This page shows what was measured, who it was measured in, and what that does not settle.
What Ustekinumab does in the body
Ustekinumab grabs that shared block, so both messengers are neutralised at once.
Two inflammatory messengers, IL-12 and IL-23, are built from two protein blocks each and they share one block, called p40. Skin cells stop being told to divide, and the plaques thin out over weeks. One injection lasts three months.
Why people take it. Psoriasis, psoriatic arthritis and inflammatory bowel disease
What happened in people
PASI 75 at week 12 in 67.1% and 66.4% versus 3.1% on placebo
✎ 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 recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.
That blocking IL-12 contributes to the psoriasis benefit; IL-23-only successors clear skin better
Where it acts
Skin dermis, synovium and intestinal lamina propria
Kind of result
The kind of result is not recorded
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 · FU77B4U5Z0 · read 2026-08-29
Where each sentence above came from
A person wrote this explanation into the record, with the studies named in the path below.
The recorded use, written for a reader without medical training. Not signed off.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 74 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.
Absolute difference
An absolute difference is how many more people in a hundred were affected.
A picture of it, and where the picture fails
It is like counting heads in two rooms of a hundred.
Where that stops being true. Heads are easy to count. Study results carry a margin of error too.
What people get wrong. It is confused with a percentage change, which can look far larger.
The arithmetic difference in event rates between arms.
Confidence interval
A confidence interval is the range the true answer is likely to sit in.
A picture of it, and where the picture fails
It is like a weather forecast giving a range rather than one number.
Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.
What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.
An interval estimate that would contain the true parameter in a stated proportion of repeated studies.
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
Focus
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
…Waiting for a reviewer1 registered performance measure of this kind.
∅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.
Which registered measures put each goal on this table
Focus
who develop cognitive decline
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.
… Waiting for a reviewer
1 registered performance measure of this kind.
— Not recorded
Harms were not a registered measure for this goal.
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.
Results from the one trial this record names
In NCT01369329, Number of participants with clinical response at Week 6, defined as a reduction from baseline in the Crohn's Disease Activity Index score of at least 100 points: primary outcome, comparing a single intravenous ustekinumab 130 mg dose with placebo (a third group received a tiered dose of about 6 mg/kg and is not recorded here) was Ustekinumab: 84 of 245 participants against Placebo: 53 of 247 participants in the comparison group at Baseline and Week 6. (p=0.002 (Cochran-Mantel-Haenszel chi-square test))
ClinicalTrials.gov record · NCT01369329 · read 2026-08-28
PASI 75 at week 12
✓ The study showed what it set out to show
Who was studied
PHOENIX 1 (NCT00267969)
How many people
766
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
p < 0.0001; 63.9 percentage point difference versus placebo (95% CI 57.8-70.1)
Repeated elsewhere
Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
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. Subcutaneous prefilled syringe, with weight-based intravenous induction in inflammatory bowel disease
Interval reported. 95% CI 57
Written into the record, not signed off as a reviewed claim.
RNAWiki holds 2 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.3 registered measures of this kind. No reviewed result.
■What a body can do day to dayEvidence recorded. Walking, dressing, breathing, recovering.1 registered measure of this kind.
■Measured performanceEvidence recorded. How much was lifted, how far was run, how fast.1 registered measure of this kind.
■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.6 registered measures 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 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 changes in the body◇Read from sources, not yet reviewed
The path through the body
From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.
Where a source records it acting
Immune and lymphatic system: Binds the p40 protein subunit shared by the IL-12 and IL-23 cytokines, which are involved in inflammatory and immune responses such as natural killer cell activation and CD4+ T-cell differentiation and activation
US prescribing information · c77a9664-e3bb-4023-b400-127aa53bca2b · read 2026-08-28
Skin: In a small exploratory trial, a decrease was observed in the expression of mRNA of its molecular targets IL-12 and IL-23 in lesional skin biopsies of subjects with plaque psoriasis
US prescribing information · c77a9664-e3bb-4023-b400-127aa53bca2b · read 2026-08-28
Start
Ustekinumab
What a person takes: Subcutaneous prefilled syringe, with weight-based intravenous induction in inflammatory bowel disease.
The measurement behind this step
45 mg or 90 mg subcutaneously at weeks 0 and 4 then every 12 weeks in psoriasis, dosed by body weight above and below 100 kg. Bowel disease starts with a single weight-based infusion.
