Epidiolex, Epidyolex(cannabidiol)
Epidiolex, Epidyolex (cannabidiol) is a small molecule pharmaceutical. Cannabidiol was first approved as Epidiolex on 2018-09-28. It is used to treat anxiety, lennox gastaut syndrome, myoclonic epilepsies, and pain in the USA. It has been approved in Europe to treat lennox gastaut syndrome and myoclonic epilepsies. It is known to target transient receptor potential cation channel subfamily V member 2, G-protein coupled receptor 55, transient receptor potential cation channel subfamily M member 8, N-arachidonyl glycine receptor, transient receptor potential cation channel subfamily A member 1, transient receptor potential cation channel subfamily V member 3, and cannabinoid receptor 1.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Epidiolex
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Cannabidiol
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| EPIDIOLEX | GW Research | N-210365 RX | 2018-09-28 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| epidiolex | New Drug Application | 2020-10-29 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| anxiety | EFO_0005230 | D001007 | F41.1 |
| lennox gastaut syndrome | — | D065768 | G40.81 |
| myoclonic epilepsies | EFO_1001900 | D004831 | G40.4 |
| pain | EFO_0003843 | D010146 | R52 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
CANNABIDIOL, EPIDIOLEX, GW RES LTD | |||
| 2027-07-31 | ODE-326, ODE-332 | ||
| 2025-09-28 | ODE-216 | ||
| 2023-09-28 | NCE | ||
| 2023-07-31 | NPP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Cannabidiol, Epidiolex, Gw Res Ltd | |||
| 11160795 | 2041-03-01 | U-3233 | |
| 11406623 | 2041-03-01 | U-3233 | |
| 11207292 | 2039-04-26 | DP | U-3235, U-3236, U-3277 |
| 10918608 | 2035-10-13 | U-3071, U-3072, U-3073 | |
| 11065209 | 2035-10-13 | U-3071 | |
| 11096905 | 2035-10-13 | DS, DP | U-2780, U-2781 |
| 11400055 | 2035-10-13 | U-3071 | |
| 9949937 | 2035-06-17 | U-2421 | |
| 9956183 | 2035-06-17 | U-2422, U-2423 | |
| 9956184 | 2035-06-17 | U-2424 | |
| 9956185 | 2035-06-17 | U-2425 | |
| 9956186 | 2035-06-17 | U-2426 | |
| 10092525 | 2035-06-17 | U-2427 | |
| 10111840 | 2035-06-17 | U-2442, U-2443 | |
| 10137095 | 2035-06-17 | U-2454, U-2455 | |
| 10603288 | 2035-06-17 | U-2780, U-2781, U-2782, U-2783 | |
| 10709671 | 2035-06-17 | U-2862 | |
| 10709673 | 2035-06-17 | DP | |
| 10709674 | 2035-06-17 | U-2780, U-2781 | |
| 10849860 | 2035-06-17 | U-2427, U-2454 | |
| 10966939 | 2035-06-17 | DP | U-2780, U-2781 |
| 11154516 | 2035-06-17 | U-3235, U-3236 | |
| 11311498 | 2035-06-17 | U-3375, U-3376 | |
| 11357741 | 2035-06-17 | U-2862 | |
| 11446258 | 2035-06-17 | U-2780, U-2781, U-3071 | |
| 11633369 | 2035-06-17 | DP | U-2780, U-2781, U-3071 |
HCPCS
No data
Clinical
Clinical Trials
230 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Epilepsy | D004827 | EFO_0000474 | G40.9 | 4 | 5 | 6 | 1 | 6 | 22 |
| Myoclonic epilepsies | D004831 | EFO_1001900 | G40.4 | 2 | 3 | 6 | 1 | 1 | 11 |
| Lennox gastaut syndrome | D065768 | G40.81 | 2 | 2 | 6 | 2 | 1 | 11 | |
| Seizures | D012640 | G40.4 | 3 | 1 | 4 | 1 | — | 8 | |
| Anxiety | D001007 | EFO_0005230 | F41.1 | — | 3 | — | 1 | 1 | 5 |
| Tuberous sclerosis | D014402 | HP_0009720 | Q85.1 | — | — | 3 | 1 | — | 4 |
| Social phobia | D000072861 | EFO_1001917 | F40.1 | — | 2 | 1 | 1 | — | 4 |
| Arthralgia | D018771 | HP_0002829 | M25.5 | — | 1 | — | 1 | — | 2 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | 1 | — | 1 | — | 2 |
| Postoperative pain | D010149 | G89.18 | 1 | — | — | 1 | — | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alcoholism | D000437 | EFO_0003829 | F10.1 | 4 | 8 | 1 | — | — | 9 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | 2 | 6 | 1 | — | — | 6 |
| Psychotic disorders | D011618 | F20.81 | 2 | 3 | 1 | — | — | 6 | |
