NDAORALSOLUTIONPriority Review
Approved
Jun 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
EPIDIOLEX (cannabidiol) by Jazz Pharmaceuticals is cytochrome p450 2c8 inhibitors [moa]. First approved in 2018.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EPIDIOLEX is an oral cannabidiol solution approved by the FDA in June 2018 for seizure disorders, operating as a cytochrome P450 2C8 inhibitor. It represents Jazz Pharmaceuticals' first-to-market cannabinoid therapeutic with a well-defined mechanism of action. The drug is currently in its peak commercial lifecycle stage with strong market penetration.
$0.197BPart D
PeakStable
14.7 years to LOEEPIDIOLEX is at peak commercial maturity with $197M in Part D spending across 41K claims in 2023, indicating a stable, mature commercial infrastructure requiring ongoing field and marketing support.
Mechanism of Action
Cytochrome P450 2C8 Inhibitors
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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
Mechanisms of Cannabidiol and Sleep in the Context of Alcohol Use
Started Jul 2026
58 enrolled
SleepAlcohol Misuse
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)
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
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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.