Getting in
Intravenous induction then subcutaneous maintenance
In bowel disease the first dose goes into a vein to load quickly; in skin disease it is injected under the skin from the start. Maintenance is one injection every eight or twelve weeks.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Weight-based intravenous induction in inflammatory bowel disease, 45 mg or 90 mg subcutaneously in psoriasis at weeks 0 and 4 then every 12 weeks. Terminal half-life is approximately three weeks.
It reaches the tissues where dendritic cells are broadcasting the inflammatory signal to the T cells around them.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Distributes into inflamed dermis, synovium and intestinal lamina propria where activated myeloid dendritic cells and macrophages secrete IL-12 and IL-23.
Both messengers are built from two blocks and share one. The antibody grabs the shared block, so neither can dock onto a T cell.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Binds the p40 subunit common to IL-12 (p35 with p40) and IL-23 (p19 with p40), preventing engagement of IL-12Rbeta1 on T cells and natural killer cells. The IgG1 Fc is intact but the target is a soluble cytokine, so effector function is not the point.
Without the IL-23 signal, the T cells that had been producing the skin-thickening messenger stop being maintained, and the loop that kept the plaque alive runs down.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Loss of IL-23R signalling removes STAT3-dependent maintenance of Th17 and gamma-delta T cell populations, cutting IL-17A, IL-17F and IL-22 output. Blocking IL-12 additionally cuts STAT4-dependent interferon-gamma production, which appears to contribute little to psoriasis benefit.
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
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.
short inflammatory bowel disease questionnaire
Measured
Things only a test, a scale or a device shows.
maximum observed plasma concentration
vascular inflammation
biomarker assessment
c reactive protein concentration
maximum observed serum concentration
time to reach maximum observed serum concentration
Meaningful
Things that change how a life goes, not only a number.
who experienced psoriasis relapse
who develop cognitive decline
clinical remission at week 52
hospitalized infection or death
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 (29)
an american college of rheumatology 20 response at week 12
predicted forced vital capacity at week 16
american college of rheumatology 20 response at week 24
coronary calcium
repeated coronary ct angiography
psoriasis area severity index
static physician global assessment success at week 12
psoriasis area severity index 75 at week 12
psoriasis area severity index 100 at week 12
t regulatory cell /total cluster of differentiation 4 +
major structural malformations
primary safety endpoints
safety and tolerability
pasi improvement
iga mod 2011 0 or 1 at week 12
endoscopic response at week 48
adverse events
a psoriasis area and severity index 90 response at week 16
an investigator s global assessment response at week 16
transcriptomic features
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. mean half-life ranged from 14.9 ± 4.6 to 45.6 ± 80.2 days
Read from the label, which states: “The mean (±SD) half-life ranged from 14.9 ± 4.6 to 45.6 ± 80.2 days across all trials in subjects with plaque psoriasis following subcutaneous administration.”
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.
Adults and adolescents with moderate-to-severe plaque psoriasis, adults with active psoriatic arthritis, and adults with Crohn disease or ulcerative colitis, usually after failing conventional therapy or an anti-TNF agent.
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.
Who a named study recorded including and excluding
It included: Have Crohn's disease of at least 3 months' duration with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, or endoscopy; Have active Crohn's disease, defined as a baseline Crohn's Disease Activity Index (CDAI) score of greater than or equal to 220 and less than or equal to 450; Have received infliximab, adalimumab, or certolizumab pegol at a dose approved for the treatment of Crohn disease and did not respond initially (ie, primary nonresponse), or responded initially but then lost response with continued therapy (ie, secondary nonresponse), or were intolerant to the medication; Have screening laboratory test results within protocol-specified parameters.
ClinicalTrials.gov record · NCT01369329 · read 2026-08-28
It excluded: Patients who have had any kind of bowel resection within 6 months; Are pregnant or planning pregnancy (both men and women) while enrolled in the study or for 20 weeks after receiving study agent; Patients who have received infliximab, adalimumab or certolizumab pegol less than or equal to 8 weeks before the first administration of study drug; Patients with certain complications of Crohn's disease that would make it hard to assess response to study drug; Patients with a history of or ongoing chronic or recurrent infectious disease; Patients who have previously received a biologic agent targeting IL-12 or IL-23, including but not limited to ustekinumab (CNTO 1275) or briakinumab (ABT-874).
