This page shows what was measured, who it was measured in, and what that does not settle.
What Omalizumab does in the body
Chronic Spontaneous Urticaria Omalizumab binds to IgE and lowers free IgE levels.
From the FDA-approved label: Asthma, Chronic Rhinosinusitis with Nasal Polyps, and IgE-Mediated Food Allergy Omalizumab inhibits the binding of IgE to the high-affinity IgE receptor (FcεRI) on the surface of mast cells, basophils, and dendritic cells, resulting in FcεRI down-regulation on these cells. In allergic asthmatics, treatment with omalizumab inhibits IgE-mediated inflammation, as evidenced by reduced blood and tissue eosinophils and reduced inflammatory mediators, including IL-4, IL-5, and IL-13. Subsequently, IgE receptors (FcεRI) on cells down-regulate.
Why people take it. Allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods
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. It is a prescription or clinician-administered medicine where it is approved.
What the registries record it as
The substance registry classes this as protein.
FDA substance registry · 2P471X1Z11 · read 2026-08-29
Where each sentence above came from
A person wrote this explanation into the record, with the studies named in the path below.
The recorded use, written for a reader without medical training. Not signed off.
No statement of the main limit is recorded.
The four opening statements run to 116 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.
Oral corticosteroid courses for asthma exacerbations in risk cohort.
✗ The study did not show it
Who was studied
NCT01449409
How many people
3000
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
Incidence of all serious adverse events.
✗ The study did not show it
Who was studied
NCT00401596
How many people
1899
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
Mean Change From Baseline in UAS7 at Week 12 (Multiple Imputation) of Adult Subjects
✗ The study did not show it
Who was studied
NCT03580356
How many people
1078
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
Mean Change From Baseline in UAS7 at Week 12 (Multiple Imputation) of Adult Subjects
✗ The study did not show it
Who was studied
NCT03580369
How many people
1072
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
Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)
✗ The study did not show it
Who was studied
NCT06455202
How many people
976
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
Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)
✗ The study did not show it
Who was studied
NCT06445023
How many people
963
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
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 lifeEvidence recorded. Pain, tiredness, mood, sleep, as the person rated it.4 registered measures of this kind.
■A number that stands in for healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.1 registered measure of this kind.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
□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.
trend of asthma control questionnaire
trend of asthma quality of life questionnaire
trend of severe asthma questionnaire
trend of pesam questionnaire
Measured
Things only a test, a scale or a device shows.
serum creatinine
Meaningful
Things that change how a life goes, not only a number.
disease remission
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (34)
at least 1 adverse event
live births
serious adverse events
incidence of all serious adverse events
basophil histamine release
urticaria activity 7 from baseline to week 4
adverse events
occurrence of one or more asthma exacerbations
prescribed budesonide dose at baseline
asthma exacerbation
total urticaria severity
asthma exacerbation rate
nasal polyp
adverse events and serious adverse events
pregnancy rate
acq5
asthma control during the treatment
responders
pharmacokinetic outcome measures
urticaria activity over 7 days at week 16
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: “In asthma patients omalizumab serum elimination half-life averaged 26 days, with apparent clearance averaging 2.4 ± 1.1 mL/kg/day.”
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.
XOLAIR is an anti-IgE antibody indicated for: Moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids ( 1.1 ) Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response…
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: “XOLAIR was evaluated in 2 trials in 926 (XOLAIR 624; placebo 302) pediatric patients 6 to <12 years of age with moderate to severe persistent asthma who had a positive skin test or in vitro reactivity to a perennial aeroallergen.”
US prescribing information · 7f6a2191-adfb-48b9-9bfa-0d9920479f0d · read 2026-08-30
On older people, the label states: “In clinical studies, 134 asthma patients, 20 CRSwNP patients, 37 CSU patients and no IgE-mediated food allergy patients 65 years of age or older were treated with XOLAIR.”
US prescribing information · 7f6a2191-adfb-48b9-9bfa-0d9920479f0d · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary A registry study of XOLAIR exposure during pregnancy showed no increase in the rate of major birth defects or miscarriage.”
US prescribing information · 7f6a2191-adfb-48b9-9bfa-0d9920479f0d · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There is no information regarding the presence of omalizumab in human milk, or the effects on milk production.”
