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

Stem definitionDrug idCAS RN
cannabinoid receptors agonists 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: 6.94
  • LIPINSKI: None
  • HAC: 2
  • HDO: 2
  • TPSA: 40.46
  • ALOGS: -4.40
  • ROTB: 6

  • Status: ONP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.70 g O

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
S (Water solubility) 0.00 mg/mL Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Bocci G, Oprea TI, Benet LZ

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
Seizure 184.76 21.28 130 6024 132504 63350364
Multiple-drug resistance 131.45 21.28 39 6115 5131 63477737
Device related thrombosis 124.91 21.28 30 6124 1755 63481113
Off label use 108.18 21.28 215 5939 674247 62808621
Drug resistance 101.87 21.28 48 6106 22885 63459983
Product administration interrupted 91.16 21.28 29 6125 4807 63478061
Blood pressure diastolic decreased 87.15 21.28 43 6111 22663 63460205
Nail disorder 66.40 21.28 30 6124 12985 63469883
Large intestine polyp 52.00 21.28 22 6132 8135 63474733
Heart rate irregular 50.99 21.28 30 6124 22391 63460477
Tonic convulsion 47.44 21.28 13 6141 1284 63481584
Breast cancer metastatic 46.81 21.28 23 6131 11995 63470873
Skin exfoliation 43.65 21.28 35 6119 43067 63439801
Drug interaction 42.45 21.28 78 6076 229053 63253815
Cystic fibrosis 39.26 21.28 14 6140 3282 63479586
Body temperature decreased 38.02 21.28 24 6130 20295 63462573
Metastases to bone 37.27 21.28 24 6130 20995 63461873
Drug ineffective 36.12 21.28 197 5957 1044568 62438300
Blood pressure systolic increased 32.84 21.28 31 6123 47366 63435502
Pyelonephritis chronic 32.80 21.28 7 6147 239 63482629
Bone loss 32.56 21.28 12 6142 3087 63479781
Therapeutic product effective for unapproved indication 32.46 21.28 6 6148 96 63482772
Metastases to liver 32.37 21.28 23 6131 23616 63459252
Drug level increased 30.86 21.28 22 6132 22714 63460154
Sinus headache 28.81 21.28 13 6141 5603 63477265
Finger deformity 27.73 21.28 14 6140 7731 63475137
Therapeutic product ineffective for unapproved indication 27.70 21.28 6 6148 220 63482648
Therapeutic response shortened 27.26 21.28 16 6138 11872 63470996
Hip fracture 25.80 21.28 22 6132 29452 63453416
Neoplasm progression 25.56 21.28 24 6130 36404 63446464
Cough 23.57 21.28 72 6082 292671 63190197
Psychomotor hyperactivity 23.53 21.28 14 6140 10649 63472219
Feeling jittery 23.01 21.28 15 6139 13388 63469480
Skin reaction 21.61 21.28 15 6139 14834 63468034

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
Seizure 291.82 30.17 159 3228 104698 34848846
Product administration interrupted 114.26 30.17 28 3359 1787 34951757
Off label use 95.09 30.17 155 3232 419369 34534175
Behaviour disorder 66.75 30.17 23 3364 4887 34948657
Drug interaction 59.82 30.17 90 3297 225856 34727688
Multiple-drug resistance 57.74 30.17 21 3366 5218 34948326
Hospitalisation 44.96 30.17 40 3347 56862 34896682
Drug ineffective 39.83 30.17 115 3272 456636 34496908
Somnolence 39.33 30.17 51 3336 111065 34842479
Social avoidant behaviour 36.25 30.17 13 3374 3101 34950443
Status epilepticus 34.40 30.17 19 3368 12595 34940949
Blood pressure systolic abnormal 33.24 30.17 13 3374 3935 34949609
Blood pressure diastolic abnormal 30.74 30.17 13 3374 4805 34948739
Blood pressure diastolic increased 30.21 30.17 13 3374 5012 34948532

FDA Adverse Event Reporting System (Geriatric)

