Epidiolex

(Cannabidiol)

ApprovedSmall molecule

Cannabidiol is used to treat certain types of seizures, particularly in people with rare epilepsy conditions like Dravet syndrome and Lennox-Gastaut syndrome. It may help reduce the frequency and severity of seizures.[2] Epidiolex is currently approved and in use across 104 indications[4].[1]

Epidiolex is one of 1683 small molecule programs targeting Hepatic steatosis. It is currently in Approved.

104

Indications

166

Total Trials

Active Trials

1,682

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Hepatic SteatosisApproved

GastroparesisActive, not recruiting

HIV InfectionApproved

Nicotine DependenceApproved

Lennox-Gastaut SyndromeActive, not recruiting

Neuropathic PainApproved

HamartomaActive, not recruiting

Neck PainApproved

Post Operative Nausea and VomitingApproved

Migraine DisorderApproved

Hepatic SteatosisApproved

Approved

GastroparesisPhase 2

Active, not recruiting

HIV InfectionApproved

Approved

Nicotine DependenceApproved

Approved

Lennox-Gastaut SyndromeApproved

Active, not recruiting

Neuropathic PainApproved

Approved

HamartomaApproved

Active, not recruiting

Neck PainApproved

Approved

Post Operative Nausea and VomitingApproved

Approved

Migraine DisorderApproved

Approved

Showing 10 of 102 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Epidiolex

Jazz Pharmaceuticals

Approved

2 2

Avastin

BBio-Thera Solutions

Preclinical

153 3

Cymbalta

Alnylam Pharmaceuticals

Preclinical

3 4

Lexiscan

Astellas

Preclinical

1 5

Adenocard

Astellas

Preclinical

1 6

Spravato

WWim Janssens

Preclinical

2 7

Nubain

AAultman Health Foundation

Preclinical

1 8

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 9

Chirocaine

PPurdue Pharma LP

Preclinical

1 10

Vfend

PPrism Pharmaceuticals

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 1Recruiting

Opioid Use Disorder

NCT04587791

Phase 2Recruiting

Pain

NCT03984565

Post-ApprovalRecruiting

Social Anxiety Disorder

NCT05649059

Phase 2/3Recruiting

Osteoarthritis

NCT05020028

Q4 2026

Phase 2Recruiting

Osteoarthritis

NCT04992624

Phase 2Recruiting

Trial

NCT06213233

Clinical

Trials by Indication[1]

Epilepsy9 trials

Safety and Tolerability of Cannabidiol in Subjects With Drug Resistant Epilepsy

Approved for marketing·UUniversity of Nebraska··NCT02660255

A Double-Blind Trial to Evaluate Efficacy and Safety of Cannabidiol as an add-on Therapy for Treatment in Refractory Epilepsy

Unknown status·AAntonio Waldo Zuardi·Phase 3·NCT02783092·126 enrolled

Cannabidiol (CBD) to 27 Patients (Aged 2 Years - 19 Years) With Drug Resistant Epilepsy

Completed·UUniversity of Utah·Phase 1·NCT02286986·26 enrolled

Show 6 more trials

Cannabidiol for Drug Resistant Pediatric Epilepsy (Expanded Access Use)

Available·JJohn··NCT03676049

The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children With Severe Epilepsy

Terminated·GGillette Children's Specialty Healthcare·Phase 1/2·NCT02815540·2 enrolled

Treatment of Drug Resistant Epilepsy

No longer available·UUniversity of Florida··NCT02461706

Cannabidiol for Pediatric Epilepsy (Compassionate Use)

No longer available·UUniversity of California, Los Angeles··NCT02556008

Epidiolex and Drug Resistant Epilepsy in Children

Available·—··NCT02397863

Cannabidiol in Children and Young Adults With Rare Disease-associated Severe Epilepsy

Unknown status·MMeyer Children's Hospital IRCCS·Phase 2·NCT05803434·30 enrolled

Psychosis5 trials

Cannabidiol for Treatment of Non-affective Psychosis and Cannabis Use

Active, not recruiting·LLone Baandrup·Phase 2·NCT04105231·64 enrolled

Cannabidiol Treatment in Patients With Early Psychosis

Completed·YYale University·Phase 2·NCT02504151·18 enrolled

Evaluation of the Antipsychotic Efficacy of Cannabidiol in Acute Schizophrenic Psychosis

