Our pharmaceutically manufactured oral cannabidiol formulation is being clinically developed for use in heart diseases
CardiolRx™ is pharmaceutically manufactured under cGMP to meet the highest standards for product purity, consistency, and stability. Cardiol has completed a Phase I safety and pharmacokinetic study of CardiolRx™.
CardiolRx™ is currently being evaluated in a Phase II multi-national study, the ARCHER trial, to evaluate its the safety and tolerability as well as its impact on myocardial recovery, in patients presenting with acute myocarditis. ARCHER is expected to enroll 100 patients at major cardiac centers in North America, Europe, Latin America, and Israel.
In May 2022, Cardiol received Investigational New Drug Application (IND) authorization from the United States Food and Drug Administration (FDA) to conduct a Phase II open-label pilot study designed to evaluate the tolerance and safety of CardiolRx™ in patients with recurrent pericarditis. The study will also assess the improvement in objective measures of disease, and during an extension period, assess the feasibility of weaning concomitant background therapy including corticosteroids, while taking CardiolRx™.
The Company is planning to pursue the development of CardiolRx™ as an Orphan Drug for the treatment of acute myocarditis and recurrent pericarditis.