Abilify

(aripiprazole)

ApprovedSmall molecule

Aripiprazole is used to treat mental health conditions like schizophrenia, bipolar disorder, and depression by helping to balance certain chemicals in the brain that affect mood and behavior.[2] Abilify is currently approved and in use across 46 indications[4].[1]

Abilify is one of 769 small molecule programs targeting Metabolic Syndrome. It is currently in Approved.

Indications

266

Total Trials

Active Trials

768

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Metabolic SyndromeActive, not recruiting

Asperger SyndromeApproved

Pervasive Developmental DisorderActive, not recruiting

HyperprolactinemiaActive, not recruiting

Methamphetamine DependenceApproved

Bipolar I DisorderActive, not recruiting

Depressive DisorderApproved

Mental or Behavioural DisorderApproved

Cocaine AbuseApproved

Cognitive ImpairmentActive, not recruiting

Metabolic SyndromeApproved

Active, not recruiting

Asperger SyndromeApproved

Approved

Pervasive Developmental DisorderPhase 3

Active, not recruiting

HyperprolactinemiaPreclinical

Active, not recruiting

Methamphetamine DependenceApproved

Approved

Bipolar I DisorderPhase 3

Active, not recruiting

Depressive DisorderApproved

Approved

Mental or Behavioural DisorderApproved

Approved

Cocaine AbuseApproved

Approved

Cognitive ImpairmentPhase 2

Active, not recruiting

Showing 10 of 45 indications

Competition

Competitive Landscape

583 competitors in Schizophrenia

#DrugCompanyPhaseTrials

Abilify

Otsuka

Approved

71 2

Celexa

AbbVie

Preclinical

4 3

Ozempic

Novo Nordisk

Preclinical

1 4

Inapsine

Alnylam Pharmaceuticals

Preclinical

1 5

Zocor

OOrganon and Co

Preclinical

6 6

Depakote

Ibrance

Comtan

Orion Corporation, Orion Pharma

Preclinical

1 9

Luvox

SSolvay Pharmaceuticals

Preclinical

1 10

Catapres

Boehringer Ingelheim

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2027

Phase 1/2Recruiting

Adolescent

NCT05814640

Q4 2027

Post-ApprovalNot yet recruiting

Adolescent

NCT07011693

Phase 2Not yet recruiting

Aripiprazole

NCT05545891

Clinical

Trials by Indication[1]

Schizophrenia51 trials

Family Intervention in Recent Onset Schizophrenia Treatment (FIRST)

Completed· Johnson & Johnson logo

Johnson & Johnson··NCT02600741·296 enrolled

An Efficacy and Safety Study of Extended-Release (ER) Paliperidone in Adolescent Participants With Schizophrenia

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01009047·228 enrolled

Pragmatic RCT Comparing Aripiprazole, Olanzapine and Haloperidol in the Treatment of Schizophrenia

Completed· Mario Negri Institute for Pharmacological Research logo

Mario Negri Institute for Pharmacological Research·Phase 4·NCT01052389·300 enrolled

Show 48 more trials

Pan European Collaboration on Antipsychotic Naïve Schizophrenia II

Completed·UUniversity of Copenhagen·Phase 4·NCT02339844·130 enrolled

Twelve Month Study Comparing Paliperidone Palmitate and Select Oral Antipsychotics in Adults With Schizophrenia Who Have Been Recently Discharged From an Inpatient Psychiatric Hospital

Withdrawn· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT01193166

Schizophrenia Trial of Aripiprazole

Completed· Otsuka logo

Otsuka·Phase 3·NCT00237913·700 enrolled

Aripiprazole for Schizophrenia Outpatients Completing BMS Clinical Trials

Completed· Otsuka logo

Otsuka·Phase 3·NCT00239356·119 enrolled

Aripiprazole for the Treatment of Schizophrenia With Co-Morbid Social Anxiety

Completed·UUniversity of Medicine and Dentistry of New Jersey·Phase 4·NCT00177008·18 enrolled

Best Event Schizophrenia Trial--A Randomized Double-Blind Trial of Aripiprazole and Risperidone in Schizophrenia

Terminated·KKettering Health Network·Phase 4·NCT00712270·21 enrolled

A Follow-on Study of the Long-Term Safety of Aripiprazole in Patients With Chronic Schizophrenia

Terminated· Otsuka logo

Otsuka·Phase 3·NCT02435836·631 enrolled

Olanzapine Versus Aripiprazole in the Treatment of Acutely Ill Patients With Schizophrenia

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00103571·600 enrolled

A Study of Safety and Tolerability in Subjects With Schizophrenia

Completed·DDenovo Biopharma LLC·Phase 1·NCT01354353·75 enrolled

European Long-acting Antipsychotics in Schizophrenia Trial

Completed·UUMC Utrecht·Phase 4·NCT02146547·536 enrolled

Switching Medication to Treat Schizophrenia

Completed·IIcahn School of Medicine at Mount Sinai·Phase 4·NCT00044655·219 enrolled

