This page shows what was measured, who it was measured in, and what that does not settle.
What Ruxolitinib does in the body
OPZELURA is a Janus kinase (JAK) inhibitor indicated for: the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 2 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
From the FDA-approved label: Ruxolitinib, a kinase inhibitor, inhibits Janus Associated Kinases (JAKs), JAK1 and JAK2, which mediate the signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. JAK signaling involves recruitment of STATs (signal transducers and activators of transcription) to cytokine receptors, activation, and subsequent localization of STATs to the nucleus leading to modulation of gene expression. MF and PV are myeloproliferative neoplasms (MPNs) known to be associated with dysregulated JAK1 and JAK2 signaling.
Why people take it. OPZELURA is a Janus kinase (JAK) inhibitor indicated for: the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 2 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
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.
Where each sentence above came from
The use the label states, quoted from it. No plain-language version of this sentence has been written.
The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.
No statement of the main limit is recorded.
The four opening statements run to 196 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Stand-in result
A stand-in result is a number measured because the real result takes too long.
A picture of it, and where the picture fails
It is like judging a journey by the speedometer rather than by arriving.
Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.
What people get wrong. A stand-in result is often reported as the result itself.
A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.
Formulation
A formulation is the exact made-up form a substance comes in.
A picture of it, and where the picture fails
It is like the difference between a whole bean and instant coffee.
Where that stops being true. Coffee tastes different. A formulation can change how much reaches the blood.
What people get wrong. Two products with the same name are assumed to behave the same. They often do not.
The specific composition and physical form of a product, including salt, excipients and release profile.
Receptor
A receptor is a part of a cell that a signal fits into.
A picture of it, and where the picture fails
A receptor is like a lock waiting for one key.
Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.
What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.
A protein that binds a specific ligand and converts that binding into a cellular response.
Pathway
A pathway is a chain of steps inside a cell, each one setting off the next.
A picture of it, and where the picture fails
A pathway is like a row of dominoes.
Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.
What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.
An ordered series of molecular interactions producing a defined cellular change.
What happened in people◇Read from sources, not yet reviewed
What was measured, goal by goal
One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.
Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.
There is no single score. A strong test result and a weak life result are different facts.
Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Body weight
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
△Only a number moved1 registered test measure.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Energy
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
…Waiting for a reviewer1 registered symptom measure.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Body weight
body weight
Energy
fatigue
Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.
What each mark on this table means
∅ Nothing in the sources checked
No registered study lists a life outcome for this goal.
△ Only a number moved
1 registered test measure.
— Not recorded
Harms were not a registered measure for this goal.
… Waiting for a reviewer
Who was studied is listed further down the page.
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.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) up to 5 Years
✗ The study did not show it
Who was studied
NCT01493414
How many people
2233
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
Event Free Survival (EFS)
✗ The study did not show it
Who was studied
NCT07297914
How many people
1000
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 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
Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8
✗ The study did not show it
Who was studied
NCT03745638
How many people
631
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
VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8
✗ The study did not show it
Who was studied
NCT03745651
How many people
618
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
To compare spleen volume reduction (SVR35) between Arm 1 and Arm 2
✗ The study did not show it
Who was studied
NCT06479135
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 happened in people◇Read from sources, not yet reviewed
How close this is to real life
The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.
■Living longer, or avoiding a major eventEvidence recorded. Death, a heart attack, a stroke, a hospital stay.4 registered measures of this kind. 2 written-up studies measured this and did not show a benefit.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
■Symptoms and quality of lifeEvidence recorded. Pain, tiredness, mood, sleep, as the person rated it.1 registered measure of this kind.
■A number that stands in for healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.1 registered measure of this kind.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
■AnimalsEvidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse. A result in animals says what to test next. It does not say what happens in people.
