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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: 22 May 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

  • 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.
  • 11 Feb 2025 According to a Travere Therapeutics media release, based on data form DUPLEX and DUET studies the company plans to submit a supplemental New Drug Application (sNDA) around the end of the first quarter of 2025 seeking traditional approval of FILSPARI for focal segmental glomerulosclerosis (FSGS).
  • 22 Apr 2024 Status changed from active, no longer recruiting to completed.

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