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Pegunigalsidase alfa - Chiesi/Protalix Biotherapeutics

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Drug Profile

Pegunigalsidase alfa - Chiesi/Protalix Biotherapeutics

Alternative Names: Alpha-galactosidase; CHF-6657; Elfabrio; Modified recombinant human alpha-GAL-A protein; Pegunigalsidase alfa; Pegunigalsidase alfa-iwxj; Pegunigalsidase-alfa-Protalix-Biotherapeutics; PRX-102; Recombinant human alpha galactosidase-A-Protalix; Recombinant-alpha-galactosidase-Protalix

Latest Information Update: 03 Jan 2025

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At a glance

  • Originator Protalix Biotherapeutics
  • Developer Chiesi; Protalix BioTherapeutics
  • Class Enzymes; Galactosidases; Recombinant proteins
  • Mechanism of Action Alpha-galactosidase replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Fabry's disease
  • New Molecular Entity No

Highest Development Phases

  • Registered Fabry's disease

Most Recent Events

  • 20 Dec 2024 Phase-II/III clinical trials in Fabry's disease (In children, In adolescents) in United Kingdom, Spain, Norway, France, Austria, USA (IV) (NCT06328608)
  • 09 Dec 2024 European Medicines Agency (EMA) validates the variation submission for allowing a less frequent dosing regimen of 2 mg/kg every four weeks in Fabry disease
  • 25 Mar 2024 Chiesi Farmaceutici in collaboration with ICON plc plans a phase II/III trial for Fabry's-disease (In children, In-adolescent) (IV, infusion) (NCT06328608)

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