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Aristada, Abilify(aripiprazole lauroxil)
Abilify, Aristada (aripiprazole lauroxil) is a small molecule pharmaceutical. Aripiprazole lauroxil was first approved as Abilify on 2004-06-04. It is used to treat schizophrenia and schizophrenia spectrum and other psychotic disorders in the USA. It has been approved in Europe to treat bipolar disorder and schizophrenia. The pharmaceutical is active against D(2) dopamine receptor. In addition, it is known to target 5-hydroxytryptamine receptor 1A, 5-hydroxytryptamine receptor 2C, 5-hydroxytryptamine receptor 6, D(4) dopamine receptor, 5-hydroxytryptamine receptor 7, histamine H1 receptor, 5-hydroxytryptamine receptor 2A, 5-hydroxytryptamine receptor 1B, and 5-hydroxytryptamine receptor 1D.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
mental disordersD001523
Trade Name
FDA
EMA
Aristada
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Aripiprazole lauroxil
Tradename
Company
Number
Date
Products
ARISTADAAlkermesN-207533 RX2015-10-05
4 products, RLD, RS
ARISTADA INITIO KITAlkermesN-209830 RX2018-06-29
1 products, RLD
Labels
FDA
EMA
Brand Name
Status
Last Update
abilify asimtufiiNew Drug Application2023-05-03
aripiprazoleANDA2023-05-30
aristadaNew Drug Application2021-03-31
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
schizophreniaEFO_0000692D012559F20
schizophrenia spectrum and other psychotic disorders—D019967—
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Aripiprazole Lauroxil, Aristada, Alkermes Inc
112731582039-04-06U-543
94521312035-03-19U-2402
95267262035-03-19DP
102386512035-03-19U-2402
108139282035-03-19U-2402, U-2983
114066322035-03-19U-2402
91936852033-10-24DPU-543
110970062033-10-24DPU-764
90348672032-11-07DPU-543
102264582032-03-19U-543
84315762030-10-26DP
87962762030-06-24U-543
101129032030-06-24DPU-543
Aripiprazole Lauroxil, Aristada Initio Kit, Alkermes Inc
100164152035-09-08DP
106880912035-08-17DP
108498942035-08-17U-543
111545522035-08-17DP
ATC Codes
N: Nervous system drugs
— N05: Psycholeptics
— N05A: Antipsychotics
— N05AX: Other antipsychotics in atc
— N05AX12: Aripiprazole
HCPCS
Code
Description
J1943
Injection, aripiprazole lauroxil, (aristada initio), 1 mg
J1944
Injection, aripiprazole lauroxil, (aristada), 1 mg
Clinical
Clinical Trials
28 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Ischemic strokeD0000832421211—4
ThrombosisD013927—1—1—2
ThrombocytopeniaD013921HP_0001873D69.6———2—2
StrokeD020521EFO_0000712I63.9—1—1—2
Covid-19D000086382U07.1———1—1
Coronary artery bypassD001026EFO_0003776———1—1
Chronic kidney failureD007676EFO_0003884N18.6———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Venous thromboembolismD054556EFO_0004286I74——1——1
Female genital neoplasmsD005833——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Coronary artery diseaseD003324I25.1—1———1
Unstable anginaD000789EFO_1000985I20.0—1———1
Brain ischemiaD002545I67.82—1———1
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Respiratory insufficiencyD012131HP_0002093J96.9————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameARIPIPRAZOLE LAUROXIL
INNaripiprazole
Description
Aripiprazole lauroxil is a dodecanoate ester obtained by formal condensation of the carboxy group of dodecanoic acid with the hydroxy group of 7-{4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy}-2-oxo-3,4-dihydroquinolin-1(2H)-yl]methanol. A prodrug for aripiprazole, it is used for treatment of schizophrenia. It has a role as a H1-receptor antagonist, a second generation antipsychotic, a serotonergic agonist and a prodrug. It is a dodecanoate ester, a quinolone, a dichlorobenzene, a N-arylpiperazine, a N-alkylpiperazine, an aromatic ether and a delta-lactam.
Classification
Small molecule
Drug classantiulcer agents (benzimidazole derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CCCCCCCCCCCC(=O)OCN1C(=O)CCc2ccc(OCCCCN3CCN(c4cccc(Cl)c4Cl)CC3)cc21
Identifiers
PDB—
CAS-ID1259305-29-7
RxCUI1673265
ChEMBL IDCHEMBL2219425
ChEBI ID—
PubChem CID49831411
DrugBankDB14185
UNII ID82VFR53I78 (ChemIDplus, GSRS)
Target
Agency Approved
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)
Alternate
HTR1A
HTR1A
HTR2C
HTR2C
HTR6
HTR6
DRD4
DRD4
HTR7
HTR7
HRH1
HRH1
HTR2A
HTR2A
HTR1B
HTR1B
HTR1D
HTR1D
Organism
Homo sapiens
Gene name
HTR1A
Gene synonyms
ADRB2RL1, ADRBRL1
NCBI Gene ID
3350
Protein name
5-hydroxytryptamine receptor 1A
Protein synonyms
5-HT1a receptor, 5-hydroxytryptamine (serotonin) receptor 1A, G protein-coupled, G-21, guanine nucleotide-binding regulatory protein-coupled receptor, Serotonin receptor 1A
Uniprot ID
Q6LAE7
Mouse ortholog
Htr1a (15550)
5-hydroxytryptamine receptor 1A (Q8BGS4)
Variants
Clinical Variant
No data
Financial
Aristada - Alkermes
$
€
£
₣
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Abilify - Bristol Myers Squibb
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 12,882 documents
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Safety
Black-box Warning
Black-box warning for: Abilify asimtufii, Aripiprazole, Aristada
Adverse Events
Top Adverse Reactions
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1,181 adverse events reported
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