Pegzilarginase
| Clinical data | |
|---|---|
| Trade names | Loargys |
| Other names | AEB-1102, pegzilarginase-nbln |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a626051 |
| License data | |
| Routes of administration | Intravenous, subcutaneous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| PubChem SID | |
| DrugBank | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C1554H2492N416O463S6 |
| Molar mass | 34603.84 g·mol−1 |
Pegzilarginase, sold under the brand name Loargys, is a medication used for the treatment of hyperargininemia.[1][2][3] Pegzilarginase is an arginine specific enzyme.[1]
The most common side effects include allergic reactions.[2]
Pegzilarginase was authorized for medical use in the European Union in December 2023,[3] and was approved for medical use in the United States in February 2026.[4][5]
Medical uses
In the EU, pegzilarginase is indicated for the treatment of arginase 1 deficiency, also known as hyperargininemia.[2][3]
In the US, pegzilarginase is indicated for the treatment of hyperargininemia in people aged two years of age and older with arginase 1 deficiency, in conjunction with dietary protein restriction.[1]
Society and culture
Legal status
In October 2023, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization under exceptional circumstances for the medicinal product Loargys, intended for the treatment of hyperargininemia.[2] The applicant for this medicinal product is Immedica Pharma AB.[2] Pegzilarginase was authorized for medical use in the European Union in December 2023.[2][3]
Brand names
Pegzilarginase is the international nonproprietary name.[6]
References
- 1 2 3 4 5 "Loargys- pegzilarginase-nbln injection". DailyMed. 23 February 2026. Retrieved 3 July 2026.
- 1 2 3 4 5 6 7 8 "Loargys EPAR". European Medicines Agency (EMA). 14 July 2016. Retrieved 26 December 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- 1 2 3 4 5 "Loargys Product information". Union Register of medicinal products. 18 December 2023. Retrieved 26 December 2023.
- ↑ "Novel Drug Approvals for 2026". U.S. Food and Drug Administration. 24 July 2026. Retrieved 26 July 2026.
- ↑ "U.S. FDA has granted accelerated approval of Loargys (pegzilarginase-nbln) for the treatment of hyperargininemia in patients 2 years and older with arginase 1 deficiency (ARG1-D)". Immedica (Press release). Retrieved 27 February 2026.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79". WHO Drug Information. 32 (1). 2018. hdl:10665/330941.
External links
- "Pegzilarginase (Code C125143)". NCI Thesaurus. 27 November 2023. Archived from the original on 17 January 2017. Retrieved 26 December 2023.
- Clinical trial number NCT03921541 for "Efficacy and Safety of Pegzilarginase in Patients With Arginase 1 Deficiency" at ClinicalTrials.gov