ZYN001 – THC Pro-Drug Patch

Being developed for neuropsychiatric disorders including Tourette Syndrome

ZYN001 is a  pro-drug of THC that is designed to enable effective transdermal delivery via a patch. A Phase 1 clinical program for ZYN001 is ongoing. ZYN001 is patent-protected through 2031. Learn more about pro-drugs below.

Addressing Limitations of Current Treatments

Challenge: Oral administration
Oral administration can lead to limitations in safety and efficacy including low bioavailability, inconsistent plasma levels and significant first-pass liver metabolism. First-pass liver metabolism refers to the process by which the liver breaks down therapeutics ingested directly or indirectly through the gastrointestinal system, such as through oral or oral mucosal delivery methods, allowing only a small amount of drug to be absorbed into the circulatory system.

Potential Benefit of ZYN001:
Transdermal therapeutics are absorbed through the skin directly into the systemic circulation, avoiding first-pass liver metabolism and potentially allowing for a lower dose to achieve efficacy and better tolerability profile.

Challenge: THC delivered orally causes high peak levels of THC in the blood, leading to increased psychoactive side effects

Potential Benefit of ZYN001:
ZYN001 may have an improved tolerability profile because of more consistent blood levels with fewer peaks and valleys.

Challenge: Oral THC is dosed multiple times a day

Potential Benefit of ZYN001:
ZYN001 may provide once-daily dosing with an easy-to-apply patch.

Challenge: Botanically derived cannabinoids
Botanical cannabinoids may create significant challenges for drug manufacturers because of the natural resources and security measures required to grow Cannabis, as well as the strict batch controls required by regulatory agencies in pharmaceutical manufacturing.

Potential Benefit of ZYN001:
ZYN001 is pharmaceutically manufactured in a CGMP (Current Good Manufacturing Practice) facility that will comply with stringent FDA/CGMP regulations, and is not extracted from the Cannabis plant.


What Is a Pro-Drug?

Pro-drugs are drugs administered in an inactive or less active form and designed to enable more effective delivery, and then converted into a different form through a normal metabolic process.

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Tourette Syndrome

Tourette Syndrome (TS) is a neurodevelopmental disorder characterized by motor and vocal tics. It is evident in early childhood, and impacts approximately 140,000 children and adolescents in the U.S.; 86% have additional mental, developmental or behavioral conditions. The National Institute of Neurological Disorders and Stroke estimate that 200,000 Americans have the most severe form of TS, and as many as one in 100 exhibit milder and less complex symptoms such as chronic motor or vocal tics.

Tourette Syndrome patient resources