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Sparsentan - Travere Therapeutics

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Drug Profile

Sparsentan - Travere Therapeutics

Alternative Names: DARA; FILSPARI; PS-433540; RE-021

Latest Information Update: 15 Sep 2025

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At a glance

  • Originator Bristol-Myers Squibb
  • Developer CSL Vifor; Renalys Pharma; Retrophin; Travere Therapeutics
  • Class Anti-inflammatories; Antihypertensives; Isoxazoles; Nerve growth factors; Small molecules; Spiro compounds; Sulfonamides; Urologics; Vascular disorder therapies
  • Mechanism of Action Angiotensin type 2 receptor antagonists; Endothelin A receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - IgA nephropathy; Focal segmental glomerulosclerosis
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed IgA nephropathy
  • Preregistration Focal segmental glomerulosclerosis
  • Phase II Anti-neutrophil cytoplasmic antibody-associated vasculitis; Hereditary nephritis; Vasculitis
  • Discontinued Hypertension

Most Recent Events

  • 10 Sep 2025 The US FDA informed Travere Therapeutics that an advisory committee is no longer needed for Focal segmental glomerulosclerosis
  • 10 Sep 2025 USFDA assigns PDUFA action date of 13/01/2026 for sNDA for Sparsentan for Focal segmental glomerulosclerosis
  • 10 Sep 2025 Updated efficacy data from the phase-III DUPLEX trial in Focal segmental glomerulosclerosis released by Travere Therapeutics

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