NDAORALSOLUTIONPriority Review
Approved
Jun 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Mechanism of Action
Cytochrome P450 2C8 Inhibitors
Clinical Trials (5)
A Study to Investigate the Transition of Children From 'Artisanal" Cannabidiol (CBD) to Epidiolex
Started Feb 2026
25 enrolled
Dravet Syndrome (DS)Lennox-Gastaut Syndrome (LGS)
A Study to Evaluate the Efficacy and Safety of Cannabidiol Oral Solution (CBD-OS [GWP42003-P, JZP926]) for the Treatment of Focal-Onset Seizures
Started Nov 2025
100 enrolled
Focal Seizures
Study of Cannabidiol and Neuroimaging on Stress
Started Oct 2025
160 enrolled
Early Life AdversityTraumaStress
Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy
Started Aug 2025
50 enrolled
Maternal ComplicationsPregnancy ComplicationBirth Outcomes, Adverse+1 more
A Trial to Investigate the Effects of Cannabidiol Plus Naltrexone on Alcohol Craving in Patients With Alcohol Dependence
Started Jul 2025
150 enrolled
Alcohol AddictionAlcoholism
Loss of Exclusivity
LOE Date
Mar 1, 2041
182 months away
Patent Expiry
Mar 1, 2041
Exclusivity Expiry
Jul 31, 2027