Pegzilarginase Injection 5 mg/mL (2 mg/0.4 mL vial) Suppliers & Bulk Manufacturers

Available Forms: Solution vial (IV or subcutaneous)

Available Strengths: 5 mg/mL (2 mg/0.4 mL vial)

Reference Brands: Loargys (Immedica)

Category: Orphan Drugs

Pegzilarginase (Loargys, Immedica) is an enzyme therapy that lowers blood arginine in arginase 1 deficiency (ARG1-D). It was approved in the EU in December 2023 and by the US FDA in February 2026. PharmaTradz handles enquiries for authorised supply of the originator product (named-patient and import-permit orders), and connects developers and licensees preparing for patent and exclusivity expiry.

Product Description:

Arginase 1 deficiency (ARG1-D) is a rare inherited urea-cycle disorder. Without working arginase 1, the amino acid arginine builds up in the blood and damages the nervous system, causing progressive stiffness and weakness of the legs (spasticity), seizures and developmental problems. Pegzilarginase is a PEGylated form of human arginase 1 that breaks down arginine in the blood, replacing the missing enzyme.

The European Commission approved pegzilarginase as Loargys in December 2023, and the US FDA granted accelerated approval in February 2026, for patients aged 2 and over with ARG1-D, alongside dietary management. It is given weekly, by intravenous infusion at first and then by subcutaneous injection, with the dose adjusted to blood arginine levels.

Sourcing and licensing notes. Pegzilarginase is an ultra-orphan biologic made only by Immedica; there is no biosimilar. Supply is on a named-patient or registered basis, which we confirm for each destination. It is a cold-chain product.