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A phase IIb/III pivotal study of CS1 candidate

Trial Profile

A phase IIb/III pivotal study of CS1 candidate

Status: Planning
Phase of Trial: Phase II/III

Latest Information Update: 03 Dec 2025

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At a glance

  • Drugs Valproic acid (Primary)
  • Indications Pulmonary arterial hypertension
  • Focus Registrational; Therapeutic Use
  • Sponsors Cereno Scientific

Most Recent Events

  • 10 Nov 2025 According to Cereno Scientific media release, company announced the submission of the clinical trial protocol for the planned global Phase IIb trial of its lead drug candidate CS1 to the U.S. Food and Drug Administration (FDA). This protocol has been developed in alignment with the FDA's feedback from our recent Type C meeting, and we now look forward to the agency's review ahead of initiating the trial. and trial is planned to begin during H1 2026
  • 07 Oct 2024 New trial record
  • 28 Sep 2024 According to Cereno Scientific media release, company to gather additional CS1 usage documentation for regulatory discussions and company shows intention for a Phase IIb/III pivotal study design planning.

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