■Cells in a dishEvidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
fatigue
Measured
Things only a test, a scale or a device shows.
body weight
Meaningful
Things that change how a life goes, not only a number.
overall survival
progression free survival
survival
rate of event free survival
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (34)
adverse events
achieving american college of rheumatology 20 improvement
prostate specific antigen response
response rate
treatment emergent adverse events
maximum tolerated dose and/or recommended phase ii dose
toxicity
pharmacokinetics
achieving a primary response at week 32
dose limiting toxicities
objective response
overall response rate
spleen volume at week 24
objective response rate
time to progression
clinical activity
phase i maximum tolerated dose
anemia response
duration of response
residual disease as measured by polymerase chain reaction
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
JAKAFI/JAKAFI XR is a kinase inhibitor indicated for treatment of: intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis in adults. ( 1.1 ) polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea.
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 OPZELURA have not been established in pediatric patients younger than 2 years of age with atopic dermatitis.”
US prescribing information · 24da5509-6631-4795-9d42-273faecd08e7 · read 2026-08-30
On older people, the label states: “Clinical trials of OPZELURA in subjects with nonsegmental vitiligo did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects.”
US prescribing information · 24da5509-6631-4795-9d42-273faecd08e7 · read 2026-08-30
On people who are pregnant, the label states: “Exposure Registry There is a pregnancy registry that monitors pregnancy outcomes in pregnant persons exposed to OPZELURA during pregnancy.”
US prescribing information · 24da5509-6631-4795-9d42-273faecd08e7 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of ruxolitinib in human milk, the effects on the breastfed child, or the effects on milk production.”
US prescribing information · 24da5509-6631-4795-9d42-273faecd08e7 · read 2026-08-30
Where the result stopped carrying
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied for a different goal
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
A different form was studied
The studied form is not the form on the shelf.
On this record: This record is linked to 1 related forms. Evidence does not carry across all of them.
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 (9)
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: S1, S4, S6.
No source is stored against this line.
What is in the pack
Sold as tablet, cream, tablet, extended release, given by the oral, topical route.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take∅Nothing found in the sources checked
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
Reports sent to a regulator
These are reports people sent to a regulator. They do not show the medicine caused the reaction.
Nobody counted how many people took the medicine and reported nothing.
The same event can be reported more than once, and many reports are incomplete.
News coverage, lawsuits and new warnings change how often people report.
A count is not a rate and not a risk.
Ruxolitinib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 7081 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
anaemia — 1171 reaction mentions
fatigue — 1106 reaction mentions
haemoglobin decreased — 990 reaction mentions
platelet count decreased — 977 reaction mentions
thrombocytopenia — 608 reaction mentions
splenomegaly — 541 reaction mentions
weight increased — 518 reaction mentions
platelet count increased — 419 reaction mentions
white blood cell count increased — 408 reaction mentions
contusion — 343 reaction mentions
open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
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
42 products list this as an active ingredient in the United States drug directory. 42 of them contain it and nothing else.
FDA National Drug Code directory · 11014-0450 · read 2026-08-29
They are sold as cream, powder, tablet and tablet, extended release, taken oral and topical.
FDA National Drug Code directory · 11014-0450 · read 2026-08-29
The regulator's established pharmacologic class for it is janus kinase inhibitor [epc], janus kinase inhibitors [moa] and kinase inhibitor [epc].
FDA National Drug Code directory · 11014-0450 · read 2026-08-29
2 published labels name it as an active ingredient. 2 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 24da5509-6631-4795-9d42-273faecd08e7 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 24da5509-6631-4795-9d42-273faecd08e7 · read 2026-08-29
OPZELURA is topical at 3 DOSAGE FORMS AND STRENGTHS Cream: 15 mg of ruxolitinib per gram (1.5%) of white to off-white cream supplied in 60 g and 100 g tubes Cream: 1.5% ruxolitinib supplied in 60 g and 100 g tubes ( 3 ), recorded as fda label in effect 2026-06-30 in the United States.
US prescribing information · 24da5509-6631-4795-9d42-273faecd08e7 · 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.
This order is fixed in code and does not count clicks or time on the page.
What is not here
6 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.
The path through the body — found nothing in the sources checked.
