Stage (next event)
Phase 3 (FDA Meeting to Discuss Results)
Catalyst Info & Data Links
TITLE: Zygel (ZYN002 CBD Gel) for Fragile X Syndrome (FXS) - FDA Meeting to Discuss Results
Active - ClinicalTrial.gov (NCT03802799) Open Label Extension to Assess the Long-Term Safety and Tolerability of ZYN002 in Children and Adolescents With FXS
Completed - ClinicalTrial.gov (NCT03614663) Clinical Study Of caNNabidiol in childrEn and adolesCenTs With Fragile X (CONNECT-FX) (CONNECT-FX)
WHAT IS THE NEXT CATALYST EVENT?
FDA Meeting to Discuss Results
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
Q4 2020 (see slide 4)
2020: ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents With Fragile X Syndrome: Role of Methylation Status as a Correlate to Disease Severity and as a Prognostic Biomarker. Joint 16th International Child Neurology Congress (ICNC) & 49th Annual Child Neurology Society (CNS) Meeting.
2020: Cannabidiol Transdermal Gel for the Treatment of Fragile X Syndrome: Post Hoc Analysis of FAB-C and Pattern of Efficacy on Domains of the Aberrant Behavior Checklist-Community for FXS (ABC-CFXS) Through 116 Weeks of Treatment. American Academy of Neurology (AAN) Science Highlights Virtual Session, 2020.
Post Hoc Analysis: Fragile X Syndrome FAB-C
Mechanism of Action
MECHANISM OF ACTION / RATIONALE
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. Zygel is being developed for patients suffering from FXS, ASD in pediatric patients, 22q, and a heterogeneous group of rare and ultra-rare epilepsies known as developmental and epileptic encephalopathies (DEE) (Learn more HERE).
Updated by HC
Prior Data (click to view full image)
Trial Design / Revenue (click to view full image)
See what the community is saying - click to see full post