This page shows what was measured, who it was measured in, and what that does not settle.
What Mepolizumab does in the body
NUCALA is an interleukin-5 (IL-5) antagonist 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.
From the FDA-approved label: Mepolizumab is an IL-5 antagonist (IgG1 kappa). IL-5 is the major cytokine responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils. Mepolizumab binds to IL-5 with a dissociation constant of 100 pM, inhibiting the bioactivity of IL-5 by blocking its binding to the alpha chain of the IL-5 receptor complex expressed on the eosinophil cell surface. Inflammation is an important component in the pathogenesis of asthma, CRSwNP, COPD, EGPA, and HES. , histamine, eicosanoids, leukotrienes, cytokines) are involved in inflammation.
Why people take it. NUCALA is an interleukin-5 (IL-5) antagonist 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.
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 · 90Z2UF0E52 · read 2026-08-29
Where each sentence above came from
The use the label states, quoted from it. No plain-language version of this sentence has been written.
The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.
No statement of the main limit is recorded.
The four opening statements run to 163 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.
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. 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
Comparison of quality of life over 5 years according to the asthmatic status of the patients
✗ The study did not show it
Who was studied
NCT06501807
How many people
900
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
Rate of Moderate or Severe Exacerbations in Participants in the High Stratum
✗ The study did not show it
Who was studied
NCT02105948
How many people
837
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
Annualized Rate of Moderate or Severe Exacerbations
✗ The study did not show it
Who was studied
NCT04133909
How many people
806
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 severe asthma patients eligible for one or more biologic treatments for asthma
✗ The study did not show it
Who was studied
NCT02293265
How many people
767
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
Rate of Moderate or Severe Exacerbations
✗ The study did not show it
Who was studied
NCT02105961
How many people
674
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.2 registered measures 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.4 registered measures of this kind.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
□AnimalsNo evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
□Cells in a dishNo evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
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.
heart rate at the indicated time
inflammation
pulmonary inflammation
peak concentration
Meaningful
Things that change how a life goes, not only a number.
who achieved main remission at both weeks 36 and 48
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 (30)
pharmacokinetics
safety
fev1
adverse drug reaction
adverse drug reactions
total endoscopic nasal polyps at week 52
adverse events and serious adverse events
serious aes
response rate based on global assessment of effectiveness
dysphagia
serious adverse events and non serious adverse events
adverse events of special interest
modified rodnan skin
acq5
asthma control during the treatment
infections
exacerbations
asthma control test
peripheral blood eosinophil and b cell levels
cmax
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. 16 to 22 days
Read from the label, which states: “Elimination Following subcutaneous administration of mepolizumab in adult subjects with asthma, the mean terminal half-life (t 1/2 ) ranged from 16 to 22 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.
NUCALA is an interleukin-5 (IL-5) antagonist 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 ) • Add-on maintenance treatment of adult patients aged 18 years and older with chronic rhinosinusitis with nasal polyps (CRSwNP).
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: “A total of 28 adolescents aged 12 to 17 years with severe asthma were enrolled in the Phase 3 asthma trials.”
US prescribing information · fefb887c-e4ac-431e-8893-e9d1a5a63fea · read 2026-08-30
On older people, the label states: “Of the total number of patients treated with NUCALA (n = 4106) for severe asthma, HES, EGPA, CRSwNP, and COPD, 1073 (26%) were 65 years of age and older and 241 (6%) were 75 years of age and older [see Clinical Studies ( 14 )] .”
US prescribing information · fefb887c-e4ac-431e-8893-e9d1a5a63fea · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary The data on pregnancy exposure are insufficient to inform on drug-associated risk.”
US prescribing information · fefb887c-e4ac-431e-8893-e9d1a5a63fea · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There is no information regarding the presence of mepolizumab in human milk, the effects on the breastfed infant, or the effects on milk production.”
US prescribing information · fefb887c-e4ac-431e-8893-e9d1a5a63fea · 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 injectable, injection, solution, injection, powder, for solution, given by the subcutaneous, subcutaneous lyophilized power 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.
Mepolizumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 6900 reaction mentions were counted. One report can name several reactions.
loss of personal independence in daily activities — 379 reaction mentions
productive cough — 379 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. 8 of them contain it and nothing else.
