TheraRadar
Data updated: May 26, 2026

EPIDIOLEX (cannabidiol)

Cytochrome P450 2C8 Inhibitors Trial Activity: Stable 29 active trials
Orphan Drug Priority Review Fast Track
CNS Approved 2018-06-25

EPIDIOLEX is indicated for the treatment of Lennox-Gastaut Syndrome; Dravet Syndrome; Tuberous Sclerosis Complex; Seizures.

Source: FDA Label • JAZZ PHARMS RES
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How EPIDIOLEX Works

The precise mechanisms by which cannabidiol exerts its anticonvulsant effect in humans are currently unknown. Evidence suggests that the drug does not appear to produce its therapeutic effects through interaction with cannabinoid receptors. The medication functions as an anticonvulsant to reduce seizure activity associated with specific neurological conditions.

Source: FDA Label

Development Insights

University of Colorado, Denver conducting 7 trials (8%)
110 indications explored (Broad Platform)
→ healthy (5 trials)
→ alcohol use disorder (5 trials)
→ post traumatic stress disorder (4 trials)
3
Indications
--
Phase 3 Trials
2
Priority Reviews
7
Years on Market

Details

Status
Prescription
First Approved
2018-06-25
Patent Cliff
2041
Revenue
$285M (Q4-2025)

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
SOLUTION

Companies

JAZZ PHARMS RES
Active Ingredient: CANNABIDIOL

EPIDIOLEX Approval History

2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
14 FDA actions from 2018 to 2025 · 1 indication expansions
Jun 2025 SUPPL
Label · Labeling
FDA Letter Label
Mar 2024 SUPPL
Label · Labeling
FDA Letter Label
Oct 2023 SUPPL
Efficacy
FDA Letter Label

What EPIDIOLEX Treats

4 indications

EPIDIOLEX is approved for 4 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Lennox-Gastaut Syndrome
  • Dravet Syndrome
  • Tuberous Sclerosis Complex
  • Seizures
Source: FDA Label

EPIDIOLEX Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

SUBVENITE
OWP PHARMS
2025 5 indic.
PERAMPANEL
MSN
2025 3 indic.
Unlock 8 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to EPIDIOLEX

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

FENFLURAMINE
FENFLURAMINE
3 shared
Apotex
Shared indications:
Dravet SyndromeLennox-Gastaut SyndromeSeizures
FINTEPLA
FENFLURAMINE HYDROCHLORIDE
3 shared
UCB INC
Shared indications:
Dravet SyndromeLennox-Gastaut SyndromeSeizures
AFINITOR
EVEROLIMUS
2 shared
Novartis
Shared indications:
Tuberous Sclerosis ComplexSeizures
View all 20 similar drugs Pro
📋

