This page shows what was measured, who it was measured in, and what that does not settle.
What Canakinumab does in the body
The following autoinflammatory Periodic Fever Syndromes
From the FDA-approved label: Canakinumab is a human monoclonal anti-human IL-1β antibody of the IgG1/κ isotype. Canakinumab binds to human IL-1β and neutralizes its activity by blocking its interaction with IL-1 receptors, but it does not bind IL-1α or IL-1 receptor antagonist (IL-1ra). CAPS refer to rare genetic syndromes generally caused by mutations in the NLRP-3 [nucleotide-binding domain, leucine rich family (NLR), pyrin domain containing 3] gene (also known as Cold-Induced Autoinflammatory Syndrome-1 [CIAS1]). CAPS disorders are inherited in an autosomal dominant pattern with male and female offspring equally affected.
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 · 37CQ2C7X93 · read 2026-08-29
Where each sentence above came from
The recorded explanation is written in label language rather than for a beginner. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
No statement of the main limit is recorded.
The four opening statements run to 110 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Stand-in result
A stand-in result is a number measured because the real result takes too long.
A picture of it, and where the picture fails
It is like judging a journey by the speedometer rather than by arriving.
Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.
What people get wrong. A stand-in result is often reported as the result itself.
A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.
Enzyme
An enzyme is a protein that speeds up one chemical change.
A picture of it, and where the picture fails
An enzyme is like a machine on a production line doing one cut.
Where that stops being true. A machine is switched on and off by a person. Enzymes are controlled by the cell.
What people get wrong. Enzymes are thought to be used up. They are not; they work again and again.
A catalytic protein that lowers the activation energy of a specific reaction.
Receptor
A receptor is a part of a cell that a signal fits into.
A picture of it, and where the picture fails
A receptor is like a lock waiting for one key.
Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.
What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.
A protein that binds a specific ligand and converts that binding into a cellular response.
Pathway
A pathway is a chain of steps inside a cell, each one setting off the next.
A picture of it, and where the picture fails
A pathway is like a row of dominoes.
Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.
What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.
An ordered series of molecular interactions producing a defined cellular change.
What happened in people◇Read from sources, not yet reviewed
What was measured, goal by goal
One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.
Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.
There is no single score. A strong test result and a weak life result are different facts.
Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Blood sugar
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
△Only a number moved1 registered test measure.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Healthy ageing
…Waiting for a reviewer1 registered study measure of this kind. No reviewed result yet.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Blood sugar
plasma hba1c
Healthy ageing
all cause mortality
Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.
What each mark on this table means
∅ Nothing in the sources checked
No registered study lists a life outcome for this goal.
△ Only a number moved
1 registered test measure.
— Not recorded
Harms were not a registered measure for this goal.
… Waiting for a reviewer
Who was studied is listed further down the page.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Analysis of Core Phase First CEC Confirmed Major Adverse Cardiovascular Events (MACE) and Its Components
✗ The study did not show it
Who was studied
NCT01327846
How many people
10066
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. Subcutaneous
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
Measurement of inflammatory cytokines (interleukin (IL) 1 beta, IL-1RA, IL-6, IL-18, tumor necrosis factor (TNF) alpha, CXCL9 and CXCL10) on serum of patients
✗ The study did not show it
Who was studied
NCT05670301
How many people
2500
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Subcutaneous
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
Disease Free Survival (DFS) by Local Investigator
✗ The study did not show it
Who was studied
NCT03447769
How many people
1382
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Subcutaneous
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
Quantitative ratio post booster vs. pre-booster of IgG against SARS-CoV-2 using electrochemiluminescent (ECL) technology against the receptor binding domain (RBD) of spike protein, stratified by treatment arm
✗ The study did not show it
Who was studied
NCT05080218
How many people
841
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. Subcutaneous
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
Part 1 (Safety Run-in): Number of Participants With Dose-limiting Toxicities (DLTs)
✗ The study did not show it
Who was studied
NCT03631199
How many people
673
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. Subcutaneous
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
Number of Participants With Adverse Events (AEs), Serious Adverse Events, Death and Clinical Significant AEs During 4 Months (Period II)
✗ The study did not show it
Who was studied
NCT00900146
How many people
556
Study design
Phase 2/Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Subcutaneous
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.4 registered measures of this kind. 2 written-up studies measured this and did not show a benefit.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
■Symptoms and quality of lifeEvidence recorded. Pain, tiredness, mood, sleep, as the person rated it.1 registered measure of this kind.
