This page shows what was measured, who it was measured in, and what that does not settle.
What Guselkumab does in the body
TREMFYA is an interleukin-23 antagonist indicated for the treatment of: adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate-to-severe plaque psoriasis and who are candidates for systemic therapy or phototherapy.
From the FDA-approved label: Guselkumab is a human monoclonal IgG1λ antibody that selectively binds to the p19 subunit of interleukin 23 (IL-23) and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Guselkumab inhibits the release of proinflammatory cytokines and chemokines.
Why people take it. TREMFYA is an interleukin-23 antagonist indicated for the treatment of: adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate-to-severe plaque psoriasis and who are candidates for systemic therapy or phototherapy.
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 · 089658A12D · 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 145 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 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.
GALAXI 1: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12
✗ The study did not show it
Who was studied
NCT03466411
How many people
1409
Study design
Phase 2/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. Injection
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 1: Percentage of Participants With Clinical Response at Week I-12
✗ The study did not show it
Who was studied
NCT04033445
How many people
1064
Study design
Phase 2/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. Injection
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 Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24
✗ The study did not show it
Who was studied
NCT04882098
How many people
1054
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. Injection
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 Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 48
✗ The study did not show it
Who was studied
NCT03090100
How many people
1048
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. Injection
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 Achieving 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI 100)
✗ The study did not show it
Who was studied
NCT03573323
How many people
1027
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. Injection
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 Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16
✗ The study did not show it
Who was studied
NCT02207244
How many people
992
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. Injection
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.1 registered measure 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.9 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 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.
blood pressure
maximum observed plasma concentration
time to reach maximum concentration
maximum observed serum concentration
time to reach maximum observed serum concentration
parts 1 2 and 3 skin tissue versus serum concentration
part 1 colon tissue versus serum concentration
parts 2 and 3 colon tissue versus serum concentration
parts 2 and 3 synovial tissue versus serum concentration
Meaningful
Things that change how a life goes, not only a number.
clinical remission at week 48
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 (30)
physician global assessment of cleared or minimal at week 16
number and type of adverse events
clinical laboratory values
electrocardiogram
pulse rate
major structural malformations
antibody to cnto1959
papule/pustule count at week 16
elimination half life
total systemic clearance
volume of distribution
apparent total systemic clearance
apparent volume of distribution
bioavailability
biomarkers at week 12
biomarkers at week 24
incidence of treatment emergent adverse events
laser speckle contrast imaging
reported outcomes
treatment emergent adverse events
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. 15 to 18 days
Read from the label, which states: “Mean half-life of guselkumab was approximately 15 to 18 days in subjects with plaque psoriasis across trials.”
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.
TREMFYA is an interleukin-23 antagonist indicated for the treatment of: adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate-to-severe plaque psoriasis and who are candidates for systemic therapy or phototherapy. ( 1.1 ) adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with active psoriatic arthritis.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “The safety and effectiveness of TREMFYA have not been established in pediatric patients with plaque psoriasis who are younger than 6 years of age.”
US prescribing information · 1e6dc9ae-1c4c-42d9-87aa-c315ecc51b56 · read 2026-08-30
On older people, the label states: “Clinical studies of TREMFYA, within each indication, 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 · 1e6dc9ae-1c4c-42d9-87aa-c315ecc51b56 · read 2026-08-30
On people who are pregnant, the label states: “Exposure Registry There is a pregnancy registry that monitors pregnancy outcomes in women exposed to TREMFYA during pregnancy.”
US prescribing information · 1e6dc9ae-1c4c-42d9-87aa-c315ecc51b56 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of guselkumab in human milk, the effects on the breastfed infant, or the effects on milk production.”
US prescribing information · 1e6dc9ae-1c4c-42d9-87aa-c315ecc51b56 · 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
Injection
✎ 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, given by the injection, subcutaneous, intravenous 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.
Guselkumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1384 reaction mentions were counted. One report can name several reactions.
drug delivery system malfunction — 92 reaction mentions
psoriatic arthropathy — 67 reaction mentions
nausea — 59 reaction mentions
syringe issue — 36 reaction mentions
product leakage — 28 reaction mentions
dizziness — 26 reaction mentions
vomiting — 26 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
Injection
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
4 products list this as an active ingredient in the United States drug directory. 4 of them contain it and nothing else.
