Otsuka Pharmaceuticals Reports Promising Results for Kidney Treatment
Otsuka Pharmaceutical Development & Commercialization, Inc., along with Otsuka Pharmaceutical Co., Ltd., recently shared encouraging findings from their Phase 3 VISIONARY trial. The study focused on VOYXACT (sibeprenlimab-szsi), a treatment for adults with primary IgA nephropathy (IgAN), a kidney condition that can worsen over time. The results indicate that VOYXACT helps stabilize kidney function, preventing the typical decline for up to two years.
At the GlomCon Hawaii 2026 conference, researchers presented data showing that participants taking VOYXACT had a slight increase in their estimated glomerular filtration rate (eGFR) by +0.3 mL/min/1.73 m²/year, compared to a decline of -4.2 mL/min/1.73 m²/year with a placebo. This translates to a significant difference of +4.5, confirming VOYXACT’s positive impact on kidney health.
Dr. Dana Rizk, a nephrology expert at the University of Alabama at Birmingham, noted that maintaining kidney function represents a significant step forward for managing IgAN. The study met key treatment goals, showing how VOYXACT can fundamentally change the disease’s progression. This, along with a good safety profile, brings hope for improved long-term outcomes for those living with this condition.
The eGFR measurements were taken regularly throughout the two-year trial, highlighting VOYXACT’s effectiveness. By the end of the study, the average eGFR improvement in patients taking VOYXACT was +1.3 mL/min/1.73 m², while those on placebo experienced a decline of -7.9 mL/min/1.73 m².
John Kraus, Otsuka’s Chief Medical Officer, stated that this trial is the largest of its kind for IgAN, offering significant insights into real-world clinical practice. The results indicate not just symptom management, but a real chance to stabilize kidney function and slow disease progression, potentially transforming treatment options.
Otsuka expressed gratitude to all patients, families, and researchers involved in the trial, emphasizing the ongoing commitment to advancing IgAN research and finding new solutions for patients.
VOYXACT is unique as the first U.S. FDA-approved selective APRIL inhibitor, specifically targeting IgAN drivers to change the disease’s course. It received accelerated approval in November 2025, having shown significant improvement in protein levels over a nine-month period. The favorable safety profile of VOYXACT reinforces its potential for long-term use. The latest eGFR findings round out the Phase 3 data, supporting Otsuka’s application for traditional FDA approval.
This development marks a hopeful chapter in the fight against IgAN and may lead to better treatment options for many patients.