How long anything takes — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
Claims that go past the evidence — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
Recorded evidence blocks (12)
Q2
What did Ruxolitinib's largest trial (5621 people) and its longest (24 years) measure?
5621 people in Ruxolitinib's largest registered study, 24 years in its longest registered window, measuring Median Survival. ClinicalTrials.gov · 2026-09-01
205 phase2, 121 phase1, 56 phase3, 23 na or unstated, 14 phase4, 5 na, 3 early phase1; NCT00044304; 2027-03-10; no ageing endpoint recorded. Last human test completed 2026, NCT05621733.
Interpretation These counts include studies where Ruxolitinib was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.
Show the evidence
phase2
205
phase1
121
phase3
56
na or unstated
23
phase4
14
na
5
2 more recorded rows
early phase1
3
Last recorded human testNCT05621733
2026-05-08
recorded 2026-09-01 · last checked 2026-09-04
Q3
From mouse to human: where has Ruxolitinib shown lifespan?
"According to the protocol, the sponsor terminated the study after it was determined that less than 2 of the first 22 patients showed a PSA50 response."; 58 of 366 registered studies
Show the evidence
Trial
NCT00638378
terminated; "According to the protocol, the sponsor terminated the study after it was determined that less than 2 of the first 22 patients showed a PSA50 response."
NCT00726232
terminated; "Termination of the clinical trial by sponsor."
NCT01251965
terminated; "Study was stopped by the principal investigator due to nonsatisfactory clinical benefit even in patients treated at the highest dose (200 mg )."
NCT01562873
terminated; "Not enough responses to continue treatment."
NCT01620216
terminated; "Unable to recruit enough eligible subjects"
NCT01712659
terminated; "The adult T-cell leukemia (ATL) research program was terminated after the death of the T-cell malignancy group Lead investigator."
14 further recorded trials
NCT01751425
terminated; "Per PI Request. 2) No additional benefit was noted with the addition of Ruxolitinib."
NCT01822756
terminated; "Dose escalation ended after Cohort B1, RUX 10 mg BID - GCSF in October 2014."
NCT02072057
terminated; "Poor recruiting"
NCT02091752
terminated; "The study was terminated due to low enrollment."
NCT02117479
terminated; "The study was terminated early based on the results of the planned interim analysis."
NCT02119650
terminated; "The study was terminated as other related studies of ruxolitinib did not provide sufficient efficacy to warrant continuation."
NCT02119663
terminated; "The safety committee found no safety issues but recommended halting the study based on a lack of efficacy in a similar trial. The sponsor terminated the trial."
NCT02119676
terminated; "Substudy 1 was terminated for futility at interim analysis and Substudy 2 was terminated per sponsor decision."
NCT02120417
terminated; "The study was terminated as other related studies of ruxolitinib did not provide sufficient efficacy to warrant continuation."
NCT02152956
terminated; "Business decision"
NCT02420717
terminated; "Study was closed early due to low accrual and lack of response."
NCT02469974
withdrawn; "no enrollments"
NCT02528877
withdrawn; "The study design was revised so a new protocol will be opened."
NCT02553330
terminated; "The study was terminated early based on the results of a planned interim analysis."
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Ruxolitinib used Ruxolitinib 25 mg — over how long?
12 recorded entries; human; also "Ruxolitinib 25 mg", "Ruxolitinib 1.5% Phosphate Cream", "Jakafi 15Mg Tablet"
Show the evidence
human
NCT00639002
Ruxolitinib 25 mg
NCT02809976
Ruxolitinib 1.5% Phosphate Cream
NCT02960945
Jakafi 15Mg Tablet
NCT03011892
Ruxolitinib 0.15% Cream QD
NCT03011892
Ruxolitinib 0.5% Cream QD
NCT03011892
Ruxolitinib 1.5% Cream QD
6 more recorded rows
humanNCT03011892
Ruxolitinib 1.5% Cream BID
humanNCT03274778
Ruxolitinib 20 MG
humanNCT03395340
Ruxolitinib 1.5% cream
humanNCT04403243
Ruxolitinib 5 MG
humanNCT05123040
Ruxolitinib 10 MG Oral Tablet
humanNCT06768476
Ruxolitinib 10 MG
recorded 2026-09-01 · last checked 2026-09-04
Q6
Which of achieving a primary response at week 32, achieving american college of rheumatology 20 improvement and adverse events did Ruxolitinib's trials measure?
