Our lead product candidate, ZygelTM is a CBD gel currently being evaluated for Fragile X syndrome (FXS), Autism Spectrum Disorder (ASD) in pediatric patients, 22q, and a heterogeneous group of rare and ultra-rare epilepsies known as developmental and epileptic encephalopathies (DEE). 22q is a rare midline condition featuring physical abnormalities and debilitating neuropsychiatric and behavioral symptoms including anxiety, withdrawn behavior, and social interaction problems. THC is the principal psychoactive cannabinoid. Developing novel transdermal CBD treatments to treat patients suffering rare epilepsies and neurological disorders, Lead development candidate Zygel offers a potential goldmine of therapies for multiple conditions, Zygel is being developed for patients suffering from Fragile X syndrome, a genetic condition that causes learning disabilities, Will discuss the pivotal CONNECT-FX data and the regulatory path for potential approval of Zygel with the FDA in the fourth quarter, Expects to submit its NDA for Zygel in Fragile X syndrome to the FDA in the second half of 2020, with potential approval by mid-year 2021, If successful, Zygel has the potential to become the first product for the treatment of behavioral symptoms of Fragile X syndrome, A positive data readout for Zynerba in any one of its many clinical trials can create serious momentum. Zygel is also being tested for a heterogeneous group of rare and ultra-rare epilepsies known as developmental and epileptic encephalopathies (DEE). Transdermal delivery of Zygel avoids the gastrointestinal tract and potential degradation to THC in stomach acid, which should minimize the risk of negative psychoactive effects. Zynerba Pharmaceuticals is on track to report top-line results from tests of Zygel, a CBD gel treatment for children and adolescents with Fragile X syndrome, the most common form of inherited learning disability and autism spectrum disorder. ** Orphan Drug designation. This site uses cookies to give you a better browsing experience. This is in addition to the patent it received in December 2019 for Zygel to treat Fragile X syndrome. ", Contact the author Uttara Choudhury at uttara@proactiveinvestors.com, Create your account: sign up and get ahead on news and events. ZygelTM (ZYN002 CBD Gel) Zygel is the first and only pharmaceutically-produced CBD, a non-euphoric cannabinoid, formulated as a patent-protected permeation-enhanced gel for transdermal delivery through the skin and into the circulatory system. Zynerba Pharmaceuticals well-funded for its CBD clinical trials into 2021. Potential Benefit of Zygel: