Drug intelligence / Profile preview

SHP623

Development stage
Phase 1
Lead developer
Takeda
Modality
Recombinant Proteins and Enzymes
Administration
Intravenous, Subcutaneous
01

Overview

SHP623 is an investigational recombinant human C1 esterase inhibitor (rhC1-INH) that was developed by Shire (now part of Takeda) for the treatment of hereditary angioedema (HAE). HAE is a rare genetic disorder caused by a deficiency or malfunction of the C1 esterase inhibitor protein, leading to unregulated activation of the kallikrein-kinin system and resulting in recurrent, painful episodes of edema. SHP623 was designed as an enzyme replacement therapy to restore C1-INH activity, thereby inhibiting key proteases such as plasma kallikrein and C1s to prevent bradykinin-mediated swelling. The candidate was evaluated in a Phase 1 clinical trial (NCT02511834) to assess its safety, tolerability, and pharmacokinetics following intravenous and subcutaneous administration in healthy volunteers. Development appears to have ceased following the acquisition of Shire by Takeda and the prioritization of other HAE therapies like lanadelumab.

Other names
Recombinant human C1 esterase inhibitorrhC1-INHrhC-1-INHrhC 1-INH
02

Targets

KLKB1 (Plasma kallikrein)FXIIa (Coagulation Factor XIIa)Factor XIaC1R (Complement component 1r subcomponent)C1S (Complement component 1s subcomponent serine protease)

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