achieving a primary response at week 32, achieving american college of rheumatology 20 improvement and adverse events lead 40 outcome terms across Ruxolitinib's trials. ClinicalTrials.gov · 2026-09-01
response rate, treatment emergent adverse events, maximum tolerated dose and/or recommended phase ii dose, toxicity, pharmacokinetics and achieving a primary response at week 32 follow.
Show the evidence
adverse events
1
achieving american college of rheumatology 20 improvement
1
prostate specific antigen response
1
response rate
1
treatment emergent adverse events
1
maximum tolerated dose and/or recommended phase ii dose
1
14 more recorded rows
toxicity
1
pharmacokinetics
1
achieving a primary response at week 32
1
dose limiting toxicities
1
objective response
1
overall survival
1
overall response rate
1
spleen volume at week 24
1
objective response rate
1
time to progression
1
clinical activity
1
phase i maximum tolerated dose
1
anemia response
1
duration of response
1
recorded 2026-09-01 · last checked 2026-09-04
Q7
Which of Ruxolitinib's 141 ongoing trials reports first?
peripheral blood absolute eosinophil count.; Change in fatigue; latest 2045-03
Show the evidence
Trial
NCT00044304
"Tyrosine Kinase Inhibition to Treat Myeloid Hypereosinophilic Syndrome"; n 70; "peripheral blood absolute eosinophil count."; 2027-03-10
NCT02131584
"Ruxolitinib Phosphate in Reducing Fatigue in Patients With Chronic Lymphocytic Leukemia"; n 10; "Change in fatigue"; 2026-09-30
NCT02386800
"CINC424A2X01B Rollover Protocol"; n 279; "Incidence and severity of AEs and SAEs"; 2032-04-05
NCT02494882
"Adding Ruxolitinib to a Combination of Dasatinib Plus Dexamethasone in Remission Induction Therapy in Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Patients Aged 40 Years or Older"; n 12; "Clinical response"; 2027-06
NCT02577926
"The Ruxo-BEAT Trial in Patients With High-risk Polycythemia Vera or High-risk Essential Thrombocythemia"; n 207; "The rate of complete clinicohematologic response rate (CHR) as defined by Barosi et al 2009"; 2028-12
NCT02955940
"An Open-Label Study to Enable Continued Treatment Access for Subjects Previously Enrolled in Studies of Ruxolitinib"; n 10; "Frequency and types of adverse events and serious adverse events"; 2027-09-30
14 further recorded trials
NCT02974647
"Study of Ruxolitinib in Relapsed or Refractory T or NK Cell Lymphoma"; n 83; "disease control rate"; 2027-11
NCT03017820
"A Vaccine (VSV-hIFNβ-NIS) With or Without Cyclophosphamide and Combinations of Ipilimumab, Nivolumab, and Cemiplimab in Treating Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia or Lymphoma"; n 99; "Incidence of adverse events of grade 3 or higher"; 2032-04-01
NCT03069326
"A Clinical Study to Test the Effects of Ruxolitinib And Thalidomide Combination for Patients With Myelofibrosis"; n 30; "best objective response rate (ORR)"; 2027-02
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
NCT03120624
"VSV-hIFNbeta-NIS With or Without Ruxolitinib Phosphate in Treating Stage IV or Recurrent Endometrial Cancer"; n 34; "Participants Who Experienced a Dose-limiting Toxicity (DLT)"; 2028-01-01
NCT03286530
"Ruxolitinib + Allogeneic Stem Cell Transplantation in AML"; n 64; "1-year GVHD/relapse free survival rate (GRFS rate)"; 2026-12
NCT03571321
"Ruxolitinib and Chemotherapy in Adolescents and Young Adults With Ph-like Acute Lymphoblastic Leukemia"; n 15; "Feasibility of adding ruxolitinib to a standard-of-care pediatric-based chemotherapy regimen in adolescents and young adult patients as determined by rate of side effects seen when combination is given"; 2027-09-05
NCT03610971
"Treatment Free Remission After Combination Therapy With Ruxolitinib Plus Tyrosine Kinase Inhibitors"; n 24; "12 Month Treatment Free Remission (TFR)"; 2026-10
NCT03654768
"Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for Chronic Myeloid Leukemia"; n 81; "Rate of Molecular Response 4.5 (MR4.5)"; 2028-07-01
