- The FDA has signed off Cardiol Therapeutics Inc's CRDL Investigational New Drug (IND) application for CardiolRx.
- Cardiol will commence a Phase 2, multi-center, double-blind, randomized, placebo-controlled trial to assess the safety and tolerability of CardiolRx in acute myocarditis patients.
- Myocarditis is an acute inflammatory condition of the myocardium, characterized by inflammation of the heart muscle.
- The study will enroll 100 patients.
- The primary endpoints of the trial, which will be evaluated after 12 weeks of double-blind therapy, consist of left ventricular function (ejection fraction and longitudinal strain) and myocardial edema (extra-cellular volume).
- CardiolRx is a pharmaceutically produced oral cannabidiol formulation investigated in Phase 2/3 outcomes study (the LANCER trial) to evaluate CardiolRx as a cardioprotective therapy to reduce mortality and major cardiovascular events.
- Related content: Benzinga's Full FDA Calendar.
- Price Action: CRDL shares are up 9.90% at $3.33 during the premarket session on the last check Tuesday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Posted In:
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in