Drug intelligence / Profile preview

cannabidiol + tetrahydrocannabinol (St. Joseph's Healthcare Hamilton)

Development stage
Phase 3
Lead developer
McMaster University and St. Joseph's Healthcare Hamilton
Modality
Metabolically Activated Prodrugs → Prodrugs/Conditional Activator Small Molecules → Small Molecules, Classical Binding Small Molecules → Small Molecules
Administration
Oral
01

Overview

This cannabis-infused oil is an investigational drug product containing a combination of cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC) in specific ratios, primarily 25:1 and 5:1. Developed by St. Joseph's Healthcare Hamilton in collaboration with McMaster University, it is being evaluated in a Phase 2 clinical trial (NCT05041647) for the treatment of insomnia in adults with major depressive disorder (MDD). The formulation leverages the therapeutic properties of CBD, a non-intoxicating cannabinoid with potential anxiolytic and sedative effects, and low-dose THC, which may enhance efficacy through the entourage effect. The study aims to assess the safety and efficacy of high-dose (50 mg/mL) versus low-dose (10 mg/mL) CBD concentrations in improving sleep parameters such as sleep latency and wake after sleep onset.

Brand names
Avidekel
Other names
cannabis-infused oilCBD/THC oil25:1 CBD/THC5:1 CBD/THC
02

Targets

HTR1A (Serotonin receptor 1A (5-hydroxytryptamine receptor 1A))CNR1 (Cannabinoid receptor 1)CNR2 (Cannabinoid receptor type 2)TRPV1 (Transient receptor potential cation channel subfamily V member 1)

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