■A number that stands in for healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.3 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.
■AnimalsEvidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse. A result in animals says what to test next. It does not say what happens in people.
■Cells in a dishEvidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
health related quality of life
Measured
Things only a test, a scale or a device shows.
plasma hba1c
maximum concentration as measured by pk sampling
pharmacokinetics peak plasma concentration
Meaningful
Things that change how a life goes, not only a number.
adverse events serious adverse events and death
adverse events death and serious adverse events
all cause mortality
progression free survival
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (32)
safety and tolerability
adverse events and serious adverse events
forced expiratory volume in 1 second
forced vital capacity
core study mean number of gout flares per
plaque burden
time to first new flare
part a number of intolerance events
polymyalgia rheumatica activity
recurrence of atrial fibrillation
adverse events
erythrocyte sedimentation rate
frequency of dose interruptions
frequency of dose reductions
overall response rate
part 1 number of dose limiting toxicities
incidence of adverse events
elimination rate constant as measured by pk sampling
half life as measured by pk sampling
absorption rate constant as measured by pk sampling
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What it would be like to take◇Read from sources, not yet reviewed
How long anything takes
Nine different lengths of time that get confused with each other. None of them is worked out from another.
Before anything is noticed.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before a test result moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before performance moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
How long the result was watched.No finished study window is recorded for a study that tested this substance.
How long people took it.How long people actually took it is not stored. The study window is not the same thing.
How long people were followed.Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.
How fast the body clears it. 26 days
Read from the label, which states: “The mean terminal half-life was 26 days.”
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.
ILARIS is an interleukin-1β blocker indicated for the treatment of: • Periodic Fever Syndromes ( 1.1 ): - Cryopyrin-Associated Periodic Syndromes (CAPS), in adults and children 4 years of age and older, including: ◾ Familial Cold Auto-inflammatory Syndrome (FCAS) ◾ Muckle-Wells Syndrome (MWS) - Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients - Hyperimmunoglobulin D…
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 ILARIS in CAPS patients less than 4 years of age has not been established [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14.1)] .”
US prescribing information · 7d271f3b-e4f9-4d80-8dcf-28d49123f80e · read 2026-08-30
On older people, the label states: “Clinical studies of ILARIS in patients with CAPS, TRAPS, HIDS/MKD, FMF and Still’s disease, did not include sufficient numbers of patients 65 years and older to determine whether they respond differently from younger patients.”
US prescribing information · 7d271f3b-e4f9-4d80-8dcf-28d49123f80e · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Available human data from postmarketing experience and published case reports on ILARIS use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, and adverse maternal or fetal outcomes.”
US prescribing information · 7d271f3b-e4f9-4d80-8dcf-28d49123f80e · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There is no information regarding the presence of canakinumab in human milk or the effects on milk production.”
US prescribing information · 7d271f3b-e4f9-4d80-8dcf-28d49123f80e · read 2026-08-30
On people with reduced liver function, the label states: “No formal studies have been conducted to examine the pharmacokinetics of ILARIS administered subcutaneously in patients with hepatic impairment.”
US prescribing information · 7d271f3b-e4f9-4d80-8dcf-28d49123f80e · read 2026-08-30
On people with reduced kidney function, the label states: “No formal studies have been conducted to examine the pharmacokinetics of ILARIS administered subcutaneously in patients with renal impairment.”
US prescribing information · 7d271f3b-e4f9-4d80-8dcf-28d49123f80e · 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
Subcutaneous
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Suppression classes recorded: S1.
No source is stored against this line.
What is in the pack
Sold as injectable, injection, solution, solution/ drops, pellet, given by the subcutaneous, oral route.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to 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.
Canakinumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 2259 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
pyrexia — 382 reaction mentions
pain — 330 reaction mentions
joint swelling — 228 reaction mentions
diverticulitis — 204 reaction mentions
renal failure — 202 reaction mentions
pulmonary embolism — 201 reaction mentions
deep vein thrombosis — 199 reaction mentions
apparent death — 195 reaction mentions
pneumonia — 168 reaction mentions
condition aggravated — 150 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
✎ 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
8 products list this as an active ingredient in the United States drug directory. 3 of them contain it and nothing else.
FDA National Drug Code directory · 17089-295 · read 2026-08-29
They are sold as injection, solution, liquid, pellet and solution/ drops, taken oral and subcutaneous.