US prescribing information · 7f6a2191-adfb-48b9-9bfa-0d9920479f0d · 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. It is a prescription or clinician-administered medicine where it is approved.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
The identity record classes it as Monoclonal Antibody (mAb).
No source is stored against this line.
What is in the pack
Sold as vial, syringe, injection, solution, given by the subcutaneous 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.
Omalizumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 21649 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
asthma — 3906 reaction mentions
dyspnoea — 3139 reaction mentions
urticaria — 2649 reaction mentions
cough — 1945 reaction mentions
anaphylactic reaction — 1852 reaction mentions
wheezing — 1764 reaction mentions
malaise — 1700 reaction mentions
fatigue — 1692 reaction mentions
pruritus — 1503 reaction mentions
headache — 1499 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
11 products list this as an active ingredient in the United States drug directory. 11 of them contain it and nothing else.
FDA National Drug Code directory · 0078-1336 · read 2026-08-29
They are sold as injection, solution and liquid, taken subcutaneous.
FDA National Drug Code directory · 0078-1336 · read 2026-08-29
The regulator's established pharmacologic class for it is anti-ige [epc], decreased ige activity [pe] and ige-directed antibody interactions [moa].
FDA National Drug Code directory · 0078-1336 · 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 · 7f6a2191-adfb-48b9-9bfa-0d9920479f0d · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 7f6a2191-adfb-48b9-9bfa-0d9920479f0d · read 2026-08-29
XOLAIR is subcutaneous at 3 DOSAGE FORMS AND STRENGTHS Injection: a clear to slightly opalescent and colorless to pale brownish-yellow solution available in the following: 75 mg/0.5 mL single-dose prefilled syringe with needle shield 75 mg/0.5 m…, recorded as fda label in effect 2026-08-13 in the United States.
US prescribing information · 7f6a2191-adfb-48b9-9bfa-0d9920479f0d · 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 Omalizumab 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 Omalizumab 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)
2P471X1Z11
RxNorm concept
1657209
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Written into the record, not signed off.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✓ Passed
Safety mode resolved
The identity record classes it as Monoclonal Antibody (mAb).
✓ 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 BLA103976, approved 20030620 to GENENTECH.
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 (11)
Q1
What did Omalizumab's largest trial (16246 people) and its longest (19 years) measure?
16246 people in Omalizumab's largest registered study, 19 years in its longest registered window, measuring Change in Logarithmically Transformed (log2) Allergen PC15 Concentration (Allergen Concentration Required to Evoke a 15% Decrease in FEV1). ClinicalTrials.gov · 2026-09-01
55 phase2, 51 phase4, 46 phase3, 26 phase1, 21 na or unstated, 11 na, 3 early phase1; NCT06456450; 2043-02-28; no ageing endpoint recorded. Last human test completed 2025, NCT06438757.
Interpretation These counts include studies where Omalizumab 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
55
phase4
51
phase3
46
phase1
26
na or unstated
21
na
11
2 more recorded rows
early phase1
3
Last recorded human testNCT06438757
2025-12-20
recorded 2026-09-01 · last checked 2026-09-04
Q2
Omalizumab was tested only in human — what did it show?
Change in Logarithmically Transformed (log2) Allergen PC15 Concentration (Allergen Concentration Required to Evoke a 15% Decrease in FEV1) — the recorded outcome words.
Show the evidence
humanNCT00434434
biomarker; Change in Logarithmically Transformed (log2) Allergen PC15 Concentration (Allergen Concentration Required to Evoke a 15% Decrease in FEV1); 203
8 recorded entries; human; subcutaneous, injection; also "Mepolizumab 100mg SC", "Xolair 300 mg", "Omalizumab 150mg"
Show the evidence
human
NCT00481676
Omalizumab 75-375 mg
NCT02654145
Mepolizumab 100mg SC
NCT03964051
Xolair 300 mg
NCT04361812
Omalizumab 150mg
NCT06494345
subcutaneous; Xolair®, solution for subcutaneous administration, 150 mg
NCT06683261
Mepolizumab 100 mg
2 more recorded rows
humanNCT06943534
injection; 5mg/kg omalizumab injection
humanNCT06943534
injection; 15mg/kg omalizumab injection
recorded 2026-09-01 · last checked 2026-09-04
Q5
Omalizumab's half-life is 26 days — which schedules were studied?
