This page shows what was measured, who it was measured in, and what that does not settle.
What Benralizumab does in the body
Eosinophilic granulomatosis with polyangiitis
From the FDA-approved label: Benralizumab is a humanized afucosylated, monoclonal antibody (IgG1, kappa) that directly binds to the alpha subunit of the human interleukin-5 receptor (IL-5Rα) with a dissociation constant of 11 pM. The IL-5 receptor is expressed on the surface of eosinophils and basophils. 5 nM) to FcɣRIII receptors on immune effector cells, such as natural killer (NK) cells, leading to apoptosis of eosinophils and basophils through antibody-dependent cell-mediated cytotoxicity (ADCC). Inflammation is an important component in the pathogenesis of asthma, EGPA, and HES.
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 · 71492GE1FX · 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 102 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.
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils >=300/uL
✗ The study did not show it
Who was studied
NCT01928771
How many people
2681
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
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL
✗ The study did not show it
Who was studied
NCT01914757
How many people
2508
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
Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL
✗ The study did not show it
Who was studied
NCT02155660
How many people
2255
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
Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients
✗ The study did not show it
Who was studied
NCT02258542
How many people
2133
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
Annualized Rate of Clinically Significant Exacerbations Over 52 Weeks
✗ The study did not show it
Who was studied
NCT04718389
How many people
1717
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
Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL
✗ The study did not show it
Who was studied
NCT02138916
How many people
1656
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 lifeEvidence recorded. Pain, tiredness, mood, sleep, as the person rated it.5 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
asthma control questionnaire
Measured
Things only a test, a scale or a device shows.
maximum observed concentration
Meaningful
Things that change how a life goes, not only a number.
who achieved main remission at both weeks 36 and 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 (20)
nasal polyp
sputum eosinophil percentage
adverse events and serious adverse events
steroid requiring exacerbations
asthma control during the treatment
peripheral blood eosinophil and b cell levels
severity of aes
time to first asthma exacerbation
fluctuation pattern of spirometry
fluctuation pattern of feno
fluctuation pattern of ios
treatment success biological
predicting asthma outcomes and therapeutic responses
responses to the biologic therapies at the single cell level
status of asthma control
status of asthma exacerbations
reduction of daily oral corticosteriod dose
pre bd fev1
adverse events
annualized asthma exacerbation rate
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. 3.5 days
Read from the label, which states: “Absorption Following subcutaneous administration to patients with asthma, the absorption half-life was approximately 3.5 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.
FASENRA is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody (IgG1, kappa) indicated for: • add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma, and with an eosinophilic phenotype. ( 1.1 ) • treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
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 in patients younger than 6 years of age have not been established.”
US prescribing information · da6aca1a-19ed-44a4-abb7-696c7d58b784 · read 2026-08-30
On older people, the label states: “EGPA and HES Clinical studies of FASENRA for EGPA and HES did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.”
US prescribing information · da6aca1a-19ed-44a4-abb7-696c7d58b784 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary The data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk.”
US prescribing information · da6aca1a-19ed-44a4-abb7-696c7d58b784 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There is no information regarding the presence of benralizumab in human or animal milk, and the effects of benralizumab on the breast fed infant and on milk production are not known.”
US prescribing information · da6aca1a-19ed-44a4-abb7-696c7d58b784 · 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. 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 injectable, injection, solution, given by the injection, 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.
Benralizumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1672 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
asthma — 505 reaction mentions
dyspnoea — 236 reaction mentions
headache — 211 reaction mentions
pyrexia — 154 reaction mentions
wheezing — 110 reaction mentions
urticaria — 109 reaction mentions
cough — 105 reaction mentions
chest discomfort — 85 reaction mentions
hypersensitivity — 81 reaction mentions
chills — 76 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
6 products list this as an active ingredient in the United States drug directory. 6 of them contain it and nothing else.
FDA National Drug Code directory · 17228-2730 · read 2026-08-29
They are sold as injection, solution and liquid, taken subcutaneous.
FDA National Drug Code directory · 17228-2730 · read 2026-08-29
The regulator's established pharmacologic class for it is interleukin 5 receptor alpha-directed antibody interactions [moa] and interleukin-5 receptor alpha-directed cytolytic antibody [epc].