ClinicalTrials.gov record · NCT01369329 · read 2026-08-28
What the label states about particular groups
On pediatric, the label states: “The safety and effectiveness of Ustekinumab-aauz have not been established in pediatric patients less than 6 years of age with plaque psoriasis.”
US prescribing information · a6d75316-c9a7-49cf-83be-b7b6c6cecf7a · read 2026-08-30
On older people, the label states: “Clinical trials of ustekinumab 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 · a6d75316-c9a7-49cf-83be-b7b6c6cecf7a · 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 Pregnancy Registry, published literature and pharmacovigilance in pregnant women have not identified a ustekinumab associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes ( see Data ).”
US prescribing information · a6d75316-c9a7-49cf-83be-b7b6c6cecf7a · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary Limited data from published literature suggests that ustekinumab is present in human breast milk.”
US prescribing information · a6d75316-c9a7-49cf-83be-b7b6c6cecf7a · read 2026-08-30
Where the result stopped carrying
The 249-patient phase 2 multiple sclerosis trial found no effect on new inflammatory brain lesions
The p40 target was superseded within a decade by p19-specific antibodies that proved superior head to head in psoriasis
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
Subcutaneous prefilled syringe, with weight-based intravenous induction in inflammatory bowel disease
✎ 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
45 mg or 90 mg subcutaneously at weeks 0 and 4 then every 12 weeks in psoriasis, dosed by body weight above and below 100 kg. Bowel disease starts with a single weight-based infusion.
✎ 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.
The recorded stepping schedule
What follows is the schedule printed on the label, recorded as it is written there. It is a record of what was done, not a recommendation.
US prescribing information · c77a9664-e3bb-4023-b400-127aa53bca2b · read 2026-08-28
Initially and 4 weeks later — adults with plaque psoriasis weighing 100 kg or less: 45 mg subcutaneously
US prescribing information · c77a9664-e3bb-4023-b400-127aa53bca2b · read 2026-08-28
Thereafter — adults with plaque psoriasis weighing 100 kg or less: 45 mg every 12 weeks
US prescribing information · c77a9664-e3bb-4023-b400-127aa53bca2b · read 2026-08-28
Initially and 4 weeks later — adults with plaque psoriasis weighing more than 100 kg: 90 mg subcutaneously
US prescribing information · c77a9664-e3bb-4023-b400-127aa53bca2b · read 2026-08-28
Thereafter — adults with plaque psoriasis weighing more than 100 kg: 90 mg every 12 weeks
US prescribing information · c77a9664-e3bb-4023-b400-127aa53bca2b · read 2026-08-28
What it would be like to take◇Read from sources, not yet reviewed
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.
·Worth asking a clinician aboutWritten into the record from the studies named on this page
No boxed warning. Serious infection and reactivation of latent tuberculosis are the principal risks, and screening before treatment is required. Reversible posterior leukoencephalopathy syndrome has been reported rarely.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
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.
Ustekinumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 10423 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
psoriasis — 1795 reaction mentions
pneumonia — 1374 reaction mentions
crohn's disease — 1298 reaction mentions
hypersensitivity — 997 reaction mentions
drug intolerance — 938 reaction mentions
infusion related reaction — 847 reaction mentions
synovitis — 811 reaction mentions
rheumatoid arthritis — 806 reaction mentions
treatment failure — 806 reaction mentions
alopecia — 751 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
Subcutaneous prefilled syringe, with weight-based intravenous induction in inflammatory bowel disease
✎ 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
Bowel disease starts with a single weight-based infusion.
✎ 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 which forms are sold and how they compare.
No source is stored against this line.
What is recorded as being sold
48 products list this as an active ingredient in the United States drug directory. 48 of them contain it and nothing else.
FDA National Drug Code directory · 72606-028 · read 2026-08-29
They are sold as injection, injection, solution, injection, solution, concentrate and solution, taken intravenous and subcutaneous.
FDA National Drug Code directory · 72606-028 · read 2026-08-29
The regulator's established pharmacologic class for it is interleukin-12 antagonist [epc], interleukin-12 antagonists [moa] and interleukin-23 antagonist [epc].
FDA National Drug Code directory · 72606-028 · read 2026-08-29
11 published labels name it as an active ingredient. 11 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · e8a14922-7902-4d9f-8ba5-d91dccffed29 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · e8a14922-7902-4d9f-8ba5-d91dccffed29 · read 2026-08-29
Stelara is injection: solution in a single-dose prefilled syringe or single-dose vial (subcutaneous), and solution in a single-dose vial (intravenous infusion) at Subcutaneous: 45 mg/0.5 mL or 90 mg/mL prefilled syringe, 45 mg/0.5 mL vial. Intravenous: 130 mg/26 mL (5 mg/mL) vial, recorded as prescription product; fda label in effect 2026-07-21 in the United States.
