Dronabinol
Dronabinol, Marinol (dronabinol) is a small molecule pharmaceutical. Dronabinol was first approved as Marinol on 1985-05-31. It is used to treat anorexia, nausea, and vomiting in the USA. The pharmaceutical is active against cannabinoid receptor 1. In addition, it is known to target N-arachidonyl glycine receptor, glycine receptor subunit alpha-1, glycine receptor subunit alpha-2, cannabinoid receptor 2, transient receptor potential cation channel subfamily A member 1, G-protein coupled receptor 55, glycine receptor subunit alpha-3, transient receptor potential cation channel subfamily V member 2, and transient receptor potential cation channel subfamily M member 8.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Dronabinol, Marinol (discontinued: Dronabinol, Syndros)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dronabinol
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MARINOL | Alkem Laboratories | N-018651 RX | 1985-05-31 | 3 products, RLD |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| dronabinol | NDA authorized generic | 2024-07-31 |
| just cbd - cbd and thc ultra relief | C200263 | 2024-04-23 |
| marinol | New Drug Application | 2023-02-14 |
| syndros | New Drug Application | 2024-05-30 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| vomiting | HP_0002013 | D014839 | R11.1 |
| nausea | HP_0002018 | D009325 | R11.0 |
| anorexia | HP_0002039 | D000855 | R63.0 |
Agency Specific
FDA
EMA
No data
HCPCS
Code | Description |
|---|---|
| Q0167 | Dronabinol, 2.5 mg, oral, fda approved prescription anti-emetic, for use as a complete therapeutic substitute for an iv anti-emetic at the time of chemotherapy treatment, not to exceed a 48 hour dosage regimen |
Clinical
Clinical Trials
568 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Marijuana abuse | D002189 | EFO_0007191 | F12 | 57 | 52 | 6 | 1 | 28 | 128 |
| Cannabis | D002188 | — | — | 45 | 24 | 3 | 4 | 20 | 92 |
| Pain | D010146 | EFO_0003843 | R52 | 12 | 12 | 23 | 1 | 2 | 48 |
| Syndrome | D013577 | — | — | 15 | 22 | 9 | 1 | 11 | 48 |
| Healthy volunteers/patients | — | — | — | 34 | — | — | 1 | 4 | 39 |
| Sclerosis | D012598 | — | — | 1 | 7 | 25 | 1 | 1 | 32 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 2 | 7 | 22 | 1 | 1 | 30 |
| Chronic pain | D059350 | HP_0012532 | — | 3 | 10 | 10 | 1 | 5 | 27 |
| Wiskott-aldrich syndrome | D014923 | EFO_0003903 | D82.0 | 9 | 10 | 2 | 1 | 9 | 24 |
| Muscle spasticity | D009128 | HP_0001257 | — | 2 | 5 | 13 | 1 | 1 | 20 |
Show 31 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neuralgia | D009437 | EFO_0009430 | — | 4 | 7 | 13 | — | 4 | 25 |
| Neoplasms | D009369 | — | C80 | 7 | 7 | 9 | — | 3 | 22 |
| Nausea | D009325 | HP_0002018 | R11.0 | 2 | 7 | 4 | — | 2 | 13 |
| Peripheral nervous system diseases | D010523 | HP_0009830 | G64 | 3 | 3 | 9 | — | — | 13 |
| Back pain | D001416 | HP_0003418 | M54 | 1 | 5 | 7 | — | — | 12 |
| Marijuana use | D000074609 | — | — | 3 | 7 | 1 | — | 3 | 12 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 1 | 9 | 1 | — | — | 11 |
| Dementia | D003704 | EFO_0003862 | F03 | 1 | 9 | 1 | — | 1 | 11 |
| Vomiting | D014839 | HP_0002013 | R11.1 | 2 | 4 | 4 | — | 2 | 10 |
| Marijuana smoking | D008385 | — | — | 1 | 8 | 1 | — | 2 | 10 |
Show 79 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 9 | 1 | — | — | 3 | 13 |
| Driving under the influence | D000066448 | — | — | 6 | 3 | — | — | 3 | 11 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | 4 | 2 | — | — | 3 | 9 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 4 | 3 | — | — | 1 | 7 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | 1 | 6 | — | — | — | 6 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | 2 | 1 | — | — | 2 | 5 |
