Drug intelligence / Profile preview

Neutralase

Development stage
Discontinued
Lead developer
BioMarin
Modality
Therapeutic Enzymes → Recombinant Proteins and Enzymes
Administration
Intravenous
01

Overview

Neutralase is a recombinant form of the enzyme heparinase I (EC 4.2.2.7), a heparin-degrading polysaccharide lyase developed as an intravenous agent to reverse systemic heparin anticoagulation as an alternative to protamine, particularly in settings such as cardiopulmonary bypass and coronary artery bypass graft (CABG) surgery.[2][4][5] By enzymatically cleaving heparin chains, Neutralase inactivates circulating unfractionated heparin and rapidly normalizes coagulation parameters, with preclinical and early clinical data showing effective reversal of heparin-induced anticoagulation and fewer acute hemodynamic disturbances than protamine.[2][4] The drug was originally developed by IBEX Technologies and later advanced clinically by BioMarin Pharmaceutical, but its phase 3 program in CABG surgery was halted and the overall development of Neutralase was terminated due to an unfavorable risk–benefit profile.[5][6]

Brand names
Neutralase
Other names
heparinase Iheparin lyase I

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