d5fc-4b35-ba9f-72ce3a314fdc · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Based on findings from animal data, posaconazole may cause fetal harm when administered to pregnant women.”

    US prescribing information · c551e121-d5fc-4b35-ba9f-72ce3a314fdc · read 2026-08-30

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

    US prescribing information · c551e121-d5fc-4b35-ba9f-72ce3a314fdc · read 2026-08-30

  • On people with reduced liver function, the label states: “It is recommended that no dose adjustment of posaconazole injection is needed in patients with mild to severe hepatic impairment (Child-Pugh Class A, B, or C) [see Dosage and Administration (2) and Warnings and Precautions (5.5) ] .”

    US prescribing information · c551e121-d5fc-4b35-ba9f-72ce3a314fdc · read 2026-08-30

  • On people with reduced kidney function, the label states: “Posaconazole injection should be avoided in patients with moderate or severe renal impairment (eGFR <50 mL/min), unless an assessment of the benefit/risk to the patient justifies the use of posaconazole injection.”

    US prescribing information · c551e121-d5fc-4b35-ba9f-72ce3a314fdc · 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 takeRead from sources, not yet reviewed

Why it might seem to do nothing

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

It was studied 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 takeRead from sources, not yet reviewed

What taking it involves

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

How it is supplied

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

RNAWiki has not recorded a supervision or regulatory status for this substance.

Quoted from a source

Where this came from

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

No register row and no identity class settled the question.

No source is stored against this line.

What is in the pack

Sold as tablet, delayed release, solution, for suspension, delayed release, injection, given by the oral, intravenous, solution 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 takeNothing 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 unclearRead from sources, not yet reviewed

Does the exact form matter?

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

The form that was studied

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

  • 62 products list this as an active ingredient in the United States drug directory. 62 of them contain it and nothing else.

    FDA National Drug Code directory · 14501-0067 · read 2026-08-29

  • They are sold as granule, injection, injection, solution, powder, powder, for suspension and solution, taken intravenous and oral.

    FDA National Drug Code directory · 14501-0067 · read 2026-08-29

  • The regulator's established pharmacologic class for it is azole antifungal [epc] and azoles [cs].

    FDA National Drug Code directory · 14501-0067 · read 2026-08-29

  • 33 published labels name it as an active ingredient. 33 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · c551e121-d5fc-4b35-ba9f-72ce3a314fdc · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · c551e121-d5fc-4b35-ba9f-72ce3a314fdc · read 2026-08-29

  • POSACONAZOLE is intravenous at 3 DOSAGE FORMS AND STRENGTHS Posaconazole injection Posaconazole injection (300 mg per vial) is available as a clear, colorless to yellow sterile liquid in a single-dose vial. • Posaconazole injection : 300 mg per vial…, recorded as fda label in effect 2025-01-31 in the United States.

    US prescribing information · c551e121-d5fc-4b35-ba9f-72ce3a314fdc · read 2026-08-30

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

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

What you could measure

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

RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.

Questions worth asking

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

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

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

What is missing or unclearRead from sources, not yet reviewed

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 Posaconazole are recorded. Results from one form may not transfer to another.

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

What would answer it

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

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

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

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

What would answer it

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

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

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

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

How many documents were read

  • 32 documents were read for this substance.

    RNAWiki source record

  • 23 of them state the same bioavailability, and they agree.

    RNAWiki source record

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

    RNAWiki source record

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

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
6TK1G07BHZ
RxNorm concept
1492043

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

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

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Not passed

    Safety mode resolved

    No register row and no identity class settled the question.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

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

What the approval register records

  • 27 approved applications cover products containing this substance. The earliest was NDA022003, approved 20060915 to SCHERING.

    Drugs@FDA application register · NDA022003 · read 2026-08-29

  • Marketing status on the register: discontinued, none (tentative approval) and prescription.

    Drugs@FDA application register · NDA022003 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20060915.