FDA National Drug Code directory · 17228-2730 · 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 · da6aca1a-19ed-44a4-abb7-696c7d58b784 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · da6aca1a-19ed-44a4-abb7-696c7d58b784 · read 2026-08-29
FASENRA is subcutaneous at 3 DOSAGE FORMS AND STRENGTHS Injection: clear to opalescent, colorless to slightly yellow solution and may contain a few translucent or white to off‑white particles available as: • 10 mg/0.5 mL solution in a single-dose…, recorded as fda label in effect 2026-05-13 in the United States.
US prescribing information · da6aca1a-19ed-44a4-abb7-696c7d58b784 · 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 Benralizumab 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 Benralizumab 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)
71492GE1FX
RxNorm concept
1989104
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 BLA761070, approved 20171114 to ASTRAZENECA AB.
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 Benralizumab's largest trial (2681 people) and its longest (19 years) measure?
2681 people in Benralizumab's largest registered study, 19 years in its longest registered window, measuring Area Under the Concentration-time Curve From Zero to Infinity (AUCinf). ClinicalTrials.gov · 2026-09-01
35 phase3, 18 phase2, 11 na or unstated, 10 phase4, 4 phase1, 1 na; NCT06456450; 2043-02-28; no ageing endpoint recorded. Last human test completed 2026, NCT06465485.
Interpretation These counts include studies where Benralizumab 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
35
phase2
18
na or unstated
11
phase4
10
phase1
4
na
1
1 more recorded row
Last recorded human testNCT06465485
2026-05-13
recorded 2026-09-01 · last checked 2026-09-04
Q2
Benralizumab was tested only in human — what did it show?
safety (1), futility/efficacy (4), accrual/recruitment (2), sponsor decision unspecified (1) and other (3): Benralizumab's stop wording, clustered. ClinicalTrials.gov · 2026-09-01
"Study terminated due to sponsor decision"; 11 of 77 registered studies
Show the evidence
Trial
NCT01947946
terminated; "Study terminated due to sponsor decision"
NCT04108962
withdrawn; "Difficult to find eligible patients willing to participate."
NCT04157335
terminated; "The study has a double-blind period and an open-label period. The study did not meet its primary endpoints after the primary LSLV and the decision was taken to terminate the study early."
NCT04543409
terminated; "High-level results from the MESSINA Phase III trial showed that AstraZeneca's Fasenra (benralizumab) did not meet one of the two dual-primary endpoints. Given the lack of clear benefit in this patient population, study has been terminated."
NCT04605094
terminated; "The study did not meet the primary endpoint."
NCT04612725
terminated; "Study did not meet primary endpoint"
5 further recorded trials
NCT04612790
terminated; "Independent Data Monitoring Committee recommended terminating the study following a pre-planned analysis as the efficacy results did not meet the pre-defined futility guidelines. There were no new safety concerns identified from this…"
NCT05006573
terminated; "Due to the decision to stop recruitment early, enrolment into the MAHALE trial was terminated in August 2022; 139 patients were screened and 100 randomised to IP."
NCT05251909
terminated; "The study was terminated by the Sponsor based on emerging evidence in the pathology of eosinophilic upper gastrointestinal diseases. Recruitment for the study was terminated and only a small number of patients were recruited."
NCT05528913
withdrawn; "Financing has been withdrawn"
NCT05966584
terminated; "Limited amount of eligible participants"
recorded 2026-09-01 · last checked 2026-09-04
Q4
Human studies of Benralizumab used Benralizumab 25 mg — over how long?
8 recorded entries; human; also "Benralizumab 100 mg", "Benralizumab 200 mg", "Benralizumab 2 mg"
Show the evidence
human
NCT00783289
Benralizumab 25 mg
NCT00783289
Benralizumab 100 mg
NCT00783289
Benralizumab 200 mg
NCT01238861
Benralizumab 2 mg
NCT01238861
Benralizumab 20 mg
NCT04108962
Fasenra, 30 Mg/mL Subcutaneous Solution
2 more recorded rows
humanNCT04157335
Benralizumab 30 mg
humanNCT04617171
Benralizumab 30 MG/ML [Fasenra]
recorded 2026-09-01 · last checked 2026-09-04
Q5
Benralizumab's half-life is 3.5 days — which schedules were studied?