Clinical Trial Registry

86 trials
Trial Sponsor ID Phase Status Title
NCT07527338 CALM 25-0483 Ph 2 not yet recruiting Mechanisms of Cannabidiol and Sleep in the Context of Alcohol Use
NCT03518801 CBD-PE MHBB-001-17F Ph 2 completed Cannabidiol and Prolonged Exposure
NCT07564245 CBD-SIB APHP240090 2025-521161-27-00 Ph 2 not yet recruiting Efficacy of Cannabidiol in the Management of Self-injuries in Children and Adolescents With Severe Neurodevelopmental Disorders.
NCT07549256 ProCan 2024-513951-33-00 2024-513951-33-00, F2024-111 Ph 2 not yet recruiting Cannabidiol for Pain Relief of Patients With End-stage mCRPC
NCT05044819 GWEP19022 Ph 4 active not recruiting Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution
NCT06381791 CBD PRO00036811 Ph 1, Ph 2 recruiting CBD for Pain Following Orthopedic Shoulder Surgery
NCT06333041 32977-01-00 Ph 2, Ph 3 recruiting Study of Cannabidiol in Sanfilippo Syndrome
NCT05457465 2022P000825 Ph 2 recruiting Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder
NCT03984565 2023P001774 Ph 2 recruiting PAIN: A Project Assessing the Impact of a Novel Cannabinoid Product
NCT06477406 2024P001549 Ph 2 recruiting Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis
NCT05942911 CHAPPII IHL675ARAPhII Ph 2 terminated Safety and Effect on Pain and Function According to RAPID-3 of IHL-675A in Patients With Rheumatoid Arthritis
NCT05651607 EBCBD APHP220741 2022-003411-28 Ph 2 completed Evaluation of the Efficacy of CANNABIDIOL on the Pruritus in Children With Hereditary Epidermolysis Bullosa
NCT04550377 19-00962 Ph 2 recruiting Cannabidiol as a Treatment for PTSD and PTSD Comorbid With TBI
NCT04978428 IRB21-1147 Ph 2 completed Epidiolex in Obsessive Compulsive Disorder and Related Disorders
NCT06854783 MRX1-1-001 Ph 1 completed Safety and Pharmacokinetics of Cannabidiol in Healthy Volunteers
NCT04105231 CBD-P 2018-004893-84 Ph 2 active not recruiting Cannabidiol for Treatment of Non-affective Psychosis and Cannabis Use
NCT05388058 results posted MC211003 NCI-2022-02479, 21-011969 Ph 2 completed Topical Cannabidiol for the Treatment of Chemotherapy-Induced Peripheral Neuropathy
NCT05571592 22-00568-R61 Ph 2 completed Cannabidiol as a Treatment for Social Anxiety Disorder (R61)
NCT05632627 22-1427 Ph 2 completed Cannabinoids and Traumatic Brain Injury: A Randomized, Placebo Controlled Trial
NCT05299944 21-5122 Ph 2 completed Reducing Pain and Opioid Use With CBD
NCT07278505 SCANS STUDY-25-00337 1R01MH139940 Ph 1, Ph 2 recruiting Study of Cannabidiol and Neuroimaging on Stress
NCT06940674 ACROS STUDY-24-01494 UH3DA050323 Ph 3 recruiting Adjunctive Cannabidiol for Recovery From Opioid Study
NCT06731894 24435 NCI-2024-08847, 24435 Ph 2 recruiting Phytocannabinoids for Reducing Chronic Chemotherapy-Induced Peripheral Neuropathy in Breast and Colon Cancer Survivors
NCT05649059 CAN-SAD 2206000688 Ph 4 recruiting Investigating the Effects of Cannabidiol on Social Anxiety Disorder
NCT05015439 IRB00267739 Ph 1 recruiting Cannabidiol (CBD) in Adults With ASD
NCT04517799 181455 Ph 2 active not recruiting Trial of Cannabidiol to Treat Severe Behavior Problems in Children With Autism
NCT06381180 CBH Warrior CARE: CBH Ph 1, Ph 2 not yet recruiting Warrior CARE: Cannabis Behavioral Health
NCT05023070 STUDY-19-02132 Ph 1 completed Investigation of the Pharmacokinetic Profile of CBD - Phase 1 ANANDA
NCT07001930 CREWS IRB00440948 R01DA027232-09A1 Ph 1 recruiting Effects of Cannabidiol on Stress and Nicotine Withdrawal
NCT05317546 results posted Pro00119770 Ph 2 completed Cannabidiol in Youth Alcohol Use Disorder
NCT06192589 results posted SCR-016 Ph 1 completed Clinical Study to Evaluate Cannabidiol Liver Enzyme Elevations and Drug Interactions
NCT06448923 CAM-POT 2025-2105 Ph 2 recruiting Cannabidiol After Multi-Trauma for Pain and Opioid Therapy
NCT04482244 results posted 19-886 Ph 2 active not recruiting RCT of CBD for Anxiety in Advanced Breast Cancer
NCT06930703 SPICE STUDY-24-00903 IN123001222 Ph 1, Ph 2 recruiting Cannabidiol in Sickle Cell Disease
NCT06213233 HUM00231202 VMR2022-03 Ph 2 recruiting MIVetsCan: Cannabidiol (CBD)-Care Trial
NCT05867849 CBD-BD H23-00105 Ph 3 recruiting Cannabidiol for Bipolar Depression (CBD-BD)
NCT06108349 HSR230375 Ph 2 not yet recruiting Topical Cannabidiol for Treating Carpal Tunnel Syndrome
NCT06574100 NFL-CBD-02 Bio-4317, 286992 Ph 1 recruiting Relative Bioavailability of Two Orally Administered CBD Formulations in Healthy Male Adults
NCT02492074 GEI-TCP I Ph 1 withdrawn Gene-Environment-Interaction: Influence of the COMT Genotype on the Effects of Different Cannabinoids - a PET Study
NCT05269706 STUDY-19-00681 Ph 1 completed Investigation of the Pharmacokinetic Profile of CBD
NCT04749628 2019-1688 Ph 4 completed Cannabidiol for Bilateral Total Knee Arthroplasty
NCT05823753 801460 Ph 2 completed Cannabidiol to Reduce Anxiety Reactivity
NCT02088060 CBD-FEP 2012-004335-23 Ph 2 terminated A Four-week Clinical Trial Investigating Efficacy and Safety of Cannabidiol As a Treatment for Acutely Ill Schizophrenic Patients
NCT04873453 20-2694 Ph 2 completed CBD for the Treatment of Alcohol Use Disorder
NCT05822362 23-0619 Ph 2 recruiting CBD for Individuals at Risk for Alzheimer's Disease
NCT05613608 22-1894 R01AA029606 Ph 2, Ph 3 recruiting Alcohol Use Disorder and Cannabidiol
NCT04760613 results posted s21-00230 19-A0-00-1002274 Ph 1, Ph 2 completed CBD for Chronic Radicular Pain on Chronic Opioid Therapy (COT)
NCT03904849 00086168 Ph 1, Ph 2 withdrawn Cannabidiol for Alcohol Use Disorder
NCT05646459 0217-20-FB Ph 1 withdrawn Effect of Local Cannabidiol on Clinical and Inflammatory Outcomes in Periodontal Maintenance Patients.
NCT03582137 results posted 17-2318 Ph 2 completed A Study of Tolerability and Efficacy of Cannabidiol on Motor Symptoms in Parkinson's Disease

