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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Commercial
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 |
|---|---|---|---|---|
| XENAZINE | Bausch Health Companies | N-021894 RX | 2008-08-15 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| tetrabenazine | ANDA | 2024-11-25 |
| xenazine | New Drug Application | 2022-06-22 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| huntington disease | Orphanet_399 | D006816 | G10 |
| hyperkinesis | — | D006948 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
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 disease | D006816 | Orphanet_399 | G10 | 2 | — | 5 | 2 | 1 | 10 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | 1 | — | 1 |
| Cerebral palsy | D002547 | — | G80 | — | — | — | 1 | — | 1 |
| Impulsive behavior | D007175 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tardive dyskinesia | D000071057 | — | G24.01 | — | 3 | 1 | — | — | 4 |
| Dyskinesias | D020820 | — | G24 | — | 3 | 1 | — | — | 4 |
| Chorea | D002819 | EFO_0004152 | G25.5 | — | — | 3 | — | — | 3 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | 2 | — | — | 2 | 4 |
| Psychotic disorders | D011618 | — | F20.81 | — | 2 | — | — | 2 | 4 |
| Tourette syndrome | D005879 | EFO_0004895 | F95.2 | — | 1 | — | — | — | 1 |
| Syndrome | D013577 | — | — | — | 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 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 1 | — | — | — | — | 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 reactions | D064420 | — | T88.7 | — | — | — | — | 1 | 1 |
| Drug interactions | D004347 | — | — | — | — | — | — | 1 | 1 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | — | 1 | 1 |
| Emergencies | D004630 | — | — | — | — | — | — | 1 | 1 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | — | — | — | 1 | 1 |
| Movement disorders | D009069 | EFO_0004280 | G25 | — | — | — | — | 1 | 1 |
| Hyperkinesis | D006948 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Tetrabenazine |
| INN | tetrabenazine |
| 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) |  |
| Structure (InChI/SMILES or Protein Sequence) | COc1cc2c(cc1OC)C1CC(=O)C(CC(C)C)CN1CC2 |
Identifiers
| PDB | — |
| CAS-ID | 58-46-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL117785 |
| ChEBI ID | 64028 |
| PubChem CID | 6018 |
| DrugBank | DB04844 |
| UNII ID | Z9O08YRN8O (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
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,632 documents
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Safety
Black-box Warning
Black-box warning for: Tetrabenazine, Xenazine
Adverse Events
Top Adverse Reactions
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12,745 adverse events reported
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