Shots:
- Renalys Pharma has reported topline P-III trial data assessing sparsentan (RE-021; PO) in Japanese pts with IgA nephropathy, with MHLW’s NDA submission based on trial results planned in 2026
- Trial met its 1EP, with a least-squares geometric mean UPCR reduction of 58.54% after 36wks. in Japanese IgAN pts (N=35) & showed favorable safety
- Additionally, sparsentan’s sNDA for the treatment of Focal Segmental Glomerulosclerosis is under the US FDA’s review, with a PDUFA action date of Jan 13, 2026
Ref: Renalys Pharma | Image: Renalys Pharma | Press Release
Related News: Otsuka Pharmaceutical Receives the US FDA Accelerated Approval for Primary Immunoglobulin A Nephropathy (IgAN)
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