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A Phase 3 Multi-Center Study to Evaluate the Safety and Efficacy of Subcutaneous Injections of Pegvaliase in Adolescent Subjects (Ages 12-17) With Phenylketonuria Featuring an Open-Label Randomized Two-Arm (Active vs Diet-Only Control) Design

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Trial Profile

A Phase 3 Multi-Center Study to Evaluate the Safety and Efficacy of Subcutaneous Injections of Pegvaliase in Adolescent Subjects (Ages 12-17) With Phenylketonuria Featuring an Open-Label Randomized Two-Arm (Active vs Diet-Only Control) Design

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

Latest Information Update: 07 Apr 2025

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At a glance

  • Drugs Pegvaliase (Primary)
  • Indications Phenylketonuria
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms PEGASUS
  • Sponsors BioMarin Pharmaceutical

Most Recent Events

  • 02 Apr 2025 Results presented in a BioMarin Media Release.
  • 02 Apr 2025 According to BioMarin Media release, company plans to submit for regulatory approval later this year.
  • 02 Apr 2025 According to BioMarin Media release, detailed results from this study will be presented at an upcoming medical meeting and submitted to global health authorities starting later this year to request a label expansion for PALYNZIQ to include adolescents.

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