    FDA National Drug Code directory · 14501-0067 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

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

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

What is not here

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 (11)

On the Posaconazole label: indicated for what?


"Posaconazole is an azole antifungal indicated as follows: Posaconazole delayed-release tablets are indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell…": indications and usage on Posaconazole's label. DailyMed label · f8a26673-261c-4e8e-b1e1-9e23aaf7f285 · 2026-08-03

72 registered trials of Posaconazole — at which phases?


Registered studies posting no result
42 of 72

72 registered studies of Posaconazole: 18 phase1, 18 phase2, 15 phase3, 10 na or unstated, 10 phase4, 3 early phase1, 2 na. CLINICALTRIALS_SNAPSHOT · 2026-09-01

131 with a PubMed record

Show the evidence
  • phase1
    18
  • phase2
    18
  • phase3
    15
  • na or unstated
    10
  • phase4
    10
  • early phase1
    3
9 more recorded rows
  • na
    2
  • completed
    47
  • terminated
    7
  • recruiting
    6
  • not yet recruiting
    5
  • withdrawn
    3
  • unknown
    2
  • approved for marketing
    1
  • enrolling by invitation
    1

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

9 of Posaconazole's trials stopped: futility/efficacy, accrual/recruitment, funding/business, other?


futility/efficacy (1), accrual/recruitment (2), funding/business (1) and other (5): Posaconazole's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Study is complete Analysis is complete"; 9 of 72 registered studies

Show the evidence

Trial

  • NCT00177749
    terminated; "Study is complete Analysis is complete"
  • NCT01667107
    terminated; "Study terminated due to an unfavorable risk-benefit analysis"
  • NCT01716234
    terminated; "Study was terminated early (10 July 2015) based on preliminary analysis of pharmacokinetic data."
  • NCT02203773
    terminated; "Strategic considerations"
  • NCT03095547
    withdrawn; "study no longer required in current format"
  • NCT03760445
    withdrawn; "It was determined that the study design may not be optimal given the changing AML treatment landscape."
3 further recorded trials
  • NCT04825275
    terminated; "The study was stopped due to slow accrual."
  • NCT04876716
    terminated; "futility"
  • NCT04966585
    terminated; "Recruitment challenges; changes in manufacturing"

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

Human studies of Posaconazole used Posaconazole oral suspension 40 mg/mL — over how long?


Human studies of Posaconazole used "Posaconazole oral suspension 40 mg/mL". ClinicalTrials.gov · 2026-09-01

10 recorded entries; human; oral, IV; also "Posaconazole 12 mg/kg/day BID", "Posaconazole 18 mg/kg/day BID", "Posaconazole 18 mg/kg/day TID"

Show the evidence

human

  • NCT01436578
    oral; Posaconazole oral suspension 40 mg/mL
  • NCT01716234
    Posaconazole 12 mg/kg/day BID
  • NCT01716234
    Posaconazole 18 mg/kg/day BID
  • NCT01716234
    Posaconazole 18 mg/kg/day TID
  • NCT01716234
    Posaconazole 12 mg/kg/day TID
  • NCT01777763
    Posaconazole 200 mg
4 more recorded rows
  • human NCT01777763
    Posaconazole 300 mg
  • human NCT03378479
    SOC +Posaconazole 18 MG/ML (milligram/milliliter)
  • human NCT04665037
    IV; Posaconazole IV 6 mg/kg
  • human NCT04665037
    Posaconazole PFS 6 mg/kg

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

Posaconazole's half-life is 26 to 31 hours — which schedules were studied?


26 to 31 hours, the half-life Posaconazole's label states: "Posaconazole delayed-release tablet is eliminated with a mean half-life (t ½ ) ranging between 26 to 31 hours." DailyMed label · f8a26673-261c-4e8e-b1e1-9e23aaf7f285 · 2026-08-03

tmax 0-24 hr; bioavailability 54 %.

