Renalys Pharma Completes Primary Endpoint Data Collection in Phase III Sparsentan Trial for IgA Nephropathy

13 October 2025 | Monday | News


With 36-week efficacy and safety data now collected, Renalys advances toward NDA submission in Japan, aligning local results with global Phase III findings to accelerate access for patients with kidney disease.

Renalys Pharma, Inc. (Headquarters: Chuo-ku, Tokyo; "Renalys") announced that it has completed data collection for the primary endpoint in the Phase III clinical trial of sparsentan (development code: RE-021) for IgA nephropathy in Japan.

The primary endpoint evaluated was the urine protein creatinine ratio (24-hour urine collection) at 36 weeks and data have now been collected for all eligible patients. Renalys will proceed with analyses of efficacy and safety through 36 weeks of treatment, as well as comparisons with global Phase III trial results, in preparation for the submission of a New Drug Application (NDA).

Renalys is committed to improving the lives of patients in Japan and across Asia by developing innovative therapies for kidney disease, with a primary focus on delivering sparsentan to patients as quickly as possible.

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