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Vorinostat

  • 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 Vorinostat does in the body

Cutaneous manifestations

From the FDA-approved label: Vorinostat inhibits the enzymatic activity of histone deacetylases HDAC1, HDAC2 and HDAC3 (Class I) and HDAC6 (Class II) at nanomolar concentrations (IC 50 <86 nM). These enzymes catalyze the removal of acetyl groups from the lysine residues of proteins, including histones and transcription factors. In some cancer cells, there is an overexpression of HDACs, or an aberrant recruitment of HDACs to oncogenic transcription factors causing hypoacetylation of core nucleosomal histones. Hypoacetylation of histones is associated with a condensed chromatin structure and repression of gene transcription.

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 · 58IFB293JI · read 2026-08-29

  • Its recorded molecular formula is C14H20N2O3, weighing 264.32.

    US prescribing information · cd86ee78-2781-468b-930c-3c4677bcc092 · read 2026-08-30

Where each sentence above came from

The recorded explanation is written in label language rather than for a beginner. The page opens with what it is taken for instead, and the recorded explanation follows below.

Shown as the opening line on this page.

No statement of the main limit is recorded.

The four opening statements run to 104 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.

Overall survival

The study did not show it

Who was studied
NCT01554852
How many people
4420
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

Event-free survival of ALL patients (EFS)

The study did not show it

Who was studied
NCT03117751
How many people
790
Study design
Phase 2/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

Event-free Survival (EFS)

The study did not show it

Who was studied
NCT01802333
How many people
754
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

Overall Survival (OS)

The study did not show it

Who was studied
NCT00128102
How many people
661
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

Progression-Free Survival (PFS)

The study did not show it

Who was studied
NCT00773747
How many people
637
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 days from start of therapy to date of first relapse

The study did not show it

Who was studied
NCT02559778
How many people
500
Study design
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 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.

  • ZOLINZA ® is indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease on or following two systemic therapies.

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 ZOLINZA in pediatric patients have not been established.”

    US prescribing information · cd86ee78-2781-468b-930c-3c4677bcc092 · read 2026-08-30

  • On older people, the label states: “Clinical studies of ZOLINZA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.”

    US prescribing information · cd86ee78-2781-468b-930c-3c4677bcc092 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Based on its mechanism of action and findings from animal studies, ZOLINZA can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] .”

    US prescribing information · cd86ee78-2781-468b-930c-3c4677bcc092 · read 2026-08-30

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

    US prescribing information · cd86ee78-2781-468b-930c-3c4677bcc092 · 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

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: S1, S3, S4.

No source is stored against this line.

What is in the pack

Sold as capsule, given by the oral 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

  • 4 products list this as an active ingredient in the United States drug directory. 4 of them contain it and nothing else.

    FDA National Drug Code directory · 0006-0568 · read 2026-08-29

  • They are sold as capsule and powder, taken oral.

    FDA National Drug Code directory · 0006-0568 · read 2026-08-29

  • The regulator's established pharmacologic class for it is histone deacetylase inhibitor [epc] and histone deacetylase inhibitors [moa].

    FDA National Drug Code directory · 0006-0568 · read 2026-08-29

  • 1 published label names it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · cd86ee78-2781-468b-930c-3c4677bcc092 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · cd86ee78-2781-468b-930c-3c4677bcc092 · read 2026-08-29

  • ZOLINZA is oral at 3 DOSAGE FORMS AND STRENGTHS Capsules: 100 mg white, opaque, hard gelatin capsules with "568" over "100 mg" printed within radial bar in black ink on the capsule body., recorded as fda label in effect 2024-11-12 in the United States.

    US prescribing information · cd86ee78-2781-468b-930c-3c4677bcc092 · 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.

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 Vorinostat 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 Vorinostat 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.

Where else this substance is registered

FDA substance identifier (UNII)
58IFB293JI
RxNorm concept
668579

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: S1, S3, S4.

  • 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

  • 1 approved application covers products containing this substance. The earliest was NDA021991, approved 20061006 to MSD SUB MERCK.

    Drugs@FDA application register · NDA021991 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · NDA021991 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20061006.

    FDA National Drug Code directory · 0006-0568 · 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 Vorinostat label: indicated for what?


"ZOLINZA ® is indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease on or following two systemic therapies. ZOLINZA is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous manifestations in…": indications and usage on Vorinostat's label. DailyMed label · cd86ee78-2781-468b-930c-3c4677bcc092 · 2024-11-12

250 registered trials of Vorinostat — at which phases?


