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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: 22 Mar 2026

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At a glance

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

Most Recent Events

  • 11 Mar 2026 According to a Curatis media release, the company announced that a meeting with the Japanese drug regulatory authority PMDA to discuss the registration enabling study is planned for summer 2026, and the clinical study is expected to start in 2027.
  • 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.

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