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Pegzilarginase - Spyre Therapeutics

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Drug Profile

Pegzilarginase - Spyre Therapeutics

Alternative Names: AEB-1102; AERase; Co-ArgI-PEG - Spyre Therapeutics; Co-ArgI-PEG modified human arginase I - Spyre Therapeutics; Loargys; Optimised human arginase I - Spyre Therapeutics; PEG-arginase - Spyre Therapeutics; Pegarginase - Spyre Therapeutics

Latest Information Update: 21 Nov 2024

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At a glance

  • Originator Aeglea Biotherapeutics
  • Developer Immedica; Merck AG; Spyre Therapeutics
  • Class Antineoplastics; Enzymes; Immunotherapies; Polyethylene glycols; Recombinant proteins; Ureohydrolases
  • Mechanism of Action Arginase replacements
  • Orphan Drug Status

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

    Yes - Hyperargininaemia
  • New Molecular Entity Yes

Highest Development Phases

  • Registered Hyperargininaemia
  • Phase I/II Small cell lung cancer
  • No development reported Non-small cell lung cancer; Solid tumours
  • Discontinued Acute myeloid leukaemia; Myelodysplastic syndromes

Most Recent Events

  • 05 Nov 2024 US FDA accepts BLA for pegzilarginase for Hyperargininaemia for priority review
  • 30 Aug 2024 Phase-III clinical trials in Hyperargininaemia (In infants, In neonates) in United Kingdom (SC) (NCT06582524)
  • 21 Dec 2023 Preregistration for Hyperargininaemia (In adolescents, In children, In the elderly, In adults) in United Kingdom (IV) Prior to December 2023

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