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Dronabinol
Marinol, Syndros (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 G-protein coupled receptor 55, transient receptor potential cation channel subfamily M member 8, glycine receptor subunit alpha-2, transient receptor potential cation channel subfamily A member 1, N-arachidonyl glycine receptor, cannabinoid receptor 2, glycine receptor subunit alpha-1, glycine receptor subunit alpha-3, and transient receptor potential cation channel subfamily V member 2.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Marinol, Syndros (generic drugs available since 2008-06-27)
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
MARINOLAlkem LaboratoriesN-018651 RX1985-05-31
3 products, RLD
SYNDROSBENUVIA OPERATIONSN-205525 RX2017-03-23
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
dronabinolNDA authorized generic2023-03-30
marinolNew Drug Application2021-03-28
syndrosNew Drug Application2021-01-21
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
anorexiaHP_0002039D000855R63.0
nauseaHP_0002018D009325R11.0
vomitingHP_0002013D014839R11.1
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Dronabinol, Syndros, Benuvia Operations
82222922028-08-06DS, DP
93457712028-08-06DS, DP
102652932028-08-06DS, DP
112534722028-08-06DS, DP
ATC Codes
A: Alimentary tract and metabolism drugs
— A04: Antiemetics and antinauseants
— A04A: Antiemetics and antinauseants
— A04AD: Other antiemetics in atc
— A04AD10: Dronabinol
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
19 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Secondary hyperparathyroidismD006962EFO_10011731—17—9
Chronic renal insufficiencyD051436N181—14—6
Chronic kidney failureD007676EFO_0003884N18.61——1—2
Kidney transplantationD016030———1—1
Renal insufficiencyD051437HP_0000083N19———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Vitamin d deficiencyD014808EFO_0003762E55——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic neoplasmsD011471C61—2———2
PsoriasisD011565EFO_0000676L40—1———1
LeukemiaD007938C95—1———1
Myelodysplastic syndromesD009190D46—1———1
Myelodysplastic-myeloproliferative diseasesD054437—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C801————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic kidney disease-mineral and bone disorderD012080EFO_1001152N25.0————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDRONABINOL
INNdronabinol
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 classcannabinol 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
PDB7P4J
CAS-ID1972-08-3
RxCUI10402
ChEMBL IDCHEMBL465
ChEBI ID66964
PubChem CID16078
DrugBankDB00470
UNII ID7J8897W37S (ChemIDplus, GSRS)
Target
Agency Approved
CNR1
CNR1
Organism
Homo sapiens
Gene name
CNR1
Gene synonyms
CNR
NCBI Gene ID
1268
Protein name
cannabinoid receptor 1
Protein synonyms
CANN6, cannabinoid receptor 1 (brain), central cannabinoid receptor
Uniprot ID
Q9UNN0
Mouse ortholog
Cnr1 (12801)
cannabinoid receptor 1 (Q5SF33)
Alternate
GPR55
GPR55
TRPM8
TRPM8
GLRA2
GLRA2
TRPA1
TRPA1
GPR18
GPR18
CNR2
CNR2
GLRA1
GLRA1
GLRA3
GLRA3
TRPV2
TRPV2
Organism
Homo sapiens
Gene name
GPR55
Gene synonyms
NCBI Gene ID
9290
Protein name
G-protein coupled receptor 55
Protein synonyms
Uniprot ID
Q9Y2T6
Mouse ortholog
Gpr55 (227326)
G-protein coupled receptor 55 (Q3UJF0)
Variants
Clinical Variant
No data
Financial
Dronabinol - Insys Therapeutics
$
€
£
₣
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Syndros - Insys Therapeutics
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,702 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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441 adverse events reported
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