NCT03669965
"KRT-232 Compared to Ruxolitinib in Patients With Phlebotomy-Dependent Polycythemia Vera"; n 20; "Proportion of patients with splenomegaly achieving a response at Week 32"; 2022-10
NCT03674047
"Ruxolitinib for Bronchiolitis Obliterans Syndrome (BOS) After Allogeneic Hematopoietic Cell Transplantation (HCT)"; n 50; "absolute FEV1 increase"; 2025-12
NCT03681561
"Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma"; n 54; "Maximum Tolerated Dose"; 2027-07
NCT03722407
"Ruxolitinib for the Treatment of Chronic Myelomonocytic Leukemia (CMML): A Phase 2 Expansion"; n 29; "Overall Response"; 2027-05-01
NCT03801434
"Ruxolitinib in Treating Patients With Hypereosinophilic Syndrome or Primary Eosinophilic Disorders"; n 8; "Overall response rate (ORR)"; 2029-02
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which running trial of Ruxolitinib could settle lifespan?
NCT05622318 measures The number of subjects who experience GVHD-free survival., reading out 2026-09.
16 open trials; n 56; "De-escalated Cyclophosphamide (PTCy) and Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis"
Show the evidence
Trial
NCT05622318
"De-escalated Cyclophosphamide (PTCy) and Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis"; n 56; "The number of subjects who experience GVHD-free survival."; 2026-09
NCT03286530
"Ruxolitinib + Allogeneic Stem Cell Transplantation in AML"; n 64; "1-year GVHD/relapse free survival rate (GRFS rate)"; 2026-12
NCT07238712
"Optimization of Post-transplantation Benadamustine and Cyclophosphamide in Patients With High-risk Myeloid Malignancies and a Partially Mismatched Donor"; n 60; "Overall survival analysis"; 2026-12-10
NCT07249346
"Dose-Expansion Study of Low Dose Post-Transplant Cyclophosphamide/Tacrolimus/Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis in Myeloablative Allogeneic Peripheral Blood Stem Cell Transplantation"; n 124; "Severe acute GVHD-free Survival (SGFS)"; 2027-06-01
NCT06199427
"PTCy and and Ruxolitinib for GVHD Prophylaxis After HSCT With Thymoglobulin in Conditioning Regimen in Patients With Inborn Errors of Immunity"; n 100; "Event-free survival"; 2027-12-31
NCT05762640
"Ruxolitinib as First Line Treatment in Primary Haemophagocytic Lymphohistiocytosis (R-HLH)"; n 20; "Survival until HSCT"; 2028-03
10 further recorded trials
NCT05088356
"Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft"; n 66; "Determine the GVHD-free relapse-free survival (GRFS) post-HCT ( Arm-A)"; 2028-05
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
NCT07131059
"MRD-positive AML Clinical Study"; n 537; "relapse-free survival rate"; 2028-10-30
NCT07359859
"A Study of Ruxolitinib for Preventing Graft-Versus-Host Disease in People With a Hematologic Malignancy Who Will Receive a Stem Cell Transplant"; n 40; "assess cGVHD-free survival"; 2029-01
NCT06477549
"BeFluBu vs FluBuRux Conditioning in Haploidentical HCT"; n 220; "Event-free survival"; 2029-06
NCT07252050
"Ruxolitinib-Enhanced Haplo HCT for Children and Young Adults With Sickle Cell Disease"; n 24; "Event Free Survival"; 2029-11-19
NCT04116502
"MITHRIDATE: Ruxolitinib Versus Hydroxycarbamide or Interferon as First Line Therapy in High Risk Polycythemia Vera"; n 586; "Event Free Survival (EFS)"; 2030-04-01
NCT06991101
"Ruxolitinib With Radiation and Temozolomide Compared to Radiation and Temozolomide for Newly Diagnosed Glioblastoma"; n 190; "Overall survival (OS) at end of study"; 2030-12
NCT06615050
"A Study of Tacrolimus/Methotrexate/Ruxolitinib Versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation (BMT CTN 2203)"; n 572; "GVHD-free survival (GFS)"; 2031-01-17
NCT07297914
"Framework for Optimizing, Refining, and Unifying Management of HSCT in Pediatric ALL"; n 1000; "Event Free Survival (EFS)"; 2032-12-01
Q9
Which 39 trials of Ruxolitinib posted no result?
