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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: 03 Nov 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

  • 15 Sep 2025 According to Curatis media release, the company met with the FDA on 9 September 2025 to achieve alignment on the design of a pivotal Phase 3 clinical trial for corticorelin as well as on key non-clinical and manufacturing aspects. The outcome of the meeting was positive. Further details will be published once the minutes of the FDA meeting are available.
  • 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.

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