Completed·UUniversity of Cologne·Phase 2·NCT00628290·42 enrolled

Show 2 more trials

Effects of Cannabidiol (CBD) Versus Placebo as an Adjunct to Treatment in Early Psychosis

Recruiting·UUniversity of California, San Diego·Phase 3·NCT04411225·120 enrolled

Stratification and Treatment in Early Psychosis Study - PROMOTE

Not yet recruiting·UUniversity of Oxford·Phase 3·NCT07434973·586 enrolled

Opioid Use Disorder5 trials

Cannabidiol in Opioid Use Disorder and Chronic Pain

Recruiting·YYale University·Phase 1·NCT04587791·34 enrolled

Cannabidiol in the Treatment of Opioid Use Disorder

Completed·YYasmin Hurd·Phase 2·NCT06206291·141 enrolled

Cannabidiol Use to Reduce Cravings in Individuals With Opioid Use Disorder on Buprenorphine

Completed·—·Phase 2·NCT04192370·8 enrolled

Show 2 more trials

Neuroimaging and CBD for Opioid Use Disorder

Completed·YYasmin Hurd·Phase 2·NCT04567784·66 enrolled

Cannabidiol Effects on Craving and Relapse Prevention in Opioid Use Disorder

Completed·UUniversity of California, Los Angeles·Phase 2·NCT03787628·35 enrolled

Seizure5 trials

Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Childhood Absence Seizures

Terminated·RRadius Pharmaceuticals, Inc.·Phase 2·NCT03355300·11 enrolled

Epidiolex in Typical Absence Seizures

Completed·UUniversity of South Florida·Phase 4·NCT04899050·14 enrolled

Cannabidiol Oral Solution in Pediatric Participants With Treatment-resistant Seizure Disorders

Completed·IINSYS Therapeutics Inc·Phase 1/2·NCT02324673·61 enrolled

Show 2 more trials

Cannabidiol Oral Solution as an Adjunctive Treatment for Treatment-resistant Seizure Disorder

Completed·IINSYS Therapeutics Inc·Phase 3·NCT02318602·52 enrolled

Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Childhood Absence Seizures

Terminated·RRadius Pharmaceuticals, Inc.·Phase 2·NCT03336242·20 enrolled

Peripheral Neuropathy4 trials

Phytocannabinoids for Reducing Chronic Chemotherapy-Induced Peripheral Neuropathy in Breast and Colon Cancer Survivors

Recruiting·—·Phase 2·NCT06731894·120 enrolled

Topical Cannabidiol for the Treatment of Chemotherapy-Induced Peripheral Neuropathy

Completed·MMayo Clinic·Phase 2·NCT05388058·40 enrolled

Phytocannabinoids for the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy in Breast and Colon Cancer Survivors

Withdrawn·—·Phase 1·NCT05672342

Show 1 more trial

Cannabidiol for the Treatment of Diabetic Peripheral Neuropathy: Pilot Study

Not yet recruiting·FFlorida A&M University·Phase 1/2·NCT07298408·20 enrolled

99 more indications

Alcohol Use Disorder4 trials

Cannabidiol in Youth Alcohol Use Disorder

Completed·MMedical University of South Carolina·Phase 2·NCT05317546·36 enrolled

CBD for the Treatment of Alcohol Use Disorder

Completed·UUniversity of Colorado, Denver·Phase 2·NCT04873453·45 enrolled

Alcohol Use Disorder and Cannabidiol

Recruiting·UUniversity of Colorado, Denver·Phase 2/3·NCT05613608·180 enrolled

Show 1 more trial

Cannabidiol for Alcohol Use Disorder

Withdrawn·MMedical University of South Carolina·Phase 1/2·NCT03904849

Osteoarthritis4 trials

Home-Based Quadriceps Isometric Exercise for Knee Osteoarthritis Pain

Completed·UUniversidad del Valle de México, Campus Cuernavaca·N/A·NCT07445568·50 enrolled

Cannabinoid Interactions With Central and Peripheral Pain Mechanisms in Osteoarthritis of the Knee

Recruiting·SSteven E Harte, PhD·Phase 2·NCT04992624·200 enrolled

Efficacy of Cannabidiol in Knee Osteoarthritis

Completed·MMedical University of Vienna·Phase 4·NCT04607603·86 enrolled

Show 1 more trial

Cannabidiol (CBD) in Pain Reduction for Knee Osteoarthritis

Recruiting·NNYU Langone Health·Phase 2/3·NCT05020028·100 enrolled

COVID-193 trials

Cannabidiol Treatment for Severe and Critical Coronavirus (COVID-19) Pulmonary Infection

