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Efficacy and Safety of Sparsentan (RE-021), a Dual Endothelin Receptor and Angiotensin Receptor Blocker, in Patients With Focal Segmental Glomerulosclerosis (FSGS): a Randomized, Double-Blind, Active-Control, Dose-Escalation Study

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Trial Profile

Efficacy and Safety of Sparsentan (RE-021), a Dual Endothelin Receptor and Angiotensin Receptor Blocker, in Patients With Focal Segmental Glomerulosclerosis (FSGS): a Randomized, Double-Blind, Active-Control, Dose-Escalation Study

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 21 Oct 2025

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At a glance

  • Drugs Sparsentan (Primary) ; Irbesartan
  • Indications Focal segmental glomerulosclerosis
  • Focus Adverse reactions; Proof of concept; Registrational; Therapeutic Use
  • Acronyms DUET
  • Sponsors Travere Therapeutics

Most Recent Events

  • 27 Aug 2025 According to a Travere Therapeutics media release, a supplemental New Drug Application (sNDA) for FILSPARI in FSGS is currently under review with the FDA, with a Prescription Drug User Fee Act (PDUFA) target action date of January 13, 2026.
  • 27 Aug 2025 According to a Travere Therapeutics media release, the reduction of FILSPARI liver monitoring REMS from monthly to every three months from the onset of treatment was supported by safety data from this trial.
  • 17 Mar 2025 According to a Travere Therapeutics media release,the Company has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking priority review for traditional approval of FILSPARI (sparsentan) for the treatment of focal segmental glomerulosclerosis (FSGS). The submission is supported by results from the Phase 3 DUPLEX Study and the Phase 2 DUET Study.

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