Cannabidiol
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2018
- First approval year
- 2018
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Cannabidiol
- Molecular weight
- 314.47
- Structure (SMILES)
- C=C(C)[C@@H]1CCC(C)=C[C@H]1c1c(O)cc(CCCCC)cc1O
- epidiolex
- Epidiolex
- epidyolex
- Epidyolex
- .delta.1(2)-trans-cannabidiol
- (-)-cannabidiol
- (-)-cbd
- (-)-trans-cannabidiol
- 100 mg Cannabidiol (CBD)
- 100 mg cannabidiol cbd
- 1200 mg cannabidiol
- 1200 mg Cannabidiol
- 300 mg cannabidiol
- 300 mg Cannabidiol
- 300 mg Cannabidiol (CBD) oil
- 300 mg cannabidiol cbd oil
- 400 mg cannabidiol
- 400 mg Cannabidiol
- 50 mg Cannabidiol (CBD)
- 50 mg cannabidiol cbd
- 600 mg cannabidiol
- 600 mg Cannabidiol
- 600 mg cannabidiol (CBD)
- 600 mg cannabidiol cbd
- 800 mg cannabidiol
- 800 mg Cannabidiol
- arm 2
- Arm 2
- ARM 2
And 207 more, listed on the interactive page.
- CAS registry numbers
- 13956-29-1
- ChEMBL ID
- CHEMBL190461
- InChIKey
- QHMBSVQNZZTUGM-ZWKOTPCHSA-N
- PubChem compound IDs
- 644019
- RxNorm IDs (RxCUI)
- 2045371
- FDA ingredient codes (UNII)
- 19GBJ60SN5
- N03AX
- N03AX24
Sources for recorded values
- Applicant
- JAZZ PHARMS RES
- Approval date
- 25 Jun 2018
- Application number
- NDA210365
- Status
- Authorised
- Status date
- 19 Sept 2019
- Authorisation date
- 19 Sept 2019
- Approved indications
- Epidyolex is indicated for use as adjunctive therapy of seizures associated with Lennox Gastaut syndrome (LGS) or Dravet syndrome (DS), in conjunction with clobazam, for patients 2 years of age and older.
- Product number
- EMEA/H/C/004675
- Authorisation holder
- Jazz Pharmaceuticals Ireland Limited
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Epilepsies, Myoclonic
- Lennox Gastaut Syndrome
European medicines record
- Patents
- 32
- Designations
- 6
- Earliest recorded loss of exclusivity
- 1 Mar 2041
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- Yes
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- United States (FDA)
- Approved
- European Union (EMA)
- Authorised
- Pharmacology name
- cannabidiol
- Type
- Natural product
- Drug name stem
- -nab-
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- Action
- Activation
- Action type
- ACTIVATION
- Target
- TRPV2
- Gene symbol
- TRPV2
- Protein identifier
- Q9Y5S1
- Median affinity
- 4.5
- Affinity units
- pEC50
- Action
- Antagonist
- Action type
- Antagonist
- Target
- GPR55
- Gene symbol
- GPR55
- Protein identifier
- Q9Y2T6
- Affinity units
- pIC50
- Action
- Channel blocker
- Action type
- Channel blocker
- Target
- Nav1.1
- Gene symbol
- SCN1A
- Protein identifier
- P35498
- Median affinity
- 4.9
- Affinity units
- pIC50
- Action
- Channel blocker
- Action type
- Channel blocker
- Target
- Nav1.1
- Gene symbol
- SCN1A
- Protein identifier
- P35498
- Median affinity
- 5.54
- Affinity units
- pIC50
- Action
- Channel blocker
- Action type
- Channel blocker
- Target
- Nav1.4
- Gene symbol
- SCN4A
- Protein identifier
- P35499
- Median affinity
- 5.72
- Affinity units
- pIC50
- Action
- Channel blocker
- Action type
- Channel blocker
- Target
- Nav1.4
- Gene symbol
- SCN4A
- Protein identifier
- P35499
- Median affinity
- 5
- Affinity units
- pIC50
- Action
- Channel blocker
- Action type
- Channel blocker
- Target
- Nav1.5
- Gene symbol
- SCN5A
- Protein identifier
- Q14524
- Median affinity
- 5.42
- Affinity units
- pIC50
- Action
- Channel blocker
- Action type
- Channel blocker
- Target
- Nav1.7
- Gene symbol
- SCN9A
- Protein identifier
- Q15858
- Affinity units
- pIC50
- Action
- Channel blocker
- Action type
- Channel blocker
- Target
- Nav1.2
- Gene symbol
- SCN2A
- Protein identifier
- Q99250
- Median affinity
- 5.54
- Affinity units
- pIC50
- Action
- Channel blocker
- Action type
- Channel blocker
- Target
- Nav1.3
- Gene symbol
- SCN3A
- Protein identifier
- Q9NY46
- Median affinity
- 5.48
- Affinity units
- pIC50
- Action
- Channel blocker
- Action type
- Channel blocker
- Target
- Nav1.6
- Gene symbol
- SCN8A
- Protein identifier
- Q9UQD0
- Median affinity
- 5.52
- Affinity units
- pIC50
- Mechanism
- Cannabinoid CB1 receptor negative allosteric modulator
- Action type
