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Drug ReportsTetrabenazine
Tetrabenazine
Tetrabenazine, Xenazine (tetrabenazine) is a small molecule pharmaceutical. Tetrabenazine was first approved as Xenazine on 2008-08-15. It is used to treat huntington disease and hyperkinesis in the USA. The pharmaceutical is active against synaptic vesicular amine transporter. In addition, it is known to target chromaffin granule amine transporter.
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Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
hereditary congenital and neonatal diseases and abnormalitiesD009358
signs and symptoms pathological conditionsD013568
mental disordersD001523
Trade Name
FDA
EMA
Tetrabenazine, Xenazine (discontinued: Tetrabenazine)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Tetrabenazine
Tradename
Company
Number
Date
Products
XENAZINEBausch Health CompaniesN-021894 RX2008-08-15
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
tetrabenazineANDA2024-10-01
xenazineNew Drug Application2022-06-22
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
N: Nervous system drugs
— N07: Other nervous system drugs in atc
— N07X: Other nervous system drugs in atc
— N07XX: Other nervous system drugs in atc
— N07XX06: Tetrabenazine
HCPCS
No data
Clinical
Clinical Trials
22 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Huntington diseaseD006816Orphanet_399G102—52110
PainD010146EFO_0003843R52———1—1
Cerebral palsyD002547—G80———1—1
Impulsive behaviorD007175—————1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Tardive dyskinesiaD000071057—G24.01—31——4
DyskinesiasD020820HP_0002310G24—31——4
ChoreaD002819EFO_0004152G25.5——3——3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SchizophreniaD012559EFO_0000692F20—2——24
Psychotic disordersD011618—F20.81—2——24
Tourette syndromeD005879EFO_0004895F95.2—1———1
SyndromeD013577———1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———2————2
MalnutritionD044342EFO_0008572E40-E461————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Drug-related side effects and adverse reactionsD064420—T88.7————11
Drug interactionsD004347——————11
Type 2 diabetes mellitusD003924EFO_0001360E11————11
EmergenciesD004630——————11
Bipolar disorderD001714EFO_0000289F30.9————11
Movement disordersD009069HP_0100022—————11
HyperkinesisD006948HP_0000752—————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTetrabenazine
INNtetrabenazine
Description
9,10-dimethoxy-3-isobutyl-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-one is a benzoquinolizine that is 1,2,3,4,4a,9,10,10a-octahydrophenanthrene in which the carbon at position 10a is replaced by a nitrogen and which is substituted by an isobutyl group at position 2, an oxo group at position 3, and methoxy groups at positions 6 and 7. It is a benzoquinolizine, a cyclic ketone and a tertiary amino compound.
Classification
Small molecule
Drug class—
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
COc1cc2c(cc1OC)C1CC(=O)C(CC(C)C)CN1CC2
Identifiers
PDB—
CAS-ID58-46-8
RxCUI—
ChEMBL IDCHEMBL117785
ChEBI ID64028
PubChem CID6018
DrugBankDB04844
UNII IDZ9O08YRN8O (ChemIDplus, GSRS)
Target
Agency Approved
SLC18A2
SLC18A2
Organism
Homo sapiens
Gene name
SLC18A2
Gene synonyms
SVMT, VMAT2
NCBI Gene ID
Protein name
synaptic vesicular amine transporter
Protein synonyms
monoamine neurotransmitter transporter, Monoamine transporter, solute carrier family 18 (vesicular monoamine transporter), member 2, Solute carrier family 18 member 2, synaptic vesicle amine transporter, brain, synaptic vesicle monoamine transporter, brain, VAT2, vesicle monoamine transporter type 2, vesicle monoamine/H+ antiporter, Vesicular amine transporter 2
Uniprot ID
Mouse ortholog
Slc18a2 (214084)
synaptic vesicular amine transporter (Q8CC55)
Alternate
SLC18A1
SLC18A1
Organism
Homo sapiens
Gene name
SLC18A1
Gene synonyms
VAT1, VMAT1
NCBI Gene ID
Protein name
chromaffin granule amine transporter
Protein synonyms
solute carrier family 18 (vesicular monoamine transporter), member 1, solute carrier family 18 (vesicular monoamine), member 1, Solute carrier family 18 member 1, VAT1, Vesicular amine transporter 1
Uniprot ID
Mouse ortholog
Slc18a1 (110877)
chromaffin granule amine transporter (Q8R090)
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,533 documents
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Safety
Black-box Warning
Black-box warning for: Tetrabenazine, Xenazine
Adverse Events
Top Adverse Reactions
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11,596 adverse events reported
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