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A Phase III study of vafidemstat in borderline personality disorder (BPD)

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Trial Profile

A Phase III study of vafidemstat in borderline personality disorder (BPD)

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 15 May 2025

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At a glance

  • Drugs Vafidemstat (Primary)
  • Indications Borderline personality disorders
  • Focus Registrational; Therapeutic Use
  • Acronyms PORTICO-2
  • Sponsors Oryzon

Most Recent Events

  • 12 May 2025 According to an Oryzon media release, PORTICO-2 Phase III study has the potential to be one of the two registrational trials required by the FDA.
  • 03 Mar 2025 According to an Oryzon media release, announced that it has established the primary and key secondary endpoints for its planned Phase III clinical trial, aligned with FDA standards.
  • 24 Oct 2024 According to an Oryzon media release,company has received the minutes from the end-of-Phase II meeting with the U.S. Food and Drug Administration (FDA). Based on the positive feedback received, ORYZON has started preparations for Phase III, including the preparation of a full protocol for the PORTICO-2 Phase III trial to submit to the FDA for study approval which is expected to obtain by end of 1Q2025.

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