FDA National Drug Code directory · 17089-295 · read 2026-08-29
6 published labels name 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 · 23886c49-5992-4a59-af52-e24eb3c9fbc5 · read 2026-08-29
Those labels are classed as human otc drug and human prescription drug.
US prescribing information · 23886c49-5992-4a59-af52-e24eb3c9fbc5 · read 2026-08-29
Ilaris is subcutaneous at 3 DOSAGE FORMS AND STRENGTHS Injection: 150 mg/mL, clear to slightly opalescent, colorless to a slightly brownish yellow tint solution, in single-dose vials., recorded as fda label in effect 2026-06-08 in the United States.
US prescribing information · 7d271f3b-e4f9-4d80-8dcf-28d49123f80e · 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 Canakinumab 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
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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.
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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 Canakinumab are recorded. Results from one form may not transfer to another.
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A study that measures it, and a reviewer to sign it off.
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No reviewed mechanism story exists for this substance.
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Check any of this yourself
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FDA substance identifier (UNII)
37CQ2C7X93
RxNorm concept
1864324
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1 approved application covers products containing this substance. The earliest was BLA125319, approved 20090617 to NOVARTIS PHARMS.
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5 questions this page could not answer
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Recorded evidence blocks (12)
Q2
What did Canakinumab's largest trial (10066 people) and its longest (8 years) measure?
10066 people in Canakinumab's largest registered study, 8 years in its longest registered window, measuring All-cause Mortality. ClinicalTrials.gov · 2026-09-01
57 phase2, 32 phase3, 16 phase1, 4 na or unstated, 1 early phase1, 1 phase4; NCT01327846; 2019-04-14. Last human test completed 2026, NCT04905316.
Interpretation These counts include studies where Canakinumab was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.
Show the evidence
phase2
57
phase3
32
phase1
16
na or unstated
4
early phase1
1
phase4
1
1 more recorded row
Last recorded human testNCT04905316
2026-07-06
recorded 2026-09-01 · last checked 2026-09-04
Q3
From mouse to human: where has Canakinumab shown lifespan?
"recommendation by Data Monitoring Committee"; 18 of 104 registered studies
Show the evidence
Trial
NCT00886769
terminated; "recommendation by Data Monitoring Committee"
NCT00900146
terminated; "Numerically modest lowering of HbA1c with canakinumab in combination with metformin was inadequate to continue patients with T2DM into Period IV of this study."
NCT01364389
terminated; "Data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period."
NCT01589029
terminated; "The results of the interim analysis showed that the primary endpoint was not met"
NCT01731990
terminated; "The study got terminated based on result from primary endpoint analysis"
NCT02007252
terminated; "The results of a third interim analysis (ad hoc) indicated a lack of efficacy and futility in continuing the trial."
12 further recorded trials
NCT02204293
terminated; "Recruitment issues due to marketing authorization of study drug"
NCT03064854
terminated; "Recruitment halted prematurely due to competitive landscape for lung cancer therapies"
NCT03447769
terminated; "Upon review of the primary analysis results, the benefit-risk was assessed by the Steering Committee Members with the decision that the study will be closed. No new safety signals were observed for canakinumab."
NCT03626545
terminated; "The study was early terminated due to the lack of efficacy of study treatment observed in the analysis of the primary endpoint of the randomized part"
NCT03631199
terminated; "Results of primary analysis showed addition of canakinumab to combination treatment did not improve tumor response or overall survival; the decision to stop the trial was not due to safety concerns"
NCT03742349
terminated; "This was a sponsor decision and was not a consequence of any safety concern"
NCT03968419
terminated; "Study early terminated due to low enrollment compared to the anticipated figures."
NCT04795466
terminated; "Terminated by Sponsor"
NCT04810611
terminated; "Business reasons"
NCT04814368
terminated; "Sponsor Decision"
NCT05237713
terminated; "Slow recruitment. It is not considered likely that the CANFIRE trial will be able to reach the target number of patients. Clinical responders will be further treated within the trial (expected duration: 3 years after stop of enrollment)."
NCT05725343
terminated; "Novartis has decided to terminate the trial due to the recent results made available from the Novartis CANOPY A study (CACZ885T2301), this decision is not related to any safety data for Canakinumab"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Canakinumab used Canakinumab 150 mg — over how long?
6 recorded entries; human; also "Canakinumab 150 mg", "Canakinumab 10 mg/kg", "ACZ885 150 mg (Canakinumab)"
Show the evidence
human
NCT01029652
Canakinumab 150 mg
NCT01250171
Canakinumab 10 mg/kg
NCT02296424
ACZ885 150 mg (Canakinumab)
NCT02296424
ACZ885 150 mg
NCT04365153
Canakinumab Injection 600mg
NCT04365153
Canakinumab Injection 300mg
recorded 2026-09-01 · last checked 2026-09-04
Q6
Canakinumab's half-life is 26 days — which schedules were studied?
26 days, the half-life Canakinumab's label states. openfda-label · 7d271f3b-e4f9-4d80-8dcf-28d49123f80e · 2026-08-30
bioavailability 66% %.
Show the evidence
half life
26 days; The mean terminal half-life was 26 days.
bioavailability
66% %; The absolute bioavailability of subcutaneous canakinumab was estimated to be 66%.
recorded 2026-08-30 · last checked 2026-09-04
Q7
Which of absorption rate constant as measured by pk sampling, adverse events and adverse events and serious adverse events did Canakinumab's trials measure?
absorption rate constant as measured by pk sampling, adverse events and adverse events and serious adverse events lead 40 outcome terms across Canakinumab's trials. ClinicalTrials.gov · 2026-09-01
forced vital capacity, plasma hba1c, core study mean number of gout flares per, adverse events serious adverse events and death, plaque burden and time to first new flare follow.
Show the evidence
safety and tolerability
1
adverse events and serious adverse events
1
forced expiratory volume in 1 second
1
forced vital capacity
1
plasma hba1c
1
core study mean number of gout flares per
1
14 more recorded rows
adverse events serious adverse events and death
1
plaque burden
1
time to first new flare
1
adverse events death and serious adverse events
1
part a number of intolerance events
1
polymyalgia rheumatica activity
1
recurrence of atrial fibrillation
1
adverse events
1
all cause mortality
1
erythrocyte sedimentation rate
1
frequency of dose interruptions
1
frequency of dose reductions
1
overall response rate
1
part 1 number of dose limiting toxicities
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Canakinumab's 13 ongoing trials reports first?
Hematological improvement (HI); Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling; latest 2030-04-01
Show the evidence
Trial
NCT04239157
"A Phase II, Open-Label, Study of Subcutaneous Canakinumab, an Anti-IL-1β Human Monoclonal Antibody, for Patients With Low or Int-1 Risk IPSS/IPSS-R Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia"; n 76; "Hematological improvement (HI)"; 2026-12-31
NCT04278404
"Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)"; n 5000; "Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling"; 2026-12
NCT04789681
"Canakinumab for the Prevention of Lung Cancer, the Can-Prevent-Lung Trial"; n 50; "Regression of indeterminate pulmonary nodules (IPNs)"; 2027-12-31
NCT04798339
"Canakinumab With Darbepoetin Alfa in PTs With Lower-Risk MDS Who Have Failed ESA"; n 13; "Phase 1b: Maximum Tolerated Dose (MTD)"; 2026-07
NCT05401578
"Canakinumab for the Treatment of Postprandial Hypoglycemia"; n 56; "Change in Health related quality of life (mental health)"; 2026-05-31
NCT05467800
"Study of Canakinumab in Patients With Myelofibrosis"; n 14; "Number of participant with response based on IWG-MRT criteria"; 2027-07-01
7 further recorded trials
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
NCT05641831
"Canakinumab for the Prevention of Progression to Cancer in Patients With Clonal Cytopenias of Unknown Significance, IMPACT Study"; n 110; "Time to overt myeloid malignancy"; 2028-12-31
NCT05984602
"A Phase IB Study to Determine the Safety and Tolerability of Canakinumab and Tislelizumab in Combination With Nab-Paclitaxel and Gemcitabine in the Neo-adjuvant Treatment of Patients With Pancreatic Cancer"; n 9; "Number of dose limiting toxicities (DLTs)"; 2026-07-01
NCT06691217
"Effects of IL-1 Beta Inhibition on Vascular Inflammation in TET2 Clonal Hematopoiesis"; n 120; "Between-group difference (canakinumab versus placebo) in the change in perivascular fat attenuation index (Hounsfield units) measured by coronary computed tomography angiography"; 2030-04-01
NCT06724562
"IL1 Inhibition in FOP"; n 11; "Number of flares that a patient experiences."; 2027-11-05
NCT06838143
"Ilaris NIS in Korea"; n 25; "Incidence of adverse events and serious adverse events"; 2028-09-30
NCT07138898
"Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty"; n 80; "Incidence of wound complications"; 2028-01
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which 15 trials of Canakinumab posted no result?