FDA National Drug Code directory · 71124-0063 · read 2026-08-29
They are sold as injection, powder, for solution, injection, solution and liquid, taken subcutaneous.
FDA National Drug Code directory · 71124-0063 · read 2026-08-29
The regulator's established pharmacologic class for it is interleukin-5 antagonist [epc] and interleukin-5 antagonists [moa].
FDA National Drug Code directory · 71124-0063 · 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 · fefb887c-e4ac-431e-8893-e9d1a5a63fea · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · fefb887c-e4ac-431e-8893-e9d1a5a63fea · read 2026-08-29
Nucala is subcutaneous at 3 DOSAGE FORMS AND STRENGTHS For Injection • 100 mg white to off-white lyophilized powder in a single-dose vial for reconstitution., recorded as fda label in effect 2025-08-06 in the United States.
US prescribing information · fefb887c-e4ac-431e-8893-e9d1a5a63fea · 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 Mepolizumab 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 Mepolizumab 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)
90Z2UF0E52
RxNorm concept
1720601
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Quoted from a stored source.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✓ Passed
Safety mode resolved
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
2 approved applications cover products containing this substance. The earliest was BLA125526, approved 20151104 to GLAXOSMITHKLINE LLC.
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 Mepolizumab's largest trial (7938 people) and its longest (19 years) measure?
7938 people in Mepolizumab's largest registered study, 19 years in its longest registered window, measuring Mean Area Under the Plasma-concentration Time Curve (AUC) Following SC and IV Administration of Mepolizumab. ClinicalTrials.gov · 2026-09-01
30 phase3, 26 na or unstated, 17 phase2, 15 phase4, 6 phase1, 3 early phase1, 2 na; NCT06456450; 2043-02-28; no ageing endpoint recorded. Last human test completed 2026, NCT07591753.
Interpretation These counts include studies where Mepolizumab 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
30
na or unstated
26
phase2
17
phase4
15
phase1
6
early phase1
3
2 more recorded rows
na
2
Last recorded human testNCT07591753
2026-03-31
recorded 2026-09-01 · last checked 2026-09-04
Q2
Mepolizumab was tested only in human — what did it show?
Interpretation Mean Area Under the Plasma-concentration Time Curve (AUC) Following SC and IV Administration of Mepolizumab — the recorded outcome words.
Show the evidence
humanNCT01366521
biomarker; Mean Area Under the Plasma-concentration Time Curve (AUC) Following SC and IV Administration of Mepolizumab; 95
"Study terminated by sponsor (29 Sep 2010). Subjects eligible to continue mepolizumab treatment were transferred into the compassionate use program (MHE104317)"; 5 of 95 registered studies
Show the evidence
Trial
NCT00097370
terminated; "Study terminated by sponsor (29 Sep 2010). Subjects eligible to continue mepolizumab treatment were transferred into the compassionate use program (MHE104317)"
NCT02594332
terminated; "recruitment problems"
NCT03055195
terminated; "Study reached pre-determined futility criteria following interim analysis. No safety concerns were noted."
NCT04128371
terminated; "Study was closed after the first five participants completed their participation due to lack of efficacy."
NCT04305678
withdrawn; "Funding lost from Sponsor."
recorded 2026-09-01 · last checked 2026-09-04
Q4
Human studies of Mepolizumab used Mepolizumab 100mg — over how long?
6 recorded entries; human; also "Mepolizumab 300 mg", "Mepolizumab 100 mg", "Mepolizumab 100 MG"
Show the evidence
human
NCT02555371
Mepolizumab 100mg
NCT02836496
Mepolizumab 300 mg
NCT03055195
Mepolizumab 100 mg
NCT04641741
Mepolizumab 100 MG
NCT05902325
Mepolizumab 100 MG Injection
NCT07343661
Mepolizumab 100 MG Injection [Nucala]
recorded 2026-09-01 · last checked 2026-09-04
Q5
Mepolizumab's half-life is 16 to 22 days — which schedules were studied?
16 to 22 days, the half-life Mepolizumab's label states. openfda-label · fefb887c-e4ac-431e-8893-e9d1a5a63fea · 2026-08-30
bioavailability 80% %.
