Sibeprenlimab

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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
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]

Mechanism of action

Sibeprenlimab blocks the action of a proliferation-inducing ligand (APRIL), which is implicated in the development of IgA nephropathy, which is mediated through four consecutive processes. APRIL mediates autoimmunity during the last step through binding to transmembrane activator and calcium-modulating cyclophilin ligand interactor. [3] It then causes B cells to produce autoantigen complexes, which are deposited in the glomerular mesangium. Moreover, APRIL, by interaction with B-cell maturation antigen receptors, increases plasma cell survival rate, further enhancing the damaging role of these autoantigens. Sibeprenlimab decreases levels of all types of immunoglobulins (IgA, IgG and IgM, including disease-specific IgA autoantigen) connected with the disease. [4]

In genome-wide association studies, APRIL was selected as a susceptibility gene for IgA nephropathy. [5] [6]

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] [7]

Names

Sibeprenlimab is the international nonproprietary name. [8]

Sibeprenlimab is sold under the brand name Voyxact. [7]

References

  1. 1 2 3 4 5 "Voyxact (sibeprenlimab-szsi) injection, for subcutaneous use" (PDF). U.S. Food and Drug Administration (FDA).
  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. ↑ Yeo SC, Barratt J (December 2023). "The contribution of a proliferation-inducing ligand (APRIL) and other TNF superfamily members in pathogenesis and progression of IgA nephropathy". Clinical Kidney Journal. 16 (Suppl 2): ii9 –ii18. doi:10.1093/ckj/sfad200. PMC   10695512 . PMID   38053976.
  4. ↑ Cheung CK, Barratt J, Liew A, Zhang H, Tesar V, Lafayette R (1 February 2024). "The role of BAFF and APRIL in IgA nephropathy: pathogenic mechanisms and targeted therapies". Frontiers in Nephrology. 3 1346769. doi: 10.3389/fneph.2023.1346769 . PMC   10867227 . PMID   38362118.
  5. ↑ Kiryluk K, Sanchez-Rodriguez E, Zhou XJ, Zanoni F, Liu L, Mladkova N, et al. (July 2023). "Genome-wide association analyses define pathogenic signaling pathways and prioritize drug targets for IgA nephropathy". Nature Genetics. 55 (7): 1091–1105. doi:10.1038/s41588-023-01422-x. PMC   11824687 . PMID   37337107.
  6. ↑ Yu XQ, Li M, Zhang H, Low HQ, Wei X, Wang JQ, et al. (December 2011). "A genome-wide association study in Han Chinese identifies multiple susceptibility loci for IgA nephropathy". Nature Genetics. 44 (2): 178–182. doi:10.1038/ng.1047. PMID   22197929.
  7. 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.
  8. ↑ 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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