26 days, the half-life Omalizumab's label states. openfda-label · 7f6a2191-adfb-48b9-9bfa-0d9920479f0d · 2026-08-30
bioavailability 62% %.
Show the evidence
half life
26 days; In asthma patients omalizumab serum elimination half-life averaged 26 days, with apparent clearance averaging 2.4 ± 1.1 mL/kg/day.
bioavailability
62% %; 12.3 Pharmacokinetics After SC administration, omalizumab was absorbed with an average absolute bioavailability of 62%.
recorded 2026-08-30 · last checked 2026-09-04
Q6
Could one person measure Omalizumab's effect on at least 1 adverse event?
At least 1 adverse event: measured in Omalizumab's trials.
at least 1 adverse event is the recorded endpoint.
Show the evidence
biomarkers
at least 1 adverse event; 2026-09-01
live births; 2026-09-01
serious adverse events; 2026-09-01
incidence of all serious adverse events; 2026-09-01
basophil histamine release; 2026-09-01
urticaria activity 7 from baseline to week 4; 2026-09-01
14 more recorded rows
biomarkers
adverse events; 2026-09-01
biomarkers
occurrence of one or more asthma exacerbations; 2026-09-01
biomarkers
serum creatinine; 2026-09-01
biomarkers
prescribed budesonide dose at baseline; 2026-09-01
biomarkers
asthma exacerbation; 2026-09-01
biomarkers
total urticaria severity; 2026-09-01
biomarkers
asthma exacerbation rate; 2026-09-01
biomarkers
nasal polyp; 2026-09-01
biomarkers
adverse events and serious adverse events; 2026-09-01
biomarkers
pregnancy rate; 2026-09-01
biomarkers
disease remission; 2026-09-01
biomarkers
acq5; 2026-09-01
biomarkers
asthma control during the treatment; 2026-09-01
biomarkers
responders; 2026-09-01
half life
2026-09-04; halfLife; 26 days; 2026-08-30
human trials at or under30
69
smallest human trial
0; NCT00109187; PHASE3; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; COMPLETED
Q7
Which of acq5, adverse events and adverse events and serious adverse events did Omalizumab's trials measure?
acq5, adverse events and adverse events and serious adverse events lead 40 outcome terms across Omalizumab's trials. ClinicalTrials.gov · 2026-09-01
incidence of all serious adverse events, basophil histamine release, urticaria activity 7 from baseline to week 4, adverse events, occurrence of one or more asthma exacerbations and serum creatinine follow.
Show the evidence
at least 1 adverse event
1
live births
1
serious adverse events
1
incidence of all serious adverse events
1
basophil histamine release
1
urticaria activity 7 from baseline to week 4
1
14 more recorded rows
adverse events
1
occurrence of one or more asthma exacerbations
1
serum creatinine
1
prescribed budesonide dose at baseline
1
asthma exacerbation
1
total urticaria severity
1
asthma exacerbation rate
1
nasal polyp
1
adverse events and serious adverse events
1
pregnancy rate
1
disease remission
1
acq5
1
asthma control during the treatment
1
responders
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Omalizumab's 20 ongoing trials reports first?