Posted no result
39 of 39 completed trials
Registrations
NCT02015208, NCT02960945, NCT02593760, NCT02253277, NCT01877005 and NCT02076191, and 33 more
Completion dates
oldest 2015-07; newest 2024-05-15
Show the evidence
Trial
NCT02015208
2015-07
NCT02960945
2017-03
NCT02593760
2017-07-12
NCT02253277
2018-04-03
NCT01877005
2018-06-12
NCT02076191
2018-07-20
14 further recorded trials
NCT02142036
2018-08
NCT01965119
2018-09-18
NCT02779283
2018-09-20
NCT01914484
2018-12-31
NCT01702064
2019-01-09
NCT02806375
2019-04
NCT02997280
2019-04
NCT01895842
2019-04-02
NCT02164500
2019-05-17
NCT03920852
2019-12-26
NCT01433445
2020-06-22
NCT04403243
2020-08-23
NCT03257644
2020-10-07
NCT02370706
2020-11-09
Q10
At the median, Ruxolitinib's trials enrolled 50 people — anything larger?
Median enrolment
50
Largest enrolment
5621
Registered trials counted
359
Q11
What do 7081 spontaneous reports say about Ruxolitinib — 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.
Ruxolitinib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 7081 reaction mentions were counted: anaemia 1171; fatigue 1106; haemoglobin decreased 990; platelet count decreased 977. open-targets-adr · CHEMBL1789941 · 2026-06-24
Show the evidence
anaemia
1171
fatigue
1106
haemoglobin decreased
990
platelet count decreased
977
thrombocytopenia
608
splenomegaly
541
4 more recorded rows
weight increased
518
platelet count increased
419
white blood cell count increased
408
contusion
343
recorded 2026-06-24 · last checked 2026-09-04
Q12
Ruxolitinib and CYP3A4, P-GP and BCRP: shared by which compounds?
CYP3A4, P-GP and BCRP appear in Ruxolitinib's recorded interaction sentences, 8 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP1A2pharmacokinetics
In Vitro Studies Cytochrome P450 (CYP) Enzymes: Ruxolitinib is not expected to inhibit CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 and CYP3A4 or induce CYP1A2, 2B6 and 3A4 following topical application.
CYP2C9pharmacokinetics
Metabolism Ruxolitinib is primarily metabolized by CYP3A4 and to a lesser extent by CYP2C9 in vitro.
CYP3A4
pharmacokinetics
Metabolism Ruxolitinib is primarily metabolized by CYP3A4 and to a lesser extent by CYP2C9 in vitro.
pharmacokinetics
In Vitro Studies Cytochrome P450 (CYP) Enzymes: Ruxolitinib is not expected to inhibit CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 and CYP3A4 or induce CYP1A2, 2B6 and 3A4 following topical application.
pharmacokinetics
CYP3A4 inducers: The C max and AUC of ruxolitinib decreased 32% and 61%, respectively, with the oral administration of 50 mg single dose of ruxolitinib following rifampin 600 mg once daily for 10 days, compared to receiving the oral ruxolitinib dose alone in healthy subjects.
