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Abilify(aripiprazole)
Abilify (aripiprazole) is a small molecule pharmaceutical. Aripiprazole was first approved as Abilify on 2002-11-15. 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 1B, histamine H1 receptor, 5-hydroxytryptamine receptor 2A, 5-hydroxytryptamine receptor 2C, 5-hydroxytryptamine receptor 1D, D(4) dopamine receptor, 5-hydroxytryptamine receptor 7, and 5-hydroxytryptamine receptor 6.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
mental disordersD001523
Trade Name
FDA
EMA
Abilify, Abilify asimtufii (generic drugs available since 2015-04-28)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Aripiprazole
Tradename
Company
Number
Date
Products
ABILIFYOtsukaN-021436 RX2002-11-15
6 products, RLD
ABILIFY MYCITE KITOtsukaN-207202 RX2017-11-13
6 products, RLD
ABILIFY ASIMTUFIIOtsukaN-217006 RX2023-04-27
2 products, RLD, RS
ABILIFY MAINTENA KITOtsukaN-202971 RX2013-02-28
4 products, RLD, RS
Show 3 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
abilify asimtufiiNew Drug Application2023-05-03
aripiprazoleANDA2023-05-30
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, Abilify Maintena Kit, Otsuka Pharm Co Ltd
105250572034-03-08U-543, U-1632, U-2723
109808032033-09-24U-543, U-1632
111545532033-09-24U-814, U-1632, U-3245
113445472033-09-24U-814, U-1632, U-3245
114000872033-09-24U-814, U-1632, U-3245
78076802024-10-19DP
80303132024-10-19U-543, U-1632
87226792024-10-19DP
Aripiprazole, Abilify Mycite Kit, Otsuka
92689092033-10-15DPU-2168
105175072032-06-13DP
93204552031-12-15DP
112293782031-07-11DP
85472482030-12-18DPU-2167
82589622030-11-25DP
89614122030-11-17DP
99419312030-11-04DP
114644232030-09-15DP
81140212030-06-21DP
85454022030-04-27DP
88477662030-03-29DPU-2167
91495772029-12-15DP
87181932029-12-05DP
94333712029-09-15DP
89450052029-08-19DPU-2167
104411942029-07-26DP
89562882029-07-06DPU-2167
86748252029-04-09DPU-2170
90607082029-03-05DP
92580352029-03-05DP
91195542028-12-16DP
94445032027-11-19DPU-2169
79780642026-09-14DP
114769522026-04-28DP
Aripiprazole, Abilify Asimtufii, Otsuka
105179512033-04-23DPU-814, U-3245
110970072033-04-23DPU-814, U-3245
116387572033-04-23DPU-814, U-3245
83994692025-06-29DP
83384272025-03-15DPU-543, U-1530, U-1633
83384282023-08-06DPU-543, U-1530, U-1633
87593512023-08-06DPU-1530, U-1633
Aripiprazole, Abilify, Otsuka
87593502027-03-02U-1529
91259392026-07-28U-1749
71155872024-07-21DPU-764
75504452024-07-21DP
80176152024-06-16DP
93871822023-12-25U-1529
ATC Codes
N: Nervous system drugs
— N05: Psycholeptics
— N05A: Antipsychotics
— N05AX: Other antipsychotics in atc
— N05AX12: Aripiprazole
HCPCS
Code
Description
J0400
Injection, aripiprazole, intramuscular, 0.25 mg
J0401
Injection, aripiprazole, extended release, 1 mg
J1943
Injection, aripiprazole lauroxil, (aristada initio), 1 mg
J1944
Injection, aripiprazole lauroxil, (aristada), 1 mg
Clinical
Clinical Trials
351 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_0000692F202017426419156
Bipolar disorderD001714EFO_0000289F30.94324181361
Psychotic disordersD011618F20.81238261149
Major depressive disorderD003865EFO_0003761F22111312330
Autistic disorderD001321EFO_0003758F84.0—372214
Tourette syndromeD005879EFO_0004895F95.2——72110
Tic disordersD013981F95—14228
Metabolic syndromeD024821EFO_0000195E88.81——1236
DepressionD003863F33.9—11226
AlcoholismD000437EFO_0003829F10.1—331—6
Show 34 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Anorexia nervosaD000856EFO_0004215F50.0——1—12
Behavioral symptomsD001526HP_0000708——2——2
Post-traumatic stress disordersD013313EFO_0001358F43.1—11——2
Psychophysiologic disordersD011602F45.9——1——1
Drug therapyD004358—11——1
Postpartum depressionD019052EFO_0007453F53.0——1——1
Body weight changesD001836——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Obsessive-compulsive disorderD009771EFO_0004242F42—1——23
Cocaine-related disordersD019970F1412———3
Asperger syndromeD020817EFO_0003757F84.5—3———3
Nervous system diseasesD009422G00-G9911———2
Mental disordersD001523EFO_0000677F91.911———2
Hiv infectionsD015658EFO_0000764B20—1———1
Fragile x syndromeD005600Q99.2—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—4————4
Depressive disorderD003866EFO_1002014F32.A2————2
ImmunoassayD0071181————1
Amphetamine-related disordersD019969EFO_0004701F151————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
RecurrenceD012008————11
Body weightD001835EFO_0004338————11
Therapeutic equivalencyD013810————11
Dissociative disordersD004213F44.1————11
CognitionD003071EFO_0003925————11
TrichotillomaniaD014256HP_0012167F63.3————11
Mood disordersD019964EFO_0004247F30-F39————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameARIPIPRAZOLE
INNaripiprazole
Description
Aripiprazole is an N-arylpiperazine that is piperazine substituted by a 4-[(2-oxo-1,2,3,4-tetrahydroquinolin-7-yl)oxy]butyl group at position 1 and by a 2,3-dichlorophenyl group at position 4. It is an antipsychotic drug used for the treatment of Schizophrenia, and other mood disorders. It has a role as a H1-receptor antagonist, a serotonergic agonist, a second generation antipsychotic and a drug metabolite. It is a quinolone, a N-arylpiperazine, a N-alkylpiperazine, a dichlorobenzene, 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)
O=C1CCc2ccc(OCCCCN3CCN(c4cccc(Cl)c4Cl)CC3)cc2N1
Identifiers
PDB7VOE
CAS-ID129722-12-9
RxCUI89013
ChEMBL IDCHEMBL1112
ChEBI ID31236
PubChem CID60795
DrugBankDB01238
UNII ID82VFR53I78 (ChemIDplus, GSRS)
Target
Agency Approved
DRD2
DRD2
Organism
Homo sapiens
Gene name
DRD2
Gene synonyms
NCBI Gene ID
Protein name
D(2) dopamine receptor
Protein synonyms
Dopamine D2 receptor, seven transmembrane helix receptor
Uniprot ID
Mouse ortholog
Drd2 (13489)
D(2) dopamine receptor (Q0VGH9)
Alternate
HTR1A
HTR1A
HTR1B
HTR1B
HRH1
HRH1
HTR2A
HTR2A
HTR2C
HTR2C
HTR1D
HTR1D
DRD4
DRD4
HTR7
HTR7
HTR6
HTR6
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
Clinical Variant
No data
Financial
Abilify - Bristol Myers Squibb
$
€
£
₣
Mock data
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 12,872 documents
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Safety
Black-box Warning
Black-box warning for: Abilify asimtufii, Aripiprazole
Adverse Events
Top Adverse Reactions
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1,836 adverse events reported
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