FDA accepts Travere's sNDA for FILSPARI in FSGS; PDUFA Jan 13, 2026

Travere Therapeutics, Inc.

FDA accepted sNDA for traditional approval of FILSPARI (sparsentan) to treat focal segmental glomerulosclerosis (FSGS).
PDUFA target action date is January 13, 2026; FDA plans an advisory committee meeting.
If approved, FILSPARI would be first FDA-approved drug for FSGS, affecting over 40,000 U.S. patients.
sNDA supported by Phase 3 DUPLEX (met interim proteinuria endpoint, missed primary eGFR slope) and Phase 2 DUET studies.
No approved pharmacologic treatment currently exists for FSGS.

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