Pharmacologic Treatment of Acute Episode of Schizophrenia: a Real World Study

Completed·PPeking University·Phase 4·NCT03289026·770 enrolled

A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia

Completed· Otsuka logo

Otsuka·Phase 3·NCT01942148·68 enrolled

Efficacy & Safety Study of Oral Aripiprazole in Adolescents With Schizophrenia

Completed· Otsuka logo

Otsuka·Phase 3·NCT01149655·252 enrolled

Safety and Efficacy of Brexpiprazole in the Treatment of Schizophrenia

Completed· Otsuka logo

Otsuka·Phase 3·NCT03874494·371 enrolled

Study of Aripiprazole in Patients With Schizophrenia- Effects on Glucose Metabolism-

Completed· Otsuka logo

Otsuka·Phase 4·NCT00392197·111 enrolled

Antipsychotic Effects on Brain Function in Schizophrenia

Terminated·UUniversity of California, San Francisco·Phase 4·NCT01913327·4 enrolled

15 Month Study for Adults Who Have Been Diagnosed With Schizophrenia and Incarcerated

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT01157351·450 enrolled

A Study of Aripiprazole in Patients With Schizophrenia in General Psychiatric Practices

Completed· Otsuka logo

Otsuka·Phase 3·NCT00292409·400 enrolled

Pan European Collaboration on Antipsychotic Naive Schizophrenia (PECANS)

Completed·UUniversity of Copenhagen·N/A·NCT01154829·136 enrolled

Trial to Evaluate the Short-term Safety & Efficacy of Brexpiprazole Monotherapy in the Treatment of Adolescents With Schizophrenia

Completed· Otsuka logo

Otsuka·Phase 3·NCT03198078·316 enrolled

Aripiprazole Augmentation for Clozapine-Treated Patients With Refractory Schizophrenia

Completed·SSeoul National University Hospital·Phase 4·NCT00328367·61 enrolled

Comparative Study of Aripiprazole and Olanzapine in the Treatment of Patients With Acute Schizophrenia

Completed· Otsuka logo

Otsuka·Phase 3·NCT00712686·690 enrolled

Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 and Aripiprazole for Treatment of Acute Schizophrenia

Completed· Otsuka logo

Otsuka·Phase 2·NCT00905307·459 enrolled

Cognitive Improvement With Aripiprazole (Abilify) in Patients With Schizophrenia (BMS)

Terminated·LLouisiana State University Health Sciences Center Shreveport·N/A·NCT00211302·8 enrolled

Dose-response Study to Evaluate Safety, Efficacy, and Pharmacokinetics of PF-00217830 Compared With Placebo in Acute Exacerbation of Schizophrenia

Completed· Pfizer logo

Pfizer·Phase 2·NCT00580125·164 enrolled

A Long-Term, Open-Label, Study on Schizophrenia

Terminated· Eli Lilly logo

Eli Lilly·Phase 2/3·NCT01129674·1,210 enrolled

The Effect of Switching to Aripiprazole on Heart Health in Overweight and Obese Patients With Schizophrenia

Completed·UUniversity of Pittsburgh·Phase 4·NCT00222833·30 enrolled

A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder

Completed· Otsuka logo

Otsuka·Phase 1/2·NCT04030143·266 enrolled

Standard Comprehensive Intervention to Treat First-episode Schizophrenia

Unknown status·PPeking University·N/A·NCT01057849·600 enrolled

A Study of Aripiprazole in the Management of Patients With Schizophrenia in the General Psychiatric Practices

Completed· Otsuka logo

Otsuka·Phase 3·NCT00237939·1,200 enrolled

Multidisciplinary Design to Optimize Schizophrenia Treatment Based on Multi-omics Data and Systems Biology Analysis

Unknown status·CConsorcio Centro de Investigación Biomédica en Red (CIBER)·Phase 4·NCT06060886·244 enrolled

Evaluation of the Strategies of Switching Schizophrenia Patients to Aripiprazole From Other Antipsychotic Agents

Completed·NNational Taiwan University Hospital·Phase 4·NCT00545467·79 enrolled

Study to Determine the Pharmacokinetics, Safety & Tolerability of Aripiprazole in Adults With Schizophrenia

Completed· Otsuka logo

Otsuka·Phase 1·NCT03150771·36 enrolled

Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Acute Schizophrenia

Completed· Otsuka logo

Otsuka·Phase 3·NCT02054702·97 enrolled

Comparison of Optimal Antipsychotic Treatments for Adults With Schizophrenia

Completed·NNational Institute of Mental Health (NIMH)·Phase 4·NCT00802100·21 enrolled

