cannabidiol Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 5288 | 13956-29-1 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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.
|
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| 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:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| 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 term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients 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 term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | N03AX24 | NERVOUS SYSTEM ANTIEPILEPTICS ANTIEPILEPTICS Other antiepileptics |
Drug Use (View source of the data)
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Lennox-Gastaut syndrome | indication | 230418006 | |
| Severe myoclonic epilepsy in infancy | indication | 230437002 |
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 9.34 | acidic |
| pKa2 | 11.34 | acidic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent 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 strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 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:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA 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:
| ID | Source |
|---|---|
| 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:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| 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 |