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A Phase 3 registrational clinical trial of tildacerfont in pediatric classic congenital adrenal hyperplasia (CAH)

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Trial Profile

A Phase 3 registrational clinical trial of tildacerfont in pediatric classic congenital adrenal hyperplasia (CAH)

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 15 Mar 2024

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At a glance

  • Drugs Tildacerfont (Primary)
  • Indications Congenital adrenal hyperplasia
  • Focus Registrational; Therapeutic Use
  • Sponsors Spruce Biosciences

    • Most Recent Events

    • 13 Mar 2024 According to a Spruce Biosciences media release, assuming positive results from CAHmelia-204 and CAHptain-205, the company plan to meet with the U.S. Food and Drug Administration (FDA) and comparable foreign regulatory authorities in early 2025 to outline the design of a registrational clinical program in adult and pediatric classic CAH.
    • 27 Aug 2021 New trial record
    • 25 Aug 2021 According to a Spruce Biosciences media release, this trial is expected to initiate in 2023.

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