Randomized Evaluation of the Effectiveness of Clozapine and Aripiprazole Versus Clozapine and Haloperidol in the Treatment of Schizophrenia

Unknown status·UUniversita di Verona·Phase 4·NCT00395915·106 enrolled

Effectiveness of Aripiprazole for Improving Side Effects of Clozapine in the Treatment of People With Schizophrenia

Completed·MMassachusetts General Hospital·Phase 4·NCT00345033·38 enrolled

Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia

Completed· Otsuka logo

Otsuka·Phase 4·NCT00080327·370 enrolled

A Study to Compare Disease Progression and Modification Following Treatment With Paliperidone Palmitate Long-Acting Injection or Oral Antipsychotics in Participant's With Recent-onset Schizophrenia or Schizophreniform

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02431702·337 enrolled

Aripiprazole in the Treatment of Patients With Schizophrenia and Symptoms of Obsessive Compulsive Disorder (OCD)

Completed·JJamaica Hospital Medical Center·N/A·NCT00374348·10 enrolled

Aripiprazole in the Treatment of Acutely Relapsed Patients With Schizophrenia

Completed·TTaiwan Otsuka Pharm. Co., Ltd·Phase 3·NCT00283179·83 enrolled

Maintenance Electroconvulsive Therapy (ECT) Versus Aripiprazole in Clozapine-resistant Schizophrenia

Not yet recruiting·—·Phase 4·NCT06501339·40 enrolled

Identification of Multi-modal Bio-markers for Early Diagnosis and Treatment Prediction in Schizophrenia Individuals

Unknown status·TTianjin Medical University General Hospital·Phase 1·NCT03790085·2,700 enrolled

The Effects of Aripiprazole on the Processing of Rewards in Schizophrenia

Terminated·EEmory University·N/A·NCT00209027·20 enrolled

Atypical Antipsychotic-induced Mitochondrial Dysfunction in Patients With Schizophrenia

Completed·—·Phase 4·NCT06236451·60 enrolled

Clinical Effectiveness of Newer Antipsychotics in Comparison With Conventional Antipsychotics in Schizophrenia

Completed·—·Phase 4·NCT01164059·149 enrolled

Preventing Relapse in Schizophrenia: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy

Completed·NNorthwell Health·Phase 4·NCT00330863·357 enrolled

Aripiprazole31 trials

Comparison of Aripiprazole Versus Higher Metabolic Risk Antipsychotic Drugs on Adiposity Using MRI

Completed·UUniversity of British Columbia··NCT01739127·83 enrolled

Aripiprazole Open-Label, Safety and Tolerability Study

Completed· Otsuka logo

Otsuka·Phase 3·NCT00102518·325 enrolled

Body Mass Index (BMI) and Metabolic Changes Following Switch to Aripiprazole From Olanzapine, Risperidone and Quetiapine

Completed·UUniversity of North Carolina, Chapel Hill··NCT00312598·30 enrolled

Show 28 more trials

Study of Alternate Formulation of Aripiprazole in Agitated Patients With Schizophrenic Disorders

Completed· Otsuka logo

Otsuka·Phase 2/3·NCT00036127

Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

Completed· Otsuka logo

Otsuka·Phase 3·NCT01418339·135 enrolled

A Placebo-Controlled, Cross-Over Trial of Aripiprazole

Completed·NNorth Suffolk Mental Health Association·Phase 4·NCT00351936·16 enrolled

Fluoxetine vs Aripiprazole Comparative Trial (FACT)

Terminated·NNorthwell Health·Phase 4·NCT02357849·9 enrolled

Potentiation of Quetiapine Treatment With Lithium or Aripiprazole in Bipolar 1 Nonresponders Patients

Unknown status·UUniversity of Sao Paulo·Phase 4·NCT01710163·50 enrolled

Drug-drug Interaction Study of Aripiprazole and Lamotrigine in Patients With Bipolar Type I Disorder

Completed· Otsuka logo

Otsuka·Phase 1·NCT00321516·20 enrolled

Open Label Drug Interaction Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) 100mg On The Pharmacokinetics Of Aripiprazole When Coadministered To Healthy Subjects

Completed· Pfizer logo

Pfizer·Phase 4·NCT01188668·38 enrolled

Oral Aripiprazole Open-Label Rollover Study

Completed· Otsuka logo

Otsuka·Phase 3·NCT01001702·85 enrolled

Aripiprazole for the Augmentation of Antidepressant Therapy

Completed·TTaiwan Otsuka Pharm. Co., Ltd·Phase 4·NCT01429831·300 enrolled

Aripiprazole Treatment of the Prodrome

Terminated·NNorthwell Health·N/A·NCT00169949·30 enrolled

The Monitor of Serum Prolactin Level in a 3 Months Aripiprazole Trial

Unknown status·YYu-Li Hospital·Phase 4·NCT00468533·50 enrolled

Open Label Trial of Aripiprazole in Children and Adolescents With Tourette's Disorder

