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.
Download report
Favorite
Commercial
Trade Name
FDA
EMA
Xenazine (generic drugs available since 2016-02-03)
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 | 2022-12-15 |
| tetrabenazine | ANDA | 2022-12-15 |
| xenazine | New Drug Application | 2019-11-29 |
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
442 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypogonadism | D007006 | E23.0 | 23 | 43 | 32 | 36 | 15 | 142 | |
| Eunuchism | D005058 | EFO_0007266 | E29.1 | 5 | 9 | 10 | 9 | 3 | 35 |
| Healthy volunteers/patients | — | 10 | 4 | 2 | 2 | 3 | 19 | ||
| Psychological sexual dysfunctions | D020018 | F52.0 | 1 | 2 | 12 | 1 | 1 | 17 | |
| Obesity | D009765 | EFO_0001073 | E66.9 | 2 | 3 | 1 | 3 | 3 | 11 |
| Sarcopenia | D055948 | EFO_1000653 | M62.84 | — | 3 | 2 | 4 | 1 | 10 |
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | 1 | 1 | 1 | 6 | 1 | 10 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | 2 | 3 | 3 | 3 | 1 | 10 |
| Aging | D000375 | GO_0007568 | R41.81 | 4 | 2 | 1 | 1 | 2 | 10 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | 3 | — | 6 | — | 9 |
Show 37 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | C61 | 5 | 12 | 1 | — | 4 | 22 | |
| Spinal cord injuries | D013119 | EFO_1001919 | 1 | 7 | 2 | — | — | 7 | |
| Infertility | D007246 | EFO_0000545 | 2 | 1 | 2 | — | 2 | 6 | |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 3 | 1 | — | 1 | 6 |
| Menopause | D008593 | EFO_0003922 | N95 | — | 4 | 1 | — | 1 | 6 |
| Transsexualism | D014189 | F64.0 | — | — | 2 | — | 2 | 4 | |
| Neoplasms | D009369 | C80 | — | 2 | 2 | — | — | 4 | |
| Hip fractures | D006620 | EFO_0003964 | S72.00 | — | 1 | 2 | — | — | 3 |
| Physiological sexual dysfunction | D012735 | — | 1 | 1 | — | — | 2 | ||
| Testicular neoplasms | D013736 | C62 | — | 2 | 1 | — | — | 2 |
Show 21 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Contraception | D003267 | 8 | 6 | — | — | — | 11 | ||
| Castration-resistant prostatic neoplasms | D064129 | 1 | 6 | — | — | — | 7 | ||
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 2 | 1 | — | — | 2 | 5 |
| Insulin resistance | D007333 | EFO_0002614 | 2 | 2 | — | — | 2 | 5 | |
| Androgen-insensitivity syndrome | D013734 | E34.5 | 1 | 3 | — | — | 1 | 4 | |
| Depression | D003863 | F33.9 | — | 2 | — | — | 2 | 4 | |
| Gonadal disorders | D006058 | 1 | 3 | — | — | 1 | 4 | ||
| Dyspareunia | D004414 | HP_0030016 | N94.1 | 2 | 1 | — | — | 1 | 3 |
| Endocrine system diseases | D004700 | EFO_0001379 | E34.9 | 1 | 3 | — | — | — | 3 |
| Cachexia | D002100 | HP_0004326 | R64 | 2 | 1 | — | — | — | 3 |
Show 32 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Male infertility | D007248 | EFO_0004248 | N46 | 1 | — | — | — | 1 | 2 |
| Facioscapulohumeral muscular dystrophy | D020391 | EFO_0000491 | G71.02 | 1 | — | — | — | — | 1 |
| Cerebral arterial diseases | D002539 | EFO_1000859 | 1 | — | — | — | — | 1 | |
| Pharmacokinetics | D010599 | 1 | — | — | — | — | 1 | ||
| Breast density | D000071060 | 1 | — | — | — | — | 1 | ||
| Postmenopause | D017698 | 1 | — | — | — | — | 1 | ||
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 1 | — | — | — | — | 1 |
| Priapism | D011317 | HP_0200023 | N48.3 | 1 | — | — | — | — | 1 |
| Virilism | D014770 | 1 | — | — | — | — | 1 | ||
| Squamous cell neoplasms | D018307 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | — | 2 | 2 |
| Delayed puberty | D011628 | HP_0000823 | E30.0 | — | — | — | — | 2 | 2 |
| Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | — | — | — | — | 1 | 1 |
| Thalassemia | D013789 | EFO_1001996 | D56 | — | — | — | — | 1 | 1 |
| Stress urinary incontinence | D014550 | HP_0010992 | — | — | — | — | 1 | 1 | |
| Hysterectomy | D007044 | EFO_0003881 | — | — | — | — | 1 | 1 | |
| Ovariectomy | D010052 | — | — | — | — | 1 | 1 | ||
| Precocious puberty | D011629 | E22.8 | — | — | — | — | 1 | 1 | |
| Duchenne muscular dystrophy | D020388 | — | — | — | — | 1 | 1 | ||
| Paraplegia | D010264 | HP_0001258 | G82.2 | — | — | — | — | 1 | 1 |
Show 27 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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 | 10390 |
| 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
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
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 2,209 documents
View more details
Safety
Black-box Warning
Black-box warning for: Tetrabenazine, Tetrabenazine, Xenazine
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
28,733 adverse events reported
View more details
Premium feature
Learn more about premium features at pharmakb.com
Learn more