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Adaptive Phase 2/3 Study for PCS499 (499) in Patients with Focal Segmental Glomerulosclerosis (FSGS)

Trial Profile

Adaptive Phase 2/3 Study for PCS499 (499) in Patients with Focal Segmental Glomerulosclerosis (FSGS)

Status: Planning
Phase of Trial: Phase II/III

Latest Information Update: 28 Nov 2025

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At a glance

  • Drugs PCS 499 (Primary)
  • Indications Focal segmental glomerulosclerosis
  • Focus Therapeutic Use

Most Recent Events

  • 28 Nov 2025 New trial record
  • 05 Nov 2025 According to a Processa Pharmaceuticals media release, the adaptive Phase 2/3 design that Processa will be discussing with FDA later this year and presenting at ASN aims to optimize dosing and accelerate the path toward regulatory approval.
  • 05 Nov 2025 According to a Processa Pharmaceuticals media release, the trial design abstract has been accepted for presentation at the American Society of Nephrology (ASN) Kidney Week 2025, taking place November 5-9, 2025, in Houston, Texas.

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