Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Pharmaceutically produced cannabidiol, Cannabidiol
CardiolRx · 3 trials · 2 indications
time to a new episode of recurrent pericarditis\* from the timepoint of stopping the IL-1 blocker to Week 24
Change in pain score from baseline using 11-point NRS after 8 weeks of treatment. Nominal Rating Scale from 0 to 10, where 0 represents no pain and 10 maximum pain.
Change of ECV from baseline at 12 weeks, measured by cardiac Cardiac MRI. ECV is measuring the degree of edema and fibrosis. The unit of measure was percentage. It was the percentage of myocardial tissue that is extracellular space (i.e. fraction of the myocardium occupied by extracellular matrix and interstitial fluid).
The outcome was the change in GLS from baseline at 12 weeks, measured by cardiac Cardiac MRI. GLS is a predictor of cardiac function. The unit of measure is percentage. It is the percent change in myocardial length relative to its original (end-diastolic) length along the long axis. Longitudinal strain during systole is usually negative, because the ventricle shortens; normal peak GLS in healthy adults is around -20% (i.e., 20% shortening relative to original length)
| Arm | Type | Description |
|---|---|---|
| CardiolRx | ACTIVE_COMPARATOR | * Initial starting dose (Day 1, evening dose to Day 3, morning dose): 5 mg/kg of body weight CardiolRx b.i.d. * Day 3, evening dose to Day 10, morning dose: 7.5 mg/kg of body weight CardiolRx b.i.d. * Day 10, evening dose to morning dose of the Week 24 Visit: 10 mg/kg of body weight CardiolRx b.i.d. |
| Placebo | PLACEBO_COMPARATOR | * Initial starting dose (Day 1, evening dose to Day 3, morning dose): 5 mg/kg of body weight matching placebo b.i.d. * Day 3, evening dose to Day 10, morning dose: 7.5 mg/kg of body weight matching placebo b.i.d. * Day 10, evening dose to morning dose of the Week 24 Visit: 10 mg/kg of body weight matching placebo b.i.d. |
| Name | Type | Description |
|---|---|---|
| CardiolRx | DRUG | The intervention will be administered orally (via syringe) with food twice daily. |
Inclusion Criteria: 1. Patients 18 years of age or older 2. A history of recurrent pericarditis with stable disease and currently being treated with an IL-1 blocker, scheduled to be discontinued. Stable disease is defined as: * treatment with an IL-1 blocker for at least 12 months, * free of...
CardiolRx is being developed for two cardiovascular conditions: acute myocarditis and recurrent pericarditis. It is an investigational small molecule and is not approved for any indication. Clinical testing has focused on patients 18 years and older, with trials conducted in the United States, Canada, Brazil, France, Israel, Greece, and Italy.
CardiolRx targets NLRP3, a component of the inflammasome. By acting on NLRP3, the small molecule is designed to modulate the inflammatory pathway implicated in acute myocarditis and recurrent pericarditis. This mechanism distinguishes it from conventional anti-inflammatory approaches that do not directly engage the NLRP3 inflammasome.
CardiolRx is being developed by Cardiol Therapeutics Inc., which trades under the ticker CRDL. The company is advancing the small molecule across cardiovascular indications, including acute myocarditis and recurrent pericarditis, through clinical trials in North America and Europe.
CardiolRx has completed Phase 2 testing and is now in Phase 3. The MAVERIC Phase-3 trial in recurrent pericarditis is currently recruiting, while two Phase 2 studies, one in recurrent pericarditis and one in acute myocarditis, have been completed. CardiolRx is investigational and has not been approved by the FDA.
CardiolRx has been studied in three registered trials. NCT06708299 is a recruiting Phase 3 trial in recurrent pericarditis across the United States, Canada, Greece, and Italy. NCT05494788 was a completed Phase 2 pilot in recurrent pericarditis, and NCT05180240 was a completed Phase 2 trial in acute myocarditis.
Across its clinical program, CardiolRx trials have enrolled 137 patients in total. The completed Phase 2 acute myocarditis study enrolled 109 patients, the completed Phase 2 recurrent pericarditis pilot enrolled 27, and the ongoing Phase 3 recurrent pericarditis trial is planned for 110 participants. The studies are randomized, double-blind, and placebo-controlled.