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Drug ReportsValbenazine
Valbenazine
Ingrezza, Valbenazine (valbenazine) is a small molecule pharmaceutical. Valbenazine was first approved as Ingrezza on 2017-04-11. It is used to treat tardive dyskinesia in the USA. The pharmaceutical is active against synaptic vesicular amine transporter.
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FDA approval date
EMA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Ingrezza, Valbenazine
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Valbenazine tosylate
Tradename
Company
Number
Date
Products
INGREZZANeurocrine BiosciencesN-209241 RX2017-04-11
3 products, RLD
INGREZZA SPRINKLENeurocrine BiosciencesN-218390 RX2024-04-30
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
ingrezzaNew Drug Application2023-08-18
ingrezza ingrezza sprinkleNew Drug Application2024-04-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
tardive dyskinesia—D000071057G24.01
Agency Specific
FDA
EMA
Expiration
Code
VALBENAZINE TOSYLATE, INGREZZA, NEUROCRINE
2030-08-18ODE-440
2026-08-18I-925
Patent Expiration
Patent
Expires
Flag
FDA Information
Valbenazine Tosylate, Ingrezza, Neurocrine
109401412040-08-10U-1995
110269312039-08-14U-1995
116541422038-11-14U-3055
110269392038-09-18DPU-1995, U-3055
113115322038-09-18DPU-1995, U-3055
108571372037-10-10U-1995
108571482037-10-10U-1995
108746482037-10-10U-1995, U-3046, U-3055
109127712037-10-10U-1995, U-3055, U-3076
109529972037-10-10U-1995
109939412037-10-10U-1995
110400292037-10-10U-1995
114396292037-10-10U-3055
109069022036-12-22DS, DP
109069032036-12-22DS, DP
109198922036-12-22DS, DP
100659522036-10-28DS, DPU-1995, U-3055
108440582036-10-28DS, DPU-1995, U-3055
108511032036-10-28DS, DPU-1995, U-3055
108511042036-10-28DPU-1995, U-3055
80396272031-04-11DS, DP
83576972027-11-08U-1995, U-3055
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
— N07XX13: Valbenazine
HCPCS
No data
Clinical
Clinical Trials
31 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DyskinesiasD020820HP_0002310G241554—14
Tardive dyskinesiaD000071057—G24.011544—13
SchizophreniaD012559EFO_0000692F20—221—5
Psychotic disordersD011618—F20.81—2—1—3
Substance withdrawal syndromeD013375EFO_0005800————1—1
TorticollisD014103HP_0000473F45.8———1—1
Dystonic disordersD020821—G24———1—1
DystoniaD004421HP_0001332G24———1—1
Bipolar disorderD001714EFO_0000289F30.9———1—1
Major depressive disorderD003865EFO_0003761F22———1—1
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Huntington diseaseD006816Orphanet_399G10——3——3
ChoreaD002819EFO_0004152G25.5——3——3
Cerebral palsyD002547—G80——1——1
ParalysisD010243HP_0003470———1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Tourette syndromeD005879EFO_0004895F95.217———8
SyndromeD013577——17———8
TrichotillomaniaD014256HP_0012167F63.3—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Liver failureD017093HP_0001399K72.91————1
Hepatic insufficiencyD048550——1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameValbenazine
INNvalbenazine
Description
Valbenazine, sold under the brand name Ingrezza, is a medication used to treat tardive dyskinesia. It acts as a vesicular monoamine transporter 2 (VMAT2) inhibitor.
Classification
Small molecule
Drug class—
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
COc1cc2c(cc1OC)[C@H]1C[C@@H](OC(=O)[C@@H](N)C(C)C)[C@H](CC(C)C)CN1CC2
Identifiers
PDB—
CAS-ID1025504-45-3
RxCUI—
ChEMBL IDCHEMBL2364639
ChEBI ID—
PubChem CID24795069
DrugBankDB11915
UNII ID54K37P50KH (ChemIDplus, GSRS)
Target
Agency Approved
SLC18A2
SLC18A2
Organism
Homo sapiens
Gene name
SLC18A2
Gene synonyms
SVMT, VMAT2
NCBI Gene ID
6571
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
Q9H3P6
Mouse ortholog
Slc18a2 (214084)
synaptic vesicular amine transporter (Q8CC55)
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
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Additional graphs summarizing 301 documents
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Safety
Black-box Warning
Black-box warning for: Ingrezza, Ingrezza ingrezza sprinkle
Adverse Events
Top Adverse Reactions
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22,134 adverse events reported
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