pharmacokinetics
Strong CYP3A4 inhibitors : The C max and AUC of ruxolitinib increased 33% and 91%, respectively, with administration of 10 mg single dose orally following ketoconazole 200 mg twice daily for four days, compared to receiving the oral ruxolitinib dose alone in healthy subjects.
pharmacokinetics
Mild or moderate CYP3A4 inhibitors : There was an 8% and 27% increase in the C max and AUC of ruxolitinib, respectively, with the administration of 10 mg single dose orally following erythromycin, a moderate CYP3A4 inhibitor, at 500 mg twice daily for 4 days, compared to receiving the oral ruxolitinib dose alone in healthy subjects.
pharmacokinetics
There are no clinical studies conducted with mild CYP3A4 inhibitor.
recorded 2026-08-30 · last checked 2026-09-04
Q13
What is recorded about Ruxolitinib and mTOR?
"This review synthesizes evidence available up to June 2026 on second-line and salvage options that complement or follow ruxolitinib, including mesenchymal stromal cells, extracorporeal photopheresis administered alone or in combination with ruxolitinib, mammalian target of rapamycin (mTOR) inhibitors with or without interleukin-2…" — where Ruxolitinib and mTOR appear together. Europe PMC · pathway abstract search · 2026-08-31
"This review synthesizes evidence available up to June 2026 on second-line and salvage options that complement or follow ruxolitinib, including mesenchymal stromal cells, extracorporeal photopheresis administered alone or in combination with ruxolitinib, mammalian target of rapamycin (mTOR) inhibitors with or without interleukin-2 receptor antagonists (IL-2RAs), the humanized anti-CD25 monoclonal…"
PMID 42673530
"We propose an evidence-based clinical sequencing algorithm that integrates ruxolitinib, MSCs, extracorporeal photopheresis (ECP), mTOR-targeted salvage, ATG, and clinical trial enrollment and supportive-care priorities, including infectious prophylaxis and organ-specific management."
AMPK
"Ruxolitinib demonstrated significantly tumor-suppressive effects on BRMM both <italic>in vitro</italic> and <italic>in vivo</italic> via down-regulation of CaMKII-γ-AMPK-ULK1 axis-mediated autophagy pathway."
autophagy
"Ruxolitinib demonstrated significantly tumor-suppressive effects on BRMM both <italic>in vitro</italic> and <italic>in vivo</italic> via down-regulation of CaMKII-γ-AMPK-ULK1 axis-mediated autophagy pathway."
senolytic
PMID 41462575
"Consistent with this, a JAK/STAT inhibitor, Ruxolitinib, which attenuates the pro-inflammatory SASP of senescent human preadipocytes, caused them to become "senolytic-resistant"."
"Consistent with this, a JAK/STAT inhibitor, Ruxolitinib, which attenuates the pro-inflammatory SASP of senescent human preadipocytes, caused them to become “senolytic-resistant”."
autophagyPMID 40645297
"Mechanistically, the enhancement of mitochondrial autophagy and the amelioration of renal fibrosis by ruxolitinib might be mediated via the PINK1/Parkin pathway."
mTORPMID 40407951
"Promising results have been observed with mTOR inhibitors like CC-115 and Vistusertib, especially when combined with immune checkpoint inhibitors, and with JAK inhibitors such as Ruxolitinib, AZD4205, and Filgotinib."
autophagyPMID 37423955
"Here, we demonstrate that ruxolitinib induced autophagy in JAK2<sup>V617F</sup> cell lines and primary MPN patient cells through the activation of protein phosphatase 2A (PP2A)."
senolyticPMID 38976646
"Fibroblast activation by CM transfer is attenuated by pre-treatment of senescent AECs with the senolytic Navitoclax and AD80, but not with the standard of care agent Nintedanib or senomorphic JAK-targeting drugs (e.g., ABT-317, ruxolitinib)."
recorded 2026-08-31 · last checked 2026-09-04
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