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Drug ReportsAripiprazole lauroxil
Aripiprazole lauroxil
Abilify, Aripiprazole, 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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Drug
Target
Variants
Financial
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Events Timeline
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1M
3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
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Study first post date
Last update post date
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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
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, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
abilifyNew Drug Application2025-01-29
abilify abilifyNew Drug Application2013-08-13
abilify abilify discmelt2008-08-28
abilify asimtufiiNew Drug Application2025-01-29
abilify maintenaNew Drug Application2025-03-05
abilify maintena kitNew Drug Application2013-04-02
abilify myciteNew Drug Application2025-01-31
aripiprazoleANDA2025-03-24
aripiprazole oral solutionANDA2016-08-31
aristadaNew Drug Application2025-01-28
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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
449 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SchizophreniaD012559EFO_0000692F201083113766
Bipolar disorderD001714EFO_0000289F30.933194432
Major depressive disorderD003865EFO_0003761F22—1112216
Depressive disorderD003866EFO_1002014F32.A—1112216
DepressionD003863—F33.9—1112115
Psychotic disordersD011618—F20.81——53210
Mental disordersD001523EFO_0000677F91.9121239
Tourette syndromeD005879EFO_0004895F95.2——61—7
Metabolic syndromeD024821EFO_0000195E88.810——11—2
SyndromeD013577————11—2
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Autistic disorderD001321EFO_0003758F84.0——5—16
Alzheimer diseaseD000544EFO_0000249F03——5——5
DementiaD003704EFO_0003862F03——3——3
Tic disordersD013981—F95——3——3
TicsD020323————3——3
ManiaD000087122—F30—11——2
Behavioral symptomsD001526————2——2
Psychomotor agitationD011595————1——1
Problem behaviorD000066553————1——1
Schizophrenia spectrum and other psychotic disordersD019967————1——1
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Nervous system diseasesD009422—G00-G9912——14
HyperkinesisD006948———1———1
Attention deficit disorder with hyperactivityD001289EFO_0003888F90—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———3————3
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Psychotic affective disordersD000341—F39————11
Mood disordersD019964EFO_0004247F30-F39————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)Loading
Structure (InChI/SMILES or Protein Sequence)
CCCCCCCCCCCC(=O)OCN1C(=O)CCc2ccc(OCCCCN3CCN(c4cccc(Cl)c4Cl)CC3)cc21
Identifiers
PDB—
CAS-ID1259305-29-7
RxCUI—
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
No data
Financial
Revenue by drug
$
€
£
₣
Abilify – Bristol Myers Squibb
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Aristada – Alkermes
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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 16,128 documents
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Safety
Black-box Warning
Black-box warning for: Abilify, Abilify abilify, Abilify abilify discmelt, Abilify asimtufii, Abilify maintena, Abilify mycite, Aripiprazole, Aripiprazole oral solution, Aristada, Aristada initio, Opipza
Adverse Events
Top Adverse Reactions
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92,822 adverse events reported
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