Show the evidence
half life
16 to 22 days; Elimination Following subcutaneous administration of mepolizumab in adult subjects with asthma, the mean terminal half-life (t 1/2 ) ranged from 16 to 22 days.
bioavailability
80% %; Absorption Following 100-mg subcutaneous administration in the upper arm of adult and adolescent subjects with asthma, the bioavailability of mepolizumab was estimated to be approximately 80%.
metabolism
Metabolism: Mepolizumab is a humanized IgG1 monoclonal antibody that is degraded by the 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 Mepolizumab's effect on heart rate at the indicated time?
Heart rate at the indicated time: measured in Mepolizumab's trials.
Interpretation heart rate at the indicated time is the recorded endpoint.
Show the evidence
biomarkers
heart rate at the indicated time; 2026-09-01
pharmacokinetics; 2026-09-01
safety; 2026-09-01
fev1; 2026-09-01
adverse drug reaction; 2026-09-01
adverse drug reactions; 2026-09-01
14 more recorded rows
biomarkers
total endoscopic nasal polyps at week 52; 2026-09-01
biomarkers
adverse events and serious adverse events; 2026-09-01
biomarkers
serious aes; 2026-09-01
biomarkers
response rate based on global assessment of effectiveness; 2026-09-01
biomarkers
dysphagia; 2026-09-01
biomarkers
who achieved main remission at both weeks 36 and 48; 2026-09-01
biomarkers
serious adverse events and non serious adverse events; 2026-09-01
biomarkers
adverse events of special interest; 2026-09-01
biomarkers
modified rodnan skin; 2026-09-01
biomarkers
acq5; 2026-09-01
biomarkers
asthma control during the treatment; 2026-09-01
biomarkers
inflammation; 2026-09-01
biomarkers
infections; 2026-09-01
biomarkers
exacerbations; 2026-09-01
half life
2026-09-04; halfLife; 16 to 22 days; 2026-08-30
human trials at or under30
16
smallest human trial
0; NCT04305678; PHASE1; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN
Q7
Which of acq5, adverse drug reaction and adverse drug reactions did Mepolizumab's trials measure?
acq5, adverse drug reaction and adverse drug reactions lead 40 outcome terms across Mepolizumab's trials. ClinicalTrials.gov · 2026-09-01
fev1, adverse drug reaction, adverse drug reactions, total endoscopic nasal polyps at week 52, adverse events and serious adverse events and serious aes follow.
Show the evidence
heart rate at the indicated time
1
pharmacokinetics
1
safety
1
fev1
1
adverse drug reaction
1
adverse drug reactions
1
14 more recorded rows
total endoscopic nasal polyps at week 52
1
adverse events and serious adverse events
1
serious aes
1
response rate based on global assessment of effectiveness
1
dysphagia
1
who achieved main remission at both weeks 36 and 48
1
serious adverse events and non serious adverse events
1
adverse events of special interest
1
modified rodnan skin
1
acq5
1
asthma control during the treatment
1
inflammation
1
infections
1
exacerbations
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Mepolizumab's 17 ongoing trials reports first?
