Kallidinogenase (DB13197): A Comprehensive Monograph on its Pharmacology, Clinical Application, and Global Status

Executive Summary

Kallidinogenase (DrugBank ID: DB13197) is a therapeutic enzyme belonging to the tissue kallikrein family of serine proteases. As a key component of the kallikrein-kinin system (KKS), its primary mechanism of action involves the enzymatic cleavage of kininogen to release potent vasoactive peptides, principally bradykinin and kallidin. This action initiates a cascade of multifaceted pharmacodynamic effects, including profound vasodilation, improvement of microcirculation, inhibition of platelet aggregation, and fibrinolysis. Beyond these hemodynamic actions, Kallidinogenase exerts significant neuroprotective, anti-inflammatory, anti-apoptotic, and pro-angiogenic effects, positioning it as a pleiotropic agent for the treatment of ischemic conditions.

The most robust clinical evidence for Kallidinogenase supports its use in the treatment of acute ischemic stroke (AIS). It is approved and recommended in clinical guidelines in China for this indication, where large-scale clinical trials have demonstrated its ability to improve neurological function and long-term functional outcomes. Its efficacy in AIS is attributed to a synergistic combination of acute improvement in cerebral perfusion and sub-acute to chronic modulation of inflammatory and regenerative processes. Other approved indications in certain Asian markets include peripheral circulatory disorders, diabetic complications, and menopausal disorders.