US prescribing information · c77a9664-e3bb-4023-b400-127aa53bca2b · read 2026-08-28
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Ustekinumab 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
Claims that go past the evidence
Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.
✗Goes past the evidence
That blocking IL-12 contributes to the psoriasis benefit; IL-23-only successors clear skin better
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That a 12-week dosing interval maintains control in every patient, when the trials permitted intensification and real-world practice uses it
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
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 Ustekinumab are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Every line above can be traced to the study named beside it. Follow the link and read it.
PHOENIX 1 and PHOENIX 2: PASI 75 in about two-thirds against 3-4% on placebo
In plain words
In 766 and 1,230 people with moderate-to-severe psoriasis, roughly two-thirds reached a 75% improvement in skin severity at 12 weeks compared with three or four in a hundred on placebo, and quarterly dosing held that response for a year.
What was measured
PASI 75 at week 12: 67.1% and 66.4% versus 3.1% placebo
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
PHOENIX 1 randomised 766 patients to ustekinumab 45 mg, 90 mg or placebo at weeks 0 and 4 then every 12 weeks. PASI 75 at week 12 was 67.1% and 66.4% against 3.1% on placebo, a 63.9 percentage point difference (95% CI 57.8-70.1). A randomised withdrawal design at week 40 showed maintenance dosing preserved response better than withdrawal. PHOENIX 2 reproduced the result in a larger cohort.
Written into the record, not signed off as a reviewed claim
UNITI: induction and maintenance of remission in Crohn disease
In plain words
The same antibody induced and maintained remission in Crohn disease, including in people whose disease had already failed anti-TNF therapy.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The UNITI programme comprised two eight-week induction trials, one in patients who had failed anti-TNF therapy and one in patients who had failed conventional therapy, and a 44-week randomised withdrawal maintenance trial. A single intravenous induction dose produced significantly higher clinical response than placebo, and subcutaneous maintenance every 8 or 12 weeks preserved remission.
Written into the record, not signed off as a reviewed claim
Multiple sclerosis: no effect on new brain lesions in a 249-patient phase 2 trial
In plain words
IL-12 was believed to drive multiple sclerosis. Blocking it made no measurable difference to new inflammatory brain lesions at any of four doses.
What was measured
No significant reduction in new gadolinium-enhancing lesions at any of four doses
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Phase 2, multicentre, randomised, double-blind, placebo-controlled trial in 249 patients with relapsing-remitting multiple sclerosis across five arms. The primary endpoint, cumulative number of new gadolinium-enhancing T1-weighted lesions through week 23, showed no significant reduction at any dose. The result was one of the earliest strong signals that the T-helper-1 and IL-12 model of autoimmune demyelination was wrong and that IL-23 and IL-17 were the relevant axis.
Written into the record, not signed off as a reviewed claim
Only half the target mattered, and the successors that dropped IL-12 worked better
In plain words
Ustekinumab blocks IL-12 and IL-23 together. When drugs were built that block IL-23 alone, they cleared skin better, not worse. Blocking IL-12 was contributing nothing useful and may have been removing a protective signal.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The p19-specific IL-23 antibodies risankizumab and guselkumab both demonstrated superiority over ustekinumab on PASI 90 in randomised head-to-head psoriasis trials. IL-12 drives the T-helper-1 and interferon-gamma axis, which appears to be redundant or even protective in psoriasis. The field moved from p40 to p19 within a decade, and ustekinumab was displaced as first-line biologic in skin disease by its own mechanistic successors.
Source
Head-to-head superiority of p19-specific IL-23 antibodies over ustekinumab in psoriasis
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
Quarterly dosing is read as quarterly disease control for everyone
In plain words
The 12-week interval was fixed in the trial protocol, not derived from measuring when each individual loses response. A substantial minority of patients flare before the next dose is due.
What was measured
That a 12-week interval maintains disease control in all patients
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
PHOENIX 1 and 2 dosed at weeks 0 and 4 then every 12 weeks by protocol. PHOENIX 1 permitted dose intensification to every 8 weeks in partial responders, and real-world practice frequently shortens the interval or raises the dose, which indicates the fixed interval was a design choice rather than a measured pharmacodynamic optimum for every patient. Weight-based dosing at 90 mg above 100 kg partly addresses this.
