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Open Label Extension Study to Evaluate the Long-term Safety and Efficacy of 2 mg/kg Pegunigalsidase Alfa (PRX-102) Administered by Intravenous Infusion Every 4 Weeks in Adult Patients With Fabry Disease

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Trial Profile

Open Label Extension Study to Evaluate the Long-term Safety and Efficacy of 2 mg/kg Pegunigalsidase Alfa (PRX-102) Administered by Intravenous Infusion Every 4 Weeks in Adult Patients With Fabry Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 May 2026

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At a glance

  • Drugs Pegunigalsidase alfa (Primary)
  • Indications Fabry's disease
  • Focus Adverse reactions; Registrational
  • Acronyms Bright 51
  • Sponsors Chiesi; Protalix Biotherapeutics

Most Recent Events

  • 22 May 2026 Status changed from active, no longer recruiting to completed.
  • 10 Mar 2026 This trial has been completed in Belgium, Denmark, Czech Republic, Norway and Italy.
  • 30 Jan 2026 According to Chiesi Global Rare Diseases media release, the company has issued a positive opinion recommending approval of the 2mg/kg E4W dosing regimen for pegunigalsidase alfa in Fabry disease adult patients stable with an enzyme replacement therapy , which will be reviewed by EC, with decision anticipated by March 2026. This positive opinion follows the CHMP's re-examination of the application for additional dosing regimen. The opinion is informed by results from BRIGHT and CLI-06657AA study

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