NDAORALSOLUTIONPriority Review
Approved
Jun 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
Priority Review
EPIDIOLEX (cannabidiol) by Jazz Pharmaceuticals is cytochrome p450 2c8 inhibitors [moa]. Approved for dravet syndrome, lennox-gastaut syndrome. First approved in 2018.
Drug data last refreshed 19h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Epidiolex (cannabidiol) is an oral solution developed by Jazz Pharmaceuticals and approved by the FDA on June 25, 2018. It is indicated for seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex in patients 1 year of age and older. The drug works as a cytochrome P450 2C8 inhibitor through a novel mechanism distinct from traditional anticonvulsants. It represents a landmark approval as the first plant-derived cannabinoid medication approved by the FDA for seizure disorders.
$0.2BPart D
14.8 years to LOEMechanism of Action
Cytochrome P450 2C8 Inhibitors
Indications (2)
Clinical Trials (20)
Effects of Cannabidiol on Psychiatric Symptoms, Cognition, and Cannabis Consumption in Cannabis Users With Recent-Onset Psychosis
Started Jan 2050
0Schizophrenia Spectrum DisordersCannabis Use
A Study to Investigate the Transition of Children From 'Artisanal" Cannabidiol (CBD) to Epidiolex
Started Jun 2026
25 enrolled
Dravet Syndrome (DS)Lennox-Gastaut Syndrome (LGS)
Mechanisms of Cannabidiol and Sleep in the Context of Alcohol Use
Started May 2026
58 enrolled
SleepAlcohol Misuse
Study of Cannabidiol in Sanfilippo Syndrome
Started Apr 2026
35 enrolled
Sanfilippo SyndromeMucopolysaccharidosis III
Cannabidiol and Alcohol Use Disorder Phenotypes
Started Mar 2026
150 enrolled
Alcohol Use Disorder
Worked on EPIDIOLEX at Jazz Pharmaceuticals? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.