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A Phase 2b, Multicenter, Double-Blind, Randomized, Placebo-controlled Trial Evaluating Efficacy and Safety of Subcutaneous Doses of TransCon CNP Administered Once Weekly for 52 Weeks in Children With Achondroplasia Followed by an Open Label Extension Period

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Trial Profile

A Phase 2b, Multicenter, Double-Blind, Randomized, Placebo-controlled Trial Evaluating Efficacy and Safety of Subcutaneous Doses of TransCon CNP Administered Once Weekly for 52 Weeks in Children With Achondroplasia Followed by an Open Label Extension Period

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

Latest Information Update: 10 Jun 2025

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At a glance

  • Drugs Navepegritide (Primary)
  • Indications Achondroplasia
  • Focus Registrational; Therapeutic Use
  • Acronyms ApproaCH
  • Sponsors Ascendis Pharma

Most Recent Events

  • 02 Jun 2025 According to an Ascendis Pharma media release, the U.S. Food & Drug Administration (FDA) has accepted for priority review its New Drug Application (NDA) for TransCon CNP (navepegritide) for the treatment of children with achondroplasia and has set a Prescription Drug User Fee Act (PDUFA) goal date of November 30, 2025 to complete its review. The FDA also informed Ascendis that they are not currently planning to hold an advisory committee meeting to discuss this application.
  • 13 May 2025 According to an Ascendis Pharma media release, data from the study was presented as oral presentation at Copenhagen University Hospital Rigshospitalet (Denmark), during ESPE & ESE 2025, the joint congress of the European Society for Paediatric Endocrinology (ESPE) and the European Society of Endocrinology (ESE).
  • 13 May 2025 Results presented in the Ascendis Pharma Media Release

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