Sibeprenlimab-Szsi
- Biologic
- Prescription only
- Identity checked
- Sources last checked 2026-09-04
This page shows what was measured, who it was measured in, and what that does not settle.
RNAWiki holds very little about this substance. The page shows what there is.
What Sibeprenlimab-Szsi does in the body
VOYXACT is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.
VOYXACT binds to APRIL with a dissociation constant (K D ) of 0.95 pM, which blocks signaling at the B cell maturation antigen (BCMA) and transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptors. Inhibition of APRIL results in reduced levels of serum galactose-deficient immunoglobulin A1 (Gd-IgA1), which is implicated in the pathogenesis of IgAN.
Why people take it. VOYXACT is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.
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
- RNAWiki has not recorded a supervision or regulatory status for this substance.
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 106 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.
Formulation
A formulation is the exact made-up form a substance comes in.
A picture of it, and where the picture fails
It is like the difference between a whole bean and instant coffee.
Where that stops being true. Coffee tastes different. A formulation can change how much reaches the blood.
What people get wrong. Two products with the same name are assumed to behave the same. They often do not.
The specific composition and physical form of a product, including salt, excipients and release profile.
What is missing or unclearRead 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.
- Proteinuria
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: “Safety and effectiveness of VOYXACT in pediatric patients have not been established.”
US prescribing information · c8a93b32-0676-4704-86dc-cb65f425c6e5 · read 2026-08-30
On older people, the label states: “Clinical studies of VOYXACT did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger adult patients.”
US prescribing information · c8a93b32-0676-4704-86dc-cb65f425c6e5 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary There are no available data on VOYXACT use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.”
US prescribing information · c8a93b32-0676-4704-86dc-cb65f425c6e5 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of sibeprenlimab-szsi in human milk, the effects of sibeprenlimab-szsi on the breastfed infant, or the effects of sibeprenlimab-szsi on milk production.”
US prescribing information · c8a93b32-0676-4704-86dc-cb65f425c6e5 · 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 takeRead 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.
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 studied form is not the form on the shelf.
On this record: This record is linked to 1 related forms. Evidence does not carry across all of them.
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)
- It was studied for a different goal
- The studies measured something else entirely. 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 takeRead 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
Prescription only
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
Not recorded.
Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No form or route is recorded.
No source is stored against this line.
Who oversees it
RNAWiki has not recorded a supervision or regulatory status for this substance.
Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
No register row and no identity class settled the question.
No source is stored against this line.
What is in the pack
Not recorded.
Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing is recorded about product quality.
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 takeNothing 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 unclearRead 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
Not recorded.
Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
The exact form studied is not recorded.
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
VOYXACT is subcutaneous at 3 DOSAGE FORMS AND STRENGTHS Injection: 400 mg/2 mL (200 mg/mL) clear to opalescent, colorless to yellow, solution in a single-dose prefilled syringe., recorded as fda label in effect 2026-03-17 in the United States.
US prescribing information · c8a93b32-0676-4704-86dc-cb65f425c6e5 · 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.
Names and forms linked to this record
Biosimilar of
Evidence on this page does not automatically apply to this one.
What it would be like to takeRead 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.
RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.
Questions worth asking
- Which of the trials of Sibeprenlimab-Szsi 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 unclearRead from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
How much did people take in the studies?
The sources RNAWiki checked hold nothing for this field.
Why it matters. A result belongs to an amount. Without the amount the result floats free.
What would answer it
A stored source that records 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 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 Sibeprenlimab-Szsi 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 peopleNothing found in the sources checked
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.
Nothing found in the sources checked
No traced study record is stored for this substance.
The sources listed were searched and held nothing. That is not the same as nothing existing.
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
Not passed
Safety mode resolved
No register row and no identity class settled the question.
Passed
Canonical metadata present
slug and display name present
What is missing or unclearRead 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 BLA761434, approved 20251125 to OTSUKA PHARM CO LTD.
Drugs@FDA application register · BLA761434 · read 2026-08-29
Marketing status on the register: prescription.
Drugs@FDA application register · BLA761434 · read 2026-08-29
What is missing or unclearRead from sources, not yet reviewed
What to learn next
Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.
- Were people like me actually studied?
- How close is this evidence to something I would notice?
- What does nobody know about this yet?
- What is a formulation?
This order is fixed in code and does not count clicks or time on the page.
What is not here
10 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.
- What happened in people — 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 (4)
On the Sibeprenlimab-Szsi label: indicated for what?
"VOYXACT is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. This indication is approved under accelerated approval based on reduction of proteinuria.": indications and usage on Sibeprenlimab-Szsi's label. DailyMed label · c8a93b32-0676-4704-86dc-cb65f425c6e5 · 2026-08-30
3 registered trials of Sibeprenlimab-Szsi — at which phases?
- Registered studies posting no result
- 2 of 3
3 registered studies of Sibeprenlimab-Szsi: 2 phase3, 1 phase1, 1 phase2. CLINICALTRIALS_SNAPSHOT · 2026-09-01
0 with a PubMed record
Show the evidence
- phase32
- phase11
- phase21
- active not recruiting1
- completed1
- enrolling by invitation1
recorded 2026-09-01 · last checked 2026-09-04
Sibeprenlimab-Szsi's half-life is 9.3 days — which schedules were studied?
9.3 days, the half-life Sibeprenlimab-Szsi's label states: "Elimination Following a single 400 mg VOYXACT dose, the mean terminal half-life is 9.3 days." DailyMed label · c8a93b32-0676-4704-86dc-cb65f425c6e5 · 2026-08-30
bioavailability 92% %.
Show the evidence
- half life recorded_background.pharmacokinetics9.3 days; Elimination Following a single 400 mg VOYXACT dose, the mean terminal half-life is 9.3 days.
- bioavailability recorded_background.pharmacokinetics92% %; The absolute bioavailability of sibeprenlimab-szsi is approximately 92% and there is no difference in relative bioavailability following administration to the abdomen, thigh, or arm.
recorded 2026-08-30 · last checked 2026-09-04
At the median, Sibeprenlimab-Szsi's trials enrolled 530 people — anything larger?
- Median enrolment
- 530
- Largest enrolment
- 600
- Registered trials counted
- 3
Where it is registered
Identifiers, relations and other names
The exact record
- UNII
- GHX28QZ7DD
- CAS number
- 2382896-07-1
Relations
- Biosimilar of Sibeprenlimab
- Trade name
- Voyxact
- Also called
- Immunogloabulin G2-kappa, anti-[Homo sapiens TNFSF13 (tumor necrosis factor (TNF) superfamily member 13, APRIL, CD256)], humanized monoclonal antibody; gamma2 heavy chain humanized (1-446) [VH (Homo sapiens IGHV1-46*01 (85.7%) -(IGHD) -IGHJ4*01 (100%)) CDR-IMGT [8.8.13] (26-33.51-58.97-109) (1-120) -Homo sapiens IGHG2*01 (100%), G2m.. CH2 V45.1 (CH1 (121-218), hinge 1-12 (219-230), CH2 V45.1 (281) (231-339), CH3 (340-444), CHS (445-446)) (121-446)], (134-218')-disulfide with kappa light chain humanized (1'-218') [V-KAPPA (Homo sapiens IGKV3-15*01 (85.9%) -IGKJ4*01 (100%)) CDR-IMGT [10.3.9] (27-36.54-56.93-101) (1'-111') -Homo sapiens IGKC*01 (100%), Km3 A45.1 (157), V101 (195) (112'-218')]; dimer (222-222'':223-223'':226-226”:229-229”)-tetrakisdisulfide, produced in a Chinese hamster ovary (CHO)-K1 derived cell line, glycoform alfa, Immunoglobulin G2, anti-(human proliferation-inducing ligand protein) (human monoclonal VIS649 γ2-chain), disulfide with human monoclonal VIS649 κ-chain, dimer, SIBEPRENLIMAB, SIBEPRENLIMAB [USAN], Sibeprenlimab [WHO-DD], sibeprenlimab [INN]
- Development code
- VIS-649, VIS649
Sources (4)
Sources
- CLINICALTRIALS_SNAPSHOT K1:GHX28QZ7DD#szsi ·
- drugsfda drugsfda ·
- DailyMed label c8a93b32-0676-4704-86dc-cb65f425c6e5 ·
- Drugs@FDA K1:GHX28QZ7DD#szsi ·
ClinicalTrials.gov — US Government work · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
How these records are assembled · Which registers were checked
Index-quality checks
- identity passed: no open identity hold
- required summary fields resolved: 3 required field(s) not terminal: Best-supported result, Biggest unanswered question, Human evidence
- public claims reviewed: 0 reviewed claim(s); drafts are never rendered
- source coverage passed: 4 source rows
- no critical contamination: no quarantine open
- canonical metadata passed: slug and display name present
- no raw internal fields: enforced by the copy-contract test over the rendered page
This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.