Showing 50 of 86 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

EPIDIOLEX FDA Label Details

Indications & Usage

FDA Label (PDF)

EPIDIOLEX is indicated for the treatment of Lennox-Gastaut Syndrome; Dravet Syndrome; Tuberous Sclerosis Complex; Seizures.

View full patent landscape →
32 OB patents · 6 families · 289 international docs across 28 countries

EPIDIOLEX Patents & Exclusivity

Latest Patent: Mar 2041
Exclusivity: Jul 2027

Patents (32 active)

US12102619 Expires Mar 1, 2041
US11160795 Expires Mar 1, 2041
US11406623 Expires Mar 1, 2041
US11207292 Expires Apr 26, 2039
US11865102 Expires Apr 26, 2039
US11065209 Expires Oct 13, 2035
US10918608 Expires Oct 13, 2035
US11400055 Expires Oct 13, 2035
US11096905 Expires Oct 13, 2035
US9956186 Expires Jun 17, 2035
US10092525 Expires Jun 17, 2035
US9956183 Expires Jun 17, 2035
US9949937 Expires Jun 17, 2035
US10111840 Expires Jun 17, 2035
US10137095 Expires Jun 17, 2035
US11633369 Expires Jun 17, 2035
US10603288 Expires Jun 17, 2035
US11357741 Expires Jun 17, 2035
US10709671 Expires Jun 17, 2035
US10709674 Expires Jun 17, 2035
US9956184 Expires Jun 17, 2035
US11963937 Expires Jun 17, 2035
US9956185 Expires Jun 17, 2035
US12064399 Expires Jun 17, 2035
US11766411 Expires Jun 17, 2035
US11154516 Expires Jun 17, 2035
US10849860 Expires Jun 17, 2035
US11311498 Expires Jun 17, 2035
US10966939 Expires Jun 17, 2035
US11446258 Expires Jun 17, 2035
US11701330 Expires Jun 17, 2035
US10709673 Expires Jun 17, 2035

Exclusivity

M-270 Until Oct 2026
ODE-326 Until Jul 2027
ODE-332 Until Jul 2027
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for EPIDIOLEX

Revenue Insights

  • • Q4-2025: $285M
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2041
  • • 57 active patents

Trial Analysis

  • • 90 total trials
  • • Stage: Stable

Competitive Landscape

  • • 20 similar drugs
  • • Same target/indication analysis
Unlock Full Intelligence

Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA210365 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment