drug
as of 2026-07-01Aripiprazole
aripiprazole, olanzapine, quetiapine or risperidonearipiprazoleAripiprazole IM DepotABILIFY MYCITEAripiprazole tablet, 10 mgAripiprazole tablet, 30 mgAripiprazole (Abilify®) IM Depot InjectionOral aripiprazole
UNII 82VFR53I78RxCUI 349490, 349545, 349547, 349553, 352307, 352308FDA_ApplNo NDA021436SPL_set_id c040bd1d-45b7-49f2-93ea-aed7220b30acFDA_sponsor OTSUKAOrangeBook_Appl A078583, A078607, A078608, A078708, A090165, A090472, A091279, A201519
at a glance
small molecule · Atypical Antipsychotic [EPC]
US-approved (2002) as ABILIFY
Orange Book protection to 2041
199 trials in the graph
Synthesized from structured facts only — each point cited above.
Mechanism & identity
Modality
small molecule
FDA class
Atypical Antipsychotic [EPC]
Mechanism of action
12.1 Mechanism of Action The mechanism of action of aripiprazole in schizophrenia or bipolar mania, is unclear. However, the efficacy of aripiprazole in the listed indications could be mediated through a combination of partial agonist activity at D 2 and 5-HT 1A receptors and antagonist activity at 5-HT 2A receptors.
Indications
Labeled
SchizophreniaBipolar depressionBipolar maniaMajor depressive disorderIrritability/AutismTourette
Investigational (via trials)
SchizophreniaCardiovascular DiseasesSchizo Affective DisorderSubstance-Related DisordersHyperlipidemiaDiseaseDepressionObsessive-Compulsive DisorderPsychosomatic DisordersSocial Anxiety DisorderBody Weight ChangeBipolar 1 DisorderMood DisordersClozapine Resistant SchizophreniaAlcohol AbuseLipid Metabolism Disorders
Patents & exclusivity
Orange Book
patent 117013522041-12-15
patent 113313152040-11-03
patent 11273158 · U-5432039-04-06
patent 12251381 · U-5432039-04-06
patent 100164152035-09-08
patent 111545522035-08-17
patent 10849894 · U-5432035-08-17
patent 106880912035-08-17
patent 11406632 · U-24022035-03-19
patent 10813928 · U-24022035-03-19
patent 95267262035-03-19
patent 9452131 · U-24022035-03-19
Adverse-event signal
FAERS spontaneous · within-drug share
Eps Akathisia8.8%
top term: TREMOR
Weight Metabolic6.6%
top term: WEIGHT INCREASED
Sedation4.7%
top term: FATIGUE
Gi4.1%
top term: NAUSEA
Mortality3.1%
top term: SUICIDE ATTEMPT
Anticholinergic1.3%
top term: CONSTIPATION
Qt Cardiac1.1%
top term: ELECTROCARDIOGRAM QT PROLONGED
Nms0.8%
top term: NEUROLEPTIC MALIGNANT SYNDROME
Orthostatic0.6%
top term: HYPOTENSION
Spontaneous reports — a signal of reporting share, not incidence.
Trials
199
Biomarkers to Enhance Early Schizophrenia Treatment
NCT06969755Phase 4Recruiting
Cerebellum-based Imaging Neural Markers for Antipsychotic Response
NCT07483294Phase 4Recruiting
Study to Evaluate Efficacy and Safety of Roluperidone in Adult Subjects With Negative Symptoms and Stable Positive Symptoms of Schizophrenia and to Evaluate the Relapse Rate of Roluperidone and Antipsychotic Medications
NCT07565428Phase 3Recruiting
Steady-state Bioequivalence Study of Aripiprazole for Injection in Patients With Schizophrenia.
NCT07547384—Not Yet Recruiting
Maintenance ElectroConvulsive Therapy in Clozapine RESISTant Schizophrenia - the MECT-RESIST Trial
NCT06456983—Recruiting
Study on the Efficacy and Safety of QLM1016 in Schizophrenia
NCT06799559Phase 3Not Yet Recruiting
A Double-Blind, Randomized Comparative Study of Carliprazine and Aripiprazole in Patients with Acute Schizophrenia
NCT06589817Phase 3Not Yet Recruiting
Real-life Assessment of Abilify Maintena + Rexult in Schizophrenia
NCT05169268—Completed
A Study Assessing the Efficacy and Safety of HS-10380 in Hospitalized Adults With Acute Schizophrenia
NCT07550387Phase 2Completed
Atypical Antipsychotic-induced Mitochondrial Dysfunction in Patients With Schizophrenia
NCT06236451Phase 4Completed
Maintenance Electroconvulsive Therapy (ECT) Versus Aripiprazole in Clozapine-resistant Schizophrenia
NCT06501339Phase 4Not Yet Recruiting
Multidisciplinary Design to Optimize Schizophrenia Treatment Based on Multi-omics Data and Systems Biology Analysis
NCT06060886Phase 4Unknown
Evaluating the Effects of Adjunctive Aripiprazole on Weight and Metabolic Outcomes in Females
NCT06590298Phase 4Not Yet Recruiting
C-Cog in Early Course Schizophrenia Study
NCT05662306Phase 4Terminated
The Impact of Aripiprazole Long-acting on Myelin and Cognition in the Onset of Schizophrenia
NCT05322031Phase 4Completed
Substance Misuse To Psychosis for Stimulants
NCT03485417Phase 2, Phase 3Completed
A Clinical Study That Will Assess the Effect of SEP-363856 or Prior Antipsychotic (PA) Standard of Care on Body-weight Associated Parameters in Subjects With Schizophrenia
NCT05542264Phase 1Completed
Striatal Connectivity and Clinical Outcome in Psychosis
NCT02822092—Completed
Add-on Aripiprazole on Cardiometabolic Profile in Treatment Resistant Schizophrenia: RCT
NCT05766540Phase 4Unknown
A Clinical Study That Will Assess How Food Moves Through the Stomach and Effects Blood Glucose Levels in Subjects With Schizophrenia Taking SEP-363856 or and Prior Antipsychotic (PA) Standard
NCT05402111Phase 1Completed
Sequential Multiple-Assignment Randomized Trials to Compare Antipsychotic Treatments(SMART-CAT)
NCT03510325Phase 3Completed
A Trial to Assess a Wearable Patch's Functioning to Detect Medication Ingestion
NCT06372210—Completed
Aripiprazole for Bipolar Disorder and Alcohol Use Disorder
NCT02918370Phase 3Completed
KOLs & investigators
12
Christoph U. Correll, MDKOL score 96
Birte Glenthøj, ProfessorKOL score 19
Caroline Ward, PhD.KOL score 13
Benedicto Crespo-Facorro, ProfessorKOL score 12
Michael Davidson, professorKOL score 11
Paolo Brambilla, ProfessorKOL score 11
Rituparna Maiti, MDKOL score 8
Niels Bilenberg, Professor, MD.KOL score 8
Scott W. Woods, MDKOL score 8
Jonathan M. Meyer, MDKOL score 8
Wolfgang Fleischhacker, professorKOL score 8
Dilip V. Jeste, MDKOL score 7
Facts & assertions
26 sourced
Anda Generic Count
140
Boxed Warning
present
Dosing Frequency
once daily
Faers Share Anticholinergic
0.013
Faers Share Eps Akathisia
0.089
Faers Share Gi
0.041
Faers Share Mortality
0.031
Faers Share Nms
0.008
Faers Share Orthostatic
0.006
Faers Share Qt Cardiac
0.011
Faers Share Sedation
0.047
Faers Share Weight Metabolic
0.066
Fda Pharm Class Epc
Atypical Antipsychotic [EPC]
Has Generic Competition
yes
Latest Patent Expiry
2041-12-15
Latest Protection Date
2041-12-15
Mechanism Of Action
12.1 Mechanism of Action The mechanism of action of aripiprazole in schizophrenia or bipolar mania, is unclear. However, the efficacy of aripiprazole in the listed indications could be mediated through a combination of partial agonist activity at D 2 and 5-HT 1A receptors and antagonist activity at
Originator Company
Otsuka
Safety Eps Akathisia
present in label
Safety Nms
present in label
Safety Orthostatic
present in label
Safety Prolactin
present in label
Safety Sedation Somnolence
present in label
Safety Weight Metabolic
present in label
Us Approved
yes
Us Original Approval Date
2002-11-15
relationships
The graph out of here
developer
trial
trial
indication
indication
indication
indication
indication
KOL
Christoph U. Correll, MD
personKOL score 96
Birte Glenthøj, Professor
personKOL score 19
Caroline Ward, PhD.
personKOL score 13
Benedicto Crespo-Facorro, Professor
personKOL score 12