Sibeprenlimab
Sibeprenlimab, sold under the brand name Voyxact, is a humanized monoclonal antibody used for the treatment of immunoglobulin A nephropathy. It is an a proliferation-inducing ligand blocker. It is given by injection under the skin.
The most common side effects include infections and injection site reactions, including injection site erythema.
Sibeprenlimab was approved for medical use in the United States in November 2025.
Medical uses
Sibeprenlimab is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk for disease progression.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. This kidney damage can cause protein to leak into the urine and progressive kidney function decline. The disease is often diagnosed in young adults and can progress to kidney failure.
Mechanism of action
Sibeprenlimab blocks the action of a proliferation-inducing ligand, 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. 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 connected with the disease.In genome-wide association studies, APRIL was selected as a susceptibility gene for IgA nephropathy.
Side effects
The most common side effects include infections and injection site reactions, including injection site erythema.History
The efficacy and safety of sibeprenlimab were evaluated in a randomized, double-blind, placebo-controlled trial in adults with biopsy-confirmed immunoglobulin A nephropathy. Half of the participants received sibeprenlimab, and the other half received a placebo. The primary efficacy endpoint assessed the change from baseline in proteinuria after nine months of treatment in the first 320 participants who had the opportunity to reach the month nine visit. 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.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.
Society and culture
Legal status
Sibeprenlimab was approved for medical use in the United States in November 2025.Names
Sibeprenlimab is the international nonproprietary name.Sibeprenlimab is sold under the brand name Voyxact.