Is Pegzilarginase approved by the US FDA?

Drugs@FDA lists 1 application product line for Pegzilarginase, including LOARGYS (Prescription).

Is Pegzilarginase authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Pegzilarginase: Loargys.

Active substance

Pegzilarginase

US FDA 1
EMA 1

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
LOARGYS	0.1MG/KG	injectable · injection	IMMEDICA PHARMA AB	Prescription	23 Feb 2026

EMA European Union — centrally authorised medicines

Loargys Immedica Pharma AB · Authorised · authorised 15 Dec 2023 · ATC A16AB24

Therapeutic indication (EMA)

Loargys is indicated for the treatment of arginase 1 deficiency (ARG1 D), also known as hyperargininemia, in adults, adolescents and children aged 2 years and older.

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.