Source
Dosing protocol and dose intensification provisions of PHOENIX 1
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
How many documents were read
2 documents were read for this substance.
RNAWiki source record
2 of them state the same halfLife, and they agree.
RNAWiki source record
2 of them state the same volumeOfDistribution, and they agree.
RNAWiki source record
Where else this substance is registered
RxNorm concept
847083
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Written into the record, not signed off.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✓ Passed
Safety mode resolved
Suppression classes recorded: S1.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or unclear◇Read from sources, not yet reviewed
How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
What the approval register records
2 approved applications cover products containing this substance. The earliest was BLA125261, approved 20090925 to CENTOCOR ORTHO BIOTECH INC.
This order is fixed in code and does not count clicks or time on the page.
What is not here
3 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — 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.
The older medicine-wide conclusion held in this record
Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.
A human antibody against the p40 subunit shared by IL-12 and IL-23 that took 67% of psoriasis patients to PASI 75 at 12 weeks against 3% on placebo, and then proved that only the IL-23 half of its target mattered.
Recorded evidence blocks (13)
Q2
What did Ustekinumab's largest trial (7500 people) and its longest (21 years) measure?
7500 people in Ustekinumab's largest registered study, 21 years in its longest registered window, measuring Number of Participants who Develop Cognitive Decline. ClinicalTrials.gov · 2026-09-01
61 phase3, 38 phase2, 34 na or unstated, 22 phase1, 16 phase4, 2 na, 1 early phase1; NCT01706692; 2032-03-15; no ageing endpoint recorded. Last human test completed 2026, NCT05083182.
Interpretation These counts include studies where Ustekinumab 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
phase3
61
phase2
38
na or unstated
34
phase1
22
phase4
16
na
2
2 more recorded rows
early phase1
1
Last recorded human testNCT05083182
2026-06-23
recorded 2026-09-01 · last checked 2026-09-04
Q3
Ustekinumab was tested only in human — what did it show?
"Manufacturer ceased to produce vials used for this study."; 16 of 165 registered studies
Show the evidence
Trial
NCT01091051
terminated; "Manufacturer ceased to produce vials used for this study."
NCT01708603
terminated; "Sponsor decision"
NCT01708629
terminated; "Sponsor decision"
NCT02437162
terminated; "Neither dose achieved the study's primary or major secondary endpoints. The safety profile was consistent with previous ustekinumab studies."
NCT02438787
terminated; "This study was stopped because ustekinumab did not achieve key endpoints in a related study. The safety profile was consistent with past ustekinumab studies."
NCT02786732
terminated; "Sponsor"
10 further recorded trials
NCT02955147
terminated; "Inefficacy"
NCT03517722
terminated; "Study terminated early as a result of the outcome of the pre-planned Interim Analysis"
NCT03712826
withdrawn; "No inclusion"
NCT03981744
terminated; "The study did not meet the primary endpoint."
NCT04060888
withdrawn; "Pre-planned IA (global study) showed lack of efficacy in this indication. No new safety signals observed, findings consistent with known profile."
NCT04305327
terminated; "Early terminated due to difficulty recruiting participants"
NCT04629196
terminated; "Other effective drugs have been introduced to market since the beginning of the study."
NCT04655807
withdrawn; "Sponsor Decision."
NCT04882072
terminated; "Due to difficulties in enrollment and ongoing feasibility issues"
NCT04978493
terminated; "Company decision"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Ustekinumab used Ustekinumab 90 mg — over how long?
