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A pivotal Phase 3 clinical trial program for NNZ-2591 to treat children with Phelan-McDermid syndrome (Telomeric-22q13-Monosomy-Syndrome)

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Trial Profile

A pivotal Phase 3 clinical trial program for NNZ-2591 to treat children with Phelan-McDermid syndrome (Telomeric-22q13-Monosomy-Syndrome)

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 23 Apr 2025

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At a glance

  • Drugs NNZ 2591 (Primary)
  • Indications Telomeric 22q13 Monosomy Syndrome
  • Focus Registrational; Therapeutic Use
  • Sponsors Neuren Pharmaceuticals

    • Most Recent Events

    • 14 Apr 2025 According to Neuren Pharmaceuticals media release, the company plans to commence the Phase 3 trial in the mid of 2025, subject to FDA review of the final version of the trial protocol.
    • 14 Apr 2025 According to Neuren Pharmaceuticals media release, primary endpoints for this trial have been confirmed at a productive Type C Meeting with the US Food and Drug Administration (FDA).
    • 25 Feb 2025 New trial record

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