This page shows what was measured, who it was measured in, and what that does not settle.
What Vedolizumab does in the body
ENTYVIO is indicated in adults for the treatment of: moderately to severely active ulcerative colitis (UC). moderately to severely active Crohn's disease (CD).
From the FDA-approved label: Vedolizumab is a humanized monoclonal antibody that specifically binds to the α4β7 integrin and blocks the interaction of α4β7 integrin with mucosal addressin cell adhesion molecule-1 (MAdCAM-1) and inhibits the migration of memory T-lymphocytes across the endothelium into inflamed gastrointestinal parenchymal tissue. Vedolizumab does not bind to or inhibit function of the α4β1 and αEβ7 integrins and does not antagonize the interaction of α4 integrins with vascular cell adhesion molecule-1 (VCAM-1). The α4β7 integrin is expressed on the surface of a discrete subset of memory T-lymphocytes that preferentially migrate into the gastrointestinal tract.
Why people take it. ENTYVIO is indicated in adults for the treatment of: moderately to severely active ulcerative colitis (UC). moderately to severely active Crohn's disease (CD).
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 protein.
FDA substance registry · 9RV78Q2002 · read 2026-08-29
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 154 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.
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.
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
Healthy ageing
…Waiting for a reviewer2 registered study measure of this kind. No reviewed result yet.
∅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.
∅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.
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.
Which registered measures put each goal on this table
Healthy ageing
transplant associated mortality; non relapse mortality
Body weight
teae related to body weight
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
… Waiting for a reviewer
2 registered study measure of this kind. No reviewed result yet.
∅ Nothing in the sources checked
No registered study lists a performance measure for this goal.
— Not recorded
Harms were not a registered measure for this goal.
△ Only a number moved
1 registered test measure.
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.
Relation between biological parameters (fecal and ileal microbiome) and outcomes of IBD
✗ The study did not show it
Who was studied
NCT07172945
How many people
4500
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous
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
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Percentage of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
✗ The study did not show it
Who was studied
NCT00790933
How many people
2243
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. Intravenous
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
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6
✗ The study did not show it
Who was studied
NCT00783692
How many people
1116
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. Intravenous
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
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Proportion of patients who have lost response to biotherapies (anti-TNF, ustekinumab, vedolizumab).
✗ The study did not show it
Who was studied
NCT03809728
How many people
1000
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous
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
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Induction Study - Number of Participants With Clinical Remission at Week 8 (As Per Global Definition)
✗ The study did not show it
Who was studied
NCT02407236
How many people
961
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. Intravenous
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
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Genotypes of IL-7R
✗ The study did not show it
Who was studied
NCT07398586
How many people
898
Study design
Phase 4
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. Intravenous
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
FDA label (openFDA SPL) · 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.16 registered measures of this kind. No reviewed result.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
□Symptoms and quality of lifeNo evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
■A number that stands in for healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.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.
□AnimalsNo evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
□Cells in a dishNo evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
No registered study measured anything of this kind.
Measured
Things only a test, a scale or a device shows.
teae related to body weight
Meaningful
Things that change how a life goes, not only a number.
who achieved clinical remission
clinical and endoscopic remission
achieving endoscopic remission at week 26
endoscopic remission
clinical remission
clinical remission at week 8
remission
clinical remission/response rate of immune mediated colitis
endoscopic remission rate at 12 months
endoscopic remission rate at week 12
and 6 more.
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 (23)
adverse events
clinically significant laboratory findings
teae related to electrocardiogram
crohn s disease activity index
adverse events of special interest
mucosal healing week 2
dose limiting toxicities
adverse events and serious adverse events
harvey bradshaw index
clinical response
treatment emergent adverse events
clinical response at week 6
treatment related adverse events as assessed by ctcae v4 0
transcriptomic features
difference in stool microbiome pattern
treatment related adverse events
dose of prednisolone
postoperative endoscopic recurrence
need for unscheduled treatment adaptation prior to week 86
overall response rate at day 28
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What it would be like to take◇Read from sources, not yet reviewed
How long anything takes
Nine different lengths of time that get confused with each other. None of them is worked out from another.