Unknown status·RRabin Medical Center·Phase 1/2·NCT04731116·40 enrolled

Burnout and Distress preventiOn With caNnabidiol in Front-line Health Care workerS deAling wIth COVID-19

Completed·UUniversity of Sao Paulo·Phase 2/3·NCT04504877·120 enrolled

CANnabiDiol for CoviD-19 pATiEnts With Mild to Moderate Symptoms

Unknown status·UUniversity of Sao Paulo·Phase 2/3·NCT04467918·100 enrolled

Adult3 trials

Relative Bioavailability of Two Orally Administered CBD Formulations in Healthy Male Adults

Recruiting·UUniversity of Saskatchewan·Phase 1·NCT06574100·20 enrolled

Cannabidiol (CBD) in Adults With ASD

Recruiting·JJohns Hopkins University·Phase 1·NCT05015439·40 enrolled

A Pharmacokinetic Study to Compare CBD-NE to Epidyolex in Healthy Adult Volunteers Under Both Fed and Fasted Conditions

Completed·Ddsm-firmenich Switzerland AG·Phase 1·NCT06578455·32 enrolled

Cannabis Use3 trials

Cannabidiol: a Novel Intervention for Cannabis Use Problems?

Completed·UUniversity College, London·Phase 2·NCT02044809·82 enrolled

Reducing the Harmful Effects of Cannabis Use: Finding the Optimal CBD:THC Ratio

Completed·KKing's College London·N/A·NCT05170217·46 enrolled

SCORE Emerging Adult Cannabis Use & Stress

Recruiting·MMedical University of South Carolina·Phase 1/2·NCT05885542·148 enrolled

Treatment3 trials

Cannabidiol as a Treatment for PTSD and PTSD Comorbid With TBI

Recruiting·NNYU Langone Health·Phase 2·NCT04550377·120 enrolled

Novel Cognitive Treatment Targets for Epidiolex in Sturge- Weber Syndrome

Completed·—·Phase 2·NCT04447846·11 enrolled

Cannabidiol as a Treatment for AUD Comorbid With PTSD

Completed·NNYU Langone Health·Phase 1/2·NCT03248167·95 enrolled

Interaction3 trials

Gene-Environment-Interaction: Influence of the COMT Genotype on the Effects of Different Cannabinoids

Completed·—·Phase 1·NCT02487381·60 enrolled

Gene-Environment-Interaction: Influence of the COMT Genotype on the Effects of Different Cannabinoids - a PET Study

Withdrawn·—·Phase 1·NCT02492074

Cannabidiol as a Different Type of an Antipsychotic: Drug Delivery and Interaction Study

Completed·—·Phase 1·NCT02051387·74 enrolled

Lennox-Gastaut syndrome3 trials

Research on Cognitive Effect of Cannabidiol on Dravet Syndrome and Lennox-Gastaut SyndromeGastaut Syndrome

Unknown status·YYonsei University·Phase 3·NCT04611438·107 enrolled

Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Lennox-Gastaut Syndrome

Withdrawn·IINSYS Therapeutics Inc·Phase 3·NCT02318537

A Long-term Safety Study to Assess the Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution

Active, not recruiting· Jazz Pharmaceuticals logo

Jazz Pharmaceuticals·Approved·NCT05044819·154 enrolled

Social Anxiety Disorder3 trials

Investigating the Effects of Cannabidiol on Social Anxiety Disorder

Recruiting·MMassachusetts Institute of Technology·Phase 4·NCT05649059·50 enrolled

Cannabidiol as a Treatment for Social Anxiety Disorder (R61)

Completed·NNYU Langone Health·Phase 2·NCT05571592·60 enrolled

Cannabidiol (CBD) for the Treatment of Social Anxiety Disorder

Completed·EEmpowerPharm Inc.·Phase 2·NCT05600114·239 enrolled

Anxiety3 trials

Cannabidiol to Reduce Anxiety Reactivity

Completed·UUniversity of California, San Diego·Phase 2·NCT05823753·63 enrolled

Cannabidiol for Anxiety

Withdrawn·CCB2 Insights·Phase 2·NCT04267679

Cannabidiol Effects on Learning and Anxiety

Recruiting·UUniversity of Connecticut·Phase 1·NCT05283382·160 enrolled

Schizophrenia3 trials

Endocannabinoid Control of Microglia Activation as a New Therapeutic Target in the Treatment of Schizophrenia