- NEGATIVE_ALLOSTERIC_MODULATOR
- Target
- Cannabinoid receptor 1
- Protein identifier
- P21554
- Action
- Negative
- Action type
- NEGATIVE
- Target
- CB1 receptor
- Gene symbol
- CNR1
- Protein identifier
- P21554
- Action
- Partial agonist
- Action type
- PARTIAL_AGONIST
- Target
- GPR18
- Gene symbol
- GPR18
- Protein identifier
- Q14330
- Median affinity
- 4.29
- Affinity units
- pEC50
Open Targets mechanisms
- Mechanism
- Cannabinoid CB1 receptor negative allosteric modulator
- Action type
- NEGATIVE ALLOSTERIC MODULATOR
- Target
- Cannabinoid receptor 1
- Action type
- ACTIVATOR
- Gene symbol
- TRPV2
- Protein identifier
- Q9Y5S1
- Organism
- Homo sapiens
- Target development level
- Chemical evidence
- Action type
- Agonist
- Gene symbol
- GPR18
- Protein identifier
- Q14330
- Organism
- Homo sapiens
- Target development level
- Biological evidence
- Action type
- Antagonist
- Gene symbol
- GPR55
- Protein identifier
- Q9Y2T6
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- Inhibitor
- Gene symbol
- TRPV1
- Protein identifier
- Q8NER1
- Organism
- Homo sapiens
- Target development level
- Clinical
- Condition
- HIV Infections
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000180
- Subject identifier
- D015658
- Condition
- Crohn Disease
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000384
- Subject identifier
- D003424
- Condition
- Epilepsy
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000474
- Subject identifier
- D004827
- Condition
- Glioblastoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000519
- Subject identifier
- D005909
- Condition
- Hypertension
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000537
- Subject identifier
- D006973
- Condition
- Wounds and Injuries
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000546
- Subject identifier
- D014947
- Condition
- Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000673
- Subject identifier
- D011471
- Condition
- Mental Disorders
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000677
- Subject identifier
- D001523
- Condition
- Arthritis, Rheumatoid
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000685
- Subject identifier
- D001172
- Condition
- Colitis, Ulcerative
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000729
- Subject identifier
- D003093
- Condition
- HIV Infections
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000764
- Subject identifier
- D015658
- Condition
- Endometriosis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001065
- Subject identifier
- D004715
- Condition
- Stress Disorders, Post-Traumatic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001358
- Subject identifier
- D013313
- Condition
- Cocaine-Related Disorders
- Highest recorded phase
- 2
- Condition identifier
- EFO:0002610
- Subject identifier
- D019970
- Condition
- Peripheral Nervous System Diseases
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003100
- Subject identifier
- D010523
- Condition
- Essential Tremor
- Highest recorded phase
- 1
- Condition identifier
- EFO:0003108
- Subject identifier
- D020329
- Condition
- Heart Failure
- Highest recorded phase
- 1
- Condition identifier
- EFO:0003144
- Subject identifier
- D006333
- Condition
- Child Development Disorders, Pervasive
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003756
- Subject identifier
- D002659
- Condition
- Autistic Disorder
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003758
- Subject identifier
- D001321
- Condition
- Tobacco Use Disorder
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003768
- Subject identifier
- D014029
- Condition
- Arthritis, Psoriatic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003778
- Subject identifier
- D015535
- Condition
- Motor Neuron Disease
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003782
- Subject identifier
- D016472
- Condition
- Pain
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003843
- Subject identifier
- D010146
- Condition
- Substance-Related Disorders
- Highest recorded phase
- 0.5
- Condition identifier
- EFO:0003890
- Subject identifier
- D019966
And 65 more, listed on the interactive page.
