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A Phase 2, Randomized, Human Growth Hormone-Controlled, Multicenter, Basket Study of Vosoritide in Children With Turner Syndrome, Short Stature Homeobox-Containing Gene Deficiency, and Noonan Syndrome With an Inadequate Response to Human Growth Hormone. (CANOPY NS, TS, SHOX-D-2)

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Trial Profile

A Phase 2, Randomized, Human Growth Hormone-Controlled, Multicenter, Basket Study of Vosoritide in Children With Turner Syndrome, Short Stature Homeobox-Containing Gene Deficiency, and Noonan Syndrome With an Inadequate Response to Human Growth Hormone. (CANOPY NS, TS, SHOX-D-2)

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 08 Aug 2025

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At a glance

  • Drugs Vosoritide (Primary)
  • Indications Noonan syndrome; Turner's syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms CANOPY NS, TS, SHOX-D-2
  • Sponsors BioMarin Pharmaceutical

Most Recent Events

  • 04 Aug 2025 According to a BioMarin Pharmaceutical media release, the company expects to share topline data from its pivotal study in the first half of 2026 and file submissions to global health authorities for approval in the second half of 2026, leading to a potential launch in 2027.
  • 12 May 2025 According to a BioMarin Pharmaceutical media release, the data from this study were presented as a poster presentation at the 2025 Joint Congress of the European Society for Paediatric Endocrinology (ESPE) and the European Society of Endocrinology (ESE) in Copenhagen, Denmark.
  • 12 May 2025 According to a BioMarin Pharmaceutical media release, data from this study were presented at the Pediatric Endocrine Society Annual Meeting (PES).

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