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
Seizure 242.76 20.46 181 8085 188653 79547469
Multiple-drug resistance 131.43 20.46 45 8221 8763 79727359
Off label use 125.03 20.46 283 7983 906932 78829190
Device related thrombosis 110.76 20.46 30 8236 2653 79733469
Drug interaction 107.56 20.46 170 8096 415013 79321109
Product administration interrupted 91.12 20.46 28 8238 3871 79732251
Behaviour disorder 85.46 20.46 30 8236 6283 79729839
Blood pressure diastolic decreased 83.55 20.46 47 8219 30169 79705953
Drug resistance 73.87 20.46 49 8217 42164 79693958
Drug ineffective 67.17 20.46 254 8012 1080659 78655463
Nail disorder 67.14 20.46 30 8236 11822 79724300
Tonic convulsion 60.72 20.46 18 8248 2202 79733920
Blood pressure systolic increased 53.80 20.46 49 8217 66937 79669185
Breast cancer metastatic 52.68 20.46 23 8243 8579 79727543
Somnolence 46.04 20.46 86 8180 238895 79497227
Heart rate irregular 45.56 20.46 33 8233 32646 79703476
Status epilepticus 43.63 20.46 29 8237 25012 79711110
Large intestine polyp 41.28 20.46 22 8244 12686 79723436
Acute kidney injury 39.59 20.46 4 8262 519400 79216722
Blood pressure diastolic abnormal 35.30 20.46 23 8243 19179 79716943
Bone loss 33.98 20.46 12 8254 2555 79733567
Social avoidant behaviour 33.19 20.46 14 8252 4800 79731322
Metastases to bone 32.54 20.46 24 8242 24403 79711719
Skin exfoliation 32.41 20.46 34 8232 55066 79681056
Cough 32.08 20.46 97 8169 366692 79369430
Therapeutic response shortened 31.63 20.46 20 8246 15843 79720279
Therapeutic product effective for unapproved indication 31.29 20.46 6 8260 110 79736012
Pyelonephritis chronic 31.16 20.46 7 8259 284 79735838
Intentional product use issue 30.84 20.46 56 8210 152056 79584066
Sudden unexplained death in epilepsy 30.07 20.46 8 8258 660 79735462
Metastases to liver 29.40 20.46 24 8242 28290 79707832
Sinus headache 29.22 20.46 13 8253 5067 79731055
Therapeutic product ineffective for unapproved indication 28 20.46 6 8260 195 79735927
Petit mal epilepsy 27.73 20.46 13 8253 5714 79730408
Alcohol intolerance 27.61 20.46 7 8259 478 79735644
Finger deformity 27.31 20.46 14 8252 7460 79728662
Microsporidia infection 27.15 20.46 8 8258 958 79735164
Body temperature decreased 26.75 20.46 24 8242 32121 79704001
Drug level increased 26.10 20.46 26 8240 39625 79696497
Intentional product misuse to child 26.06 20.46 5 8261 92 79736030
Epilepsy 25.44 20.46 26 8240 40834 79695288
Throat irritation 25.40 20.46 26 8240 40920 79695202
Hip fracture 23.70 20.46 22 8244 30739 79705383
Feeling jittery 22.67 20.46 15 8251 12826 79723296
Diarrhoea 22.53 20.46 162 8104 880327 78855795
Psychomotor hyperactivity 21.20 20.46 16 8250 16833 79719289
Blood pressure systolic abnormal 20.87 20.46 16 8250 17231 79718891
Hypersomnia 20.73 20.46 18 8248 23068 79713054
Infantile spasms 20.64 20.46 5 8261 283 79735839

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
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:33281 antibiotics
CHEBI has role CHEBI:76924 plant metabolites