Completed·UUMC Utrecht·N/A·NCT02932605·32 enrolled

Does Cannabidiol Attenuate the Acute Effects of ∆9-tetrahydrocannabinol Intoxication in Individuals Diagnosed With Schizophrenia? A Double-blind, Randomised, Placebo-controlled Experimental Study

Completed·KKing's College London·N/A·NCT04605393·36 enrolled

Cannabidiol Treatment of Cognitive Dysfunction in Schizophrenia

Completed·YYale University·Phase 2·NCT00588731·41 enrolled

Acute Graft Versus Host Disease2 trials

Safety and Efficacy of Cannabidiol for Grade I/II Acute Graft Versus Host Disease (GVHD) After Allogeneic Stem Cell Transplantation

Unknown status·RRabin Medical Center·Phase 1/2·NCT01596075·40 enrolled

Cannabidiol for the Treatment of Severe (Grades III/IV) Acute Graft-versus-host Disease

Unknown status·Mmoshe yeshurun·Phase 2·NCT02392780·10 enrolled

Bipolar Depression2 trials

Cannabidiol as an Adjunctive Treatment for Bipolar Depression

Terminated·HHospital de Clinicas de Porto Alegre·Phase 2/3·NCT03310593·36 enrolled

Cannabidiol for Bipolar Depression (CBD-BD)

Recruiting·UUniversity of British Columbia·Phase 3·NCT05867849·360 enrolled

Function2 trials

Processing of Salient Emotional Stimuli as a Function of Tetrahydrocannabinol (THC) and Cannabidiol (CBD)

Completed·—·N/A·NCT02291536·20 enrolled

Cannabidiol and Autonomic Function at Rest

Completed·—·Phase 1·NCT04731779·18 enrolled

Memory2 trials

Effects of THC and CBD on Human Episodic Memory Function

Completed·—·N/A·NCT02291562·20 enrolled

The Effect of Cannabidiol in Learning and Memory of Adults

Completed·—·Phase 2·NCT06074172·57 enrolled

Prader-Willi syndrome2 trials

Cannabidiol Oral Solution for the Treatment of Patients With Prader-Willi Syndrome

Terminated·RRadius Pharmaceuticals, Inc.·Phase 2·NCT02844933·7 enrolled

A Study to Assess the Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Participants With Prader-Willi Syndrome

Terminated·RRadius Pharmaceuticals, Inc.·Phase 2·NCT03458416·2 enrolled

Dravet syndrome2 trials

A Study to Assess the Safety and Tolerability of ZX008 in Children and Young Adults With Dravet Syndrome or Lennox Gastaut Syndrome Currently Taking Cannabidiol

Completed·ZZogenix, Inc.·Phase 1·NCT03467113·9 enrolled

Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Dravet Syndrome

Withdrawn·IINSYS Therapeutics Inc·Phase 3·NCT02318563

Breast Cancer2 trials

RCT of CBD for Anxiety in Advanced Breast Cancer

Active, not recruiting·—·Phase 2·NCT04482244·60 enrolled

Investigating the Potential Role of a Novel Quadrate Combination Therapy Mifepristone(Antiprogestrone), Tamoxifen, Retinoic Acid and Cannabidiol ( Selective Cyp 26 Inhibitor) for Treating Early Breast Cancer.

Unknown status·MMahmoud Ramadan mohamed Elkazzaz·Phase 3·NCT05016349·160 enrolled

Chronic pain2 trials

Mechanisms of CBD for Chronic Pain

Completed·UUniversity of Utah·Phase 1·NCT04044729·24 enrolled

Treatment of Chronic Pain With Cannabidiol (CBD) and Delta-9-tetrahydrocannabinol (THC)

Completed·UUniversity of Utah·Phase 1·NCT03215940·53 enrolled

Infantile Spasms2 trials

Cannabidiol Oral Solution for Treatment of Refractory Infantile Spasms

Terminated·IINSYS Therapeutics Inc·Phase 2·NCT02551731·9 enrolled

A Study to Assess Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile Spasms

Terminated·RRadius Pharmaceuticals, Inc.·Phase 3·NCT03421496·2 enrolled

CBD2 trials

Investigation of the Pharmacokinetic Profile of CBD

Completed·YYasmin Hurd·Phase 1·NCT05269706·60 enrolled

The Effects of CBD Isolate on Menstrual-Related Symptoms

Completed·CCanopy Growth Corporation·Phase 2·NCT05679830·33 enrolled

Alcohol Dependence2 trials

A Trial to Investigate the Effects of Cannabidiol Plus Naltrexone on Alcohol Craving in Patients With Alcohol Dependence

