This page shows what was measured, who it was measured in, and what that does not settle.
What Belimumab does in the body
Patients 5 years of age and older
From the FDA-approved label: BENLYSTA is a BLyS-specific inhibitor that blocks the binding of soluble BLyS, a B-cell survival factor, to its receptors on B cells. BENLYSTA does not bind B cells directly, but by binding BLyS, BENLYSTA inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.
What happened in people
RNAWiki has not yet published a reviewed conclusion for this use.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
No reviewed claim names a result for any goal on this record.
No source is stored against this line.
The limit that matters most
Not recorded.
Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
What the registries record it as
The substance registry classes this as protein.
FDA substance registry · 73B0K5S26A · read 2026-08-29
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. 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 79 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.
Placebo
A placebo is a dummy treatment given so the real one can be compared with it.
A picture of it, and where the picture fails
A placebo is like a blank control in an experiment.
Where that stops being true. A blank does nothing. People given a placebo often do get better.
What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.
An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
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.
Number of Deaths - On Treatment Period (Week 52)
✗ The study did not show it
Who was studied
NCT01705977
How many people
4019
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. 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
SLE Responder Index (SRI) Response Rate at Week 52
✗ The study did not show it
Who was studied
NCT00424476
How many people
865
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at Week 52
✗ The study did not show it
Who was studied
NCT01484496
How many people
839
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
SLE Responder Index (SRI) Response Rate at Week 52
✗ The study did not show it
Who was studied
NCT00410384
How many people
819
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
Number of Participants With Adverse Events (AE)
✗ The study did not show it
Who was studied
NCT00712933
How many people
738
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
Percent of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response Rate at Week 52 for Double-blind Phase.
✗ The study did not show it
Who was studied
NCT01345253
How many people
709
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 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.
BENLYSTA is indicated for the treatment of patients 5 years of age and older with: • Active systemic lupus erythematosus (SLE) who are receiving standard therapy, and • Active lupus nephritis who are receiving standard therapy. Limitations of Use The efficacy of BENLYSTA has not been evaluated in patients with severe active central nervous system (CNS) lupus. Use of BENLYSTA is not recommended in this situation.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “The safety and effectiveness of BENLYSTA have not been established in pediatric patients less than 5 years of age.”
US prescribing information · 2fa3c528-1777-4628-8a55-a69dae2381a3 · read 2026-08-30
On older people, the label states: “Clinical studies of BENLYSTA did not include sufficient numbers of subjects, 65 years of age or older, to determine whether they respond differently from younger subjects.”
US prescribing information · 2fa3c528-1777-4628-8a55-a69dae2381a3 · read 2026-08-30
On people who are pregnant, the label states: “Exposure Registry There is a pregnancy exposure registry that evaluates pregnancy outcomes in women with lupus exposed to BENLYSTA during pregnancy.”
US prescribing information · 2fa3c528-1777-4628-8a55-a69dae2381a3 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary No information is available on the presence of belimumab in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production.”
US prescribing information · 2fa3c528-1777-4628-8a55-a69dae2381a3 · read 2026-08-30
On people with reduced liver function, the label states: “No formal trials were conducted to examine the effects of hepatic impairment on the pharmacokinetics of belimumab.”
US prescribing information · 2fa3c528-1777-4628-8a55-a69dae2381a3 · read 2026-08-30
On people with reduced kidney function, the label states: “The safety and efficacy of BENLYSTA were evaluated in studies that included subjects with SLE who had mild (creatinine clearance [CrCl] ≥60 and <90 mL/min), moderate (CrCl ≥30 and <60 mL/min), or severe (CrCl ≥15 and <30 mL/min) renal impairment.”
US prescribing information · 2fa3c528-1777-4628-8a55-a69dae2381a3 · 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 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 (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Given by a clinician
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Injection
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Suppression classes recorded: S1.
No source is stored against this line.
What is in the pack
Sold as injectable, injection, powder, lyophilized, for solution, solution, given by the injection, intravenous, 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.
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
7 products list this as an active ingredient in the United States drug directory. 7 of them contain it and nothing else.
FDA National Drug Code directory · 0409-9966 · read 2026-08-29
They are sold as injection, powder, lyophilized, for solution, liquid and solution, taken intravenous and subcutaneous.
FDA National Drug Code directory · 0409-9966 · read 2026-08-29
The regulator's established pharmacologic class for it is b lymphocyte stimulator-directed antibody interactions [moa], b lymphocyte stimulator-specific inhibitor [epc] and decreased b lymphocyte activation [pe].
FDA National Drug Code directory · 0409-9966 · 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 · 2fa3c528-1777-4628-8a55-a69dae2381a3 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 2fa3c528-1777-4628-8a55-a69dae2381a3 · read 2026-08-29
BENLYSTA is subcutaneous at 3 DOSAGE FORMS AND STRENGTHS Intravenous Infusion For injection: 120 mg or 400 mg of belimumab as a lyophilized powder in single‑dose vials for reconstitution and dilution prior to intravenous infusion., recorded as fda label in effect 2025-06-20 in the United States.
US prescribing information · 2fa3c528-1777-4628-8a55-a69dae2381a3 · 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 Belimumab 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 Belimumab 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)
73B0K5S26A
RxNorm concept
1656395
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
Suppression classes recorded: S1.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or unclear◇Read from sources, not yet reviewed
How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
What the approval register records
2 approved applications cover products containing this substance. The earliest was BLA125370, approved 20110309 to HUMAN GENOME SCIENCES INC..
This order is fixed in code and does not count clicks or time on the page.
What is not here
9 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.
How close this is to real life — found nothing in the sources checked.
The path through the body — found nothing in the sources checked.
Felt, measured, or meaningful — found nothing in the sources checked.
How long anything takes — 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 (9)
Q2
On the Belimumab label: indicated for what?
"BENLYSTA is indicated for the treatment of patients 5 years of age and older with: • Active systemic lupus erythematosus (SLE) who are receiving standard therapy, and • Active lupus nephritis who are receiving standard therapy. Limitations of Use The efficacy of BENLYSTA has not been evaluated in patients with severe…": indications and usage on Belimumab's label. DailyMed label · 2fa3c528-1777-4628-8a55-a69dae2381a3 · 2025-06-20
Q3
78 registered trials of Belimumab — at which phases?
8 of Belimumab's trials stopped: safety, futility/efficacy, accrual/recruitment, funding/business, other?
safety (1), futility/efficacy (1), accrual/recruitment (2), funding/business (2) and other (2): Belimumab's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01
"Sponsor decision - not related to safety"; 8 of 78 registered studies
Show the evidence
Trial
NCT00583557
terminated; "Sponsor decision - not related to safety"
NCT00732940
terminated; "Sponsor terminated study for business reasons."
NCT01025193
terminated; "has not demonstrated efficacy in primary goal"
NCT01440361
withdrawn; "This study was Cancelled Before Active"
NCT01762852
withdrawn; "Withdrawn due to difficulties in to recruiting due to competing studies, changing treatment practices, unavailability of eligible study population"
NCT03591380
terminated; "Recruitment complications due to COVID-19"
2 further recorded trials
NCT04767698
terminated; "The funding source decided to stop funding the study."
NCT05604742
withdrawn; "No patients eligible for inclusion"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Belimumab used Belimumab 1 mg/kg — over how long?
studies of Belimumab used the recorded amount. ClinicalTrials.gov · 2026-09-01
14 recorded entries; human; IV, subcutaneous; also "Belimumab 1 mg/kg", "Belimumab 4 mg/kg", "Belimumab 10 mg/kg"
Show the evidence
human
NCT00071487
Belimumab 1 mg/kg
NCT00071487
Belimumab 4 mg/kg
NCT00071487
Belimumab 10 mg/kg
NCT00732940
Belimumab 100 mg SC
NCT01484496
Belimumab 200 mg SC
NCT01583530
IV; Single Dose Group: Belimumab IV 240 mg
8 more recorded rows
humanNCT01583530
Single Dose Group: Belimumab SC 2 x 120 mg
humanNCT01583530
Single Dose Group: Belimumab SC 1 x 240 mg
humanNCT01583530
Single Dose Group: Belimumab SC 1 x 200 mg
humanNCT01583530
Multiple Dose Group: Belimumab SC 2 x 120 mg weekly
humanNCT01583530
Multiple Dose Group: Belimumab SC 1 x 200 mg weekly
humanNCT01639339
Belimumab 10 mg/kg plus standard therapy
humanNCT01762852
Belimumab 10 mg
humanNCT03747159
subcutaneous; Benlysta subcutaneous injection of 200mg
recorded 2026-09-01 · last checked 2026-09-04
Q6
Belimumab's half-life is 28 days — which schedules were studied?