| Alcoholic intoxication | D000435 | — | — | 3 | 1 | — | — | 2 | 5 |
| Glioblastoma | D005909 | EFO_0000515 | — | 4 | 4 | — | — | — | 5 |
| Thrombocytopenia | D013921 | HP_0001873 | D69.6 | 2 | 3 | — | — | 1 | 5 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 3 | 3 | — | — | 1 | 5 |
Show 115 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Psychotic disorders | D011618 | — | F20.81 | 9 | — | — | — | 1 | 10 |
| Pharmacokinetics | D010599 | — | — | 5 | — | — | — | 1 | 6 |
| Adolescent behavior | D000294 | — | — | 1 | — | — | — | 2 | 3 |
| Psychomotor disorders | D011596 | — | — | 2 | — | — | — | 1 | 3 |
| Mental disorders | D001523 | EFO_0000677 | F91.9 | 2 | — | — | — | 1 | 3 |
| Tobacco use disorder | D014029 | — | F17 | 1 | — | — | — | 1 | 2 |
| Magnetic resonance imaging | D008279 | — | — | 2 | — | — | — | — | 2 |
| Psychological codependency | D017004 | — | — | 2 | — | — | — | — | 2 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 2 | — | — | — | — | 2 |
| Biological availability | D001682 | — | — | 2 | — | — | — | — | 2 |
Show 32 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic granulomatous disease | D006105 | EFO_0000338 | D71 | — | — | — | — | 3 | 3 |
| Leukocyte-adhesion deficiency syndrome | D018370 | EFO_1001359 | — | — | — | — | — | 3 | 3 |
| Lymphoproliferative disorders | D008232 | Orphanet_2442 | D47.9 | — | — | — | — | 2 | 2 |
| Hemophagocytic lymphohistiocytosis | D051359 | — | D76.1 | — | — | — | — | 2 | 2 |
| Personality disorders | D010554 | HP_0012075 | F60.6 | — | — | — | — | 2 | 2 |
| Fabry disease | D000795 | Orphanet_324 | E75.21 | — | — | — | — | 1 | 1 |
| Paralysis | D010243 | HP_0003470 | — | — | — | — | — | 1 | 1 |
| Adult children | D032721 | — | — | — | — | — | — | 1 | 1 |
| Rehabilitation | D012046 | — | — | — | — | — | — | 1 | 1 |
| X-linked genetic diseases | D040181 | — | — | — | — | — | — | 1 | 1 |
Show 52 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Dronabinol |
| INN | dronabinol |
| Description | Delta(9)-tetrahydrocannabinol is a diterpenoid that is 6a,7,8,10a-tetrahydro-6H-benzo[c]chromene substituted at position 1 by a hydroxy group, positions 6, 6 and 9 by methyl groups and at position 3 by a pentyl group. The principal psychoactive constituent of the cannabis plant, it is used for treatment of anorexia associated with AIDS as well as nausea and vomiting associated with cancer chemotherapy. It has a role as a metabolite, a non-narcotic analgesic, a hallucinogen, a cannabinoid receptor agonist and an epitope. It is a diterpenoid, a benzochromene, a polyketide and a phytocannabinoid. |
| Classification | Small molecule |
| Drug class | cannabinol derivatives |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCCCCc1cc(O)c2c(c1)OC(C)(C)[C@@H]1CCC(C)=C[C@@H]21 |
Identifiers
| PDB | — |
| CAS-ID | 1972-08-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL465 |
| ChEBI ID | 66964 |
| PubChem CID | 16078 |
| DrugBank | DB00470 |
| UNII ID | 7J8897W37S (ChemIDplus, GSRS) |
Target
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Syndros – Insys Therapeutics
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Dronabinol – Insys Therapeutics
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Estimated US medical usage
Dronabinol
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Additional graphs summarizing 41,219 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,984 adverse events reported
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