3.5 days, the half-life Benralizumab's label states. openfda-label · da6aca1a-19ed-44a4-abb7-696c7d58b784 · 2026-08-30
bioavailability 59% %.
Show the evidence
half life
3.5 days; Absorption Following subcutaneous administration to patients with asthma, the absorption half-life was approximately 3.5 days.
bioavailability
59% %; Based on population pharmacokinetic analysis, the estimated absolute bioavailability was approximately 59% and there was no clinically relevant difference in relative bioavailability in the administration to the abdomen, thigh, or arm.
metabolism
Metabolism Benralizumab is a humanized IgG1 monoclonal antibody that is degraded by proteolytic enzymes widely distributed in the body and not restricted to hepatic tissue.
recorded 2026-08-30 · last checked 2026-09-04
Q6
Could one person measure Benralizumab's effect on maximum observed concentration?
Maximum observed concentration: measured in Benralizumab's trials.
Interpretation maximum observed concentration is the recorded endpoint.
Show the evidence
biomarkers
maximum observed concentration; 2026-09-01
nasal polyp; 2026-09-01
sputum eosinophil percentage; 2026-09-01
adverse events and serious adverse events; 2026-09-01
steroid requiring exacerbations; 2026-09-01
who achieved main remission at both weeks 36 and 48; 2026-09-01
14 more recorded rows
biomarkers
asthma control during the treatment; 2026-09-01
biomarkers
peripheral blood eosinophil and b cell levels; 2026-09-01
biomarkers
severity of aes; 2026-09-01
biomarkers
time to first asthma exacerbation; 2026-09-01
biomarkers
fluctuation pattern of spirometry; 2026-09-01
biomarkers
fluctuation pattern of feno; 2026-09-01
biomarkers
fluctuation pattern of ios; 2026-09-01
biomarkers
treatment success biological; 2026-09-01
biomarkers
trend of asthma control questionnaire; 2026-09-01
biomarkers
trend of asthma quality of life questionnaire; 2026-09-01
biomarkers
trend of severe asthma questionnaire; 2026-09-01
biomarkers
trend of pesam questionnaire; 2026-09-01
biomarkers
predicting asthma outcomes and therapeutic responses; 2026-09-01
biomarkers
responses to the biologic therapies at the single cell level; 2026-09-01
half life
2026-09-04; halfLife; 3.5 days; 2026-08-30
human trials at or under30
20
smallest human trial
0; NCT04108962; PHASE4; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN
Q7
Which of adverse events, adverse events and serious adverse events and annualized asthma exacerbation rate did Benralizumab's trials measure?
adverse events, adverse events and serious adverse events and annualized asthma exacerbation rate lead 27 outcome terms across Benralizumab's trials. ClinicalTrials.gov · 2026-09-01
adverse events and serious adverse events, steroid requiring exacerbations, who achieved main remission at both weeks 36 and 48, asthma control during the treatment, peripheral blood eosinophil and b cell levels and severity of aes follow.
Show the evidence
maximum observed concentration
1
nasal polyp
1
sputum eosinophil percentage
1
adverse events and serious adverse events
1
steroid requiring exacerbations
1
who achieved main remission at both weeks 36 and 48
1
14 more recorded rows
asthma control during the treatment
1
peripheral blood eosinophil and b cell levels
1
severity of aes
1
time to first asthma exacerbation
1
fluctuation pattern of spirometry
1
fluctuation pattern of feno
1
fluctuation pattern of ios
1
treatment success biological
1
trend of asthma control questionnaire
1
trend of asthma quality of life questionnaire
1
trend of severe asthma questionnaire
1
trend of pesam questionnaire
1
predicting asthma outcomes and therapeutic responses
1
responses to the biologic therapies at the single cell level
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Benralizumab's 15 ongoing trials reports first?