| Autism spectrum disorder | D000067877 | F84.0 | 1 | 3 | 1 | — | — | 4 | |
| Cannabis | D002188 | 2 | 2 | 1 | — | 1 | 4 | ||
| Infantile spasms | D013036 | EFO_1000643 | G40.82 | — | 1 | 3 | — | — | 4 |
| Covid-19 | D000086382 | U07.1 | 1 | 3 | 2 | — | — | 3 | |
| Pain | D010146 | EFO_0003843 | R52 | 1 | 3 | 1 | — | — | 3 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | 1 | 2 | 1 | — | — | 3 |
| Crohn disease | D003424 | EFO_0000384 | K50 | 1 | 3 | 1 | — | — | 3 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Schizophrenia | D012559 | EFO_0000692 | F20 | 2 | 9 | — | — | 2 | 13 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | 2 | 7 | — | — | — | 8 |
| Chronic pain | D059350 | HP_0012532 | 3 | 1 | — | — | — | 4 | |
| Graft vs host disease | D006086 | D89.81 | 2 | 4 | — | — | — | 4 | |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 2 | — | — | — | 3 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | — | 2 | — | — | 1 | 3 |
| Colonic neoplasms | D003110 | C18 | 2 | 1 | — | — | — | 2 | |
| Neoplasms | D009369 | C80 | 1 | 1 | — | — | — | 2 | |
| Traumatic brain injuries | D000070642 | S06 | — | 2 | — | — | — | 2 | |
| Sturge-weber syndrome | D013341 | Orphanet_3205 | Q85.89 | 1 | 2 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 7 | — | — | — | 2 | 9 | ||
| Musculoskeletal pain | D059352 | 2 | — | — | — | — | 2 | ||
| Pharmacokinetics | D010599 | 1 | — | — | — | 1 | 2 | ||
| Affect | D000339 | 1 | — | — | — | — | 1 | ||
| Vomiting | D014839 | HP_0002013 | R11.1 | 1 | — | — | — | — | 1 |
| Nausea | D009325 | HP_0002018 | R11.0 | 1 | — | — | — | — | 1 |
| Cachexia | D002100 | HP_0004326 | R64 | 1 | — | — | — | — | 1 |
| Appetitive behavior | D001070 | 1 | — | — | — | — | 1 | ||
| Prostatic neoplasms | D011471 | C61 | 1 | — | — | — | — | 1 | |
| Adenocarcinoma | D000230 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug resistant epilepsy | D000069279 | — | — | — | — | 2 | 2 | ||
| Fear | D005239 | — | — | — | — | 1 | 1 | ||
| Marijuana abuse | D002189 | EFO_0007191 | F12 | — | — | — | — | 1 | 1 |
| Adolescent development | D041923 | — | — | — | — | 1 | 1 | ||
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | — | — | — | 1 | 1 |
| Metabolism | D008660 | GO_0008152 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | CANNABIDIOL |
| INN | cannabidiol |
| Description | Cannabidiol is an cannabinoid that is cyclohexene which is substituted by a methyl group at position 1, a 2,6-dihydroxy-4-pentylphenyl group at position 3, and a prop-1-en-2-yl group at position 4. It has a role as a plant metabolite. It is a member of resorcinols, an olefinic compound and a phytocannabinoid. |
| Classification | Small molecule |
| Drug class | cannabinol derivatives |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | C=C(C)[C@@H]1CCC(C)=C[C@H]1c1c(O)cc(CCCCC)cc1O |
Identifiers
| PDB | — |
| CAS-ID | 13956-29-1 |
| RxCUI | 2045371 |
| ChEMBL ID | CHEMBL190461 |
| ChEBI ID | 69478 |
| PubChem CID | 644019 |
| DrugBank | DB09061 |
| UNII ID | 19GBJ60SN5 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
TRPV2
TRPV2
GPR55
GPR55
TRPM8
TRPM8
GPR18
GPR18
TRPA1
TRPA1
TRPV3
TRPV3
CNR1
CNR1
Organism
Homo sapiens
Gene name
TRPV2
Gene synonyms
VRL
NCBI Gene ID
Protein name
transient receptor potential cation channel subfamily V member 2
Protein synonyms
Osm-9-like TRP channel 2, OTRPC2, Vanilloid receptor-like protein 1, VRL-1
Uniprot ID
Mouse ortholog
Trpv2 (22368)
transient receptor potential cation channel subfamily V member 2 (Q9WTR1)
Variants
Clinical Variant
No data
Financial
Epidiolex - Jazz Pharmaceuticals
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 12,215 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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43 adverse events reported
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