Completed·NNYU Langone Health·Phase 4·NCT00241176·11 enrolled

Aripiprazole Treatment of Prodromal Patients

Completed·YYale University·Phase 2/3·NCT00237874·15 enrolled

A Study of Adjunctive Treatment of Aripiprazole in Schizophrenic Patients

Completed· Otsuka logo

Otsuka·Phase 4·NCT00300846·200 enrolled

Aripiprazole, Abilify Maintena Collaborative Clinical Protocol

Terminated·—·N/A·NCT02717130·9 enrolled

Comparison of Aripiprazole Versus Risperidone on Brain Morphology Using MRI

Unknown status·UUniversity of British Columbia··NCT02334904·60 enrolled

Drug Interaction Study Between AZD3480 and Aripiprazole in Healthy Subjects

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT00689559·52 enrolled

Study of Aripiprazole in Subjects With Alcoholism

Completed· Otsuka logo

Otsuka·Phase 4·NCT00082199·400 enrolled

Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder (TD)

Completed· Otsuka logo

Otsuka·Phase 3·NCT01418352·83 enrolled

Study Comparing Patients Taking Olanzapine and Patients Taking Aripiprazole on Learning of Vocational Skills

Completed·TThe University of Texas Health Science Center at San Antonio·N/A·NCT00223418·43 enrolled

Comparative Bioavailability Study of Aripiprazole 10 mg Oral Soluble Film vs Abilify® 10 mg Tablet in Healthy Volunteers

Completed·CCMG Pharmaceutical Co. Ltd·Phase 1·NCT02501109·36 enrolled

Effects of Aripiprazole and Haloperidol on Mesolimbic System Functioning

Completed·OOslo University Hospital·Phase 4·NCT01161277·54 enrolled

Aripiprazole in Body Focused Repetitive Behaviors

Not yet recruiting·UUniversity of Chicago·Phase 2·NCT05545891·100 enrolled

Efficacy of Aripiprazole Versus Placebo in the Reduction of Aggressive and Aberrant Behavior in Autistic Children

Completed·UUniversity of Medicine and Dentistry of New Jersey·N/A·NCT00468130·13 enrolled

Study of Aripiprazole (Abilify) in Children With Symptoms of Mania

Completed·UUniversity Hospitals Cleveland Medical Center·Phase 3·NCT00194077·60 enrolled

Trial to Evaluate the Long-term Efficacy of Oral Aripiprazole in the Treatment of Pediatric Participants With Tourette's Disorder

Terminated· Otsuka logo

Otsuka·Phase 4·NCT03661983·36 enrolled

Aripiprazole in Patients With Acute Mania

Completed· Otsuka logo

Otsuka·Phase 3·NCT00095511·615 enrolled

Aripiprazole and Prolactin Study

Completed·UUniversity of Oxford·Phase 4·NCT01085383·15 enrolled

Bipolar Disorder17 trials

An Open-Label Trial of Aripiprazole in Children and Adolescents With Bipolar Disorder

Completed·UUniversity of Cincinnati·Phase 3·NCT00221416·30 enrolled

Study of Aripiprazole in Patients With a History of Bipolar Disorder

Completed· Otsuka logo

Otsuka·Phase 3·NCT00036348

Study of Aripiprazole in the Treatment of Patients With Acute Symptoms in Bipolar Disorder

Completed· Otsuka logo

Otsuka·Phase 3·NCT00036101

Show 14 more trials

Study of Aripiprazole (Abilify) Versus Placebo in Children With Subsyndromal Bipolar Disorder

Completed·UUniversity Hospitals Cleveland Medical Center·Phase 3·NCT00194012·62 enrolled

Study of Aripiprazole to Reduce Medical Risks in Bipolar Disorder

Terminated·UUniversity of Pittsburgh·N/A·NCT00665444·3 enrolled

Metabolic Effects of Switching to Aripiprazole in Patients With Bipolar Disorders

Completed·SSeoul National University Hospital·Phase 4·NCT00845988·28 enrolled

Side Effect Study of Antipsychotic Medicines to Treat Childhood Bipolar Disorder

Terminated·UUniversity of Maryland, Baltimore·N/A·NCT00746252·5 enrolled

Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies

Terminated·UUniversity of New Mexico··NCT02893371·1,037,352 enrolled

Aripiprazole in Late Life Bipolar Disorder

Completed·UUniversity Hospitals Cleveland Medical Center·Phase 4·NCT00194038·20 enrolled

