Aristada, Abilify(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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EMA approval date
Patent expiration date
Study first post date
Last update post date
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| mental disorders | D001523 |
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)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| abilify | New Drug Application | 2022-11-30 |
| abilify abilify | New Drug Application | 2013-08-13 |
| abilify abilify discmelt | 2008-08-28 | |
| abilify asimtufii | New Drug Application | 2024-01-30 |
| abilify maintena | New Drug Application | 2024-02-13 |
| abilify maintena kit | New Drug Application | 2013-04-02 |
| abilify mycite | New Drug Application | 2023-10-16 |
| aripiprazole | ANDA | 2024-02-14 |
| aripiprazole oral solution | ANDA | 2016-08-31 |
| aristada | New Drug Application | 2023-12-01 |
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| schizophrenia | EFO_0000692 | D012559 | F20 |
| 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 | |||
| 11273158 | 2039-04-06 | U-543 | |
| 9452131 | 2035-03-19 | U-2402 | |
| 9526726 | 2035-03-19 | DP | |
| 10238651 | 2035-03-19 | U-2402 | |
| 10813928 | 2035-03-19 | U-2402, U-2983 | |
| 11406632 | 2035-03-19 | U-2402 | |
| 9193685 | 2033-10-24 | DP | U-543 |
| 11097006 | 2033-10-24 | DP | U-764 |
| 9034867 | 2032-11-07 | DP | U-543 |
| 10226458 | 2032-03-19 | U-543 | |
| 8431576 | 2030-10-26 | DP | |
| 8796276 | 2030-06-24 | U-543 | |
| 10112903 | 2030-06-24 | DP | U-543 |
| Aripiprazole Lauroxil, Aristada Initio Kit, Alkermes Inc | |||
| 10016415 | 2035-09-08 | DP | |
| 10688091 | 2035-08-17 | DP | |
| 10849894 | 2035-08-17 | U-543 | |
| 11154552 | 2035-08-17 | DP | |
Clinical
Clinical Trials
439 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Schizophrenia | D012559 | EFO_0000692 | F20 | 22 | 22 | 46 | 70 | 42 | 196 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | 4 | 4 | 25 | 21 | 18 | 71 |
| Psychotic disorders | D011618 | — | F20.81 | 4 | 3 | 9 | 27 | 21 | 63 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 1 | 1 | 14 | 13 | 6 | 35 |
| Autistic disorder | D001321 | HP_0000717 | F84.0 | — | 3 | 7 | 2 | 2 | 14 |
| Tourette syndrome | D005879 | EFO_0004895 | F95.2 | — | — | 7 | 2 | 2 | 11 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | — | 1 | 2 | 6 | 9 |
| Depression | D003863 | — | F33.9 | 1 | 2 | 1 | 3 | 3 | 9 |
| Tic disorders | D013981 | — | F95 | — | 1 | 4 | 2 | 2 | 8 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | 3 | 3 | 1 | 1 | 7 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anorexia nervosa | D000856 | EFO_0004215 | F50.0 | — | — | 1 | — | 1 | 2 |
| Behavioral symptoms | D001526 | HP_0000708 | — | — | — | 2 | — | — | 2 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | 1 | 1 | — | — | 2 |
| Psychophysiologic disorders | D011602 | — | F45.9 | — | — | 1 | — | — | 1 |
| Drug therapy | D004358 | — | — | — | 1 | 1 | — | — | 1 |
| Low back pain | D017116 | HP_0003419 | M54.5 | — | 1 | 1 | — | — | 1 |
| Postpartum depression | D019052 | EFO_0007453 | F53.0 | — | — | 1 | — | — | 1 |
| Body weight changes | D001836 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mental disorders | D001523 | EFO_0000677 | F91.9 | 1 | 2 | — | — | 2 | 5 |
| Nervous system diseases | D009422 | — | G00-G99 | 1 | 2 | — | — | 1 | 4 |
| Cocaine-related disorders | D019970 | — | F14 | 2 | 2 | — | — | — | 4 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 2 | 1 | — | — | — | 3 |
| Obsessive-compulsive disorder | D009771 | EFO_0004242 | F42 | — | 1 | — | — | 2 | 3 |
| Asperger syndrome | D020817 | EFO_0003757 | F84.5 | — | 3 | — | — | — | 3 |
| Fragile x syndrome | D005600 | — | Q99.2 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 5 | — | — | — | — | 5 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | — | — | — | — | 1 |
| Immunoassay | D007118 | — | — | 1 | — | — | — | — | 1 |
| Central nervous system diseases | D002493 | HP_0002011 | G96.9 | 1 | — | — | — | — | 1 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | 1 | — | — | — | — | 1 |
| Amphetamine-related disorders | D019969 | EFO_0004701 | F15 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | — | — | — | 2 | 2 |
| Drug interactions | D004347 | — | — | — | — | — | — | 1 | 1 |
| Chemical and drug induced liver injury | D056486 | EFO_0004228 | — | — | — | — | — | 1 | 1 |
| Recurrence | D012008 | — | — | — | — | — | — | 1 | 1 |
| Body weight | D001835 | EFO_0004338 | — | — | — | — | — | 1 | 1 |
| Therapeutic equivalency | D013810 | — | — | — | — | — | — | 1 | 1 |
| Dissociative disorders | D004213 | — | F44.1 | — | — | — | — | 1 | 1 |
| Cognition | D003071 | EFO_0003925 | — | — | — | — | — | 1 | 1 |
| Trichotillomania | D014256 | HP_0012167 | F63.3 | — | — | — | — | 1 | 1 |
| Psychiatry | D011570 | — | — | — | — | — | — | 1 | 1 |
Show 8 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Aripiprazole lauroxil |
| INN | aripiprazole |
| 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 class | antiulcer 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-ID | 1259305-29-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2219425 |
| ChEBI ID | — |
| PubChem CID | 49831411 |
| DrugBank | DB14185 |
| UNII ID | 82VFR53I78 (ChemIDplus, GSRS) |
Target
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
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
Mouse ortholog
Htr1a (15550)
5-hydroxytryptamine receptor 1A (Q8BGS4)
Variants
No data
Financial
Revenue by drug
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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 14,699 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
Adverse Events
Top Adverse Reactions
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72,770 adverse events reported
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