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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: 03 Feb 2026

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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

  • 13 Jan 2026 According to a Travere Therapeutics media release, the U.S. Food and Drug Administration (FDA) has extended the review timeline of its supplemental New Drug Application (sNDA) for FILSPARI (sparsentan) in focal segmental glomerulosclerosis (FSGS). The new Prescription Drug User Fee Act (PDUFA) target action date is April 13, 2026.
  • 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.

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