Stem definition | Drug id | CAS RN |
---|---|---|
5288 | 13956-29-1 |
Dose | Unit | Route |
---|---|---|
0.70 | g | O |
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 |
Date | Agency | Company | Orphan |
---|---|---|---|
Sept. 19, 2019 | EMA | GW Pharma (International) B.V. | |
June 25, 2018 | FDA | GW RESEARCH LTD |
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 |
---|---|---|---|---|---|---|
Device related thrombosis | 110.67 | 22.31 | 25 | 4345 | 1327 | 53343369 |
Drug resistance | 70.93 | 22.31 | 34 | 4336 | 19928 | 53324768 |
Blood pressure diastolic decreased | 67.03 | 22.31 | 31 | 4339 | 16772 | 53327924 |
Multiple-drug resistance | 62.48 | 22.31 | 19 | 4351 | 3216 | 53341480 |
Large intestine polyp | 59.28 | 22.31 | 23 | 4347 | 8074 | 53336622 |
Nail disorder | 58.40 | 22.31 | 24 | 4346 | 9781 | 53334915 |
Body temperature decreased | 43.43 | 22.31 | 23 | 4347 | 16604 | 53328092 |
Heart rate irregular | 41.70 | 22.31 | 24 | 4346 | 20360 | 53324336 |
Tonic convulsion | 40.73 | 22.31 | 11 | 4359 | 1220 | 53343476 |
Skin exfoliation | 37.99 | 22.31 | 28 | 4342 | 36055 | 53308641 |
Blood pressure systolic increased | 36.36 | 22.31 | 27 | 4343 | 35150 | 53309546 |
Urine leukocyte esterase positive | 35.18 | 22.31 | 12 | 4358 | 2924 | 53341772 |
Hip fracture | 34.50 | 22.31 | 24 | 4346 | 28233 | 53316463 |
Therapeutic product effective for unapproved indication | 34.09 | 22.31 | 6 | 4364 | 86 | 53344610 |
Diarrhoea | 33.04 | 22.31 | 119 | 4251 | 625427 | 52719269 |
Drug interaction | 31.75 | 22.31 | 61 | 4309 | 219268 | 53125428 |
Drug level increased | 31.34 | 22.31 | 20 | 4350 | 20401 | 53324295 |
Urine abnormality | 29.17 | 22.31 | 13 | 4357 | 6447 | 53338249 |
Therapeutic product ineffective for unapproved indication | 29.15 | 22.31 | 6 | 4364 | 204 | 53344492 |
Breast cancer metastatic | 28.58 | 22.31 | 17 | 4353 | 15311 | 53329385 |
Infusion site scar | 28.43 | 22.31 | 6 | 4364 | 231 | 53344465 |
Tri-iodothyronine free decreased | 27.51 | 22.31 | 6 | 4364 | 270 | 53344426 |
Metastases to bone | 27.37 | 22.31 | 18 | 4352 | 19310 | 53325386 |
Productive cough | 27.00 | 22.31 | 28 | 4342 | 56701 | 53287995 |
Metastases to liver | 25.63 | 22.31 | 18 | 4352 | 21478 | 53323218 |
Seizure | 25.14 | 22.31 | 41 | 4329 | 129468 | 53215228 |
Cystic fibrosis | 24.69 | 22.31 | 10 | 4360 | 3921 | 53340775 |
Creatinine urine decreased | 23.65 | 22.31 | 5 | 4365 | 194 | 53344502 |
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 |
---|---|---|---|---|---|---|
Seizure | 81.33 | 27.41 | 59 | 1865 | 103795 | 32407807 |
Drug interaction | 65.57 | 27.41 | 72 | 1852 | 218113 | 32293489 |
Behaviour disorder | 57.63 | 27.41 | 17 | 1907 | 3607 | 32507995 |
Social avoidant behaviour | 38.02 | 27.41 | 12 | 1912 | 3187 | 32508415 |
Alcohol intolerance | 33.02 | 27.41 | 7 | 1917 | 384 | 32511218 |