Show the evidence
  • half life pharmacokinetics
    26 to 31 hours; Posaconazole delayed-release tablet is eliminated with a mean half-life (t ½ ) ranging between 26 to 31 hours.
  • tmax pharmacokinetics
    0-24 hr; Table 21: Arithmetic Mean (%CV) of Steady State PK Parameters in Healthy Volunteers and Patients Following Administration of Posaconazole Delayed-Release Tablets (300 mg)* N AUC 0-24 hr (ng·hr/mL) C av † (ng/mL) C max (ng/mL) C min (ng/mL) T max ‡ (hr) t 1/2 (hr) CL/F (L/hr) Healthy 12 51,618 2,151 2,764 1,785 4 31 7.5 Volunteers (25) (25) (21) (29) (3 to 6) (40) (26) Patients 50 37,900 1,580…
  • bioavailability pharmacokinetics
    54 %; The absolute bioavailability of the oral delayed-release tablet is approximately 54% under fasted conditions.
  • metabolism pharmacokinetics
    Metabolism: Posaconazole primarily circulates as the parent compound in plasma.

recorded 2026-08-03 · last checked 2026-09-04

Which running trial of Posaconazole could settle lifespan?


NCT07261150 measures Mortality at 2 weeks, reading out 2030-12-31.

1 open trial; n 664; "Histoplasmosis Induction and Consolidation Therapy Factorial Randomized Clinical Trial (Histo-FACT)"

Show the evidence
  • Trial NCT07261150
    "Histoplasmosis Induction and Consolidation Therapy Factorial Randomized Clinical Trial (Histo-FACT)"; n 664; "Mortality at 2 weeks"; 2030-12-31

Which 18 trials of Posaconazole posted no result?


Posted no result
18 of 18 completed trials
Registrations
NCT00034658, NCT00034671, NCT00034645, NCT00044486, NCT00033982 and NCT00034632, and 12 more
Completion dates
oldest 2002-03; newest 2023-06-01
Show the evidence

Trial

  • NCT00034658
    2002-03
  • NCT00034671
    2002-03
  • NCT00034645
    2003-02
  • NCT00044486
    2005-04
  • NCT00033982
    2007-02-20
  • NCT00034632
    2007-03
12 further recorded trials
  • NCT00817765
    2009-10
  • NCT00799071
    2010-08
  • NCT01162967
    2013-03
  • NCT01436578
    2013-11
  • NCT01901172
    2015-06
  • NCT03614455
    2018-10-01
  • NCT02358499
    2018-12-31
  • NCT02805946
    2019-09-07
  • NCT02875743
    2019-10-31
  • NCT03066011
    2020-04-24
  • NCT01951430
    2020-10-29
  • NCT04725942
    2023-06-01

At the median, Posaconazole's trials enrolled 68 people — anything larger?


Median enrolment
68
Largest enrolment
2015
Registered trials counted
70

What do 767 spontaneous reports say about Posaconazole — and not say?


These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.

Posaconazole appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 767 reaction mentions were counted: drug interaction 187; hypokalaemia 94; neutropenia 83; febrile neutropenia 78. FAERS via Open Targets · CHEMBL1397 · 2026-06-24

Show the evidence
  • drug interaction
    187
  • hypokalaemia
    94
  • neutropenia
    83
  • febrile neutropenia
    78
  • cholestasis
    60
  • hepatocellular injury
    59
4 more recorded rows
  • pseudoaldosteronism
    59
  • electrocardiogram qt prolonged
    55
  • drug level below therapeutic
    54
  • mucormycosis
    38

recorded 2026-06-24 · last checked 2026-09-04

Which 10 reactions does Posaconazole's label not list?


cholestasis, drug interaction and drug level below therapeutic and 7 more reported for Posaconazole, absent from its label. FAERS via Open Targets · CHEMBL1397 · 2026-06-24

