Pharmaceutically Produced Cannabidiol
Our pharmaceutically manufactured oral cannabidiol formulation has been developed specifically for medical purposes. It is free from the psychotropic effects of THC and is produced using controlled processes in approved current Good Manufacturing Practices (cGMP) pharmaceutical facilities. This allows for consistent quality, purity, and stability from batch to batch.
CardiolRx™ is an oral cannabidiol formulation being developed for the treatment of acute inflammatory heart disease. It is pharmaceutically produced under cGMP to meet the highest standards for product purity, consistency, and stability.
Cardiol received clearance from the U.S. Food and Drug Administration for its Investigational New Drug application to commence a Phase II/III, double-blind, placebo-controlled clinical trial investigating the efficacy and safety of its lead product, CardiolRx™, in hospitalized COVID-19 patients with a prior history of, or risk factors for, CVD.
Cardiol has completed a Phase I safety and pharmacokinetic study of CardiolRx and in August 2021, received clearance from the U.S. FDA for its IND application for a Phase II international trial of CardiolRx in acute myocarditis, a condition caused by inflammation in heart tissue, which remains a leading cause of sudden cardiac death in people less than 35 years of age.
The Company is also developing a subcutaneous formulation of CardiolRx for the treatment of inflammation in the heart that is associated with the development and progression of heart failure. Heart failure affects over six million people in North America and remains a leading cause of death and hospitalization with associated U.S. healthcare costs exceeding $30 billion annually.