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 A member 1, N-arachidonyl glycine receptor, transient receptor potential cation channel subfamily V member 3, cannabinoid receptor 1, G-protein coupled receptor 55, transient receptor potential cation channel subfamily V member 2, and transient receptor potential cation channel subfamily M member 8.
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FDA approval date
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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 | Jazz Pharmaceuticals | N-210365 RX | 2018-09-28 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| amour cbd | C200263 | 2024-12-08 |
| asystem radical relief gel roll-on 300mg cbd | OTC monograph not final | 2020-03-19 |
| ay bendito - cbd | C200263 | 2024-11-18 |
| ay bendito cbd | C200263 | 2025-03-18 |
| cbd | OTC monograph not final | 2020-02-10 |
| cbd blue light defense spf 30 | C200263 | 2024-12-05 |
| cbd clinic - massage oil - level 1 | OTC monograph not final | 2017-05-15 |
| cbd clinic - massage oil - level 2 | OTC monograph not final | 2017-05-15 |
| cbd clinic - massage oil - level 3 | OTC monograph not final | 2017-05-15 |
| cbd clinic - mild pain therapy | OTC monograph not final | 2016-07-11 |
Show 110 more
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
CANNABIDIOL, EPIDIOLEX, JAZZ PHARMS RES | |||
| 2027-07-31 | ODE-326, ODE-332 | ||
| 2026-10-20 | M-270 | ||
| 2025-09-28 | ODE-216 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Cannabidiol, Epidiolex, Jazz Pharms Res | |||
| 11160795 | 2041-03-01 | U-3233 | |
| 11406623 | 2041-03-01 | U-3233 | |
| 11207292 | 2039-04-26 | DP | U-3235, U-3236, U-3277 |
| 11865102 | 2039-04-26 | DS, DP | U-2781, 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 |
| 11701330 | 2035-06-17 | U-2780, U-2781 | |
| 11766411 | 2035-06-17 | U-2781 | |
HCPCS
No data
Clinical
Clinical Trials
984 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sclerosis | D012598 | — | — | — | — | 16 | 2 | 1 | 19 |
| Syndrome | D013577 | — | — | 1 | 5 | 8 | 2 | 1 | 16 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | — | 14 | 1 | 1 | 16 |
| Muscle spasticity | D009128 | — | — | — | 1 | 9 | 1 | — | 11 |
| Myoclonic epilepsies | D004831 | EFO_1001900 | G40.4 | — | 1 | 4 | 2 | 1 | 8 |
| Lennox gastaut syndrome | D065768 | — | G40.81 | — | — | 4 | 3 | 1 | 8 |
| Seizures | D012640 | — | G40.4 | — | — | 6 | 1 | 1 | 8 |
| Tuberous sclerosis | D014402 | — | Q85.1 | — | — | 3 | 2 | 1 | 6 |
| Absence epilepsy | D004832 | — | G40.A | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pain | D010146 | EFO_0003843 | R52 | — | — | 14 | — | — | 14 |
| Epilepsy | D004827 | EFO_0000474 | G40.9 | — | 5 | 6 | — | 1 | 12 |
| Neoplasms | D009369 | — | C80 | 2 | 2 | 5 | — | 1 | 8 |
| Neuralgia | D009437 | EFO_0009430 | — | — | — | 5 | — | 1 | 6 |
| Peripheral nervous system diseases | D010523 | — | G64 | — | — | 5 | — | — | 5 |
| Cancer pain | D000072716 | — | G89.3 | — | — | 2 | — | — | 2 |
| Hyperalgesia | D006930 | — | — | — | — | 2 | — | — | 2 |
| Rett syndrome | D015518 | Orphanet_778 | F84.2 | — | — | 2 | — | — | 2 |
| Spasm | D013035 | — | M62.83 | — | — | 2 | — | — | 2 |
| Infantile spasms | D013036 | EFO_1000643 | G40.82 | — | — | 2 | — | — | 2 |
Show 12 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glioblastoma | D005909 | EFO_0000515 | — | 2 | 3 | — | — | — | 3 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | 2 | — | — | — | 2 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | — | 2 | — | — | — | 2 |
| Brain stem infarctions | D020526 | EFO_1000847 | G46.3 | 1 | 2 | — | — | — | 2 |
| Sturge-weber syndrome | D013341 | Orphanet_3205 | Q85.89 | 1 | 2 | — | — | — | 2 |
| Klippel-trenaunay-weber syndrome | D007715 | EFO_0007334 | Q87.2 | 1 | 2 | — | — | — | 2 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | 1 | — | — | 1 | 2 |
| Fragile x syndrome | D005600 | — | Q99.2 | — | 2 | — | — | — | 2 |
| Autistic disorder | D001321 | EFO_0003758 | F84.0 | — | 1 | — | — | — | 1 |
| Autism spectrum disorder | D000067877 | — | F84.0 | — | 1 | — | — | — | 1 |
Show 16 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Status epilepticus | D013226 | EFO_0008526 | G41 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug resistant epilepsy | D000069279 | — | — | — | — | — | — | 1 | 1 |
| Pregnancy complications | D011248 | — | — | — | — | — | — | 1 | 1 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 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 and an antimicrobial agent. 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 | — |
| ChEMBL ID | CHEMBL190461 |
| ChEBI ID | 69478 |
| PubChem CID | 644019 |
| DrugBank | DB09061 |
| UNII ID | 19GBJ60SN5 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
TRPA1
TRPA1
GPR18
GPR18
TRPV3
TRPV3
CNR1
CNR1
GPR55
GPR55
TRPV2
TRPV2
TRPM8
TRPM8
Organism
Homo sapiens
Gene name
TRPA1
Gene synonyms
ANKTM1
NCBI Gene ID
Protein name
transient receptor potential cation channel subfamily A member 1
Protein synonyms
ankyrin-like with transmembrane domains 1, Ankyrin-like with transmembrane domains protein 1, p120, Transformation-sensitive protein p120, Wasabi receptor
Uniprot ID
Mouse ortholog
Trpa1 (277328)
transient receptor potential cation channel subfamily A member 1 (Q8BLA8)
Variants
No data
Financial
Revenue by drug
$
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£
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Epidiolex – Jazz Pharmaceuticals
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Estimated US medical usage
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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17,364 adverse events reported
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