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Drug ReportsCariprazine
Vraylar, Reagila(cariprazine)
Reagila, Vraylar (cariprazine) is a small molecule pharmaceutical. Cariprazine was first approved as Vraylar on 2015-09-17. It is used to treat bipolar disorder, schizophrenia, and schizophrenia spectrum and other psychotic disorders in the USA. It has been approved in Europe to treat schizophrenia. It is known to target D(2) dopamine receptor and D(3) dopamine receptor.
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Events Timeline
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3M
6M
YTD
1Y
2Y
5Y
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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
mental disordersD001523
Trade Name
FDA
EMA
Vraylar (discontinued: Cariprazine)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Cariprazine hydrochloride
Tradename
Company
Number
Date
Products
VRAYLARAbbVieN-204370 RX2015-09-17
4 products, RLD
Labels
FDA
EMA
Brand Name
Status
Last Update
vraylarNew Drug Application2024-11-22
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
schizophreniaEFO_0000692D012559F20
bipolar disorderEFO_0000289D001714F30.9
schizophrenia spectrum and other psychotic disorders—D019967—
Agency Specific
FDA
EMA
Expiration
Code
CARIPRAZINE HYDROCHLORIDE, VRAYLAR, ABBVIE
2025-12-16I-904
Patent Expiration
Patent
Expires
Flag
FDA Information
Cariprazine Hydrochloride, Vraylar, Abbvie
77371422029-09-17DS, DPU-1750, U-2543, U-2544, U-2545, U-3503
RE473502029-07-16U-1750, U-2543, U-2544, U-2545, U-3503
RE491102029-07-16U-2543, U-2544, U-2545, U-3503
RE493022029-07-16U-2543, U-2544, U-2545, U-3503
79436212028-12-16DS, DP
ATC Codes
N: Nervous system drugs
— N05: Psycholeptics
— N05A: Antipsychotics
— N05AX: Other antipsychotics in atc
— N05AX15: Cariprazine
HCPCS
No data
Clinical
Clinical Trials
51 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Anxiety disordersD001008EFO_0006788F41.1—1—1—2
Social phobiaD000072861EFO_1001917F40.1———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DepressionD003863—F33.9——4——4
Bipolar disorderD001714EFO_0000289F30.9——3—14
SchizophreniaD012559EFO_0000692F20——3——3
Autistic disorderD001321EFO_0003758F84.01—2——3
Autism spectrum disorderD000067877—F84.01—2——3
Pervasive child development disordersD002659EFO_0003756F84——2——2
Major depressive disorderD003865EFO_0003761F22——2——2
Depressive disorderD003866EFO_1002014F32.A——2——2
RecurrenceD012008————1——1
ManiaD000087122—F30——1——1
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCariprazine
INNcariprazine
Description
Cariprazine is an N-alkylpiperazine that is N,N-dimethyl-N'-{trans-4-[2-(piperazin-1-yl)ethyl]cyclohexyl}urea substituted at position 4 on the piperazine ring by a 2,3-dichlorophenyl group. Used (as the hydrochloride salt) for treatment of schizophrenia and bipolar disorder. It has a role as a dopamine agonist, a second generation antipsychotic and a serotonergic antagonist. It is a member of ureas, a N-alkylpiperazine, a N-arylpiperazine and a dichlorobenzene. It is a conjugate base of a cariprazine(1+).
Classification
Small molecule
Drug classAtypical antipsychotic
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1
Identifiers
PDB—
CAS-ID839712-12-8
RxCUI—
ChEMBL IDCHEMBL2028019
ChEBI ID—
PubChem CID11154555
DrugBankDB06016
UNII IDF6RJL8B278 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
DRD2
DRD2
DRD3
DRD3
Organism
Homo sapiens
Gene name
DRD2
Gene synonyms
NCBI Gene ID
1813
Protein name
D(2) dopamine receptor
Protein synonyms
Dopamine D2 receptor, seven transmembrane helix receptor
Uniprot ID
Q9UPA9
Mouse ortholog
Drd2 (13489)
D(2) dopamine receptor (Q0VGH9)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Vraylar – Allergan
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Vraylar – Warner Chilcott
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Vraylar – AbbVie
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,297 documents
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Safety
Black-box Warning
Black-box warning for: Vraylar
Adverse Events
Top Adverse Reactions
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5,613 adverse events reported
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