A Multicenter Investigative Study of the Safety and Efficacy of Long-term Administration of Aripiprazole in Combination With Mood Stabilizer for the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode

Completed· Otsuka logo

Otsuka·Phase 3·NCT00606229·41 enrolled

Aripiprazole Associated With Methylphenidate in Children and Adolescents With Bipolar Disorder and ADHD

Completed·FFederal University of Rio Grande do Sul·Phase 4·NCT00305370·20 enrolled

A Multicenter, Investigative Study of the Safety and Efficacy of Extended Administration of Aripiprazole in Combination With Mood Stabilizer for the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode

Completed· Otsuka logo

Otsuka·Phase 3·NCT00606320·59 enrolled

Efficacy and Safety of Aripiprazole in Patients With Schizophrenia or Bipolar Disorder

Completed·KKorea Otsuka Pharmaceutical Co., Ltd.··NCT00216723·3,000 enrolled

Omega-3 Fatty Acid Adjunctive to Open-Label Aripiprazole for the Treatment of Bipolar Disorder in Children and Adolescents

Terminated·MMassachusetts General Hospital·Phase 4·NCT00592683·20 enrolled

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group-comparison Trial of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode

Completed· Otsuka logo

Otsuka·Phase 3·NCT00606281·258 enrolled

ABLE: Abilify in Bipolar Disorder for Long-term Effectiveness

Completed·KKorea Otsuka International Asia Arab·Phase 4·NCT00484471·127 enrolled

Study of Aripiprazole in the Treatment of Patients With Acute Symptoms of Bipolar Disorder

Completed· Otsuka logo

Otsuka·Phase 3·NCT00046384

Psychosis17 trials

Neurocognitive Effectiveness in Treatment of First-episode Non-affective Psychosis: 1-year Follow-up

Completed·FFundación Marques de Valdecilla·Phase 4·NCT02534363·136 enrolled

Bergen Psychosis Project 2 - The Best Intro Study

Completed·HHaukeland University Hospital·Phase 4·NCT01446328·151 enrolled

Antipsychotic to Treat Psychosis Syndrome

Unknown status·—·N/A·NCT02137616·300 enrolled

Show 14 more trials

Aripiprazole in Patients With Psychosis Associated With Parkinson's Disease

Completed· Otsuka logo

Otsuka·Phase 4·NCT00095810·50 enrolled

Tolerance and Effect of Antipsychotics in Children and Adolescents With Psychosis

Completed·AAnne Katrine Pagsberg·Phase 4·NCT01119014·300 enrolled

Neurocognitive Effectiveness in Treatment of First-episode Non-affective Psychosis: 3-years Follow-up

Unknown status·FFundación Marques de Valdecilla·Phase 4·NCT03883204·115 enrolled

Comparative Study of Aripiprazole, Quetiapine and Ziprasidone in Treatment of First Episode Psychosis: 3-year Follow-up

Completed·FFundación Marques de Valdecilla·Phase 4·NCT02526030·203 enrolled

Substance Misuse To Psychosis for Stimulants

Completed·TThe University of Hong Kong·Phase 2/3·NCT03485417·165 enrolled

Efficacy and Safety of Aripiprazole in First Episode Psychosis

Completed·—·Phase 4·NCT01026584·55 enrolled

Study of Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of the Alzheimer's Type

Completed· Otsuka logo

Otsuka·Phase 3·NCT00041678

Comparison of Aripiprazole and Risperidone for the Treatment of People With First-Episode Psychosis

Completed·NNorthwell Health·Phase 4·NCT00320671·198 enrolled

Acute Psychosis Treatment in the Long Term, Unitary Group Study (APLUS)

Completed·KKorea Otsuka Pharmaceutical Co., Ltd.·Phase 4·NCT00304655·300 enrolled

Effectiveness of Second Generation Antipsychotics in First Episode Psychosis Patients: 1-year Follow-up

Unknown status·FFundación Marques de Valdecilla·Phase 4·NCT02532491·200 enrolled

Effectiveness of Second Generation Antipsychotics in First Episode Psychosis Patients: 3-year Follow-up

Unknown status·FFundación Marques de Valdecilla·Phase 4·NCT03090503·200 enrolled

Comparative Study of Aripiprazole, Quetiapine and Ziprasidone in the Treatment of First Episode Nonaffective Psychosis

Completed·FFundación Marques de Valdecilla·Phase 4·NCT02305823·203 enrolled

A Comparison of Risperidone and Aripiprazole for Treatment of Patirnts With Methamphetamine-Associated Psychosis

Terminated·WWei Hao·Phase 4·NCT01813643·50 enrolled

Study of Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of the Alzheimer's Type

Completed· Otsuka logo

Otsuka·Phase 3·NCT00036114

Bipolar I Disorder9 trials

Open-label Study to Evaluate the Effectiveness of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Bipolar I Disorder

