Last reviewed · How we verify
Epidiolex (CANNABIDIOL)
Epidiolex works by inhibiting the activity of caspase-1, a protein involved in the inflammatory response and neuronal excitability.
At a glance
| Generic name | CANNABIDIOL |
|---|---|
| Sponsor | Jazz Pharms Res |
| Target | Caspase-1 |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2018 |
| Annual revenue | 800 |
Mechanism of action
The precise mechanisms by which EPIDIOLEX exerts its anticonvulsant effect in humans are unknown. Cannabidiol does not appear to exert its anticonvulsant effects through interaction with cannabinoid receptors.
Approved indications
- Lennox-Gastaut syndrome
- Severe myoclonic epilepsy in infancy
Common side effects
- Transaminases elevated
- Decreased appetite
- Diarrhea
- Weight decreased
- Gastroenteritis
- Abdominal pain, discomfort
- Somnolence
- Fatigue, malaise, asthenia
- Lethargy
- Sedation
- Irritability, agitation
- Aggression, anger
Key clinical trials
- EFFECTS OF A FULL SPECTRUM CANNABIS EXTRACT WITH DIFFERENT DOSES OF CBD AND THC ON THE MODULATION OF FIBROMYALGIA: A PILOT, MULTICENTER, OPEN LABEL CLINICAL TRIAL (FRIDINHA) (PHASE1,PHASE2)
- Sublingual Cannabidiol for Anxiety (PHASE2)
- Safety and Effect on Pain and Function According to RAPID-3 of IHL-675A in Patients With Rheumatoid Arthritis (PHASE2)
- Consumer Perceptions of Cannabidiol (CBD) Health Claims (NA)
- Evaluating Cannabidiol as a Novel Anticraving Medication for Alcohol Use Disorder (PHASE2)
- MIVetsCan: Can-Coach Trial (Phase 2) (NA)
- CBD for Pain Following Orthopedic Shoulder Surgery (PHASE1,PHASE2)
- CBD for Breast Cancer Primary Tumors (PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Epidiolex CI brief — competitive landscape report
- Epidiolex updates RSS · CI watch RSS
- Jazz Pharms Res portfolio CI