20 recorded entries; human; also "Ustekinumab 90 mg", "Ustekinumab 4.5 mg/kg", "CNTO 1275 63 mg"
Show the evidence
human
NCT00265122
Ustekinumab 90 mg
NCT00265122
Ustekinumab 4.5 mg/kg
NCT00267956
CNTO 1275 63 mg
NCT00307437
Placebo; Ustekinumab (CNTO 1275) 45 or 90 mg
NCT00307437
Ustekinumab (CNTO 1275) 45 mg
NCT00307437
Ustekinumab (CNTO 1275) 90 mg
14 more recorded rows
humanNCT00454584
CNTO 1275 45 mg
humanNCT00454584
CNTO 1275 90 mg
humanNCT00723528
Ustekinumab 45 mg (CP)
humanNCT00723528
Ustekinumab 90 mg (CP)
humanNCT00723528
Ustekinumab 45 mg (After CP)
humanNCT00723528
Ustekinumab 90 mg (After CP)
humanNCT01009086
Ustekinumab 45 mg
humanNCT01077362
ustekinumab 45 mg
humanNCT01077362
ustekinumab 90 mg
humanNCT01389973
ustekinumab 180 mg
humanNCT02698475
Ustekinumab 0.75 mg/kg
humanNCT03464136
Ustekinumab (6 mg/kg)
humanNCT03464136
Ustekinumab (90 mg)
humanNCT03517722
Ustekinumab (approximately 6 mg/kg)
recorded 2026-09-01 · last checked 2026-09-04
Q6
Ustekinumab's half-life is mean half-life ranged from 14.9 ± 4.6 to 45.6 ± 80.2 days — which schedules were studied?
mean half-life ranged from 14.9 ± 4.6 to 45.6 ± 80.2 days, the half-life Ustekinumab's label states. openfda-label · 23b486eb-f48d-47d4-815e-1313d4ebfbfa · 2026-08-28
Show the evidence
half life
mean half-life ranged from 14.9 ± 4.6 to 45.6 ± 80.2 days; The mean (±SD) half-life ranged from 14.9 ± 4.6 to 45.6 ± 80.2 days across all trials in subjects with plaque psoriasis following subcutaneous administration.
tmax
12.3 Pharmacokinetics Absorption In adult subjects with plaque psoriasis, the median time to reach the maximum serum concentration (T max ) was 13.5 days and 7 days, respectively, after a single subcutaneous administration of 45 mg (N=22) and 90 mg (N=24) of ustekinumab.
metabolism
Metabolism The metabolic pathway of ustekinumab has not been characterized.
recorded 2026-08-28 · last checked 2026-09-04
Q7
Which of a psoriasis area and severity index 90 response at week 16, adverse events and american college of rheumatology 20 response at week 24 did Ustekinumab's trials measure?
a psoriasis area and severity index 90 response at week 16, adverse events and american college of rheumatology 20 response at week 24 lead 40 outcome terms across Ustekinumab's trials. ClinicalTrials.gov · 2026-09-01
coronary calcium, repeated coronary ct angiography, psoriasis area severity index, static physician global assessment success at week 12, psoriasis area severity index 75 at week 12 and psoriasis area severity index 100 at week 12 follow.
Show the evidence
an american college of rheumatology 20 response at week 12
1
predicted forced vital capacity at week 16
1
american college of rheumatology 20 response at week 24
1
coronary calcium
1
repeated coronary ct angiography
1
psoriasis area severity index
1
14 more recorded rows
static physician global assessment success at week 12
1
psoriasis area severity index 75 at week 12
1
psoriasis area severity index 100 at week 12
1
t regulatory cell /total cluster of differentiation 4 +
1
who experienced psoriasis relapse
1
major structural malformations
1
primary safety endpoints
1
maximum observed plasma concentration
1
vascular inflammation
1
safety and tolerability
1
biomarker assessment
1
pasi improvement
1
iga mod 2011 0 or 1 at week 12
1
who develop cognitive decline
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Ustekinumab's 36 ongoing trials reports first?
