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Sibeprenlimab
Medication From Wikipedia, the free encyclopedia
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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]
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]
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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]
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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]
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Legal status
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
External links
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