Otsuka Pharmaceutical has announced encouraging interim results from its Phase 3 VISIONARY study evaluating sibeprenlimab, a potential new treatment for immunoglobulin A nephropathy (IgAN). This chronic and progressive kidney condition often leads to end-stage kidney disease (ESKD), even with today’s best available treatments. The latest findings regarding sibeprenlimab show significant benefits* for patients. Following a Biologics License Application (BLA) submitted in March, sibeprenlimab received FDA Priority Review status, with a decision expected by November 28, 2025.

Significant Protein Reduction and Favorable Safety

The VISIONARY trial found that patients treated with sibeprenlimab saw a 51.2% drop in proteinuria after nine months, compared to those on placebo. Proteinuria, the presence of excess protein in urine, is a key indicator of kidney damage and a predictor of long-term outcomes.

“The VISIONARY Phase 3 interim analysis shows a robust proteinuria reduction…These results affirm our belief in the efficacy of sibeprenlimab,” said Dr. Dana Rizk, professor of medicine at the University of Alabama at Birmingham.

The safety profile of the drug was also reassuring.

• Only 3.9% of patients on sibeprenlimab reported serious side effects, compared to 5.4% in the placebo group, and 
• Fewer people overall experienced any side effects from the drug than those on the placebo.

Targeting the Root Cause of the Disease

Sibeprenlimab is a once-monthly injection that works by blocking APRIL, a protein that contributes to the overproduction of abnormal IgA antibodies in IgAN. These antibodies can form clumps that settle in the kidneys, causing inflammation and damage. By reducing levels of these harmful antibodies, sibeprenlimab helps to protect kidney function over time.

“Proteinuria control is an important independent predictor for long-term prognosis,” said Dr. John Kraus, executive VP and Chief Medical Officer at Otsuka. “This interim data reinforces our belief that selectively targeting APRIL has the potential to be an effective and safe approach for this progressive and irreversible kidney disease.”

Looking Ahead

The VISIONARY trial is continuing and will evaluate longer-term kidney function through early 2026. If results hold, sibeprenlimab could become the first treatment that directly targets a key driver of IgAN, offering new hope for patients living with this serious condition.

*Otsuka. (2025, June 6). Otsuka Sibeprenlimab Phase 3 Data Show a Statistically Significant and Clinically Meaningful Proteinuria Reduction for the Treatment of Immunoglobulin A Nephropathy (IgAN) [Press release]. Retrieved from https://www.otsuka-us.com/news/otsuka-sibeprenlimab-phase-3-data-show-statistically-significant-and-clinically-meaningful 

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