Prescription drug used without a prescription | 29.16 | 27.41 | 8 | 1916 | 1307 | 32510295 |
Hyperacusis | 28.29 | 27.41 | 7 | 1917 | 764 | 32510838 |
Off label use | 28.00 | 27.41 | 58 | 1866 | 306262 | 32205340 |
Source | Code | Description |
---|---|---|
ATC | N03AX24 | NERVOUS SYSTEM ANTIEPILEPTICS ANTIEPILEPTICS Other antiepileptics |
FDA CS | M0003267 | Cannabinoids |
MeSH PA | D000927 | Anticonvulsants |
MeSH PA | D002491 | Central Nervous System Agents |
FDA MoA | N0000182138 | Cytochrome P450 1A2 Inhibitors |
FDA MoA | N0000182139 | Cytochrome P450 2B6 Inhibitors |
FDA MoA | N0000182140 | Cytochrome P450 2C19 Inhibitors |
FDA MoA | N0000185504 | Cytochrome P450 2C9 Inhibitors |
FDA MoA | N0000187062 | Cytochrome P450 2C8 Inhibitors |
FDA MoA | N0000187064 | Cytochrome P450 2B6 Inducers |
FDA MoA | N0000191273 | UGT2B7 Inhibitors |
FDA MoA | N0000191278 | UGT1A9 Inhibitors |
CHEBI has role | CHEBI:76924 | plant metabolites |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Lennox-Gastaut syndrome | indication | 230418006 | |
Severe myoclonic epilepsy in infancy | indication | 230437002 |
Dissociation level | Dissociation constant | Type (acidic/basic) |
---|---|---|
pKa1 | 9.34 | acidic |
pKa2 | 11.34 | acidic |
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 | 11154516 | June 17, 2034 | USE FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME |
100MG/ML | EPIDIOLEX | GW RES LTD | N210365 | Sept. 28, 2018 | RX | SOLUTION | ORAL | 11154516 | June 17, 2034 | USE FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME |
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 | 10603288 | June 17, 2035 | USE FOR REDUCING CONVULSIVE SEIZURE FREQUENCY IN PATIENTS WITH DRAVET SYNDROME |
100MG/ML | EPIDIOLEX | GW RES LTD | N210365 | Sept. 28, 2018 | RX | SOLUTION | ORAL | 10603288 | June 17, 2035 | USE FOR REDUCING CONVULSIVE SEIZURE FREQUENCY IN PATIENTS WITH LENNOX GASTAUT SYNDROME |
100MG/ML | EPIDIOLEX | GW RES LTD | N210365 | Sept. 28, 2018 | RX | SOLUTION | ORAL | 10603288 | June 17, 2035 | USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME |
100MG/ML | EPIDIOLEX | GW RES LTD | N210365 | Sept. 28, 2018 | RX | SOLUTION | ORAL | 10603288 | June 17, 2035 | USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME |
100MG/ML | EPIDIOLEX | GW RES LTD | N210365 | Sept. 28, 2018 | RX | SOLUTION | ORAL | 10709671 | June 17, 2035 | USE FOR THE TREATMENT OF FOCAL SEIZURES IN PATIENTS WITH DRAVET SYNDROME |
100MG/ML | EPIDIOLEX | GW RES LTD | N210365 | Sept. 28, 2018 | RX | SOLUTION | ORAL | 10709674 | June 17, 2035 | USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME |
100MG/ML | EPIDIOLEX | GW RES LTD | N210365 | Sept. 28, 2018 | RX | SOLUTION | ORAL | 10709674 | June 17, 2035 | USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME |
100MG/ML | EPIDIOLEX | GW RES LTD | N210365 | Sept. 28, 2018 | RX | SOLUTION | ORAL | 10849860 | 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 | 10849860 | 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 | 10966939 | June 17, 2035 | USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME |
100MG/ML | EPIDIOLEX | GW RES LTD | N210365 | Sept. 28, 2018 | RX | SOLUTION | ORAL | 10966939 | June 17, 2035 | USE FOR THE TREATMENT OF 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 |
100MG/ML | EPIDIOLEX | GW RES LTD | N210365 | Sept. 28, 2018 | RX | SOLUTION | ORAL | 10918608 | Oct. 14, 2035 | USE FOR REDUCING SEIZURE FREQUENCY IN PATIENTS WITH TUBEROUS SCLEROSIS COMPLEX |
100MG/ML | EPIDIOLEX | GW RES LTD | N210365 | Sept. 28, 2018 | RX | SOLUTION | ORAL | 10918608 | Oct. 14, 2035 | USE FOR THE TREATMENT OF GENERALIZED SEIZURES OR FOCAL SEIZURES WITH IMPAIRMENT IN PATIENTS WITH TUBEROUS SCLEROSIS COMPLEX |
100MG/ML | EPIDIOLEX | GW RES LTD | N210365 | Sept. 28, 2018 | RX | SOLUTION | ORAL | 10918608 | Oct. 14, 2035 | USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH TUBEROUS SCLEROSIS COMPLEX |
100MG/ML | EPIDIOLEX | GW RES LTD | N210365 | Sept. 28, 2018 | RX | SOLUTION | ORAL | 11065209 | Oct. 14, 2035 | USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH TUBEROUS SCLEROSIS COMPLEX |
100MG/ML | EPIDIOLEX | GW RES LTD | N210365 | Sept. 28, 2018 | RX | SOLUTION | ORAL | 11096905 | Oct. 14, 2035 | USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME |
100MG/ML | EPIDIOLEX | GW RES LTD | N210365 | Sept. 28, 2018 | RX | SOLUTION | ORAL | 11096905 | Oct. 14, 2035 | USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME |
100MG/ML | EPIDIOLEX | GW RES LTD | N210365 | Sept. 28, 2018 | RX | SOLUTION | ORAL | 11207292 | April 26, 2039 | USE FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME |
100MG/ML | EPIDIOLEX | GW RES LTD | N210365 | Sept. 28, 2018 | RX | SOLUTION | ORAL | 11207292 | April 26, 2039 | USE FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME |
100MG/ML | EPIDIOLEX | GW RES LTD | N210365 | Sept. 28, 2018 | RX | SOLUTION | ORAL | 11207292 | April 26, 2039 | USE FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH TUBEROUS SCLEROSIS COMPLEX |
100MG/ML | EPIDIOLEX | GW RES LTD | N210365 | Sept. 28, 2018 | RX | SOLUTION | ORAL | 11160795 | March 1, 2041 | USE FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH TUBEROUS SCLEROSIS COMPLEX IN PATIENTS TAKING EVEROLIMUS |
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 | July 31, 2023 | NEW PATIENT POPULATION |
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 |
100MG/ML | EPIDIOLEX | GW RES LTD | N210365 | Sept. 28, 2018 | RX | SOLUTION | ORAL | July 31, 2027 | TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (LGS) OR DRAVET SYNDROME (DS) IN PATIENTS BETWEEN 1 AND 2 YEARS OF AGE |
100MG/ML | EPIDIOLEX | GW RES LTD | N210365 | Sept. 28, 2018 | RX | SOLUTION | ORAL | July 31, 2027 | TREATMENT OF SEIZURES ASSOCIATED WITH TUBEROUS SCLEROSIS COMPLEX (TSC) IN PATIENTS 1 YEAR OF AGE AND OLDER |