FDA National Drug Code directory · 64406-560 · read 2026-08-29
They are sold as injection and liquid, taken intravenous and subcutaneous.
FDA National Drug Code directory · 64406-560 · read 2026-08-29
The regulator's established pharmacologic class for it is interleukin-23 antagonist [epc] and interleukin-23 antagonists [moa].
FDA National Drug Code directory · 64406-560 · 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 · 1e6dc9ae-1c4c-42d9-87aa-c315ecc51b56 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 1e6dc9ae-1c4c-42d9-87aa-c315ecc51b56 · read 2026-08-29
TREMFYA is subcutaneous at 3 DOSAGE FORMS AND STRENGTHS TREMFYA is a clear and colorless to light yellow solution., recorded as fda label in effect 2026-06-04 in the United States.
US prescribing information · 1e6dc9ae-1c4c-42d9-87aa-c315ecc51b56 · 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 Guselkumab 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 Guselkumab 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.
Where else this substance is registered
FDA substance identifier (UNII)
089658A12D
RxNorm concept
1928686
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: Quoted from a stored source.
✗ 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
1 approved application covers products containing this substance. The earliest was BLA761061, approved 20170713 to JANSSEN BIOTECH.
This order is fixed in code and does not count clicks or time on the page.
What is not here
6 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
What was measured, goal by goal — found nothing in the sources checked.
The path through the body — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
Claims that go past the evidence — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
Recorded evidence blocks (12)
Q2
What did Guselkumab's largest trial (4000 people) and its longest (17 years) measure?
4000 people in Guselkumab's largest registered study, 17 years in its longest registered window, measuring Maximum observed serum concentration (Cmax) of guselkumab. ClinicalTrials.gov · 2026-09-01
36 phase3, 18 phase2, 18 phase4, 13 na or unstated, 13 phase1, 3 na, 1 early phase1; NCT02103361; 2031-02; no ageing endpoint recorded. Last human test completed 2026, NCT04936308.
Interpretation These counts include studies where Guselkumab 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
36
phase2
18
phase4
18
na or unstated
13
phase1
13
na
3
2 more recorded rows
early phase1
1
Last recorded human testNCT04936308
2026-07-02
recorded 2026-09-01 · last checked 2026-09-04
Q3
Guselkumab was tested only in human — what did it show?
safety (4), accrual/recruitment (1), sponsor decision unspecified (1) and other (3): Guselkumab's stop wording, clustered. ClinicalTrials.gov · 2026-09-01
"COVID-19 Pandemic"; 9 of 98 registered studies
Show the evidence
Trial
NCT04084665
withdrawn; "COVID-19 Pandemic"
NCT04376827
terminated; "Due to enrollment challenges, J\&J Innovative Medicine decided to stop screening and terminate the study early. This decision was not based on a safety concern."
NCT04394936
terminated; "Early termination was initiated as the recruitment of the remaining 14 moderate-to-severe patients stagnated."
NCT04533737
terminated; "The recruitment was terminated early due to delays and slow recruitment that significantly jeopardized the trial timelines. There were no safety concerns related to the early termination of the trial."
NCT04633447
terminated; "The study primary endpoint was not met"
NCT04704843
withdrawn; "Study terminated. Sponsor decision."
3 further recorded trials
NCT05083078
terminated; "The study was stopped due to unanticipated feasibility constraints."
NCT05125679
terminated; "Terminated (A strategic decision was made not to further execute the study. This decision was not based on a safety concern)"
NCT05784129
terminated; "Janssen made an internal business decision to discontinue the PROGRESS study. This decision is not related to any efficacy or safety concerns."
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Guselkumab used CNTO 1959 (5 mg) — over how long?
10 recorded entries; human; also "CNTO 1959 (5 mg)", "CNTO 1959 (15 mg)", "CNTO 1959 (50 mg)"
Show the evidence
human
NCT01483599
CNTO 1959 (5 mg)
NCT01483599
CNTO 1959 (15 mg)
NCT01483599
CNTO 1959 (50 mg)
NCT01483599
CNTO 1959 (100 mg)
NCT01483599
CNTO 1959 (200 mg)
NCT02207231
Guselkumab 100 mg
4 more recorded rows
humanNCT02325219
CNTO 1959 50 mg
humanNCT04736966
Guselkumab 30mg
humanNCT04736966
Guselkumab 70mg
humanNCT04736966
Guselkumab 100mg
recorded 2026-09-01 · last checked 2026-09-04
Q6
Guselkumab's half-life is 15 to 18 days — which schedules were studied?
