Positive top-line results from Phase III study of Renalys’ sparsentan

Japanese drug developer Renalys Pharma yesterday announced positive top-line results from its Phase III clinical study of sparsentan (development code: RE-021), an orally administered dual endothelin and angiotensin II receptor antagonist (DEARA), in Japanese patients with IgA nephropathy (IgAN).

Based on these results, the company plans to submit a New Drug Application in Japan in 2026.

The primary endpoint of the study assessed the percent change from baseline in the 24-hour urine protein-to-creatinine ratio (UPCR) after 36 weeks of oral administration of sparsentan in Japanese IgAN patients (N=35). The least-squares geometric mean percent change (95% CI) was –58.54% (–68.75%, –45.00%), confirming the efficacy of sparsentan in this patient population. Sparsentan was well-tolerated in the study with a safety profile consistent with other global trials and no new safety risks specific to Japanese patients were observed.