Amediplase (K2tu-PA) is a new thrombolytic drug obtained through recombinant DNA technology. This novel chimeric protein combines two human pro-fibrinolytic factors, being formed by part of the N-terminal sequence of tissue plasminogen activator (tPA) linked to the C-terminal sequence of single-chain urokinase.

Research was originally targeted to obtaining a thrombolytic agent for the treatment of acute myocardial infarction endowed with:

• Potent and long lasting fibrinolytic activity

• Single-bolus administration

• High fibrin specificity

• Remarkable safety profile

• No immunogenicity

Actually, amediplase possesses these characteristics and differentiates from earlier developed thrombolytic agents. In experimental models, amediplase showed to be more potent and longer lasting as compared to, e.g., recombinant tPA (alteplase, the golden standard in acute myocardial infarction thrombolytic treatment), and to be fully active after a simple bolus intravenous injection.

Amediplase is ready to enter Phase III studies, after successful implementation of Phase II clinical studies.