Drug intelligence / Profile preview

HAEGARDA

Development stage
Approved
Lead developer
CSL Behring
Modality
Recombinant Proteins and Enzymes
Administration
Subcutaneous
01

Overview

CSL830 (marketed as HAEGARDA) is a human plasma-derived, subcutaneous C1-esterase inhibitor (C1-INH) developed by CSL Behring for the routine prophylaxis of hereditary angioedema (HAE) types I and II. It is a highly concentrated, low-volume formulation (500 IU/mL) of the established intravenous C1-INH product Berinert, specifically designed for subcutaneous administration. CSL830 acts as a replacement therapy for patients with C1-INH deficiency or dysfunction, effectively restoring inhibitory control over the complement, contact (kallikrein-kinin), and fibrinolytic systems. By inhibiting key proteases such as plasma kallikrein and factor XIIa, it prevents the excessive generation of bradykinin, the primary mediator of the painful and potentially life-threatening swelling episodes characteristic of HAE. Approved by the FDA in June 2017, it was the first subcutaneous C1-INH therapy for the prevention of HAE attacks.

Brand names
HAEGARDA
Other names
C1-esterase inhibitor (human)Subcutaneous C1-esterase inhibitorSubcutaneous C1-INHBerinert SC
02

Targets

Factor XIaFXIIa (Coagulation Factor XIIa)C1R (Complement component 1r subcomponent)C1S (Complement component 1s subcomponent serine protease)KLKB1 (Plasma kallikrein)

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