Psoriasis Area Severity Index (PASI); Major structural malformations; latest 2035-06-30
Show the evidence
Trial
NCT01706692
"Swiss Dermatology Network of Targeted Therapies (SDNTT)"; n 1121; "Psoriasis Area Severity Index (PASI)"; 2032-03-15
NCT02103361
"Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project"; n 200; "Major structural malformations"; 2031-02
NCT03167437
"An Open-Label, Proof of Consent Study of Vorinostat for the Treatment of Mdoerate-to-Severe Crohn s Disease and Maintenance Therapy With Ustekinumab"; n 35; "To evaluate the safety and tolerability of vorinostat in patients with moderate to severe CD as measured by the rate, frequency, and severity of adverse events (AEs) after 12 weeks of treatment."; 2035-06-30
NCT03218488
"A Safety Study of Ustekinumab in the Treatment of Pediatric Participants Aged 6 Years and Older With Moderate to Severe Plaque Psoriasis"; n 135; "Number of Participants With Adverse Events"; 2032-08-31
NCT03466411
"A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease"; n 1409; "GALAXI 1: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12"; 2028-01-28
NCT03941132
"Clinical Phase II/III Trial of Ustekinumab to Treat Type 1 Diabetes (UST1D2)"; n 66; "Baseline change in 2-hour mixed meal-stimulated C-peptide AUC at week 52."; 2026-11-01
14 further recorded trials
NCT04372108
"A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis"; n 1536; "Incidence Rate for Malignancy"; 2030-08-30
NCT04524611
"Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD)"; n 527; "Percentage of Participants Achieving Clinical Remission at Week 24"; 2028-02
NCT04572815
"Ustekinumab for the Prevention of Acute Graft-versus-Host Disease After Unrelated Donor Hematopoietic Cell Transplant"; n 116; "Grade II-IV acute graft versus host disease (GVHD) survival"; 2027-06-30
NCT05092269
"A Long-term Extension Study of Ustekinumab in Pediatric Participants"; n 159; "Number of Participants With Adverse Events (AEs)"; 2028-03-15
NCT05169593
"Prevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic Biological Therapy"; n 292; "postoperative endoscopic recurrence (Rutgeerts score ≥i2b)"; 2030-10
NCT05270733
"Development of Predictive Psoriasis Response Endotypes Using Single Cell Transcriptomics"; n 56; "Identification of a unique differentially expressed gene set in patients with psoriasis that may predict disease response following antagonism to IL-12 and/or IL-23."; 2026-12-31
NCT05299931
"An Open-Label Extension and Long-term Efficacy and Safety Monitoring Study of Patients with Crohn's Disease Previously Included in the Loss of RESponse to Ustekinumab Treated by Dose Escalation Study"; n 108; "Proportion of patients in both treatment arms in steroid-free clinical remission"; 2026-06
NCT05387031
"Efficacy of Ustekinumab Therapy in Patients With Symptomatic Stricturing Crohn's Disease"; n 239; "Number of participants with treatment success at week 52"; 2028-08-01
NCT05535738
"Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation"; n 45; "To collect and evaluate single-cell multiomics data (RNAseq, CITEseq, TCRseq)"; 2027-12-31
NCT05725876
"Quantitative Fluorescence Molecular Imaging of Ustekinumab-800CW to Elucidate the Drug Distribution Throughout Inflamed Tissue in Crohn's Disease and Psoriasis."; n 56; "Quantification of fluorescent signal of fluorescent ustekinumab in CD and psoriasis patients."; 2027-01-06
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
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
NCT06274554
"Testing the Role of Anti-fungal Therapy in Improving the Response to Therapies for Crohn's Disease"; n 120; "Proportion of subjects achieving clinical response"; 2029-12
NCT06425549
"A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis"; n 176; "Psoriasis Area Severity Index 90 (PASI90) response at Week 16"; 2030-11-08
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which running trial of Ustekinumab 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.
3 open trials; n 4000; "Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population"
Show the evidence
Trial
NCT07177209
"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
NCT06786507
"A Direct Head-to-head Comparison of Ustekinumab with Infliximab for the Treatment of Ulcerative Colitis"; n 100; "(CRP) and Improvement degree of ulcerative colitis"; 2026-10-01
NCT04572815
"Ustekinumab for the Prevention of Acute Graft-versus-Host Disease After Unrelated Donor Hematopoietic Cell Transplant"; n 116; "Grade II-IV acute graft versus host disease (GVHD) survival"; 2027-06-30
Q10
Which 37 trials of Ustekinumab posted no result?
Posted no result
37 of 37 completed trials
Registrations
NCT01081704, NCT01330901, NCT01677598, NCT01704534, NCT01812954 and NCT02156375, and 31 more
Completion dates
oldest 2010-06; newest 2024-06-05
Show the evidence
Trial
NCT01081704
2010-06
NCT01330901
2013-05
NCT01677598
2013-11-30
NCT01704534
2014-04
NCT01812954
2014-06
NCT02156375
2014-12
14 further recorded trials
NCT01356758
2015-11
NCT02330380
2016-12
NCT02763969
2016-12-15
NCT02204397
2017-03-08
NCT01081730
2017-09-29
NCT03496831
2017-12-31
NCT03336281
2020-04-07
NCT03495973
2020-11-22
NCT04030533
2020-12-31
NCT04371185
2021-04-19
NCT03629379
2021-07-01
NCT03148860
2021-10-21
NCT04843631
2021-12-08
NCT03942120
2022-01-14
Q11
At the median, Ustekinumab's trials enrolled 149.5 people — anything larger?
