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Zenivol
- Development stage
- Phase 1
- Lead developer
- Zelira Therapeutics
- Modality
- Metabolically Activated Prodrugs → Prodrugs/Conditional Activator Small Molecules → Small Molecules, Classical Binding Small Molecules → Small Molecules
- Administration
- Sublingual
01
Overview
Zenivol (ZTL-101) is a proprietary, clinically validated, sublingual cannabinoid formulation developed by Zelira Therapeutics for the treatment of chronic insomnia. It is a plant-derived extract formulated in pharmaceutical-grade sunflower oil, containing a specific 20:2:1 ratio of delta-9-tetrahydrocannabinol (THC, 20 mg/mL), cannabinol (CBN, 2 mg/mL), and cannabidiol (CBD, 1 mg/mL), along with naturally occurring terpenes. Zenivol acts by modulating the endocannabinoid system, primarily targeting cannabinoid receptors CB1 and CB2 to promote sleep maintenance and quality. The formulation has been evaluated in a randomized, double-blind, placebo-controlled crossover Phase 1b/2a trial at the University of Western Australia, demonstrating significant improvements in Insomnia Severity Index (ISI) scores and sleep metrics. Zenivol is approved and available by prescription under special access schemes in Australia and has received regulatory approval from BfArM in Germany.
- Brand names
- Zenivol
- Other names
- THC + CBN + CBDTHC/CBN/CBDtetrahydrocannabinol + cannabinol + cannabidiol
02
Targets
CNR1 (Cannabinoid receptor 1)
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