Drug intelligence / Profile preview

SHP616

Development stage
Approved
Lead developer
Takeda
Modality
Device-based Delivery → Drug Delivery Systems, Recombinant Proteins and Enzymes
Administration
Subcutaneous
01

Overview

SHP616 was an investigational subcutaneous C1 esterase inhibitor (C1 INH) liquid for injection developed by Shire (later acquired by Takeda) for the prevention of angioedema attacks in patients with hereditary angioedema (HAE). The therapy was designed to restore the levels and activity of C1-inhibitor protein, which helps regulate bradykinin signaling and ultimately reduce the risk of swelling attacks in HAE patients. It was evaluated in the Phase 3 SAHARA trial, which met its primary and key secondary endpoints, showing a significant reduction in HAE attack rate compared to placebo. Despite promising results, development was discontinued in 2019.

Brand names
BerinertCinryzeHaegarda
Other names
human C1-esterase inhibitorC1-INHC-1-INHC 1-INHplasma-derived C1-esterase inhibitor
02

Targets

C1R (Complement component 1r subcomponent)C1S (Complement component 1s subcomponent serine protease)SELE (E-selectin)FXIIa (Coagulation Factor XIIa)SELP (P-selectin)KLKB1 (Plasma kallikrein)

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