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CBD-OS

Phase 1

Focal Seizures | Small molecule | Neurology |Jazz Pharmaceuticals plc|Last Updated: Jun 3, 2026

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07233239A Study to Evaluate the Efficacy and Safety of Cannabidiol Oral Solution (CBD-OS [GWP42003-P, JZP926]) for the Treatment of Focal-Onset SeizuresPHASE1 RECRUITING 100Nov 26, 2025Nov 29, 2027Jun 3, 202624 United States
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Study Endpoints
Primary Endpoints
Percent change in countable focal seizure frequency compared to baseline
Baseline up to 16 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CBD-OSEXPERIMENTALParticipants who will receive open-label CBD-OS.
Interventions
NameTypeDescription
CBD-OSDRUGStarting dose of CBD-OS will be administered as per the approved local product label
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Eligibility Criteria
Age Range12 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites24

Participants are eligible to be included in the main study only if all of the following criteria apply: 1. Participant has a documented diagnosis of focal epilepsy according to the ILAE Classification of Epilepsy, 2017, characterized by focal seizure types with typical interictal/ictal EEG findings...

Countries:United States
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Recent Changes (Last 90 Days)
LOWJun 4, 2026NCT07233239lastUpdatePostDate: changed
LOWJun 4, 2026NCT07233239lastUpdatePostDate: changed
LOWJun 4, 2026NCT07233239lastUpdatePostDate: changed
LOWJun 4, 2026NCT07233239lastUpdatePostDate: changed
LOWJun 4, 2026NCT07233239lastUpdatePostDate: changed
LOWMay 26, 2026NCT07233239primaryCompletionDate: changed
LOWMay 24, 2026NCT07233239studyFirstPostDate: changed