Registered studies posting no result
120 of 250

250 registered studies of Vorinostat: 156 phase1, 132 phase2, 9 phase3, 5 na, 1 early phase1, 1 na or unstated. CLINICALTRIALS_SNAPSHOT · 2026-09-01

209 with a PubMed record

Show the evidence
  • phase1
    156
  • phase2
    132
  • phase3
    9
  • na
    5
  • early phase1
    1
  • na or unstated
    1
9 more recorded rows
  • completed
    150
  • terminated
    51
  • active not recruiting
    17
  • withdrawn
    14
  • recruiting
    9
  • unknown
    6
  • no longer available
    1
  • not yet recruiting
    1
  • suspended
    1

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

57 of Vorinostat's trials stopped: safety, futility/efficacy, accrual/recruitment, funding/business, sponsor decision unspecified, other?


safety (11), futility/efficacy (4), accrual/recruitment (17), funding/business (4), sponsor decision unspecified (1) and other (20): Vorinostat's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"The study was stopped due to low enrollment."; 57 of 250 registered studies

Show the evidence

Trial

  • NCT00127101
    terminated; "The study was stopped due to low enrollment."
  • NCT00132002
    terminated; "Early termination for discouraging results"
  • NCT00251589
    terminated; "This trial is being closed based on lack of substantive efficacy, slow accrual and overall tolerance in patients treated to date."
  • NCT00363883
    terminated; "Trial stopped early for futility"
  • NCT00473889
    terminated; "The study was terminated based on the recommendation by the DSMB following a pre-planned protocol interim analysis because the endpoint was not achieved."
  • NCT00555399
    terminated; "No Sponsor funding for continuation of trial"
14 further recorded trials
  • NCT00565227
    terminated; "closed due to toxicity"
  • NCT00744354
    terminated; "Drugs unavailable- study terminated 1/2/18"
  • NCT00785798
    terminated; "sponsor requested"
  • NCT00810576
    terminated; "Terminated due to slow accrual."
  • NCT00818649
    terminated; "Met protocol stop rule \[i.e., extreme toxicity\]"
  • NCT00831493
    terminated; "Slow Accrual."
  • NCT00837174
    withdrawn; "Study never activated/opened as funding source and other support not available."
  • NCT00857324
    terminated; "The Phase I of the study was completed, but Phase 2 has not been activated"
  • NCT00882206
    terminated; "Slow accrual"
  • NCT00910000
    terminated; "Terminated due to unacceptable toxicity"
  • NCT00948688
    terminated; "Funding was withdrawn after only 10 participants were enrolled"
  • NCT00958074
    terminated; "Terminated due to slow accrual"
  • NCT00972842
    terminated; "slow recruitment"
  • NCT00976183
    terminated; "toxicities"

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

Human studies of Vorinostat used 25 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®) — over how long?


studies of Vorinostat used the recorded amount. ClinicalTrials.gov · 2026-09-01

6 recorded entries; human; also "25 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)", "50 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)", "100 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)"

Show the evidence

human

  • NCT03050450
    25 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
  • NCT03050450
    50 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
  • NCT03050450
    100 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
  • NCT03050450
    150 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
  • NCT03050450
    150 mg/m2 Lenalidomide (Revlimid®) and 230 mg/m2 Vorinostat (Zolinza®)
  • NCT03894826
    Vorinostat 100 MG

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

Vorinostat's half-life is 2.0 hours — which schedules were studied?


2.0 hours, the half-life Vorinostat's label states: "The mean terminal half-life (t ½ ) was ~2.0 hours for both vorinostat and the O -glucuronide metabolite, while that of the 4-anilino-4-oxobutanoic acid metabolite was 11 hours." DailyMed label · cd86ee78-2781-468b-930c-3c4677bcc092 · 2024-11-12

tmax 2.5 hours.

Show the evidence
  • half life pharmacokinetics
    2.0 hours; The mean terminal half-life (t ½ ) was ~2.0 hours for both vorinostat and the O -glucuronide metabolite, while that of the 4-anilino-4-oxobutanoic acid metabolite was 11 hours.
  • tmax pharmacokinetics
    2.5 hours; Therefore, oral administration of vorinostat with a high-fat meal resulted in an increase (33%) in the extent of absorption and a modest decrease in the rate of absorption (T max delayed 2.5 hours) compared to the fasted state.
  • metabolism pharmacokinetics
    Metabolism The major pathways of vorinostat metabolism involve glucuronidation and hydrolysis followed by β-oxidation.

recorded 2024-11-12 · last checked 2026-09-04

Which running trial of Vorinostat could settle lifespan?


NCT06995521 measures GVHD-free relapse-free Survival, reading out 2028-09.

3 open trials; n 55; "Vorinostat for Graft-versus-host Disease (GVHD) Prevention in Non-Malignant Adolescent and Young Adults (AYA) Population"

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Trial

  • NCT06995521
    "Vorinostat for Graft-versus-host Disease (GVHD) Prevention in Non-Malignant Adolescent and Young Adults (AYA) Population"; n 55; "GVHD-free relapse-free Survival"; 2028-09
  • NCT03117751
    "Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma"; n 790; "Event-free survival of ALL patients (EFS)"; 2028-09-30
  • NCT02553460
    "Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I"; n 50; "Percentage of Treatment-related Mortality (TRM)"; 2031-10

Which 44 trials of Vorinostat posted no result?