- Condition identifier
- EFO_0000180
- Condition identifier
- EFO_0000384
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000474
- Condition identifier
- EFO_0000519
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000546
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000616
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000649
- Condition identifier
- EFO_0000677
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000685
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000729
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000764
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001065
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001358
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002610
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003015
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003100
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003108
- Condition identifier
- EFO_0003144
- Highest recorded phase
- 1
- Condition identifier
- EFO_0003756
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003768
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003890
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003894
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003931
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004143
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004149
- Highest recorded phase
- 2
And 231 more, listed on the interactive page.
- Event
- abnormal behaviour
- Reports
- 100
- Reporting signal score
- 93.947
- Event
- aggression
- Reports
- 208
- Reporting signal score
- 286.569
- Event
- agitation
- Reports
- 175
- Reporting signal score
- 140.15
- Event
- alcohol abuse
- Reports
- 66
- Reporting signal score
- 190.152
- Event
- anaemia
- Reports
- 7
- Reporting signal score
- 80.2939
- Event
- arthralgia
- Reports
- 22
- Reporting signal score
- 79.8456
- Event
- atonic seizures
- Reports
- 28
- Reporting signal score
- 93.2757
- Event
- behaviour disorder
- Reports
- 36
- Reporting signal score
- 77.8011
- Event
- change in seizure presentation
- Reports
- 36
- Reporting signal score
- 151.939
- Event
- coma
- Reports
- 115
- Reporting signal score
- 95.2776
- Event
- decreased appetite
- Reports
- 210
- Reporting signal score
- 84.9525
- Event
- diarrhoea
- Reports
- 625
- Reporting signal score
- 211.76
- Event
- drooling
- Reports
- 42
- Reporting signal score
- 73.6627
- Event
- drug abuse
- Reports
- 466
- Reporting signal score
- 866.637
- Event
- drug dependence
- Reports
- 207
- Reporting signal score
- 374.314
- Event
- drug use disorder
- Reports
- 41
- Reporting signal score
- 77.2603
- Event
- dyspnoea
- Reports
- 58
- Reporting signal score
- 87.2181
- Event
- generalised tonic-clonic seizure
- Reports
- 106
- Reporting signal score
- 165.111
- Event
- headache
- Reports
- 68
- Reporting signal score
- 73.3965
- Event
- hypersomnia
- Reports
- 67
- Reporting signal score
- 88.492
- Event
- hypotension
- Reports
- 6
- Reporting signal score
- 69.7816
- Event
- insurance issue
- Reports
- 37
- Reporting signal score
- 83.6664
- Event
- irritability
- Reports
- 108
- Reporting signal score
- 79.1988
- Event
- lethargy
- Reports
- 130
- Reporting signal score
- 95.1143
- Event
- miosis
- Reports
- 73
- Reporting signal score
- 121.755
And 12 more, listed on the interactive page.
- NCT00309413
- NCT00588731
- NCT00628290
- NCT00916201
- NCT01491490
- NCT02006628
- NCT02051387
- NCT02088060
- NCT02504151
- NCT02926859
- NCT04421456
- NCT01037322
- NCT01562314
- NCT04056442
- NCT01284634
- NCT01311778
- NCT01605539
- NCT02539823
- NCT04238754
- NCT01385124
- NCT01596075
- NCT02478424
- NCT03840512
- NCT01502046
- NCT01776970
And 165 more, listed on the interactive page.