Before anything is noticed.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before a test result moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before performance moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
How long the result was watched.No finished study window is recorded for a study that tested this substance.
How long people took it.How long people actually took it is not stored. The study window is not the same thing.
How long people were followed.Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.
How fast the body clears it. 26 days
Read from the label, which states: “Population pharmacokinetic analyses indicated that the linear clearance was approximately 0.16 L/day, the serum half-life was approximately 26 days, and the distribution volume was approximately 5 L.”
How long effects linger.RNAWiki does not store this separately, and never works it out from another figure on this page.
Beyond the studies. Nothing is recorded about the long term.
The longest finished study sets the edge of what anyone measured.
A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.
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.
ENTYVIO is indicated in adults for the treatment of: moderately to severely active ulcerative colitis (UC). moderately to severely active Crohn's disease (CD). ENTYVIO is an integrin receptor antagonist indicated in adults for the treatment of: moderately to severely active ulcerative colitis (UC). ( 1 ) moderately to severely active Crohn's disease (CD). ( 1 )
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “Safety and effectiveness of ENTYVIO in pediatric patients have not been established.”
US prescribing information · 6e94621c-1a95-4af9-98d1-52b9e6f1949c · read 2026-08-30
On older people, the label states: “Clinical trials of ENTYVIO did not include sufficient numbers of patients aged 65 and over (72 patients with Crohn's disease or ulcerative colitis aged 65 and over were treated with ENTYVIO during controlled Phase 3 trials) to determine whether they respond differently from younger adult patients.”
US prescribing information · 6e94621c-1a95-4af9-98d1-52b9e6f1949c · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Available data from the Organization of Teratology Information Specialists (OTIS)/MotherToBaby ENTYVIO Pregnancy Registry, published literature and pharmacovigilance in pregnant women have not reliably identified an ENTYVIO-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes (see Data ) .”
US prescribing information · 6e94621c-1a95-4af9-98d1-52b9e6f1949c · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary Data from a clinical lactation study show the presence of vedolizumab in human milk.”
US prescribing information · 6e94621c-1a95-4af9-98d1-52b9e6f1949c · 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.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Given by a clinician
❝ 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
Intravenous
✎ 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.
No source is stored against this line.
What is in the pack
Sold as injectable, injection, solution, injection, powder, lyophilized, for solution, given by the intravenous, subcutaneous, injection route.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take∅Nothing found in the sources checked
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
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.
Vedolizumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 5854 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
colitis ulcerative — 1666 reaction mentions
crohn's disease — 1409 reaction mentions
abdominal pain — 671 reaction mentions
pregnancy — 432 reaction mentions
haematochezia — 401 reaction mentions
frequent bowel movements — 351 reaction mentions
therapeutic reaction time decreased — 284 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
Intravenous
✎ 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
10 products list this as an active ingredient in the United States drug directory. 10 of them contain it and nothing else.
FDA National Drug Code directory · 11532-3002 · read 2026-08-29
They are sold as injection, powder, lyophilized, for solution, injection, solution and liquid, taken intravenous and subcutaneous.
FDA National Drug Code directory · 11532-3002 · read 2026-08-29
The regulator's established pharmacologic class for it is integrin receptor antagonist [epc] and integrin receptor antagonists [moa].
FDA National Drug Code directory · 11532-3002 · 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 · 6e94621c-1a95-4af9-98d1-52b9e6f1949c · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 6e94621c-1a95-4af9-98d1-52b9e6f1949c · read 2026-08-29
ENTYVIO is subcutaneous at 3 DOSAGE FORMS AND STRENGTHS Intravenous infusion For injection: 300 mg vedolizumab in a single-dose vial., recorded as fda label in effect 2026-04-29 in the United States.
US prescribing information · 6e94621c-1a95-4af9-98d1-52b9e6f1949c · 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 take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Vedolizumab studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Vedolizumab 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.
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9RV78Q2002
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1538137
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3 approved applications cover products containing this substance. The earliest was BLA125476, approved 20140520 to TAKEDA PHARMS USA.
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Recorded evidence blocks (12)
Q2
What did Vedolizumab's largest trial (5302 people) and its longest (11 years) measure?
