Our development pipeline includes two lead product candidates, ZYN002 and ZYN001, which are being evaluated in five therapeutic indications.
Our development pipeline currently includes two programs studying synthetic cannabinoid therapeutics across multiple therapeutic areas.
ZYN002 is the first and only synthetic CBD, a non-psychoactive cannabinoid, formulated as a patent-protected permeation-enhanced gel for transdermal delivery through the skin and into the circulatory system. ZYN002 is in Phase 2 clinical development in patients with refractory epilepsy, in patients with osteoarthritis of the knee as well as in patients with Fragile X syndrome. In February 2016, the FDA granted orphan-drug designation of ZYN002 for the treatment of patients with Fragile X syndrome in the US.
ZYN001 is a pro-drug of THC that enables transdermal delivery through the skin and into the circulatory system via a patch. A Phase 1 clinical trial for ZYN001 is planned to begin in the first half of 2017.
Development Status and Upcoming Milestones
These timelines are subject to change due to regulatory, clinical and other considerations.
|ZYN002||Epilepsy in Adults with Focal Seizures – STAR 1||Phase 2 Results||July/August 2017|
|ZYN002||Osteoarthritis – STOP||Phase 2 Results||July/August 2017|
|ZYN002||Fragile X Syndrome – FAB-C||Phase 2 Results||End of 1H 2017|
|ZYN001||Safety and PK||Phase 1 Initiation||1H 2017|
|ZYN001||Fibromyalgia||Phase 2 Initiation||2H 2017|
|ZYN001||Peripheral Neuropathic Pain||Phase 2 Initiation||2H 2017|
Cannabinoids are a class of compounds derived from cannabis plants. The two primary cannabinoids contain in cannabis are cannabidiol (CBD) and Δ9-tetrahydrocannabinol (THC).
|Activity||Non-psychoactive, multiple mechanisms||Psychoactive, antinociceptive,
agonist of CB1 and CB2 receptors
|Indications Being Developed||Epilepsy
Fragile X Syndrome
Peripheral Neuropathic Pain
|Potential Future Indications||Post-Traumatic Stress Disorder
|Chronic Cancer Pain
|Zynerba Asset||CBD Gel – ZYN002||THC Pro-Drug Patch – ZYN001|
THC and CBD Safety
Clinical data suggest that THC and CBD have a high therapeutic index with low toxicity.1 In the nabiximols clinical program, dizziness and fatigue were considered very common (> 1/10) adverse events. These occurred in the first four weeks of exposure were mild to moderate and resolved within a few days with continued treatment.2 Nabiximols are not recommended for use in children or adolescents below 18 years of age due to lack of safety and efficacy data. In non-clinical studies, effects were observed at exposures considered in excess of human exposure suggesting little relevance to clinical use.2
1. Fine, PG, Rosenfeld, MJ. The Endocannabinoid System, Cannabinoids, and Pain. Rambam Maimodies Med J 2013;4 (4)E0022.
2. Sativex Summary of Product Characteristics, UK 2014.