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A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Pediatric Subjects With Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Pediatric Subjects With Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 03 Aug 2024

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At a glance

  • Drugs Crinecerfont (Primary)
  • Indications Congenital adrenal hyperplasia
  • Focus Registrational; Therapeutic Use
  • Acronyms CAHtalyst Pediatric Study
  • Sponsors Neurocrine Biosciences

    • Most Recent Events

    • 01 Aug 2024 According to a Neurocrine Biosciences media release, the agency set Prescription Drug User Fee (PDUFA) target actions dates of December 29, 2024 for the capsule formulation and December 30, 2024 for the oral solution formulation.
    • 01 Jul 2024 According to a Neurocrine Biosciences media release, the U.S. Food and Drug Administration (FDA) has accepted its two New Drug Applications (NDA) with Priority Review designations for crinecerfont in the treatment of children, adolescents and adults with classic congenital adrenal hyperplasia (CAH), PDUFA Target Action Dates in Late December 2024.
    • 03 Jun 2024 According to a Neurocrine Biosciences media release, data from this trial were published in the he New England Journal of Medicine online edition and will appear in a future print issue of the journal.

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