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Phase 2 study of CRN04777 in pediatric participants with congenital hyperinsulinism

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Trial Profile

Phase 2 study of CRN04777 in pediatric participants with congenital hyperinsulinism

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 06 Mar 2023

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At a glance

  • Drugs CRN 04777 (Primary)
  • Indications Congenital hyperinsulinism
  • Focus Therapeutic Use

Most Recent Events

  • 28 Feb 2023 According to a Crinetics Pharmaceuticals media release, this study is supported by pharmacologic proof-of-concept results from a successful Phase 1 study in healthy adult volunteers conducted under a Clinical Trial Application in Germany.
  • 22 Nov 2022 According to a Crinetics Pharmaceuticals media release, the FDA informed the company via telephonic communication that the proposed Phase 2 clinical study was not yet permitted to proceed.
  • 24 Oct 2022 According to a Crinetics Pharmaceuticals media release, the company submitted an Investigational New Drug application (IND) to the United States Food and Drug Administration (FDA) to initiate the first U.S. clinical study of CRN04777, which is designed to evaluate the compound in a pediatric population (ages 3 months - 12 years).

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