Leveraging manufacturing technology to cannabidiol

Zynerba utilizes an established pharmaceutical manufacturing process to replicate the structure and function of the cannabidiol found in the cannabis plant. Lot consistency, reproducibility, purity and supply are required elements of any pharmaceutical manufacturing process. Zynerba believes that its manufacturing process will allow it to reproducibly manufacture its transdermal cannabidiol gel to meet the stringent global regulatory agencies’ standards while ensuring consistent and efficient supply – without the costs and logistical requirements of growing and harvesting cannabis.

Our commitment to patients drives our research efforts into pharmaceutically manufactured cannabidiol – the same structure and function, without plants.

Our Lead Candidate:

Zygel™ (ZYN002 cannabidiol gel) is the first and only pharmaceutically-manufactured cannabidiol, a non-euphoric cannabinoid, formulated as a patent-protected permeation-enhanced gel for transdermal delivery through the skin and into the circulatory system. Zygel is being developed for patients suffering from neuropsychiatric conditions including Fragile X syndrome (FXS) and 22q11.2 deletion syndrome (22q). The Company has received orphan drug designation for cannabidiol, the active ingredient in Zygel, from the U.S. Food and Drug Administration (FDA) and the European Commission in the treatment of FXS and the treatment of 22q. Additionally, Zygel has been designated a Fast Track development program by the FDA for the treatment of behavioral symptoms of FXS.

Zygel is an investigational treatment. This means that it is not approved for commercial distribution by government regulatory bodies, including the FDA.

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