5302 people in Vedolizumab's largest registered study, 11 years in its longest registered window, measuring safety index (Chronic steroid-use ≥ 20 mg for ≥ 6 months, New secreting fistula, Op caused by stenosis, Mortality (all), Hospitalization > 14 days, Long-term-illness (with > 30 days off work), Early… ClinicalTrials.gov · 2026-09-01
32 phase4, 25 phase3, 23 phase2, 18 na or unstated, 8 phase1, 4 na, 3 early phase1; NCT03219359; 2028-10; no ageing endpoint recorded. Last human test completed 2026, NCT04002180.
Interpretation These counts include studies where Vedolizumab 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
phase4
32
phase3
25
phase2
23
na or unstated
18
phase1
8
na
4
2 more recorded rows
early phase1
3
Last recorded human testNCT04002180
2026-03-25
recorded 2026-09-01 · last checked 2026-09-04
Q3
Vedolizumab was tested only in human — what did it show?
safety index (Chronic steroid-use ≥ 20 mg for ≥ 6 months, New secreting fistula, Op caused by stenosis, Mortality (all), Hospitalization > 14 days,… — the recorded outcome words.
Show the evidence
humanNCT03375424
lifespan; safety index (Chronic steroid-use ≥ 20 mg for ≥ 6 months, New secreting fistula, Op caused by stenosis, Mortality (all), Hospitalization > 14 days, Long-term-illness (with > 30 days off work), Early retirement); 109
recorded 2026-09-01 · last checked 2026-09-04
Q4
16 of Vedolizumab's trials stopped: safety, futility/efficacy, accrual/recruitment, funding/business, other?
safety (2), futility/efficacy (1), accrual/recruitment (8), funding/business (1) and other (4): Vedolizumab's stop wording, clustered. ClinicalTrials.gov · 2026-09-01
"Difficult recruitment"; 16 of 109 registered studies
terminated; "Early Completed - Alternative Source of Drug Available"
NCT02760615
withdrawn; "No enrollment"
NCT02768532
terminated; "low inclusion rates"
NCT02820493
withdrawn; "Internal problems"
10 further recorded trials
NCT02834754
withdrawn; "Limited time for enrollment of required number of subjects"
NCT02878083
terminated; "the CELLVIZIO device required to analyse biopsy is available until september 2020"
NCT02929316
terminated; "Lack of enrollment"
NCT02954159
terminated; "insufficient enrollment"
NCT02993783
terminated; "Lack of efficacy of the drug; no safety concern"
NCT03237260
withdrawn; "No patient accrual"
NCT03309865
withdrawn; "Not enough patients to enroll."
NCT03802214
terminated; "Funding discontinued"
NCT06570772
terminated; "The study has been terminated based on Sponsor decision. This decision is not related to any safety concerns associated with the investigational products. It is related to the fact that study will be not required for product dossier…"
NCT06646016
withdrawn; "Study Withdrawn by Sponsor prior to Enrollment."
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Vedolizumab used Vedolizumab 300 mg — over how long?
4 recorded entries; human; IV; also "Vedolizumab 300 mg", "Vedolizumab 300 MG Injection [Entyvio]", "Entyvio for IV Infusion 300 mg"
Show the evidence
human
NCT02646657
Vedolizumab 300 mg
NCT03142321
Vedolizumab 300 MG Injection [Entyvio]
NCT03824561
IV; Entyvio for IV Infusion 300 mg
NCT06609447
Vedolizumab 300 mg Injection
recorded 2026-09-01 · last checked 2026-09-04
Q6
Vedolizumab's half-life is 26 days — which schedules were studied?
26 days, the half-life Vedolizumab's label states. openfda-label · 6e94621c-1a95-4af9-98d1-52b9e6f1949c · 2026-08-30
Show the evidence
half life
26 days; Population pharmacokinetic analyses indicated that the linear clearance was approximately 0.16 L/day, the serum half-life was approximately 26 days, and the distribution volume was approximately 5 L.
bioavailability
The bioavailability of vedolizumab following a 108 mg single-dose subcutaneous injection relative to a 300 mg single-dose intravenous infusion in healthy subjects was approximately 75%.
recorded 2026-08-30 · last checked 2026-09-04
Q7
Which of 8th week endoscopic remission rate, achieving clinical remission based on the cdai at week 12 and achieving endoscopic remission at week 26 did Vedolizumab's trials measure?
