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Rexulti, Rxulti(brexpiprazole)
Rexulti, Rxulti (brexpiprazole) is a small molecule pharmaceutical. Brexpiprazole was first approved as Rexulti on 2015-07-10. It is used to treat major depressive 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.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
mental disordersD001523
Trade Name
FDA
EMA
Rexulti (generic drugs available since 2022-08-11)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Brexpiprazole
Tradename
Company
Number
Date
Products
REXULTIOtsukaN-205422 RX2015-07-10
6 products, RLD
Labels
FDA
EMA
Brand Name
Status
Last Update
rexultiNew Drug Application2022-11-09
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
major depressive disorderEFO_0003761D003865F22
schizophreniaEFO_0000692D012559F20
schizophrenia spectrum and other psychotic disorders—D019967—
Agency Specific
FDA
EMA
Expiration
Code
BREXPIPRAZOLE, REXULTI, OTSUKA
2024-12-27NPP
Patent Expiration
Patent
Expires
Flag
FDA Information
Brexpiprazole, Rexulti, Otsuka
103074192032-10-12DP
RE480592028-12-23DP
78883622026-04-12DP
83498402026-04-12DPU-1529
86181092026-04-12U-543, U-3281
98396372026-04-12DPU-543, U-1529, U-3281
ATC Codes
N: Nervous system drugs
— N05: Psycholeptics
— N05A: Antipsychotics
— N05AX: Other antipsychotics in atc
— N05AX16: Brexpiprazole
HCPCS
No data
Clinical
Clinical Trials
86 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Major depressive disorderD003865EFO_0003761F2214183126
SchizophreniaD012559EFO_0000692F2084121125
Bipolar disorderD001714EFO_0000289F30.91—41—6
DepressionD003863F33.9——51—6
Psychotic disordersD011618F20.811——1—2
Substance-related disordersD019966EFO_0003890F13———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Mental disordersD001523EFO_0000677F91.91—7——8
Post-traumatic stress disordersD013313EFO_0001358F43.1—23——5
Mood disordersD019964EFO_0004247F30-F39——5——5
Depressive disorderD003866EFO_1002014F32.A——5——5
Alzheimer diseaseD000544EFO_0000249F03——4——4
Borderline personality disorderD001883HP_0012076F60.3—31——3
DementiaD003704F03—12——2
ManiaD000087122F30——2——2
Nervous system diseasesD009422G00-G99——2——2
AnxietyD001007EFO_0005230F41.1——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AlcoholismD000437EFO_0003829F10.1—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—1————1
Autistic disorderD001321EFO_0003758F84.01————1
Conduct disorderD019955EFO_0004216F911————1
Attention deficit and disruptive behavior disordersD019958HP_0010865F91.31————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Tic disordersD013981F95————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBREXPIPRAZOLE
INNbrexpiprazole
Description
Brexpiprazole is a N-arylpiperazine.
Classification
Small molecule
Drug classantiulcer agents (benzimidazole derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
O=c1ccc2ccc(OCCCCN3CCN(c4cccc5sccc45)CC3)cc2[nH]1
Identifiers
PDB—
CAS-ID913611-97-9
RxCUI1658314
ChEMBL IDCHEMBL2105760
ChEBI ID—
PubChem CID11978813
DrugBankDB09128
UNII ID2J3YBM1K8C (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
DRD2
DRD2
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
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 895 documents
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Safety
Black-box Warning
Black-box warning for: Rexulti
Adverse Events
Top Adverse Reactions
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2,355 adverse events reported
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