Posted no result
44 of 44 completed trials
Registrations
NCT00005634, NCT00750178, NCT00045006, NCT00132067, NCT00455351 and NCT00217412, and 38 more
Completion dates
oldest 2002-10; newest 2023-11
Show the evidence

Trial

  • NCT00005634
    2002-10
  • NCT00750178
    2005-11-01
  • NCT00045006
    2008-07
  • NCT00132067
    2008-07
  • NCT00455351
    2009-08
  • NCT00217412
    2009-09
14 further recorded trials
  • NCT00667082
    2010-01
  • NCT01132911
    2011-04-13
  • NCT00816283
    2011-06
  • NCT00791011
    2011-08
  • NCT00776503
    2011-11
  • NCT00635791
    2012-03
  • NCT00127140
    2012-04
  • NCT00983268
    2013-02
  • NCT00537121
    2013-06
  • NCT00719875
    2013-06
  • NCT00762255
    2013-07
  • NCT00918489
    2013-09
  • NCT00875745
    2013-10
  • NCT00275080
    2014-08

At the median, Vorinostat's trials enrolled 26 people — anything larger?


Median enrolment
26
Largest enrolment
4420
Registered trials counted
247

What do 706 spontaneous reports say about Vorinostat — 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.

Vorinostat appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 706 reaction mentions were counted: febrile neutropenia 104; thrombocytopenia 94; anaemia 74; diarrhoea 74. FAERS via Open Targets · CHEMBL98 · 2026-06-24

Show the evidence
  • febrile neutropenia
    104
  • thrombocytopenia
    94
  • anaemia
    74
  • diarrhoea
    74
  • nausea
    73
  • dehydration
    67
4 more recorded rows
  • vomiting
    66
  • neutropenia
    56
  • pyrexia
    53
  • decreased appetite
    45

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

Which 10 reactions does Vorinostat's label not list?


anaemia, decreased appetite and dehydration and 7 more reported for Vorinostat, absent from its label. FAERS via Open Targets · CHEMBL98 · 2026-06-24

2 label terms; 10 reported and unlisted; cd86ee78-2781-468b-930c-3c4677bcc092

Show the evidence
  • anaemia
    count not stated
  • decreased appetite
    count not stated
  • dehydration
    count not stated
  • diarrhoea
    count not stated
  • febrile neutropenia
    count not stated
  • nausea
    count not stated
4 more recorded rows
  • neutropenia
    count not stated
  • pyrexia
    count not stated
  • thrombocytopenia
    count not stated
  • vomiting
    count not stated

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

Vorinostat and P-GP, CYP2C9 and CYP3A4: shared by which compounds?


P-GP, CYP2C9 and CYP3A4 appear in Vorinostat's recorded interaction sentences, 8 in all. DailyMed label · cd86ee78-2781-468b-930c-3c4677bcc092 · 2024-11-12

CYP2C9, CYP3A4, P-gp, P-gp, P-gp; 5 shared nodes; pharmacokinetics, clinical_pharmacology

Show the evidence

Interaction statement

  • pharmacokinetics
    Gene expression studies in human hepatocytes detected some potential for suppression of CYP2C9 and CYP3A4 activities by vorinostat at concentrations higher (≥10 µM) than pharmacologically relevant.
  • pharmacokinetics
    In vitro studies indicate that vorinostat is not a substrate of human P-glycoprotein (P-gp).
  • pharmacokinetics
    In addition, vorinostat has no inhibitory effect on human P-gp-mediated transport of vinblastine (a marker P-gp substrate) at concentrations of up to 100 µM.
  • pharmacokinetics
    Thus, vorinostat is not likely to inhibit P-gp at the pharmacologically relevant serum concentration of 2 µM (C max ) in humans.
  • clinical_pharmacology
    Gene expression studies in human hepatocytes detected some potential for suppression of CYP2C9 and CYP3A4 activities by vorinostat at concentrations higher (≥10 µM) than pharmacologically relevant.
  • clinical_pharmacology
    In vitro studies indicate that vorinostat is not a substrate of human P-glycoprotein (P-gp).
2 more recorded rows
  • Interaction statement clinical_pharmacology
    In addition, vorinostat has no inhibitory effect on human P-gp-mediated transport of vinblastine (a marker P-gp substrate) at concentrations of up to 100 µM.
  • Interaction statement clinical_pharmacology
    Thus, vorinostat is not likely to inhibit P-gp at the pharmacologically relevant serum concentration of 2 µM (C max ) in humans.
  • CYP2C9
    FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Golodirsen, Tinidazole, Naldemedine
  • CYP3A4
    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
  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Vincristine
  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Vincristine

recorded 2024-11-12 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL98
PubChem CID
5311
CAS number
149647-78-9
RxCUI
194337
InChIKey
WAEXFXRVDQXREF-UHFFFAOYSA-N
Development code
MK-0683, MK0683, NSC-701852, NSC-748799, NSC-759852
Also called
Suberoylanilide hydroxamic acid, saha, vor, VORINOSTAT [JAN], VORINOSTAT [MART.], VORINOSTAT [MI], VORINOSTAT [ORANGE BOOK], VORINOSTAT [USAN]
Trade name
Zolinza
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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