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A pivotal study of C-PTBE-01

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Trial Profile

A pivotal study of C-PTBE-01

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 30 May 2025

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At a glance

  • Drugs C-PBTE-01 (Primary)
  • Indications Brain oedema
  • Focus Registrational; Therapeutic Use
  • Sponsors Curatis

Most Recent Events

  • 23 May 2025 According to Curatis media release, meeting with the FDA is targeted for Q3 of this year to gain agreement on the design of a pivotal Phase 3 trial of corticorelin which the company plans to initiate in 2026.
  • 27 Mar 2025 According to Curatis media release, a meeting with the US Food and Drug Administration (FDA) to discuss a possible pivotal Phase III trial for C-PTBE-01 is in preparation. The meeting with the FDA is planned for Q2 2025. Initial discussions are also taking place in the area of partnering and will be intensified after the meeting with the FDA.
  • 09 Sep 2024 New trial record

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