Completed· Otsuka logo

Otsuka·Phase 3·NCT01710709·748 enrolled

Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder

Completed· Otsuka logo

Otsuka·Phase 3·NCT00665366·493 enrolled

Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depression Episode

Completed· Otsuka logo

Otsuka·Phase 3·NCT00080314·400 enrolled

Show 6 more trials

Aripiprazole in Children and Adolescents With Bipolar I Disorder

Completed· Otsuka logo

Otsuka·Phase 3·NCT00110461·296 enrolled

Trial Comparing the Effects of Aripiprazole With Those of Standard of Care on Non-HDL Cholesterol in Patients With Schizophrenia or Bipolar I Disorder Who Have Metabolic Syndrome

Terminated· Otsuka logo

Otsuka·Phase 3·NCT00857818·64 enrolled

Study of Aripiprazole in Patients With Bipolar I Disorder

Completed· Otsuka logo

Otsuka·Phase 3·NCT00257972·400 enrolled

A Trial of Single- and Multiple-doses of Aripiprazole in Adult Subjects With Schizophrenia or Bipolar I Disorder

Completed· Otsuka logo

Otsuka·Phase 1·NCT03854409·72 enrolled

Safety and Tolerability of Aripiprazole in Adolescents With Schizophrenia or Children and Adolescents With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features.

Terminated· Otsuka logo

Otsuka·Phase 3·NCT01122927·524 enrolled

Adherence to Treatment, Safety and Tolerability Study of the Medical Information Device #1 (MIND1) in Subjects With Schizophrenia or Bipolar I Disorder

Withdrawn· Otsuka logo

Otsuka·Phase 2·NCT01981811

46 more indications

Schizoaffective Disorder4 trials

Effects of Aripiprazole in Overweight Patients Treated With Olanzapine for Schizophrenia or Schizoaffective Disorder

Completed· Otsuka logo

Otsuka·Phase 3·NCT00095524·300 enrolled

RP5063 in Subjects With Schizophrenia or Schizoaffective Disorder

Completed·RReviva Pharmaceuticals·Phase 2·NCT01490086·234 enrolled

Comparison of Antipsychotics for Metabolic Problems in Schizophrenia or Schizoaffective Disorder

Completed·NNational Institute of Mental Health (NIMH)·Phase 4·NCT00423878·215 enrolled

Show 1 more trial

A Study of Relapse Prevention and the Effectiveness of Long-acting Injectable Risperidone and Quetiapine Tablets in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00216476·753 enrolled

Bipolar Depression4 trials

A Preliminary Study of the Effectiveness and Tolerability of Aripiprazole in Bipolar Depression

Completed·LLindner Center of HOPE·Phase 4·NCT00363337·31 enrolled

Aripiprazole Treatment of Bipolar Depression

Completed·IIndiana University School of Medicine·Phase 4·NCT00198198·10 enrolled

12- Week Open Label Treatment of Refractory Bipolar Depression

Completed·TThe University of Texas Health Science Center at San Antonio·Phase 4·NCT00223496·32 enrolled

Show 1 more trial

Aripiprazole in the Treatment of Bipolar Depression

Completed·CCambridge Health Alliance·N/A·NCT00226317·20 enrolled

Autism4 trials

Study of Aripiprazole to Treat Children and Adolescents With Autism

Completed·UUniversity of North Carolina, Chapel Hill·Phase 2·NCT00619190·30 enrolled

Aripiprazole in Children With Autism: A Pilot Study

Completed·—·Phase 2·NCT00208533·11 enrolled

Evaluating the Effectiveness of Aripiprazole and D-Cycloserine to Treat Symptoms Associated With Autism

Completed·IIndiana University·Phase 3·NCT00198107·81 enrolled

Show 1 more trial

Biomarkers in Autism of Aripiprazole and Risperidone Treatment (BAART)

Completed·MMedical University of South Carolina·Phase 4·NCT01333072·80 enrolled

Antipsychotics4 trials

Metabolic Effects of Antipsychotics in Children

Completed·WWashington University School of Medicine·Phase 4·NCT00205699·144 enrolled

Atypical Antipsychotics Influence on the Safety of the Heart and Monitoring Indicators Model Building

Unknown status·SShanghai Mental Health Center·Phase 4·NCT04446234·350 enrolled

Side Effects of Newer Antipsychotics in Older Adults

Completed·VVeterans Medical Research Foundation·Phase 4·NCT00245206·406 enrolled

Show 1 more trial

Aripiprazole as an Adjunct to Atypical Antipsychotics for Weight Reduction and Improvement in Metabolic Profile

