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This is a **combination drug** consisting of **cannabidiol (CBD)**, **tetrahydrocannabinol (THC)**, and **palmitoylethanolamide (PEA)**. The most closely related, clinically-trialed form is THX-110 or THX-TS01, which contains THC and PEA; evidence for a triple cannabinoid formulation is very limited, but combinations with CBD are feasible given pharmaceutical and supplement trends[1][3][5]. - **Mechanism of action**: - CBD acts as a modulator of multiple receptors (including serotonin, TRPV1, and CB2), and has anti-inflammatory, anxiolytic, and neuroprotective effects[6]. - THC is a partial agonist of **Cannabinoid receptor 1 (CB1)** and **Cannabinoid receptor 2 (CB2)**, with psychoactive and anti-inflammatory properties, affecting neurotransmitter release such as dopamine, glutamate, and GABA[3][1]. - PEA is an endogenous fatty acid amide with anti-inflammatory and analgesic effects, primarily acting as an agonist of **Peroxisome proliferator-activated receptor alpha (PPAR-α)**, and also interacting with **Transient receptor potential vanilloid type 1 (TRPV1)**, GPR55, GPR119, with indirect enhancement of CB1/CB2 activity (“entourage effect”)[2][3][5]. - The **combination (“entourage effect”)** aims to enhance cannabinoid receptor activity and reduce dosage-related side effects by synergistically improving therapeutic efficacy, particularly for conditions like neuroinflammatory disorders and Tourette’s syndrome[3][1][5]. - **Primary indications** (as studied): Tic disorders (notably Tourette Syndrome), chronic pain, inflammation, neuropsychiatric disorders, anxiety, sleep disturbance, neurodegenerative diseases[1][5][3]. - **Developed by**: Therapix Biosciences, with Catalent Pharma Solutions as a noted production partner for related combinations; Yale University has led clinical trials for THX-110/THX-TS01[1][3]. - **Notable trials**: Phase 2 trial in Tourette’s syndrome combining THC (dronabinol) and PEA; CBD’s role often adjunctive, but no evidence for a regulatory-approved triple combination yet[1][3][5]. - **Supplement context**: PEA is sold as a supplement in Europe (Normast, Pelvilen), and both CBD and THC (medical cannabis) are widely available, but combined pharmaceutical products are under investigation[2][3][5].
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