ZYNE

Zygel (ZYN002 CBD Gel)

Fragile X Syndrome (FXS)

Stage (next event)

Expected Date

Phase 3 (FDA Meeting to Discuss Results)

Q4 2020

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?


PRIOR DATA

PRESS RELEASES

POSTERS


  • 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 TreatmentAmerican 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)

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Trial Design / Revenue (click to view full image)

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