Sparsentan is a first-in-class, orally active, single molecule that functions as a high-affinity, dual-acting antagonist of both endothelin type A (ETA) and angiotensin II subtype 1 (AT1) receptors, which are associated with progression of kidney disease. Its development for IgA nephropathy and FSGS promises to halt that progression for many patients and fills a gap in the treatment armamentarium.
January 2021:
• Orphan drug designation: U.S. Food and Drug Administration (FDA)
February 2021:
• Orphan drug designation: European Commission (EC)
May 2022:
• Priority review of New Drug Application (NDA) accepted: U.S. FDA
August 2022:
• Conditional marketing authorization accepted: European Medicines Agency (EMA)
February 17, 2023
• PDUFA date
Expected approval for IgAN:
• 2023: the United States and the European Union
Patents estimated to expire beginning in 2030
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