15 to 18 days, the half-life Guselkumab's label states. openfda-label · 1e6dc9ae-1c4c-42d9-87aa-c315ecc51b56 · 2026-08-30
Show the evidence
half life
15 to 18 days; Mean half-life of guselkumab was approximately 15 to 18 days in subjects with plaque psoriasis across trials.
bioavailability
The absolute bioavailability of guselkumab following a single 100 mg subcutaneous injection was estimated to be approximately 49% in healthy adult subjects.
metabolism
Metabolism The exact pathway through which guselkumab is metabolized has not been characterized.
recorded 2026-08-30 · last checked 2026-09-04
Q7
Which of adverse events, aes leading to discontinuation of study intervention and antibody to cnto1959 did Guselkumab's trials measure?
adverse events, aes leading to discontinuation of study intervention and antibody to cnto1959 lead 40 outcome terms across Guselkumab's trials. ClinicalTrials.gov · 2026-09-01
Interpretation electrocardiogram, pulse rate, blood pressure, major structural malformations, maximum observed plasma concentration and time to reach maximum concentration follow.
Show the evidence
physician global assessment of cleared or minimal at week 16
1
number and type of adverse events
1
clinical laboratory values
1
electrocardiogram
1
pulse rate
1
blood pressure
1
14 more recorded rows
major structural malformations
1
maximum observed plasma concentration
1
time to reach maximum concentration
1
antibody to cnto1959
1
papule/pustule count at week 16
1
maximum observed serum concentration
1
elimination half life
1
total systemic clearance
1
volume of distribution
1
time to reach maximum observed serum concentration
1
apparent total systemic clearance
1
apparent volume of distribution
1
bioavailability
1
biomarkers at week 12
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Guselkumab's 47 ongoing trials reports first?
Major structural malformations; Part 1: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16; latest 2032-02-25
Show the evidence
Trial
NCT02103361
"Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project"; n 200; "Major structural malformations"; 2031-02
NCT03451851
"A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants"; n 120; "Part 1: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16"; 2026-12-18
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
NCT04033445
"A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis"; n 1064; "Induction Study 1: Percentage of Participants With Clinical Response at Week I-12"; 2027-07-16
NCT04882098
"A Study of Guselkumab in Participants With Active Psoriatic Arthritis"; n 1054; "Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24"; 2027-10-06
NCT04929210
"A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease"; n 411; "Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Week 24"; 2027-04-13
14 further recorded trials
NCT05004727
"Multi-Center PAMPA Study"; n 176; "Change in Musculoskeletal, Power Doppler Ultrasound (MSK-PDUS) Composite Score"; 2028-11-02
NCT05049798
"A Study of Guselkumab and Interleukin-17 (IL-17) Inhibitor Therapies in Participants With Psoriatic Arthritis in Routine Clinical Practice"; n 1314; "The Start and Stop Date of Guselkumab, as Applicable, For Each Participant"; 2027-08-02
NCT05242471
"A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease"; n 703; "Percentage of Participants with Clinical Remission at Week 48"; 2029-11-05
NCT05242484
"A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis"; n 577; "Percentage of Participants with Clinical Remission at Week 48"; 2029-03-27
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
NCT05347095
"A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease"; n 288; "Percentage of Participants who Achieve Combined Fistula Remission at Week 24"; 2027-03-25
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
NCT05669833
"Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients"; n 63; "Achievement of cDAPSA low disease activity"; 2026-10
NCT05858632
"Immune Spatial Features of Guselkumab Cutaneous Response"; n 10; "Change in psoriasis scalp severity index score (PSSI)"; 2028-06-30
NCT05923073
"A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease"; n 120; "Percentage of Participants with Clinical Remission at Week 52"; 2028-08-14
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
NCT06260163
"A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis"; n 112; "Percentage of Participants with Clinical Remission at Week 56"; 2027-04-28
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
NCT06398106
"Proactive TDM Versus Standard Use of Biologics in Psoriasis"; n 210; "Non-inferiority of sustained disease control"; 2028-03-01
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which running trial of Guselkumab 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 16 trials of Guselkumab posted no result?