Median enrolment
149.5
Largest enrolment
7500
Registered trials counted
164
Q12
What do 10423 spontaneous reports say about Ustekinumab — 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.
Ustekinumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 10423 reaction mentions were counted: psoriasis 1795; pneumonia 1374; crohn's disease 1298; hypersensitivity 997. open-targets-adr · CHEMBL1201835 · 2026-06-24
Show the evidence
psoriasis
1795
pneumonia
1374
crohn's disease
1298
hypersensitivity
997
drug intolerance
938
infusion related reaction
847
4 more recorded rows
synovitis
811
rheumatoid arthritis
806
treatment failure
806
alopecia
751
recorded 2026-06-24 · last checked 2026-09-04
Q13
Ustekinumab and CYP1A2, CYP2C19 and CYP2C9: shared by which compounds?
CYP1A2, CYP2C19 and CYP2C9 appear in Ustekinumab's recorded interaction sentences, 5 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP1A2
pharmacokinetics
Drug Interaction Studies The effects of IL-12 or IL-23 on the regulation of CYP450 enzymes were evaluated in an in vitro study using human hepatocytes, which showed that IL-12 and/or IL-23 at levels of 10 ng/mL did not alter human CYP450 enzyme activities (CYP1A2, 2B6, 2C9, 2C19, 2D6, or 3A4).
pharmacokinetics
No clinically significant changes in exposure of caffeine (CYP1A2 substrate), warfarin (CYP2C9 substrate), omeprazole (CYP2C19 substrate), dextromethorphan (CYP2D6 substrate), or midazolam (CYP3A substrate) were observed when used concomitantly with ustekinumab at the approved recommended dosage in subjects with Crohn’s disease. [see Drug Interactions ( 7.2 )] .
CYP2C19pharmacokinetics
No clinically significant changes in exposure of caffeine (CYP1A2 substrate), warfarin (CYP2C9 substrate), omeprazole (CYP2C19 substrate), dextromethorphan (CYP2D6 substrate), or midazolam (CYP3A substrate) were observed when used concomitantly with ustekinumab at the approved recommended dosage in subjects with Crohn’s disease. [see Drug Interactions ( 7.2 )] .
CYP2C9pharmacokinetics
No clinically significant changes in exposure of caffeine (CYP1A2 substrate), warfarin (CYP2C9 substrate), omeprazole (CYP2C19 substrate), dextromethorphan (CYP2D6 substrate), or midazolam (CYP3A substrate) were observed when used concomitantly with ustekinumab at the approved recommended dosage in subjects with Crohn’s disease. [see Drug Interactions ( 7.2 )] .
CYP2D6pharmacokinetics
No clinically significant changes in exposure of caffeine (CYP1A2 substrate), warfarin (CYP2C9 substrate), omeprazole (CYP2C19 substrate), dextromethorphan (CYP2D6 substrate), or midazolam (CYP3A substrate) were observed when used concomitantly with ustekinumab at the approved recommended dosage in subjects with Crohn’s disease. [see Drug Interactions ( 7.2 )] .
recorded 2026-08-30 · last checked 2026-09-04
Q14
What is recorded about Ustekinumab and mTOR?
"Although the new definition of MRONJ excludes antiangiogenic molecules, tyrosine kinase inhibitors, and mTOR inhibitors alone, some cases have been reported with ustekinumab." — where Ustekinumab and mTOR appear together. Europe PMC · pathway abstract search · 2024-10-05
mTOR; PMID 39498062, 36996348
Show the evidence
mTOR
PMID 39498062
"Although the new definition of MRONJ excludes antiangiogenic molecules, tyrosine kinase inhibitors, and mTOR inhibitors alone, some cases have been reported with ustekinumab."
PMID 36996348
"Therapies of potential interest and wider use in CVID include mTOR-inhibitors like sirolimus, JAK-inhibitors like tofacitinib, the monoclonal IL-12/23 antibody ustekinumab, the anti-BAFF antibody belimumab and abatacept."
recorded 2024-10-05 · 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
✗ required summary fields resolved: 5 required field(s) not terminal: Why people use it, Best-supported result, Most important common problem, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 11 source rows
✓ no critical contamination: no quarantine open
✓ canonical metadata passed: slug and display name present
✓ no raw internal fields: enforced by the copy-contract test over the rendered page
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