Recruiting·—·Phase 2·NCT06845124·150 enrolled

The Efficacy and Neurobehavioural Mechanism of Cannabidiol (CBD) for Alcohol Dependence

Unknown status·SSouth West Sydney Local Health District·Phase 2·NCT05387148·20 enrolled

Cognition2 trials

Effects of Cannabidiol on Psychiatric Symptoms, Cognition, and Cannabis Consumption in Cannabis Users With Recent-Onset Psychosis

Withdrawn·UUniversity of Maryland, Baltimore·Phase 2·NCT03883360

Cannabis Use, Cognition, and the Endocannabinoid System in HIV

Recruiting·UUniversity of California, San Diego·Phase 1·NCT04883255·138 enrolled

Insomnia2 trials

The CANabidiol Use for RElief of Short Term Insomnia

Completed·BBod Australia·Phase 2·NCT05253417·208 enrolled

A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of CBD TPM Capsules in Adults for Use in the Reduction of Insomnia Severity

Active, not recruiting·AAvecho Biotechnology·Phase 3·NCT05840822·519 enrolled

Sleep2 trials

Mechanisms of Cannabidiol in Persons With MS: the Role of Sleep and Pain Phenotype

Recruiting·—·Phase 2·NCT05269628·166 enrolled

CBD for Sleep in People With HIV

Withdrawn·MMariana Cherner, PhD·Phase 2·NCT05097651

Sturge-Weber syndrome1 trial

Cannabidiol Expanded Access Study in Medically Refractory Sturge-Weber Syndrome

Completed·—·Phase 1/2·NCT02332655·5 enrolled

Efficacy and Safety1 trial

A Four-week Clinical Trial Investigating Efficacy and Safety of Cannabidiol As a Treatment for Acutely Ill Schizophrenic Patients

Terminated·—·Phase 2·NCT02088060·150 enrolled

Cardiovascular1 trial

Cannabidiol Effects on Cardiovascular System and Exercise Responses

Withdrawn·—·Phase 1·NCT05232123

Endometriosis1 trial

Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis

Recruiting·MMclean Hospital·Phase 2·NCT06477406·30 enrolled

Trial1 trial

MIVetsCan: Cannabidiol (CBD)-Care Trial

Recruiting·KKevin Boehnke·Phase 2·NCT06213233·468 enrolled

Parkinson's Disease1 trial

A Study of Tolerability and Efficacy of Cannabidiol on Motor Symptoms in Parkinson's Disease

Completed·UUniversity of Colorado, Denver·Phase 2·NCT03582137·74 enrolled

Gastroparesis1 trial

Efficacy and Safety of Cannabidiol for Gastroparesis and Functional Dyspepsia

Completed·MMayo Clinic·Phase 2·NCT03941288·92 enrolled

Obsessive-Compulsive Disorder1 trial

Epidiolex in Obsessive Compulsive Disorder and Related Disorders

Completed·UUniversity of Chicago·Phase 2·NCT04978428·4 enrolled

Carpal Tunnel Syndrome1 trial

Topical Cannabidiol for Treating Carpal Tunnel Syndrome

Not yet recruiting·UUniversity of Virginia·Phase 2·NCT06108349·20 enrolled

Outcome1 trial

Effect of Local Cannabidiol on Clinical and Inflammatory Outcomes in Periodontal Maintenance Patients.

Withdrawn·UUniversity of Nebraska·Phase 1·NCT05646459

Drug1 trial

Study of Cannabidiol for Drug-Resistant Epilepsies

No longer available·EEric Marsh, MD··NCT03014440

Analgesic1 trial

Characterization of the Analgesic Effect of CBD in Healthy, Normal Volunteers

Completed·UUniversity of California, Los Angeles·Phase 1/2·NCT02751359·18 enrolled

Kidney Stones1 trial

A Study to Assess the Effect of Cannabidiol Oil on Pain After Ureteroscopy for Kidney Stones

