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Synonyms: sibeprenlimab-szsi | VIS-649 | VIS649 | Voyxact®
sibeprenlimab is an approved drug
Compound class:
Antibody
Comment: Sibeprenlimab (VIS-649) is a fully humanized IgG2κ monoclonal antibody that targets the B-cell growth factor APRIL (TNFSF13) [2,5]. The antibody binds with high affinity to human trimeric APRIL, and potently blocks APRIL binding to its receptors TACI (transmembrane activator and CAML interactor) and BCMA (B-cell maturation antigen). APRIL mediates antibody class switching in mature B cells and promotes plasma-cell survival. APRIL acts to elevate production of IgA and pathogenic galactose-deficient IgA1, by mediating class switching in mature B cells and promoting plasma-cell survival. Galactose-deficient IgA1 is a key driver of the IgA nephropathy pathology. Hence targeting APRIL is considered as a mechanism to reduce IgA-mediated kidney damage.
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| No information available. |
Summary of Clinical Use  |
| Sibeprenlimab was advanced to phase 3 clinical evaluations, to determine safety and efficacy as a mechanism to reduce pathological levels of circulating IgA in patients with IgA nephropathy [1]. First approval was granted by the FDA for this indication in November 2025. |
| Clinical Trials | |||||
| Clinical Trial ID | Title | Type | Source | Comment | References |
| NCT03719443 | First in Human Study to Assess Safety of VIS649 in Healthy Subjects | Phase 1 Interventional | Visterra, Inc. | Data from the first-in-human trial in healthy volunteers indicated that sibeprenlimab is safe and well tolerated. Target engagement was validated by reversible (and dose-dependent) suppression of APRIL levels, and reduction in circulating immunoglobulins (IgA, IgG, IgM). | 4 |
| NCT05248659 | Phase 2/3 Open-Label Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy | Phase 2/Phase 3 Interventional | Otsuka Pharmaceutical Development & Commercialization, Inc. | ||
| NCT05248646 | Visionary Study: Phase 3 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy (IgAN) | Phase 3 Interventional | Otsuka Pharmaceutical Development & Commercialization, Inc. | 6 | |
| NCT04287985 | Safety and Efficacy Study of VIS649 for IgA Nephropathy | Phase 2 Interventional | Visterra, Inc. | 3 | |
