Sibeprenlimab

Last updated

Sibeprenlimab
Monoclonal antibody
Type Whole antibody
Source Humanized
Target A proliferation-inducing ligand (TNFSF13)
Clinical data
Trade names Voyxact
Other namesVIS-649, sibeprenlimab-szsi
License data
Routes of
administration 		Subcutaneous
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG
Chemical and physical data
Formula C6488H10002N1744O2013S52
Molar mass 146310.70 g·mol−1

Sibeprenlimab, sold under the brand name Voyxact, is a humanized monoclonal antibody used for the treatment of immunoglobulin A nephropathy. [1] It is an a proliferation-inducing ligand blocker. [1] It is given by injection under the skin (subcutaneous). [1]

Contents

The most common side effects include infections (including upper respiratory tract infection) and injection site reactions, including injection site erythema (skin redness). [2]

Sibeprenlimab was approved for medical use in the United States in November 2025. [2]

Medical uses

Sibeprenlimab is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk for disease progression. [1] [2]

Immunoglobulin A nephropathy is a serious kidney disease that occurs when an abnormal form of an antibody called immunoglobulin A deposits in the kidneys, causing kidney inflammation and damage. [2] This kidney damage can cause protein to leak into the urine (proteinuria) and progressive kidney function decline. [2] The disease is often diagnosed in young adults and can progress to kidney failure. [2]

Side effects

The most common side effects include infections (including upper respiratory tract infection) and injection site reactions, including injection site erythema (skin redness). [2]

History

The efficacy and safety of sibeprenlimab were evaluated in a randomized, double-blind, placebo-controlled trial (NCT05248646) in adults with biopsy-confirmed immunoglobulin A nephropathy. [2] Half of the participants received sibeprenlimab, and the other half received a placebo. [2] The primary efficacy endpoint assessed the change from baseline in proteinuria (urine protein-to-creatinine ratio sampled from a 24-hour urine collection) after nine months of treatment in the first 320 participants who had the opportunity to reach the month nine visit. [2] At nine months, participants in the sibeprenlimab group had a 50% reduction in proteinuria as compared to a 2% increase in proteinuria in the placebo group. [2]

The US Food and Drug Administration granted the application for sibeprenlimab accelerated approval based on the reduction of proteinuria along with priority review and breakthrough therapy designations. [2]

Society and culture

Sibeprenlimab was approved for medical use in the United States in November 2025. [2] [3]

Names

Sibeprenlimab is the international nonproprietary name. [4]

Sibeprenlimab is sold under the brand name Voyxact. [3]

References

  1. 1 2 3 4 5 "Highlights of prescribing information - VOYXACT® (sibeprenlimab-szsi) injection, for subcutaneous use" (PDF). www.accessdata.fda.gov.
  2. 1 2 3 4 5 6 7 8 9 10 11 12 13 "FDA approves a new treatment for primary immunoglobulin A nephropathy". U.S. Food and Drug Administration (FDA). 25 November 2025. Retrieved 26 November 2025.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  3. 1 2 "Otsuka Receives FDA Accelerated Approval for Voyxact (sibeprenlimab-szsi) for the Reduction of Proteinuria in Adults with Primary Immunoglobulin A Nephropathy (IgAN) at Risk for Disease Progression" (Press release). Otsuka Pharmaceutical. 26 November 2025. Retrieved 26 November 2025.
  4. ↑ World Health Organization (2021). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 86". WHO Drug Information. 35 (3). hdl: 10665/346562 .


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