Completed·MMayo Clinic·Phase 2/3·NCT04387617·90 enrolled

Alzheimer's Disease1 trial

CBD for Individuals at Risk for Alzheimer's Disease

Recruiting·UUniversity of Colorado, Denver·Phase 2·NCT05822362·236 enrolled

AIN1 trial

Effects of Cannabidiol (CBD) on the Brain

Unknown status·—·N/A·NCT04831294·15 enrolled

Pediatrics1 trial

Population Pharmacokinetics of Antiepileptic in Pediatrics

Completed·AAssistance Publique - Hôpitaux de Paris··NCT03196466·753 enrolled

Sex Differences1 trial

Sex Differences in Neural Response to Cannabidiol

Completed·YYale University·Phase 1·NCT04777643·19 enrolled

Total Knee Arthroplasty1 trial

Cannabidiol for Bilateral Total Knee Arthroplasty

Completed·HHospital for Special Surgery, New York·Phase 4·NCT04749628·37 enrolled

Glioblastoma Multiforme1 trial

A Study of the Efficacy of Cannabidiol in Patients With Multiple Myeloma, Glioblastoma Multiforme, and GI Malignancies

Unknown status·LLeaf Vertical Inc.·Phase 1/2·NCT03607643·160 enrolled

Opioid Use1 trial

Reducing Pain and Opioid Use With CBD

Completed·UUniversity of Colorado, Denver·Phase 2·NCT05299944·126 enrolled

Sickle Cell Disease1 trial

Cannabidiol in Sickle Cell Disease

Recruiting·IIcahn School of Medicine at Mount Sinai·Phase 1/2·NCT06930703·52 enrolled

Pain1 trial

PAIN: a Project Assessing the Impact of a Novel Cannabinoid Product

Recruiting·SStaci Gruber, Ph.D.·Phase 2·NCT03984565·25 enrolled

Prevention1 trial

Extended Use of Cannabidiol for the Prevention of Graft-versus-host-disease

Unknown status·RRabin Medical Center·Phase 2·NCT02478424·10 enrolled

Fibromyalgia1 trial

Cannabidiol for Fibromyalgia (The CANNFIB Trial)

Completed·MMarius Henriksen·Phase 3·NCT04729179·200 enrolled

Neuroimaging1 trial

Study of Cannabidiol and Neuroimaging on Stress

Recruiting·IIcahn School of Medicine at Mount Sinai·Phase 1/2·NCT07278505·160 enrolled

Inflammatory Bowel Disease1 trial

Cannabidiol for Inflammatory Bowel Disease

Completed·MMeir Medical Center·Phase 1/2·NCT01037322·20 enrolled

Autoimmune Hepatitis1 trial

A Phase 2a Study to Evaluate the Safety and Efficacy of Cannabidiol Only as Maintenance Therapy and Steroid Sparing in Patients With Stable Autoimmune Hepatitis

Terminated·SStero Biotechs Ltd.·Phase 2·NCT04129489·2 enrolled

Opioid1 trial

Cannabidiol After Multi-Trauma for Pain and Opioid Therapy

Recruiting·CCentre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal·Phase 2·NCT06448923·225 enrolled

Safety and Efficacy1 trial

Study to Test the Safety and Efficacy of Cannabidiol as a Treatment Intervention for Opioid Relapse

Completed·HHurd,Yasmin, Ph.D.·Phase 1·NCT01311778·18 enrolled

Chemotherapy1 trial

The Effect of Cannabidiol on Lean Body Mass in Patients Receiving Chemotherapy

Completed·UUniversity of Copenhagen·Phase 1·NCT04585841·32 enrolled

Tremor1 trial

A Study of Tolerability and Efficacy of Cannabidiol on Tremor in Parkinson's Disease

Completed·UUniversity of Colorado, Denver·Phase 2·NCT02818777·13 enrolled

Drug Interactions1 trial

Clinical Study to Evaluate Cannabidiol Liver Enzyme Elevations and Drug Interactions

Completed·FFood and Drug Administration (FDA)·Phase 1·NCT06192589·241 enrolled

Cannabis1 trial

Warrior CARE: Cannabis Behavioral Health

Not yet recruiting·WWayne State University·Phase 1/2·NCT06381180·500 enrolled

Epidermolysis Bullosa1 trial

Evaluation of the Efficacy of CANNABIDIOL on the Pruritus in Children With Hereditary Epidermolysis Bullosa

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT05651607·10 enrolled

Cannabis Use Disorder1 trial

Cannabidiol Pharmacotherapy for Adults With Cannabis Use Disorder

Completed·MMclean Hospital·Phase 1·NCT03102918·10 enrolled

Brain Injury1 trial

Cannabinoids and Traumatic Brain Injury: A Randomized, Placebo Controlled Trial

Completed·UUniversity of Colorado, Denver·Phase 2·NCT05632627·43 enrolled

Phase 11 trial

Investigation of the Pharmacokinetic Profile of CBD - Phase 1 ANANDA

Completed·IIcahn School of Medicine at Mount Sinai·Phase 1·NCT05023070·24 enrolled

