ZYN002 ( DrugBank: - )


2 diseases
IDDisease name (Link within this page)Number of trials
20322q11.2 deletion syndrome1
206Fragile X syndrome4

203. 22q11.2 deletion syndrome


Clinical trials : 5 Drugs : 7 - (DrugBank : 1) / Drug target genes : 14 - Drug target pathways : 23
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1NCT05149898
(ClinicalTrials.gov)
March 3, 20205/10/2021Open-Label, Tolerability and Efficacy Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents With 22q11.2 Deletion SyndromeOpen-Label, Tolerability and Efficacy Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents With 22q11.2 Deletion Syndrome22Q Deletion SyndromeDrug: ZYN002Zynerba Pharmaceuticals, Inc.NULLRecruiting4 Years17 YearsAll20Phase 1/Phase 2United States;Australia

206. Fragile X syndrome


Clinical trials : 104 Drugs : 87 - (DrugBank : 32) / Drug target genes : 54 - Drug target pathways : 79
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04977986
(ClinicalTrials.gov)
September 13, 202120/7/2021Clinical Study of Cannabidiol in Children and Adolescents With Fragile X SyndromeA Randomized, Double-Blind, Placebo-Controlled Multiple-Center, Efficacy and Safety Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents With Fragile X Syndrome - RECONNECTFragile X SyndromeDrug: ZYN002 - transdermal gel;Drug: PlaceboZynerba Pharmaceuticals, Inc.NULLRecruiting3 Years17 YearsAll204Phase 3United States;Australia;Ireland;United Kingdom
2NCT03802799
(ClinicalTrials.gov)
November 9, 201826/12/2018Open Label Extension to Assess the Long-Term Safety and Tolerability of ZYN002 in Children and Adolescents With FXSAn Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of ZYN002 Administered as a Transdermal Gel to Children and Adolescents With Fragile X Syndrome - CONNECT-FX Open Label Extension (OLE)Fragile X SyndromeDrug: ZYN002 - CBD Transdermal GelZynerba Pharmaceuticals, Inc.NULLEnrolling by invitation3 Years18 YearsAll300Phase 2/Phase 3United States;Australia;New Zealand
3NCT03614663
(ClinicalTrials.gov)
June 12, 201810/7/2018Clinical Study Of caNNabidiol in childrEn and adolesCenTs With Fragile X (CONNECT-FX)A Randomized, Double-Blind, Placebo-Controlled Multiple-Center, Efficacy and Safety Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents With Fragile X SyndromeFragile X SyndromeDrug: ZYN002 - CBD Transdermal Gel;Other: Placebo Transdermal GelZynerba Pharmaceuticals, Inc.NULLCompleted3 Years17 YearsAll212Phase 2/Phase 3United States;Australia;New Zealand
4EUCTR2021-002542-33-IE
(EUCTR)
10/08/2021Effects and Safety of Test drug ZYN002, applied as a gel onto the skin of children and adolescents with a certain hereditary disease called Fragile X SyndromeA Randomized, Double-Blind, Placebo-Controlled Multiple-Center, Efficacy and Safety Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents with Fragile X Syndrome - RECONNECT - RECONNECT Fragile X syndrome (FXS) is a rare genetic disorder caused by the deficiency or absence of Fragile X mental retardation protein (FMRP), an RNA-binding protein and the gene product of the FMR1 gene. FXS is most commonly caused by silencing of the FMR1 gene due to a trinucleotide repeat expansion. In FXS patients, the relative absence of functional FMRP is associated with critical impairments in neurodevelopment and learning, as well as disruption to other neuronal and non-neuronal functions.
MedDRA version: 20.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: ZYN002
INN or Proposed INN: n/a
Other descriptive name: CANNABIDIOL
Zynerba Pharmaceuticals, Inc.NULLNAFemale: yes
Male: yes
204Phase 3United States;Ireland;Australia;United Kingdom