active asthma diagnosis; Nasal interferon-α (IFN-α); latest 2043-02-28
Show the evidence
Trial
NCT02570984
"Preventing Asthma in High Risk Kids"; n 200; "active asthma diagnosis"; 2028-03-31
NCT05332067
"Omalizumab Before Onset of Exacerbations"; n 300; "Nasal interferon-α (IFN-α)"; 2028-03-01
NCT05674695
"Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis Therapy"; n 2500; "Rates of adverse events"; 2029-01-01
NCT05938972
"Real Life Study of Biologicals in Patients With Severe CRSwNP"; n 180; "Clinical characteristics"; 2030-12-31
NCT06027073
"Biologics and Sublingual Immunotherapy"; n 150; "Assess the effectiveness of combined therapy : omalizumab+ immunotherapy"; 2028-03-01
NCT06042478
"Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension."; n 470; "Absolute change from baseline in Weekly Urticaria Activity Score (UAS7)"; 2027-07-20
14 further recorded trials
NCT06365879
"To Compare Efficacy and Safety of CMAB007 and Xolair® in Patients With Chronic Spontaneous Urticaria"; n 392; "Change From Baseline of the Itch Severity Score (ISS7) Score At Week 12"; 2026-07-01
NCT06437171
"FeNO as a Marker of Allergic Reactions to OFC and Response of OMA Treatment in Multiple FA"; n 20; "FeNO change from baseline to week 52"; 2026-12
NCT06456450
"Taiwan Severe Asthma Biologic Registry"; n 500; "Status of Asthma Control"; 2043-02-28
NCT06509334
"Trial of JYB1904 in Chronic Spontaneous Urticaria."; n 135; "Urticaria activity score used for 7 consecutive days(UAS7)"; 2026-07-15
NCT06535087
"The Impact of Airway Allergic Diseases on Children's and Parents' Quality of Life"; n 600; "Asthma control level for asthmatic children"; 2027-05-31
NCT06618963
"Effect of Omalizumab in the Skin of Food Allergy Patients"; n 40; "Lipidomic analysis"; 2026-12
NCT06683261
"Real-life Evaluation of the Efficacy of Biologicals in Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)"; n 300; "To evaluate the effect of biologicals (omalizumab, mepolizumab and dupilumab) on the nasal congestion score (NCS)."; 2026-12
NCT06934200
"Omalizumab for the Treatment of Food Allergy in Patients With Elevated Total IgE Levels"; n 32; "Number of participants without dose limiting symptoms"; 2027-10-15
NCT06943534
"Omalizumab Weight-Based Dosing Efficacy Trial"; n 30; "Proportion of participants that tolerate the 600 mg dose after treatment."; 2028-04-01
NCT07059091
"Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD"; n 334; "Rate of COPD exacerbations"; 2031-05
NCT07073404
"Omalizumab for Plant-Food Allergy Due to Sensitization to LTP or Profilin"; n 37; "Change in tolerated dose of peach or melon during physician-supervised oral food challenge (PPO) in patients with vegetable allergy due to sensitization to lipid transfer proteins (LTPs) or profilin"; 2027-12
NCT07342803
"Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in Allergic Asthma Patients"; n 200; "Mean number of asthma exacerbations per subject"; 2029-09-30
NCT07356713
"A Study to Find a Suitable Dose of Exl-111 for Further Research"; n 70; "Incidence and severity of treatment-emergent adverse events and serious adverse events for Part A and Part B"; 2026-12-07
NCT07425639
"ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab Biosimilar"; n 225; "Maintenance of disease control and/or remission 12 months after initiation of biosimilar treatment."; 2028-09
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which 59 trials of Omalizumab posted no result?
Posted no result
59 of 59 completed trials
Registrations
NCT00401596, NCT00109187, NCT00822783, NCT00109200, NCT00046748 and NCT00078195, and 53 more
Completion dates
oldest 2002-07; newest 2024-07-12
Show the evidence
Trial
NCT00401596
2002-07
NCT00109187
2003-04
NCT00822783
2003-04
NCT00109200
2003-09
NCT00046748
2004-04
NCT00078195
2005-05
14 further recorded trials
NCT00232050
2005-05
NCT00482508
2005-10
NCT00219323
2006-03
NCT00482248
2006-06
NCT00133042
2006-12
NCT01678092
2006-12
NCT00084097
2007-02-05
NCT00130234
2007-09
NCT00329381
2007-10
NCT00657891
2007-10
NCT00691873
2007-10
NCT00139152
2009-12
NCT00377390
2009-12
NCT01393340
2009-12
Q10
At the median, Omalizumab's trials enrolled 60 people — anything larger?
Median enrolment
60
Largest enrolment
16246
Registered trials counted
200
Q11
What do 21649 spontaneous reports say about Omalizumab — 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.
Omalizumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 21649 reaction mentions were counted: asthma 3906; dyspnoea 3139; urticaria 2649; cough 1945. open-targets-adr · CHEMBL1201589 · 2026-06-24
Show the evidence
asthma
3906
dyspnoea
3139
urticaria
2649
cough
1945
anaphylactic reaction
1852
wheezing
1764
4 more recorded rows
malaise
1700
fatigue
1692
pruritus
1503
headache
1499
recorded 2026-06-24 · 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: 8 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.