Drug Use | Suggest Off label Use Form| |View source of the data|

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




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

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 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 11154516 June 17, 2035 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, 2035 USE FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME
100MG/ML EPIDIOLEX GW RES LTD N210365 Sept. 28, 2018 RX SOLUTION ORAL 11311498 June 17, 2035 USE FOR THE TREATMENT OF ABSENCE SEIZURES IN PATIENTS WITH DRAVET SYNDROME
100MG/ML EPIDIOLEX GW RES LTD N210365 Sept. 28, 2018 RX SOLUTION ORAL 11311498 June 17, 2035 USE FOR THE TREATMENT OF ABSENCE SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME
100MG/ML EPIDIOLEX GW RES LTD N210365 Sept. 28, 2018 RX SOLUTION ORAL 11357741 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 11446258 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 11446258 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 11446258 June 17, 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 11633369 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 11633369 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 11633369 June 17, 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 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. 13, 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. 13, 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. 13, 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. 13, 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. 13, 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. 13, 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 11400055 Oct. 13, 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 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
100MG/ML EPIDIOLEX GW RES LTD N210365 Sept. 28, 2018 RX SOLUTION ORAL 11406623 March 1, 2041 USE FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH TUBEROUS SCLEROSIS COMPLEX IN PATIENTS TAKING EVEROLIMUS

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 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

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Transient receptor potential cation channel subfamily V member 1 Ion channel INHIBITOR IC50 5.43 CHEMBL SCIENTIFIC LITERATURE
G-protein coupled receptor 55 GPCR ANTAGONIST EC50 6.35 CHEMBL SCIENTIFIC LITERATURE
D(1A) dopamine receptor GPCR Ki 5.57 CHEMBL
5-hydroxytryptamine receptor 1A GPCR EC50 5.10 CHEMBL
5-hydroxytryptamine receptor 2C GPCR Ki 5.96 CHEMBL
Alpha-2B adrenergic receptor GPCR Ki 5.50 CHEMBL
Alpha-2C adrenergic receptor GPCR Ki 5.43 CHEMBL
Kappa-type opioid receptor GPCR Ki 5.64 CHEMBL
Delta-type opioid receptor GPCR Ki 5.19 CHEMBL
Caspase-1 Enzyme Kd 7.73 CHEMBL
Cannabinoid receptor 2 GPCR Ki 5.54 CHEMBL
Histamine H3 receptor GPCR Ki 5.51 CHEMBL
N-arachidonyl glycine receptor GPCR AGONIST EC50 4.29 IUPHAR
Cannabinoid receptor 1 GPCR Ki 5.62 CHEMBL
L-lactate dehydrogenase A chain Enzyme Ki 4.62 CHEMBL
Transmembrane protein 97 Enzyme Ki 5.47 CHEMBL
Transient receptor potential cation channel subfamily V member 2 Ion channel ACTIVATOR EC50 4.50 IUPHAR
Mu-type opioid receptor GPCR Ki 5.89 CHEMBL
5-hydroxytryptamine receptor 2A GPCR EC50 4.50 CHEMBL
Cannabinoid receptor 1 GPCR Ki 5.90 CHEMBL
Cannabinoid receptor 2 GPCR Ki 6.64 CHEMBL
Fatty-acid amide hydrolase 1 Enzyme IC50 4.27 CHEMBL
Cholinesterase Enzyme IC50 6.17 CHEMBL
Transient receptor potential cation channel subfamily M member 8 Ion channel IC50 5.55 CHEMBL
Transient receptor potential cation channel subfamily V member 2 Ion channel ACTIVATOR EC50 5.43 IUPHAR
Transient receptor potential cation channel subfamily A member 1 Ion channel IC50 6.35 CHEMBL
Heat sensitive channel TRPV3 Unclassified EC50 6.29 CHEMBL
Transient receptor potential cation channel subfamily V member 4, TrpV4 Unclassified EC50 6.05 CHEMBL
Acetylcholinesterase Enzyme IC50 4.77 CHEMBL

External reference:

IDSource
19GBJ60SN5 UNII
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
10423 INN_ID
4150 IUPHAR_LIGAND_ID
20468 MMSL
291103 MMSL
d08919 MMSL
010751 NDDF
771981005 SNOMEDCT_US
96223000 SNOMEDCT_US
4036658 VANDF
2045371 RXNORM

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Epidiolex HUMAN PRESCRIPTION DRUG LABEL 1 70127-100 SOLUTION 100 mg ORAL NDA 32 sections
Epidiolex HUMAN PRESCRIPTION DRUG LABEL 1 70127-100 SOLUTION 100 mg ORAL NDA 32 sections
Epidiolex HUMAN PRESCRIPTION DRUG LABEL 1 70127-100 SOLUTION 100 mg ORAL NDA 32 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