Alcohol Withdrawal1 trial

Cannabidiol (CBD) for the Treatment of Alcohol Withdrawal

Unknown status·SSouth West Sydney Local Health District·Phase 1·NCT04205682·52 enrolled

Tics1 trial

Safety and Pharmacokinetics of Cannabidiol in Healthy Volunteers

Completed·TTiamat Australia Pty Ltd·Phase 1·NCT06854783·20 enrolled

Liver1 trial

Cannabidiol - an in Vivo Innovative Drug Delivery Study

Terminated·—·Phase 1·NCT03471559·8 enrolled

Skin1 trial

Topical Cannabidiol Application and Skin Vascular Reactivity

Withdrawn·PPenn State University·N/A·NCT05456113

Craving1 trial

Cannabidiol and Cocaine Craving/Dependence

Completed·—·Phase 2·NCT02559167·79 enrolled

Musculoskeletal1 trial

Evaluation of a Specific Transdermal Cannabidiol Product for Chronic Musculoskeletal Joint Pain.

Withdrawn·LLouisiana State University Health Sciences Center Shreveport·Phase 1·NCT05002114

Chronic1 trial

CBD for Chronic Radicular Pain on Chronic Opioid Therapy (COT)

Completed·NNYU Langone Health·Phase 1/2·NCT04760613·14 enrolled

Crohn's Disease1 trial

Cannabidiol Usage as an Adjunct Therapy for Crohn's Disease

Withdrawn·UUniversity of Illinois at Chicago·Phase 2/3·NCT03467620

Prolonged1 trial

Cannabidiol and Prolonged Exposure

Completed·VVA Office of Research and Development·Phase 2·NCT03518801·136 enrolled

Rheumatoid Arthritis1 trial

Safety and Effect on Pain and Function According to RAPID-3 of IHL-675A in Patients With Rheumatoid Arthritis

Suspended·IIncannex Healthcare Ltd·Phase 2·NCT05942911·20 enrolled

Anorexia Nervosa1 trial

Role of CBD in Regulating Meal Time Anxiety in Anorexia Nervosa

Active, not recruiting·UUniversity of California, San Diego·Phase 1·NCT04878627·40 enrolled

Tooth Extraction1 trial

Analgesic Effects of Cannabidiol for Simple Tooth Extractions in Dental Patients

Completed·UUniversity of Tennessee·Phase 3·NCT04271917·68 enrolled

Bipolar Disorder1 trial

Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder

Recruiting·MMclean Hospital·Phase 2·NCT05457465·25 enrolled

Heart Failure1 trial

Cannabidiol in Patients With Heart Failure Failure in AHA/ACC Stages A-C

Unknown status·IInstituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud·Phase 1·NCT03634189·20 enrolled

Recovery1 trial

Adjunctive Cannabidiol for Recovery From Opioid Study

Recruiting·IIcahn School of Medicine at Mount Sinai·Phase 3·NCT06940674·450 enrolled

Psoriatic Arthritis1 trial

CBD Treatment in Hand Osteoarthritis and Psoriatic Arthritis.

Completed·—·Phase 2·NCT03693833·136 enrolled

Back pain1 trial

Investigation of Cannabidiol for Reduction of NeuroInflammation in Chronic Back Pain

Terminated·MMassachusetts General Hospital·Phase 4·NCT03891264·7 enrolled

Humans1 trial

The Effects of Cannabidiol and ∆-9-THC in Humans

Completed·YYale University·Phase 1·NCT01180374·27 enrolled

Oral1 trial

Expanded Use of Cannabidiol Oral Solution

No longer available·—··NCT03196934

Solid Tumor1 trial

A Study: Pure CBD as Single-agent for Solid Tumor.