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
Transient receptor potential cation channel subfamily V member 1 | Ion channel | INHIBITOR | UNKNOWN | SCIENTIFIC LITERATURE | |||||
G-protein coupled receptor 55 | GPCR | ANTAGONIST | EC50 | 6.35 | CHEMBL | SCIENTIFIC LITERATURE | |||
N-arachidonyl glycine receptor | GPCR | AGONIST | EC50 | 4.29 | IUPHAR | ||||
Cannabinoid receptor 1 | GPCR | Ki | 5.62 | CHEMBL | |||||
Transient receptor potential cation channel subfamily V member 2 | Ion channel | ACTIVATOR | EC50 | 4.50 | IUPHAR | ||||
Cannabinoid receptor 2 | GPCR | Ki | 5.54 | CHEMBL | |||||
Cannabinoid receptor 1 | GPCR | Ki | 5.90 | CHEMBL | |||||
Cannabinoid receptor 2 | GPCR | Ki | 6.64 | CHEMBL | |||||
Transient receptor potential cation channel subfamily V member 2 | Ion channel | ACTIVATOR | EC50 | 5.43 | IUPHAR | ||||
Fatty-acid amide hydrolase 1 | Enzyme | IC50 | 4.27 | CHEMBL |
ID | Source |
---|---|
19GBJ60SN5 | UNII |
4036658 | VANDF |
C0006863 | UMLSCUI |
CHEBI:69478 | CHEBI |
P0T | PDB_CHEM_ID |
CHEMBL190461 | ChEMBL_ID |
644019 | PUBCHEM_CID |
DB09061 | DRUGBANK_ID |
D002185 | MESH_DESCRIPTOR_UI |
D10915 | KEGG_DRUG |
4150 | IUPHAR_LIGAND_ID |
10423 | INN_ID |
2045371 | RXNORM |
010751 | NDDF |
771981005 | SNOMEDCT_US |
96223000 | SNOMEDCT_US |
20468 | MMSL |
291103 | MMSL |
d08919 | MMSL |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
Epidiolex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70127-100 | SOLUTION | 100 mg | ORAL | NDA | 31 sections |
NanoCDB | HUMAN OTC DRUG LABEL | 1 | 70658-122 | SOLUTION/ DROPS | 1.94 g | BUCCAL | Export only | 8 sections |
leafPro CBDmed Oil FS QP 3% | HUMAN OTC DRUG LABEL | 1 | 73674-001 | OIL | 3 g | ORAL | unapproved drug other | 15 sections |
leafPro CBDmed Oil FS QP 5% | HUMAN OTC DRUG LABEL | 1 | 73674-002 | OIL | 5 g | ORAL | unapproved drug other | 15 sections |
leafPro CBDmed Oil FS QP 20% | HUMAN OTC DRUG LABEL | 1 | 73674-005 | OIL | 20 g | ORAL | unapproved drug other | 15 sections |
leafPro CBDmed Oil T-FS QD 3% | HUMAN OTC DRUG LABEL | 1 | 73674-020 | OIL | 3 g | ORAL | unapproved drug other | 15 sections |
leafPro CBDmed Oil T-FS QD 5% | HUMAN OTC DRUG LABEL | 1 | 73674-021 | OIL | 5 g | ORAL | unapproved drug other | 15 sections |
leafPro CBDmed Oil T-FS QD 20% | HUMAN OTC DRUG LABEL | 1 | 73674-024 | OIL | 20 g | ORAL | unapproved drug other | 15 sections |
leafPro CBDmed Softgels FS QP 20 | HUMAN OTC DRUG LABEL | 1 | 73674-052 | CAPSULE, LIQUID FILLED | 20 mg | ORAL | unapproved drug other | 15 sections |
leafPro CBDmed Softgels T-FS QD 20 | HUMAN OTC DRUG LABEL | 1 | 73674-061 | CAPSULE, LIQUID FILLED | 20 mg | ORAL | unapproved drug other | 15 sections |
Kaydia Patch | HUMAN OTC DRUG LABEL | 3 | 75140-002 | PATCH | 0.15 g | TOPICAL | unapproved drug other | 8 sections |