- Dose
- 2.5 mg/kg
- Route
- Oral
- How often
- Twice daily
- Hydrogen bond acceptors
- 2
- Hydrogen bond donors
- 2
- Polar surface area
- 40.46
- Calculated partition coefficient (ALogP)
- 5.85
- Calculated partition coefficient (XLogP)
- 6.5
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Rule-of-five violations
- 1
- Rotatable bonds
- 6
- Heavy atoms
- 23
- Molecular formula
- C21H30O2
- Monoisotopic mass
- 314.224580195
- Natural product
- Yes
- 70127-100
- Recorded assays
- 908
- Active assays
- 197
- Confirmatory
- Other
- Anticonvulsants
These details could not be displayed.
Related records
Trials (303)
- 5-Way Crossover Study to Compare the Safety, Tolerability and Pharmacokinetics of New Oral Cannabinoid Formulations Administered as Single Doses, With Buccal Sativex®, in Healthy Volunteers
- A Clinical Trial of a Hemp-Derived, High Cannabidiol Product for Anxiety in Glioblastoma Patients
- A Clinical Trial on the Antipsychotic Properties of Cannabidiol
- A Double-Blind Trial to Evaluate Efficacy and Safety of Cannabidiol as an add-on Therapy for Treatment in Refractory Epilepsy
- A Double-Blinded Study on Rapid and Sustained Pain Relief Topical Cannabidiol for Plantar Fasciitis
- A Four-week Clinical Trial Investigating Efficacy and Safety of Cannabidiol As a Treatment for Acutely Ill Schizophrenic Patients
- A Long-term Safety Study of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett Syndrome
- A Pharmacokinetic Study to Compare CBD-NE to Epidyolex in Healthy Adult Volunteers Under Both Fed and Fasted Conditions
- 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
- A Pilot Study of GWP42003 in the Symptomatic Treatment of Ulcerative Colitis (GWID10160)
- A Randomized Controlled Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)
- A Randomized Controlled Trial of Oral CBD for the Treatment of Upper Extremity Musculoskeletal Pain
- A Study of Cannabidiol in Young Adult Cannabis Users
- A Study of Cybis™ 10:25 THC:CBD Oil in Adults With Chronic Back/Neck Pain
- A Study of GWP42003 as Adjunctive Therapy in the First Line Treatment of Schizophrenia or Related Psychotic Disorder
- A Study of Possible Drug-drug Interactions Between Stiripentol or Valproate and Cannabidiol in Patients With Epilepsy
- A Study of the Efficacy of Cannabidiol in Patients With Multiple Myeloma, Glioblastoma Multiforme, and GI Malignancies
- A Study of Tolerability and Efficacy of Cannabidiol on Motor Symptoms in Parkinson's Disease
- A Study of Tolerability and Efficacy of Cannabidiol on Tremor in Parkinson's Disease
- A Study to Assess Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile Spasms
Approved for (7)
- Dravet syndrome
- Encephalopathy, progressive, early-onset, with brain edema and/or leukoencephalopathy
- Epilepsy
- Hamartoma
- Lennox-Gastaut syndrome
- Myoclonic epilepsy
- Visual epilepsy
In development for (132)
- 22q11.2 deletion syndrome Phase 2
- Acne Phase 2
- Acute graft versus host disease Phase 2
- Acute myocarditis Phase 2
- Agoraphobia Phase 3
- Alcohol abuse Phase 2
- Alcohol dependence Phase 2
- Alcohol withdrawal Phase 2
- Alexithymia Phase 2
- Alzheimer disease Phase 2
- Amyotrophic lateral sclerosis Phase 3
- Androgenetic alopecia Phase 1
- Anorexia nervosa Early phase 1
- Anxiety Phase 2
- Anxiety disorder Phase 1
- Arthritic joint disease Phase 2
- Atopic eczema Phase 3
- Attention deficit-hyperactivity disorder Phase 2
- Autism Phase 2
- Autism spectrum disorder Phase 2
Other linked conditions (4)
- Mood disorder
- Red-green color blindness
- Tic disorder
- Urolithiasis