Posted no result
16 of 16 completed trials
Registrations
NCT01484587, NCT01866007, NCT01845987, NCT02570373, NCT02397382 and NCT02343744, and 10 more
Completion dates
oldest 2013-04-11; newest 2024-03-31
Show the evidence
Trial
NCT01484587
2013-04-11
NCT01866007
2013-10-09
NCT01845987
2014-09
NCT02570373
2016-01-12
NCT02397382
2016-08-31
NCT02343744
2018-11-02
10 further recorded trials
NCT03796858
2020-11-11
NCT04030533
2020-12-31
NCT04617691
2021-07-20
NCT03998683
2021-11-30
NCT04147338
2021-12-07
NCT03649971
2022-03-23
NCT04061395
2022-04-01
NCT04914429
2023-09-26
NCT04439526
2023-11-21
NCT04736966
2024-03-31
Q11
At the median, Guselkumab's trials enrolled 119 people — anything larger?
Median enrolment
119
Largest enrolment
4000
Registered trials counted
97
Q12
What do 1384 spontaneous reports say about Guselkumab — 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.
Guselkumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1384 reaction mentions were counted: product dose omission issue 657; psoriasis 298; needle issue 95; drug delivery system malfunction 92. open-targets-adr · CHEMBL2364648 · 2026-06-24
Show the evidence
product dose omission issue
657
psoriasis
298
needle issue
95
drug delivery system malfunction
92
psoriatic arthropathy
67
nausea
59
4 more recorded rows
syringe issue
36
product leakage
28
dizziness
26
vomiting
26
recorded 2026-06-24 · last checked 2026-09-04
Q13
Guselkumab and CYP1A2, CYP2C19 and CYP2C9: shared by which compounds?
CYP1A2, CYP2C19 and CYP2C9 appear in Guselkumab's recorded interaction sentences, 5 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP1A2pharmacokinetics
Cytochrome P450 Substrates The effects of guselkumab on the pharmacokinetics of midazolam (metabolized by CYP3A4), warfarin (metabolized by CYP2C9), omeprazole (metabolized by CYP2C19), dextromethorphan (metabolized by CYP2D6), and caffeine (metabolized by CYP1A2) were evaluated in an exploratory study with 6 to 12 evaluable subjects with moderate-to-severe plaque psoriasis.
CYP2C19pharmacokinetics
Cytochrome P450 Substrates The effects of guselkumab on the pharmacokinetics of midazolam (metabolized by CYP3A4), warfarin (metabolized by CYP2C9), omeprazole (metabolized by CYP2C19), dextromethorphan (metabolized by CYP2D6), and caffeine (metabolized by CYP1A2) were evaluated in an exploratory study with 6 to 12 evaluable subjects with moderate-to-severe plaque psoriasis.
CYP2C9pharmacokinetics
Cytochrome P450 Substrates The effects of guselkumab on the pharmacokinetics of midazolam (metabolized by CYP3A4), warfarin (metabolized by CYP2C9), omeprazole (metabolized by CYP2C19), dextromethorphan (metabolized by CYP2D6), and caffeine (metabolized by CYP1A2) were evaluated in an exploratory study with 6 to 12 evaluable subjects with moderate-to-severe plaque psoriasis.
CYP2D6pharmacokinetics
Cytochrome P450 Substrates The effects of guselkumab on the pharmacokinetics of midazolam (metabolized by CYP3A4), warfarin (metabolized by CYP2C9), omeprazole (metabolized by CYP2C19), dextromethorphan (metabolized by CYP2D6), and caffeine (metabolized by CYP1A2) were evaluated in an exploratory study with 6 to 12 evaluable subjects with moderate-to-severe plaque psoriasis.
CYP3A4pharmacokinetics
Cytochrome P450 Substrates The effects of guselkumab on the pharmacokinetics of midazolam (metabolized by CYP3A4), warfarin (metabolized by CYP2C9), omeprazole (metabolized by CYP2C19), dextromethorphan (metabolized by CYP2D6), and caffeine (metabolized by CYP1A2) were evaluated in an exploratory study with 6 to 12 evaluable subjects with moderate-to-severe plaque psoriasis.
recorded 2026-08-30 · 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: 9 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
This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.