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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: 14 Oct 2025

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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

  • 01 Oct 2025 Pegzilarginase licensed to Innovative Medicines Group in Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, Mexico, Peru, Paraguay and Uruguay
  • 29 Aug 2025 Pooled efficacy and adverse events data from the phase III PEACE and phase II AEB1102 trials in Hyperargininaemia released by Immedica
  • 05 Nov 2024 US FDA accepts BLA for pegzilarginase for Hyperargininaemia for priority review

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