8th week endoscopic remission rate, achieving clinical remission based on the cdai at week 12 and achieving endoscopic remission at week 26 lead 40 outcome terms across Vedolizumab's trials. ClinicalTrials.gov · 2026-09-01
teae related to electrocardiogram, crohn s disease activity index, who achieved clinical remission, clinical and endoscopic remission, adverse events of special interest and mucosal healing week 2 follow.
Show the evidence
adverse events
1
clinically significant laboratory findings
1
teae related to body weight
1
teae related to electrocardiogram
1
crohn s disease activity index
1
who achieved clinical remission
1
14 more recorded rows
clinical and endoscopic remission
1
adverse events of special interest
1
mucosal healing week 2
1
dose limiting toxicities
1
adverse events and serious adverse events
1
achieving endoscopic remission at week 26
1
harvey bradshaw index
1
endoscopic remission
1
clinical remission
1
clinical response
1
treatment emergent adverse events
1
clinical response at week 6
1
clinical remission at week 8
1
treatment related adverse events as assessed by ctcae v4 0
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Vedolizumab's 36 ongoing trials reports first?
Change in Crohn's Disease Activity Index (CDAI); Difference in stool microbiome pattern; latest 2033-02-07
Show the evidence
Trial
NCT03219359
"Autologous Stem Cell Transplant for Crohn's Disease"; n 50; "Change in Crohn's Disease Activity Index (CDAI)"; 2028-10
NCT03819296
"Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer"; n 800; "Difference in stool microbiome pattern"; 2026-10-31
NCT04259138
"Determination of the Optimal Treatment Target in Ulcerative Colitis"; n 672; "Difference in Time to UC-related Complication Between Treatment Target Groups 1 and 3"; 2026-03-31
NCT04407247
"Infliximab or Vedolizumab in Treating Immune Checkpoint Inhibitor-Related Colitis in Patients With Genitourinary Cancer or Melanoma"; n 47; "Clinical remission/response rate of immune-mediated colitis (IMC)"; 2027-12-31
NCT04738942
"A Study of Intravenous Vedolizumab Administered Every 4 Weeks in Japanese Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease"; n 56; "UC Cohort: Percentage of Participants With Clinical Response at Week 12 Based on Modified Mayo Score"; 2027-11-30
NCT04779320
"A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)"; n 120; "Percentage of Participants With Clinical Remission at Week 54 Based on Pediatric Crohn's Disease Activity Index (PCDAI) Score ≤10"; 2027-09-13
14 further recorded trials
NCT05169593
"Prevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic Biological Therapy"; n 292; "postoperative endoscopic recurrence (Rutgeerts score ≥i2b)"; 2030-10
NCT05442567
"A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)"; n 240; "Treatment Cohort: Number of Participants With at Least One Adverse Event (AE)"; 2033-02-07
NCT05481619
"Study of the Effect of Vedolizumab on Intestinal Microecological Changes and Its Efficacy in the Treatment of Ulcerative Colitis"; n 30; "Remission rate of patients"; 2026-01-01
NCT06045754
"A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease"; n 50; "Part A: Percentage of Participants With an Endoscopic Response Based on the Simple Endoscopic Score for (SES-CD) at Week 26"; 2027-06-28
NCT06095128
"A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)"; n 65; "Percentage of Participants Achieving Clinical Remission at Week 8 Based on Complete Mayo Score"; 2027-07-09
NCT06095596
"Efficacy and Safety of Vedolizumab Combined With Upadacitinib in Patients With Ulcerative Colitis"; n 334; "8th-week endoscopic remission rate"; 2026-10-31
NCT06100289
"A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease"; n 70; "Ctrough,ss: Steady-state Median Observed Plasma Concentration at the End of a Dosing Interval for Vedolizumab at Week 34"; 2028-05-16
NCT06180382
"Comparison of Vedolizumab Treatment to Adalimumab Dose Intensification in Crohn's Disease Patients With Loss of Response or Biomarker Activity to Adalimumab on First Line With Therapeutic Drug Concentration."; n 220; "ADA optimized versus Vedolizumab as second line"; 2028-10-31
