cannabidiol Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
5288 13956-29-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • cannabidiol
  • GWP42003-P
  • epidiolex
The precise mechanisms by which cannabidiol exerts its anticonvulsant effect in humans are unknown. Cannabidiol does not appear to exert its anticonvulsant effects through interaction with cannabinoid receptors.
  • Molecular weight: 314.47
  • Formula: C21H30O2
  • CLOGP:
  • LIPINSKI: None
  • HAC: 2
  • HDO: 2
  • TPSA: 40.46
  • ALOGS:
  • ROTB: 6

Drug dosage:

None

ADMET properties:

PropertyValueReference
Vd (Volume of distribution) 6.69 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 13.55 mL/min/kg Lombardo F, Berellini G, Obach RS
t_half (Half-life) 23.82 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Sept. 19, 2019 EMA GW Pharma (International) B.V.
June 25, 2018 FDA GW RESEARCH LTD

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug resistance 45.18 41.07 7 23 2617 2355438

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event

Pharmacologic Action:

SourceCodeDescription
ATC N03AX24 NERVOUS SYSTEM
ANTIEPILEPTICS
ANTIEPILEPTICS
Other antiepileptics

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Lennox-Gastaut syndrome indication 230418006
Severe myoclonic epilepsy in infancy indication 230437002

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.34 acidic
pKa2 11.34 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
100MG/ML EPIDIOLEX GW RES LTD N210365 Sept. 28, 2018 RX SOLUTION ORAL 10092525 June 17, 2035 USE FOR THE TREATMENT OF DROP SEIZURES IN PATIENTS WITH DRAVET SYNDROME
100MG/ML EPIDIOLEX GW RES LTD N210365 Sept. 28, 2018 RX SOLUTION ORAL 10111840 June 17, 2035 USE FOR THE TREATMENT OF ATONIC SEIZURES IN PATIENTS WITH DRAVET SYNDROME
100MG/ML EPIDIOLEX GW RES LTD N210365 Sept. 28, 2018 RX SOLUTION ORAL 10111840 June 17, 2035 USE FOR THE TREATMENT OF ATONIC SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME
100MG/ML EPIDIOLEX GW RES LTD N210365 Sept. 28, 2018 RX SOLUTION ORAL 10137095 June 17, 2035 USE FOR THE TREATMENT OF DROP SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME
100MG/ML EPIDIOLEX GW RES LTD N210365 Sept. 28, 2018 RX SOLUTION ORAL 10137095 June 17, 2035 USE IN COMBINATION WITH CLOBAZAM FOR TREATMENT OF DROP SEIZURES IN PATIENTS WITH LENNOX GASTAUT SYNDROME
100MG/ML EPIDIOLEX GW RES LTD N210365 Sept. 28, 2018 RX SOLUTION ORAL 9949937 June 17, 2035 USE IN COMBINATION WITH CLOBAZAM FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME
100MG/ML EPIDIOLEX GW RES LTD N210365 Sept. 28, 2018 RX SOLUTION ORAL 9956183 June 17, 2035 USE IN COMBINATION WITH CLOBAZAM FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME WHO HAVE BEEN PREVIOUSLY TREATED WITH CLOBAZAM
100MG/ML EPIDIOLEX GW RES LTD N210365 Sept. 28, 2018 RX SOLUTION ORAL 9956183 June 17, 2035 USE IN COMBINATION WITH CLOBAZAM FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH LENNOX GASTAUT SYNDROME WHO HAVE BEEN PREVIOUSLY TREATED WITH CLOBAZAM
100MG/ML EPIDIOLEX GW RES LTD N210365 Sept. 28, 2018 RX SOLUTION ORAL 9956184 June 17, 2035 USE IN COMBINATION WITH CLOBAZAM FOR TREATMENT OF SEIZURES IN PATIENTS WITH LENNOX GASTAUT SYNDROME
100MG/ML EPIDIOLEX GW RES LTD N210365 Sept. 28, 2018 RX SOLUTION ORAL 9956185 June 17, 2035 USE FOR THE TREATMENT OF CONVULSIVE SEIZURES IN PATIENTS WITH DRAVET SYNDROME
100MG/ML EPIDIOLEX GW RES LTD N210365 Sept. 28, 2018 RX SOLUTION ORAL 9956186 June 17, 2035 USE FOR THE TREATMENT OF CONVULSIVE SEIZURES IN PATIENTS WITH LENNOX GASTAUT SYNDROME

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
100MG/ML EPIDIOLEX GW RES LTD N210365 Sept. 28, 2018 RX SOLUTION ORAL Sept. 28, 2023 NEW CHEMICAL ENTITY
100MG/ML EPIDIOLEX GW RES LTD N210365 Sept. 28, 2018 RX SOLUTION ORAL Sept. 28, 2025 INDICATED FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (LGS) OR DRAVET SYNDROME (DS) IN PATIENTS 2 YEARS OF AGE AND OLDER

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
G-protein coupled receptor 55 GPCR ANTAGONIST UNKNOWN SCIENTIFIC LITERATURE
Transient receptor potential cation channel subfamily V member 1 Ion channel INHIBITOR UNKNOWN SCIENTIFIC LITERATURE

External reference:

IDSource
D002185 MESH_DESCRIPTOR_UI
19GBJ60SN5 UNII
10423 INN_ID
2045371 RXNORM
20468 MMSL
d08919 MMSL
771981005 SNOMEDCT_US
96223000 SNOMEDCT_US
010751 NDDF
4036658 VANDF
644019 PUBCHEM_CID
CHEBI:69478 CHEBI
CHEMBL190461 ChEMBL_ID
P0T PDB_CHEM_ID
DB09061 DRUGBANK_ID
4150 IUPHAR_LIGAND_ID
D10915 KEGG_DRUG
C000628684 MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Epidiolex HUMAN PRESCRIPTION DRUG LABEL 1 70127-100 SOLUTION 100 mg ORAL NDA 18 sections
leafPro CBDmed Oil FS QP 3% HUMAN OTC DRUG LABEL 1 73674-001 OIL 3 g ORAL unapproved drug other 9 sections
leafPro CBDmed Oil FS QP 5% HUMAN OTC DRUG LABEL 1 73674-002 OIL 5 g ORAL unapproved drug other 9 sections
leafPro CBDmed Oil FS QP 20% HUMAN OTC DRUG LABEL 1 73674-005 OIL 20 g ORAL unapproved drug other 9 sections
leafPro CBDmed Oil T-FS QD 3% HUMAN OTC DRUG LABEL 1 73674-020 OIL 3 g ORAL unapproved drug other 9 sections
leafPro CBDmed Oil T-FS QD 5% HUMAN OTC DRUG LABEL 1 73674-021 OIL 5 g ORAL unapproved drug other 9 sections
leafPro CBDmed Oil T-FS QD 20% HUMAN OTC DRUG LABEL 1 73674-024 OIL 20 g ORAL unapproved drug other 9 sections
leafPro CBDmed Softgels FS QP 20 HUMAN OTC DRUG LABEL 1 73674-052 CAPSULE, LIQUID FILLED 20 mg ORAL unapproved drug other 9 sections
leafPro CBDmed Softgels T-FS QD 20 HUMAN OTC DRUG LABEL 1 73674-061 CAPSULE, LIQUID FILLED 20 mg ORAL unapproved drug other 9 sections