Chugai and Nippon Shinyaku File Gazyva in Japan for Idiopathic Nephrotic Syndrome Following Positive Phase III INShore Results
Written By: Karthik Teja Macharla, PharmD
Reviewed By: Pharmacally Editorial Team
Chugai Pharmaceutical and Nippon Shinyaku have filed a regulatory application with Japan’s Ministry of Health, Labour and Welfare (MHLW) seeking approval of Gazyva for the treatment of idiopathic nephrotic syndrome (INS). The filing is supported by results from the global Phase III INShore study (NCT05627557) evaluating the anti-CD20 monoclonal antibody in patients aged 2 to 25 years with childhood-onset INS, including frequently relapsing nephrotic syndrome (FRNS) and steroid-dependent nephrotic syndrome (SDNS).
The randomized, open-label study compared Gazyva plus oral steroids with mycophenolate mofetil (MMF) plus oral steroids. The study met its primary endpoint, showing a statistically significant and clinically meaningful improvement in sustained complete remission at week 52 in the Gazyva arm compared with MMF. Sustained complete remission was defined as no relapses during the study together with a urine protein-to-creatinine ratio of 0.2 or less at week 52.
The trial also demonstrated improvements across several key secondary endpoints, including relapse-free survival, median time to relapse or death, cumulative corticosteroid exposure through week 52, and number of relapses. No new safety signals were identified, and the safety profile remained consistent with previous experience with Gazyva.
Chugai President and CEO Osamu Okuda said the study results suggest the potential for sustained remission and reduced steroid exposure, which may help lower long-term treatment burden in patients with recurrent disease. Toru Nakai, President of Nippon Shinyaku, said the filing could help address unmet clinical needs and expand treatment options for patients with INS.
Gazyva is a glycoengineered type II anti-CD20 monoclonal antibody designed to target CD20-positive B cells. In idiopathic nephrotic syndrome, autoreactive B cells are believed to contribute to disease progression through abnormal immune responses and autoantibody production. The companies said B-cell depletion with Gazyva may help reduce immune-mediated kidney injury and support sustained remission.
Idiopathic nephrotic syndrome accounts for around 60% of nephrotic syndrome cases overall and approximately 90% of pediatric cases. Although many children respond to steroid therapy, frequent relapses and steroid dependence remain major challenges because of the long-term adverse effects associated with steroids and immunosuppressive treatments.
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About the Writer
Karthik Teja Macharla, PharmD (LinkedIn) is a Pharm.D. graduate with a strong interest in clinical research, pharmacovigilance, and medical writing. In his words, he is passionate about converting complex medical information into clear, evidence-based scientific communication, committed to contributing to patient safety and advancing healthcare through accurate and impactful medical content.