Completed·IInstitute of Mental Health, Singapore·Phase 4·NCT02949752·67 enrolled

Treatment4 trials

Combination Treatment for Augmenting Language in Children With ASD

Completed·UUniversity of California, Los Angeles·Phase 2·NCT02574741·58 enrolled

Treatment of Children With ADHD Who do Not Fully Respond to Stimulants

Terminated·NNew York State Psychiatric Institute·Phase 2·NCT00279409·10 enrolled

The Role of miR-30 Family Dysregulation in Response to Antipsychotic Treatment

Unknown status·SShanxi Medical University·Phase 1/2·NCT02650102·200 enrolled

Show 1 more trial

A Safety Study Comparing LY2140023 to Atypical Antipsychotic Standard Treatment in Schizophrenic Patients

Completed·DDenovo Biopharma LLC·Phase 2·NCT00845026·261 enrolled

Tic Disorder3 trials

A Short Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder

Completed· Otsuka logo

Otsuka·Phase 3·NCT01617447·92 enrolled

Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)

Completed· Otsuka logo

Otsuka·Phase 3·NCT00337571·218 enrolled

A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder

Completed· Otsuka logo

Otsuka·Phase 3·NCT01617460·86 enrolled

Metabolic Syndrome3 trials

A Phase 4 Study to Assess the Effects of Aripiprazole Versus Other Atypical Antipsychotics in the Treatment of Schizophrenic Patients With Metabolic Syndrome

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT00508157·125 enrolled

The Effects of Aripiprazole on Patients With Metabolic Syndrome

Completed·NNew Mexico VA Healthcare System·Phase 4·NCT00224822·27 enrolled

Safety and Efficacy of Aripiprazole and Ziprasidone Among Schizophrenic Patients With Metabolic Syndrome

Completed·UUniversity of Malaya·Phase 4·NCT01714011·175 enrolled

Depression3 trials

Canadian Biomarker Integration Network for Depression Study

Completed·UUniversity Health Network, Toronto·Phase 3·NCT01655706·211 enrolled

A Comparison of Medication Augmentation and PST in the Treatment of Depression in Older Adults

Withdrawn·NNew York State Psychiatric Institute·Phase 4·NCT01942187

A Study of Diagnosis and Treatment of Depression Based on Biological Evidence of Dopamine Reward Pathway

Unknown status·PPeking University·Phase 4·NCT03148509·300 enrolled

Treatment Resistant Depression3 trials

Aripiprazole Augmentation Therapy in Treatment-resistant Depression

Withdrawn·UUniversity Hospital Freiburg·Phase 3·NCT00276978

Dopaminergic Effects of Adjunctive Aripiprazole on the Brain in Treatment-Resistant Depression

Completed·WWashington University School of Medicine·N/A·NCT00953745·43 enrolled

VA Aripiprazole vs Esketamine for Treatment Resistant Depression

Withdrawn·VVA Office of Research and Development·Phase 4·NCT05554627

Refractory Depression2 trials

Aripiprazole Augmentation of SSRI Therapy in Treatment Refractory Depression

Completed·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT00608543·17 enrolled

Abilify as an Adjunctive Treatment for Refractory Depression

Completed·SSt. Luke's-Roosevelt Hospital Center·Phase 4·NCT00220636·15 enrolled

Cognitive Function2 trials

Change in Brain Metabolism and Cognitive Function by Aripiprazole

Completed·SSeoul National University Hospital·N/A·NCT01562808·15 enrolled

Effect on Cognitive Function of a Treatment With Aripiprazole

Completed· Otsuka logo

Otsuka·Phase 4·NCT00329810·500 enrolled

Major Depressive Disorder2 trials

Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)

Terminated· Otsuka logo

Otsuka·Phase 3·NCT01111552·237 enrolled

Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)

Terminated· Otsuka logo

Otsuka·Phase 3·NCT01111565·137 enrolled

Hyperprolactinemia2 trials

Double-Blind Placebo Controlled Study of Adjunctive Aripiprazole for Symptomatic Hyperprolactinemia In Premenopausal Women With Schizophrenia

Completed·UUniversity of Maryland, Baltimore·N/A·NCT01338298·60 enrolled

Adjunctive Aripiprazole in the Treatment of Risperidone-Induced Hyperprolactinemia

Unknown status·—·N/A·NCT02013232·120 enrolled

Adolescent2 trials

Switching Medication and Augmentation Strategies for SSRI-Resistant Adolescent Depression（SMART-I)

Not yet recruiting·XXinyu Zhou·Phase 4·NCT07011693·400 enrolled

Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD)

Recruiting·FFirst Affiliated Hospital of Chongqing Medical University·Phase 1/2·NCT05814640·520 enrolled