Posted no result
15 of 15 completed trials
Registrations
NCT00619905, NCT00421226, NCT00487708, NCT01088880, NCT01170936 and NCT01276522, and 9 more
Completion dates
oldest 2005-08; newest 2024-05-28
Show the evidence
Trial
NCT00619905
2005-08
NCT00421226
2007-12
NCT00487708
2008-07
NCT01088880
2011-08
NCT01170936
2011-12
NCT01276522
2011-12
9 further recorded trials
NCT00991146
2012-02
NCT01245127
2012-05
NCT01105507
2012-05-12
NCT01302795
2015-11
NCT01390350
2018-05
NCT02900664
2021-03-17
NCT04510493
2021-08-17
NCT06481189
2023-05-26
NCT05080218
2024-05-28
Q10
At the median, Canakinumab's trials enrolled 45 people — anything larger?
Median enrolment
45
Largest enrolment
10066
Registered trials counted
103
Q11
What do 2259 spontaneous reports say about Canakinumab — 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.
Canakinumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 2259 reaction mentions were counted: pyrexia 382; pain 330; joint swelling 228; diverticulitis 204. open-targets-adr · CHEMBL1201834 · 2026-06-24
Show the evidence
pyrexia
382
pain
330
joint swelling
228
diverticulitis
204
renal failure
202
pulmonary embolism
201
4 more recorded rows
deep vein thrombosis
199
apparent death
195
pneumonia
168
condition aggravated
150
recorded 2026-06-24 · last checked 2026-09-04
Q12
Canakinumab and CYP450 and Cytochrome P450: shared by which compounds?
CYP450 and Cytochrome P450 appear in Canakinumab's recorded interaction sentences, 3 in all. openfda-label+europepmc · 2026-06-08
Interpretation drug_interactions
Show the evidence
Cytochrome P450drug_interactions
7.3 Cytochrome P450 Substrates The formation of CYP450 enzymes is suppressed by increased levels of cytokines (e.g., IL-1) during chronic inflammation.
CYP450
drug_interactions
Thus, it is expected that for a molecule that binds to IL-1, such as canakinumab, the formation of CYP450 enzymes could be normalized.
drug_interactions
This is clinically relevant for CYP450 substrates with a narrow therapeutic index, where the dose is individually adjusted (e.g., warfarin).
recorded 2026-06-08 · last checked 2026-09-04
Q13
What is recorded about Canakinumab and mTOR?
"These strategies include: approaches targeting IKK-b-NF-kB (salicylates, salsalate), TNF-α (etanercept, infliximab, adalimumab), IL-1β (anakinra, canakinumab) and IL-6 (tocilizumab), AMP-activated protein kinase activators, sirtuin-1 activators, mammalian target of rapamycin inhibitors and C-C motif chemokine receptor 2 antagonists." — where Canakinumab and mTOR appear together. Europe PMC · pathway abstract search · 2014-10-25
mTOR, AMPK, sirtuin; PMID 25345753
Show the evidence
mTORPMID 25345753
"These strategies include: approaches targeting IKK-b-NF-kB (salicylates, salsalate), TNF-α (etanercept, infliximab, adalimumab), IL-1β (anakinra, canakinumab) and IL-6 (tocilizumab), AMP-activated protein kinase activators, sirtuin-1 activators, mammalian target of rapamycin inhibitors and C-C motif chemokine receptor 2 antagonists."
AMPKPMID 25345753
"These strategies include: approaches targeting IKK-b-NF-kB (salicylates, salsalate), TNF-α (etanercept, infliximab, adalimumab), IL-1β (anakinra, canakinumab) and IL-6 (tocilizumab), AMP-activated protein kinase activators, sirtuin-1 activators, mammalian target of rapamycin inhibitors and C-C motif chemokine receptor 2 antagonists."
sirtuinPMID 25345753
"These strategies include: approaches targeting IKK-b-NF-kB (salicylates, salsalate), TNF-α (etanercept, infliximab, adalimumab), IL-1β (anakinra, canakinumab) and IL-6 (tocilizumab), AMP-activated protein kinase activators, sirtuin-1 activators, mammalian target of rapamycin inhibitors and C-C motif chemokine receptor 2 antagonists."
recorded 2014-10-25 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
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