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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 12 Nov 2025

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At a glance

  • Drugs Navepegritide (Primary)
  • Indications Achondroplasia
  • Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
  • Acronyms ACcomplisH
  • Sponsors Ascendis Pharma

Most Recent Events

  • 08 Oct 2025 According to an Ascendis Pharma media release, the company announced it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for TransCon CNP as a treatment for children with achondroplasia. The MAA is based on data from three randomized, double-blind, placebo-controlled clinical trials and up to three years of open-label extension data, including results from the pivotal ApproaCH Trial.
  • 29 Oct 2024 Status changed from active, no longer recruiting to completed.
  • 24 Jun 2024 According to an Ascendis Pharma media release, company announced the oral presentation of data from this trial during ICCBH 2024, the International Conference on Childrens Bone Health being held in Salzburg, Austria.

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