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PEACE (Pegzilarginase Effect on Arginase 1 Deficiency Clinical Endpoints): A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Efficacy and Safety of Pegzilarginase in Children and Adults With Arginase 1 Deficiency

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Trial Profile

PEACE (Pegzilarginase Effect on Arginase 1 Deficiency Clinical Endpoints): A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Efficacy and Safety of Pegzilarginase in Children and Adults With Arginase 1 Deficiency

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Mar 2026

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At a glance

  • Drugs Pegzilarginase (Primary) ; Pegzilarginase (Primary)
  • Indications Hyperargininaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms PEACE
  • Sponsors Aeglea Biotherapeutics; Spyre Therapeutics

Most Recent Events

  • 23 Feb 2026 According to an Immedica media release, company announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Loargys (pegzilarginase-nbln), an arginine specific enzyme indicated for the treatment of hyperargininemia in adult and pediatric patients 2 years of age and older with Arginase 1 Deficiency (ARG1-D), in conjunction with dietary protein restriction.
  • 22 Dec 2023 According to an Immedica media release, the Medicines & Healthcare products Regulatory Agency in the UK has granted marketing authorization of Loargys (pegzilarginase) for the treatment of arginase 1 deficiency (ARG1-D), also known as hyperargininaemia, in adults, adolescents and children aged 2 years and older.
  • 27 Nov 2023 According to Spyre Therapeutics media release, Aeglea Biotherapeutics has changed its name to Spyre Therapeutics

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