NCT06227910
"A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease"; n 396; "Percentage of Participants Achieving Clinical Remission Based on the CDAI at Week 12"; 2028-08-01
NCT06249555
"VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study"; n 300; "To assess time of onset of biologic therapy in pain interference"; 2026-12
NCT06257706
"VECTORS - A Study to Evaluate Transmural Healing as a Treatment Target in Crohn's Disease"; n 304; "Percentage of participants with Corticosteroid-free Endoscopic remission in group 1 and group 2 at week 48"; 2029-02-06
NCT06317220
"Vedolizumab for the Treatment of Collagenous Gastritis"; n 11; "Change in symtpoms"; 2026-10
NCT06337695
"Vedolizumab for the Prevention of ICI Related Diarrhea or Colitis in Patients With Cancer"; n 36; "To establish the feasibility of the VERIFY protocol and determine progression to the full trial"; 2030-12-01
NCT06405087
"A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)"; n 70; "Treatment Cohort: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)"; 2030-08-12
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which running trial of Vedolizumab could settle inflammatory markers?
NCT07177209 measures Proportion of patients that achieve early control of inflammation on conventional therapeutics within 6-24 months of UC diagnosis., reading out 2026-07-31.
1 open trial; n 4000; "Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population"
Show the evidence
TrialNCT07177209
"Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population"; n 4000; "Proportion of patients that achieve early control of inflammation on conventional therapeutics within 6-24 months of UC diagnosis."; 2026-07-31
Q10
Which 10 trials of Vedolizumab posted no result?
Posted no result
10 of 10 completed trials
Registrations
NCT02712866, NCT02953275, NCT02646657, NCT03629379, NCT02674308 and NCT02694588, and 4 more
Completion dates
oldest 2019-02; newest 2024-01-10
Show the evidence
Trial
NCT02712866
2019-02
NCT02953275
2019-06-13
NCT02646657
2020-08
NCT03629379
2021-07-01
NCT02674308
2021-07-30
NCT02694588
2021-12
4 further recorded trials
NCT02862132
2022-01
NCT02678052
2022-07-31
NCT02646683
2023-05-26
NCT05281614
2024-01-10
Q11
At the median, Vedolizumab's trials enrolled 100 people — anything larger?
Median enrolment
100
Largest enrolment
5302
Registered trials counted
109
Q12
What do 5854 spontaneous reports say about Vedolizumab — 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.
Vedolizumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 5854 reaction mentions were counted: colitis ulcerative 1666; crohn's disease 1409; abdominal pain 671; pregnancy 432. open-targets-adr · CHEMBL1743087 · 2026-06-24
Show the evidence
colitis ulcerative
1666
crohn's disease
1409
abdominal pain
671
pregnancy
432
haematochezia
401
frequent bowel movements
351
4 more recorded rows
therapeutic reaction time decreased
284
clostridium difficile infection
234
rectal haemorrhage
205
intestinal obstruction
201
recorded 2026-06-24 · last checked 2026-09-04
Q13
Vedolizumab and CYP450: shared by which compounds?
CYP450 appear in Vedolizumab's recorded interaction sentences, 3 in all. openfda-label+europepmc · 2026-04-29
Interpretation drug_interactions
Show the evidence
CYP450
drug_interactions
7.3 CYP450 Substrates The formation of CYP450 enzymes may be suppressed by increased levels of certain cytokines (e.g., IL-6, IL-10, TNFα, IFN) during chronic inflammation.
drug_interactions
Therefore, use of ENTYVIO may normalize the formation of CYP450 enzymes by modulating the underlying disease.
drug_interactions
Upon initiation or discontinuation of ENTYVIO in patients treated with CYP450 substrates, monitor drug concentrations or other therapeutic parameters, and adjust the dosage of the CYP substrate as needed.
recorded 2026-04-29 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
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