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 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EPIDIOLEX is an FDA-approved oral cannabidiol solution indicated for seizure disorders, developed by Jazz Pharmaceuticals. It works as a cytochrome P450 2C8 inhibitor, modulating seizure activity through a novel mechanism distinct from traditional anticonvulsants. The product has established itself as a specialized treatment option in the epilepsy market since its 2018 approval.
$0.197BPart D
PeakStable
16.0 years to LOEEstablished peak-phase product with $197M in Part D spending (2023) and ~41K annual claims, supporting a stable commercial organization focused on optimization rather than launch intensity.
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
A Study to Investigate the Transition of Children From 'Artisanal" Cannabidiol (CBD) to Epidiolex
Started Jan 2027
25 enrolled
Dravet Syndrome (DS)Lennox-Gastaut Syndrome (LGS)
A Study to Investigate the Effect of Gradual Titration to Optimize Cannabidiol Treatment in Adults With LGS
Started Nov 2026
40 enrolled
Lennox-Gastaut Syndrome
Epidiolex Trial for Presymptomatic Treatment of Sturge-Weber Syndrome
Started Aug 2026
10 enrolled
Sturge - Weber Syndrome (SWS)
Mechanisms of Cannabidiol and Sleep in the Context of Alcohol Use
Started Jul 2026
58 enrolled
SleepAlcohol Misuse
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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.