Number of Subjects Who Achieved Main Remission at Both Weeks 36 and 48; Proportion of eosinophilic vs non-eosinophilic remaining exacerbation during the treatment period; latest 2043-02-28
Show the evidence
Trial
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
NCT04578171
"Residual Exacerbations With Mepolizumab"; n 60; "Proportion of eosinophilic vs non-eosinophilic remaining exacerbation during the treatment period"; 2028-01
NCT05030155
"Study of Mepolizumab-based Regimen Compared to Conventional Therapeutic Strategy in Patients With Eosinophilic Granulomatosis With Polyangiitis (E-merge)"; n 100; "Percentage of patients who achieved a prednisone dose of 4.0 mg or less per day at day 168, without experiencing a relapse"; 2025-11
NCT05263934
"Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyangiitis (EGPA)"; n 163; "Number of participants with remission (Birmingham Vasculitis Activity Score [BVAS] =0 and a dose of oral corticosteroid [OCS] less than or equal to [<=] 4 milligram [mg] per day)"; 2026-10-27
NCT05598814
"Mepolizumab to CRSwNP Through 12 Months - Randomised to FESS and Non-FESS Within the First 2 Weeks"; n 58; "Change in The Sino-Nasal Outcome Test 22 (SNOTT22) score"; 2025-08-31
NCT05902325
"Identifying Predictors Of Response To Mepolizumab In CRSwNP"; n 36; "Persistent clinical response to mepolizumab after cessation off mepoluzimab treatment"; 2026-12-31
11 further recorded trials
NCT05938972
"Real Life Study of Biologicals in Patients With Severe CRSwNP"; n 180; "Clinical characteristics"; 2030-12-31
NCT05942222
"A Real-world, Head-to-head Comparison of Dupilumab Versus Mepolizumab in Danish Patients With Chronic Rhinosinusitis With Nasal Polyps"; n 220; "SNOT-22"; 2026-05-01
NCT05979051
"A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis （EGPA）"; n 166; "Change from baseline in oral glucocorticoid dose (OCS)"; 2028-12
NCT06041386
"REIMAGINE - Real World EvaluatIon of Mepolizumab in Severe Asthma achievinG on Treatment clinIcal remissioN, a prospEctive Study"; n 336; "Percentage (%) of Participants Achieving 4-Component Clinical Remission"; 2028-06-14
NCT06069310
"Mepolizumab Effectiveness in Patients With Chronic Rhinosinusitis, Nasal Polyps and Comorbid Severe Eosinophilic Asthma"; n 40; "Mean change from baseline in Sino-nasal outcome test-22 (SNOT-22) score"; 2027-03-30
NCT06456450
"Taiwan Severe Asthma Biologic Registry"; n 500; "Status of Asthma Control"; 2043-02-28
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
NCT07200336
"Anti-IL-5 Therapy With Simple Polypectomy Versus Extended Endoscopic Sinus Surgery for CRSwNP"; n 360; "The Change in SNOT-22 Score"; 2031-10-10
NCT07268313
"Complete Remission After Treatment With Biologics for Nasal Polyps"; n 66; "Number of patients who can continue being in complete remission being out of biologic treatment."; 2027-06-01
NCT07343661
"Beyond EOsinophils: proteoMICS to Identify Potential Biomarker of Organ Damage and Response to MEPOLIZUMAB in EGPA"; n 90; "Saliva, sputum, and plasma proteomic profile of EGPA patients"; 2028-09-30
NCT07749001
"Airway Dysfunction, Occlusions and Remodeling: COPD Patients and Mepolizumab"; n 36; "To measure the effect of mepolizumab (100mg) on MRI ventilation defect percent in participants with no severe exacerbations during the study period."; 2028-04-01
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which 11 trials of Mepolizumab posted no result?
Posted no result
11 of 11 completed trials
Registrations
NCT00266565, NCT00086658, NCT00274703, NCT00292877, NCT01471327 and NCT01705795, and 5 more
Completion dates
oldest 2005-04; newest 2023-11-30
Show the evidence
Trial
NCT00266565
2005-04
NCT00086658
2006-05-01
NCT00274703
2007-03
NCT00292877
2008-07
NCT01471327
2012-04-27
NCT01705795
2017-01-31
5 further recorded trials
NCT03453021
2017-10-31
NCT05441059
2022-05-01
NCT05576454
2023-06-19
NCT04550780
2023-07-31
NCT06348173
2023-11-30
Q10
At the median, Mepolizumab's trials enrolled 89 people — anything larger?
Median enrolment
89
Largest enrolment
7938
Registered trials counted
94
Q11
What do 6900 spontaneous reports say about Mepolizumab — 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.
Mepolizumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 6900 reaction mentions were counted: asthma 1664; dyspnoea 1133; wheezing 792; therapeutic product effect incomplete 657. open-targets-adr · CHEMBL2108429 · 2026-06-24
Show the evidence
asthma
1664
dyspnoea
1133
wheezing
792
therapeutic product effect incomplete
657
cough
649
obstructive airways disorder
449
4 more recorded rows
pneumonia
401
blood count abnormal
397
loss of personal independence in daily activities
379
productive cough
379
recorded 2026-06-24 · last checked 2026-09-04
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