Also known as: Filspari
Filspari (sparsentan) is an oral dual endothelin/angiotensin receptor antagonist used to slow kidney function decline in adults with primary IgA nephropathy at risk for progression. It is distributed under a REMS program because of embryo-fetal toxicity and requires laboratory monitoring. Initial U.S. approval was in 2023.
January and March 2026 drug pipeline updates included Phase 3 results, Fast Track designations and Priority Review decisions across multiple disease areas. Mavacamten, teplizumab-mzwv, anifrolumab, AXS-05, gedatolisib and AFTX-201 were among the programs with notable milestones.
The FDA granted full approval to Filspari to reduce proteinuria in patients aged eight and older with FSGS without nephrotic syndrome. The decision was based on Phase III DUPLEX data versus irbesartan.
The FDA is set to make decisions on four drug applications in April 2026, including Orca-T for hematological malignancies, orforglipron for obesity, sparsentan for kidney disease, and a doravirine/islatravir combination for HIV-1.
