Sibeprenlimab FDA Approval Status
Last updated by Judith Stewart, BPharm on March 31, 2025.
FDA Approved: No
Generic name: sibeprenlimab
Company: Otsuka Pharmaceutical Co., Ltd
Treatment for: Immunoglobulin A Nephropathy
Sibeprenlimab is an inhibitor of APRIL (A PRoliferation-Inducing Ligand) in development for the treatment of immunoglobulin A nephropathy.
- Immunoglobulin A nephropathy (IgAN) is an autoimmune disease characterized by the accumulation of galactose deficient IgA1 (Gd-IgA1) complexes in the kidneys. It is associated with a progressive loss of kidney function and a high risk for progression to end-stage kidney disease.
- Sibeprenlimab works by selectively binding to and inhibiting the activity of APRIL. APRIL is a cytokine in the tumor necrosis factor (TNF) family that promotes the survival and class switching of B cells to produce IgA, particularly the pathogenic Gd-IgA1. By reducing Gd-IgA1 levels, sibeprenlimab may help slow kidney damage and progression toward ESKD in patients with immunoglobulin A nephropathy.
- In 2024, the FDA granted sibeprenlimab a Breakthrough Therapy designation following favorable results of the Phase 2 ENVISION clinical trial (NCT04287985).
- A Biologics License Application (BLA) has been submitted to the U.S. Food and Drug Administration (FDA) for sibeprenlimab for the treatment of immunoglobulin A nephropathy. The BLA is supported by results from the Phase 2 ENVISION clinical trial and the Phase 3 VISIONARY clinical trial (NCT05248646), which met its primary endpoint by demonstrating that sibeprenlimab produced a statistically significant and clinically meaningful reduction in 24-hour uPCR (urine protein-to-creatine ratio) compared to placebo after nine months of treatment.
- If approved, sibeprenlimab would allow for self-administration via injection every four weeks.
Development timeline for sibeprenlimab
Further information
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