All adverse events will be reported by count of events (safety and tolerability ); Change from baseline airway function measured using 129-Xenon MRI ventilation defect percent; latest 2043-02-28
Show the evidence
Trial
NCT03010436
"Benralizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study"; n 10; "All adverse events will be reported by count of events (safety and tolerability )"; 2021-12
NCT03733535
"Evaluating the Effect of Benralizumab in Severe, Poorly-controlled Eosinophilic Asthma Using Inhaled Hyperpolarized 129-Xenon MRI"; n 29; "Change from baseline airway function measured using 129-Xenon MRI ventilation defect percent"; 2026-12
NCT03953300
"Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics"; n 75; "The change in eosinophil numbers expressed as number/mm2 in submucosa as measured by major basic protein (MBP) staining in endobronchial biopsies"; 2026-10-19
NCT04157348
"Efficacy and Safety of Benralizumab in EGPA Compared to Mepolizumab."; n 140; "Number of Subjects Who Achieved Main Remission at Both Weeks 36 and 48"; 2026-11-30
NCT04191304
"A Phase III Study to Evaluate the Efficacy and Safety of Benralizumab in Patients With Hypereosinophilic Syndrome (HES)"; n 134; "Time to First HES Worsening/Flare During the DB Treatment Period"; 2027-02-28
NCT05692180
"A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma"; n 94; "Time to first asthma exacerbation"; 2032-05-16
9 further recorded trials
NCT06385236
"Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping"; n 120; "Predicting asthma outcomes and therapeutic responses"; 2028-01-31
NCT06456450
"Taiwan Severe Asthma Biologic Registry"; n 500; "Status of Asthma Control"; 2043-02-28
NCT06512883
"A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases"; n 14; "Number of Participants with Adverse Events (AEs)"; 2029-05-14
NCT06750289
"Randomised Clinical Trial to Investigate Efficacy and Safety of Benralizumab 30 mg SC as an add-on Therapy in Uncontrolled Eosinophilic Asthma Patients Treated With Medium-dose ICS-LABA Compared to Conventional Escalation to High-dose ICS-LABA Treatment"; n 400; "Annualized asthma exacerbation rate"; 2028-11-03
NCT06862206
"This is a Non-interventional, Study to Assess Demographic Characteristics and Patient Reported Outcomes in China Patients With SEA Treated With Benralizumab"; n 1000; "asthma control questionnaire"; 2028-01-30
NCT07214753
"A Real-life Observational Study in Severe Eosinophilic Asthma Adult Participant Treated With Benralizumab in Italy"; n 335; "Number and percentage of patients achieving clinical remission, partial and complete, as per SANI Definition"; 2028-12-31
NCT07444567
"Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit From Continued Treatment"; n 230; "Safety will be evaluated by monitoring and assessing SAEs and non-serious AEs reported throughout the study and until 8 weeks after the last dose of benralizumab"; 2030-01-03
NCT07530770
"Real-World Effectiveness of Benralizumab in Allergic Bronchopulmonary Aspergillosis"; n 20; "Number of steroid requiring exacerbations"; 2026-12-01
NCT07654842
"Fasenra: An Asthma Study"; n 40; "Change in anti-inflammatory reliever inhaler use during last benralizumab dosing cycle"; 2028-01-01
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which 12 trials of Benralizumab posted no result?
Posted no result
12 of 12 completed trials
Registrations
NCT00512486, NCT00659659, NCT02772419, NCT03183024, NCT03928262 and NCT05932849, and 6 more
Completion dates
oldest 2008-10; newest 2024-06-28
Show the evidence
Trial
NCT00512486
2008-10
NCT00659659
2011-03
NCT02772419
2017-03-27
NCT03183024
2018-11-06
NCT03928262
2019-08-12
NCT05932849
2022-02-28
6 further recorded trials
NCT05180357
2022-10-28
NCT03470311
2022-11-30
NCT04742504
2023-10-13
NCT06348173
2023-11-30
NCT04102800
2024-04-23
NCT04185012
2024-06-28
Q10
At the median, Benralizumab's trials enrolled 110 people — anything larger?
Median enrolment
110
Largest enrolment
2681
Registered trials counted
77
Q11
What do 1672 spontaneous reports say about Benralizumab — 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.
Benralizumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1672 reaction mentions were counted: asthma 505; dyspnoea 236; headache 211; pyrexia 154. open-targets-adr · CHEMBL1742991 · 2026-06-24
Show the evidence
asthma
505
dyspnoea
236
headache
211
pyrexia
154
wheezing
110
urticaria
109
4 more recorded rows
cough
105
chest discomfort
85
hypersensitivity
81
chills
76
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
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✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
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