Unknown status·HHadassah Medical Organization·Phase 2·NCT02255292·60 enrolled

Arthralgia1 trial

Cannabidiol (CBD) for Treatment of Aromatase Inhibitor-Associated Arthralgias

Completed·UUniversity of Michigan Rogel Cancer Center·Phase 2·NCT04754399·40 enrolled

Botulinum Toxin1 trial

Effect of Non-psychoactive Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm

Completed·SSilkiss Eye Surgery·Phase 2/3·NCT04423341·12 enrolled

Glioblastoma1 trial

A Clinical Trial of a Hemp-Derived, High Cannabidiol Product for Anxiety in Glioblastoma Patients

Terminated·MMclean Hospital·Phase 2·NCT05753007·2 enrolled

Graft Versus Host Disease1 trial

Cannabidiol for Graft Versus Host Disease (GVHD) Prophylaxis in Allogeneic Stem Cell Transplantation

Unknown status·RRabin Medical Center·Phase 1/2·NCT01385124·30 enrolled

Post-Traumatic Stress Disorder1 trial

Enhancing Prolonged Exposure With Cannabidiol to Treat Posttraumatic Stress Disorder

Completed·TThe University of Texas Health Science Center at San Antonio·Phase 1/2·NCT05132699·21 enrolled

Tobacco Cessation1 trial

Oral Cannabidiol for Tobacco Cessation

Recruiting·JJohns Hopkins University·Phase 1·NCT05445804·50 enrolled

Interstitial Cystitis1 trial

The CBD-IC Randomized Controlled Trial: Evaluation of Hemp Cannabidiol SuppositoRies for Pain and Urinary SymptOms in INterstitial Cystitis (CHRONIC)

Withdrawn·UUniversity of New Mexico·Phase 1·NCT04349930

Tuberous Sclerosis1 trial

A Study to Investigate Behavioral and Other Co-Occurring Outcomes With Epidiolex as Add-On Therapy in Participants Aged 1 to 65 Years of Age With Tuberous Sclerosis Complex

Active, not recruiting· Jazz Pharmaceuticals logo

Jazz Pharmaceuticals·Phase 4·NCT05864846·79 enrolled

Cigarette Use1 trial

Cannabidiol for Reducing Cigarette Use

Recruiting·UUniversity of California, Los Angeles·Phase 2·NCT06218056·120 enrolled

Randomized Controlled Trial1 trial

A Randomized Controlled Trial of Oral CBD for the Treatment of Upper Extremity Musculoskeletal Pain

Not yet recruiting·BBrent DeGeorge·Phase 1·NCT06695195·100 enrolled

Neuropathy1 trial

Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy

Recruiting·FFox Chase Cancer Center·Phase 1·NCT07167446·30 enrolled

Tooth Sensitivity1 trial

Effect of an Experimental Cannabidiol Gel on Tooth Sensitivity

Not yet recruiting·UUniversidade Federal do Para·Phase 1·NCT07027566·75 enrolled

Musculoskeletal Pain1 trial

Low Dose of Cannabidiol (CBD) to Treat Mild to Moderate Musculoskeletal Pain

Completed·PPure Green·Phase 1·NCT04193631·16 enrolled

Alcohol Use Disorder (AUD)1 trial

Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving

Not yet recruiting·JJohns Hopkins University·Preclinical·NCT07148843·105 enrolled

Maternal Complications1 trial

Observational Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy to Assess the Risk of Pregnancy and Maternal Complications and Other Events of Interest on the Developing Fetus, Neonate, and Infant

Recruiting· Jazz Pharmaceuticals logo

Jazz Pharmaceuticals··NCT06113237·50 enrolled

Sanfilippo Syndrome1 trial

Randomized, Double-Blind, Placebo-Controlled Cross-Over Study to Evaluate the Effects of Cannabidiol on Neurobehavioral and Function Outcomes in Sanfilippo Syndrome

Recruiting·LLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center·Preclinical·NCT06333041·35 enrolled

Unspecified2 trials

The Role of the Endocannabinoid System in Sweet Taste Intensity and Liking

Completed·WWageningen University·N/A·NCT02112292·10 enrolled

Cannabidiol and Emotional Stimuli

Completed·UUniversity of Chicago·N/A·NCT02902081·38 enrolled

Regulatory

FDA Approval Timeline[5]

Sep 28, 2018

EPIDIOLEX

NDA NDA210365

Sources

References

[1]
ClinicalTrials.gov — 166 trial records for Cannabidiol. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Epidiolex drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Cannabidiol compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Cannabidiol. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA210365). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Epidiolex. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Jazz Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Cannabinoid CB1 Receptor Negative Allosteric Modulator[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Jazz Pharmaceuticals

Patent Landscape[6]

Patent Cliff

Jun 17, 2035

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10709673Jun 17, 2035

10092525Jun 17, 2035

9956183Jun 17, 2035

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10111840Jun 17, 2035

27 more patents

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