28 days, the half-life Belimumab's label states: "Pharmacokinetic Parameter Population Estimates (n = 563) Peak concentration at steady state (C max,ss , mcg/mL) 313 Area under the curve (AUC 0-∞ , day•mcg/mL) 3,083 Distribution half-life (t ½ , days) 1.8 Terminal half-life (t ½ , days) 19.4 Systemic clearance (CL, mL/day) 215 Volume of distribution at steady state…" DailyMed label · 2fa3c528-1777-4628-8a55-a69dae2381a3 · 2025-06-20
tmax 28 days; bioavailability 74 %.
Show the evidence
half lifepharmacokinetics
28 days; Pharmacokinetic Parameter Population Estimates (n = 563) Peak concentration at steady state (C max,ss , mcg/mL) 313 Area under the curve (AUC 0-∞ , day•mcg/mL) 3,083 Distribution half-life (t ½ , days) 1.8 Terminal half-life (t ½ , days) 19.4 Systemic clearance (CL, mL/day) 215 Volume of distribution at steady state (Vss, L) 5 Lupus Nephritis: A population pharmacokinetic analysis was conducted…
tmaxpharmacokinetics
28 days; Pharmacokinetic Parameter Population Estimates (n = 563) Peak concentration at steady state (C max,ss , mcg/mL) 313 Area under the curve (AUC 0-∞ , day•mcg/mL) 3,083 Distribution half-life (t ½ , days) 1.8 Terminal half-life (t ½ , days) 19.4 Systemic clearance (CL, mL/day) 215 Volume of distribution at steady state (Vss, L) 5 Lupus Nephritis: A population pharmacokinetic analysis was conducted…
bioavailabilitypharmacokinetics
74 %; The bioavailability of belimumab was approximately 74%.
recorded 2025-06-20 · last checked 2026-09-04
Q7
Which 11 trials of Belimumab posted no result?
Posted no result
11 of 11 completed trials
Registrations
NCT00657007, NCT01160666, NCT01008982, NCT02500251, NCT02284984 and NCT04611971, and 5 more
Completion dates
oldest 2003-03; newest 2024-04-09
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Trial
NCT00657007
2003-03
NCT01160666
2012-06
NCT01008982
2012-08
NCT02500251
2018-08
NCT02284984
2018-10-31
NCT04611971
2021-05-06
5 further recorded trials
NCT04956484
2022-04-08
NCT04515719
2022-04-10
NCT01532310
2022-11-11
NCT04570306
2023-12-16
NCT05154734
2024-04-09
Q8
At the median, Belimumab's trials enrolled 50 people — anything larger?
Median enrolment
50
Largest enrolment
4019
Registered trials counted
77
Q9
What do 1224 spontaneous reports say about Belimumab — 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.
Belimumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1224 reaction mentions were counted: systemic lupus erythematosus 394; headache 193; arthralgia 155; urinary tract infection 100. FAERS via Open Targets · CHEMBL1789843 · 2026-06-24
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systemic lupus erythematosus
394
headache
193
arthralgia
155
urinary tract infection
100
lupus nephritis
99
therapy interrupted
67
4 more recorded rows
sle arthritis
62
leukopenia
58
proteinuria
55
systemic lupus erythematosus rash
41
recorded 2026-06-24 · last checked 2026-09-04
Q10
Which 10 reactions does Belimumab's label not list?
ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
✗ required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 6 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
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