2 label terms; 10 reported and unlisted; f8a26673-261c-4e8e-b1e1-9e23aaf7f285

Show the evidence
  • cholestasis
    count not stated
  • drug interaction
    count not stated
  • drug level below therapeutic
    count not stated
  • electrocardiogram qt prolonged
    count not stated
  • febrile neutropenia
    count not stated
  • hepatocellular injury
    count not stated
4 more recorded rows
  • hypokalaemia
    count not stated
  • mucormycosis
    count not stated
  • neutropenia
    count not stated
  • pseudoaldosteronism
    count not stated

recorded 2026-06-24 · last checked 2026-09-04

Posaconazole and CYP3A4, CYP3A and P-GLYCOPROTEIN: shared by which compounds?


CYP3A4, CYP3A and P-GLYCOPROTEIN appear in Posaconazole's recorded interaction sentences, 8 in all. DailyMed label · f8a26673-261c-4e8e-b1e1-9e23aaf7f285 · 2026-08-03

CYP3A, CYP3A4, CYP3A4, P-gp; 4 shared nodes; drug_interactions

Show the evidence

Interaction statement

  • drug_interactions
    Interaction Drug Interaction Rifabutin, phenytoin, efavirenz, cimetidine, esomeprazole* Avoid coadministration unless the benefit outweighs the risks ( 7.1 , 7.2 ) Other drugs metabolized by CYP3A4 Consider dosage adjustment and monitor for adverse effects and toxicity ( 7.2 ) Digoxin Monitor digoxin plasma concentrations ( 7.2 ) Fosamprenavir, metoclopramide* Monitor for breakthrough fungal…
  • drug_interactions
    7.1 Effects of Other Drugs on Posaconazole Posaconazole is primarily metabolized via UDP-glucuronosyltransferase and is a substrate of p-glycoprotein (P-gp) efflux.
  • drug_interactions
    See Table 17 for rifabutin monitoring considerations when posaconazole affects rifabutin via CYP3A4 inhibition.
  • drug_interactions
    See Table 17 for phenytoin monitoring considerations when posaconazole affects phenytoin via CYP3A4 inhibition.
  • drug_interactions
    7.2 Effects of Posaconazole on Other Drugs Posaconazole is a strong CYP3A4 inhibitor.
  • drug_interactions
    Therefore, concomitant use of posaconazole may increase plasma concentrations of drugs that are CYP3A4 substrates [see Clinical Pharmacology (12.3) ].
2 more recorded rows
  • Interaction statement drug_interactions
    CYP3A Substrates Immunosuppressants that are CYP3A4 Substrates Mechanism and Clinical Effect(s) Posaconazole is a strong CYP3A4 inhibitor.
  • Interaction statement drug_interactions
    Therefore, plasma concentrations of CYP3A4 substrates may be increased by posaconazole use [see Clinical Pharmacology (12.3) ].
  • CYP3A
    FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, Vincristine, Naldemedine, Pemetrexed, Eravacycline, Rasburicase, Repotrectinib

CYP3A4

  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium
  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium
  • P-gp
    FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Vincristine

recorded 2026-08-03 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1397
PubChem CID
468595
CAS number
171228-49-2
RxCUI
282446
InChIKey
RAGOYPUPXAKGKH-XAKZXMRKSA-N
Trade name
Noxafil, Noxafil powdermix kit, Posaconazole accord, Posaconazole ahcl, Posaconazole sp, Noxafil / Noxafil Powdermix Kit, Posatex, Mometamax Ultra
Also called
Posaconazol, mk-5592, pcz, pos, Posaconazole [EMA EPAR], Posaconazole [GREEN BOOK], Posaconazole [HSDB], Posaconazole [INN], Posaconazole [JAN], Posaconazole [MART.], Posaconazole [MI], Posaconazole [ORANGE BOOK]
Development code
SCH 56592
Salt form
POSACONAZOLE DELAYED-RELEASE
Sources (6)

Sources

ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 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

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