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Cannabidivarin

Phase 2

Autism Spectrum Disorder | Small molecule | Psychiatry |Jazz Pharmaceuticals plc|Last Updated: Oct 22, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03202303Cannabidivarin (CBDV) vs. Placebo in Children With Autism Spectrum Disorder (ASD)PHASE2 RECRUITING 100Apr 12, 2019Feb 1, 2027Oct 22, 20252 United States
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Study Endpoints
Primary Endpoints
Aberrant Behavior Checklist-Irritability (ABC-I) Subscale
Change from Baseline to Week 12 (Change over 12 weeks)

Change in aberrant behavior from baseline will be assessed using the irritability subscale of the ABC. The ABC is an informative rating instrument that was empirically derived by principal component analysis to measure behavior in those with developmental disability and autism spectrum disorder (ASD). The ABC-I will be completed by any adult who knows the patient well, such as a parent/caregiver. The ABC-I subscale consists of 15 items that address the presence of aggression, tantrums, and/or self-injury. Scores for each item on the subscale range from 0 (no problem at all) to 3 (problem is severe in degree), yielding an overall possible score for the subscale from 0-45, such that higher scores are indicative of increased severity of irritability. Scores will be summarized by study arm using basic descriptive statistics.

Secondary Endpoints
Repetitive Behavior Scale-Revised (RBS-R)
Change in RBS-R from Baseline to Week 12 (Change over 12 weeks)
Montefiore Einstein Rigidity Scale-Revised (MERS-R)
Change in MERS-R from Baseline to Week 12 (Change over 12 weeks)
Aberrant Behavior Checklist-Social Withdrawal (ABC-SW) Subscale
Change in ABC-SW from Baseline to Week 12 (Change over 12 weeks)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cannabidivarin (CBDV)EXPERIMENTALWeight-based dosing of 10 mg/kg/day of CBDV for 12 weeks
Matched PlaceboPLACEBO_COMPARATORWeight-based dosing of 10 mg/kg/day of placebo for 12 weeks
Interventions
NameTypeDescription
CannabidivarinDRUGWeight-based dosing of 10 mg/kg/day of CBDV
Matched PlaceboDRUGWeight-based dosing of 10 mg/kg/day of placebo
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Eligibility Criteria
Age Range5 Years — 18 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria 1. Male or Female pediatric outpatients aged between and including ages 5 to 18. Diagnosis of Autism Spectrum Disorder (ASD) confirmed by the ADOS-2 and DSM-5 criteria.\*During special circumstances (e.g. COVID-19 pandemic) where the ADOS-2 cannot be performed due to site restric...

Countries:United States
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Competitive Landscape -Autism Spectrum Disorder 17 trials
Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT03202303studyFirstPostDate: changed