Major Depressive Episode2 trials

A Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depressive Episode

Completed· Otsuka logo

Otsuka·Phase 3·NCT00094432·650 enrolled

A Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depressive Episode

Withdrawn· Otsuka logo

Otsuka·Phase 3·NCT00338273

Irritability1 trial

Phase IV Long-term Maintenance Study of Aripiprazole in the Treatment of Irritability Associated With Autistic Disorder

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT01227668·215 enrolled

Chronic Tic Disorder1 trial

Aripiprazole in Children and Adolescents With Chronic Tic Disorder or Tourette's Disorder

Completed·KKorea Otsuka Pharmaceutical Co., Ltd.·Phase 3·NCT00706589·61 enrolled

Drug Monitoring1 trial

Therapeutic Drug Monitoring in Child and Adolescent Psychiatry

Completed·MMedical University of Vienna··NCT01057329·200 enrolled

Autism Spectrum Disorder1 trial

An Open-Label Trial of Aripiprazole in Autism Spectrum Disorders

Completed·CCambridge Health Alliance·Phase 2·NCT00308074·14 enrolled

Drug1 trial

An Observational Drug Utilization Study of Asenapine in the United Kingdom (P08308)

Completed·OOrganon and Co··NCT01498770·42 enrolled

Cocaine Dependence1 trial

A Double-Blind, Controlled Study of Aripiprazole in Co-Morbid Schizophrenia and Cocaine Dependence

Unknown status·PPaul Saenger·Phase 2·NCT00737256·44 enrolled

Major Depression1 trial

The Combination of Aripiprazole and Antidepressants in Psychotic Major Depression

Completed·MMassachusetts General Hospital·Phase 3·NCT00556140·16 enrolled

Trichotillomania1 trial

Trial of Aripiprazole in Trichotillomania

Completed·SStanford University·N/A·NCT00947154·12 enrolled

Postpartum Depression1 trial

Aripiprazole and Resistant Postpartum Depression

Completed·LLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's·Phase 3·NCT01386086·10 enrolled

Obsessive-Compulsive Disorder1 trial

Acceptance and Commitment Therapy in SSRI-Resistant Obsessive Compulsive Disorder

Withdrawn·SShanghai Mental Health Center·N/A·NCT02955654

Sexual Dysfunction1 trial

A Multicenter Study to Evaluate the Effects of Switching to Aripiprazole 12 Weeks on the Sexual Dysfunction From Risperidone or Paliperidone in Patients With Schizophrenia Spectrum Disorders or Bipolar Spectrum Disorders

Unknown status·SSi Tianmei·Phase 4·NCT01742390·120 enrolled

Post-Traumatic Stress Disorder1 trial

Aripiprazole in the Treatment of Post-Traumatic Stress Disorder Symptoms

Completed·FFederal University of São Paulo·Phase 3·NCT00440713·40 enrolled

Methamphetamine Dependence1 trial

Aripiprazole for Methamphetamine Dependence: Double Blind Placebo Trial

Withdrawn·UUS Department of Veterans Affairs·Phase 4·NCT00728312

Methamphetamine1 trial

Assessment of Interactions Between Methamphetamine and Aripiprazole - 1

Unknown status·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT00089440·17 enrolled

Pediatric1 trial

Long-term Antipsychotic Pediatric Safety Trial

Completed·—··NCT03522168·509 enrolled

Tardive Dyskinesia1 trial

Aripiprazole for Neuroleptic-Induced Tardive Dyskinesia

Unknown status·TTaoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan·Phase 4·NCT00837707·25 enrolled

Medication1 trial

A Study to Assess the Clinical Utility of Antipsychotic Medication Levels in Plasma as Determined by Liquid Chromatography-Tandem Mass Spectrometry

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02462473·9 enrolled

Cognitive impairment1 trial

A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication

Completed· Astellas logo

Astellas·Phase 2·NCT03557931·233 enrolled

Attention Deficit Hyperactivity Disorder1 trial

Aripiprazole in Children and Adolescents With Bipolar Disorder and Attention Deficit Hyperactivity Disorder (ADHD)

Completed·FFederal University of Rio Grande do Sul·N/A·NCT00116259·50 enrolled

Tourette's Syndrome1 trial

Aripiprazole in the Treatment of Tourette's Syndrome

Terminated·UUniversity of Florida·N/A·NCT00282139·40 enrolled

Dementia1 trial

Intramuscular Aripiprazole in Acutely Agitated Patients Diagnosed With Dementia

Completed· Otsuka logo

Otsuka·Phase 3·NCT00095719·125 enrolled

Children1 trial

Metabolic Effects of Antipsychotic Substitution in Children

Withdrawn·WWashington University School of Medicine·Phase 2/3·NCT00910780

Substance Abuse1 trial

Abilify Therapy for Reducing Comorbid Substance Abuse

Completed·—·Phase 4·NCT00208169·30 enrolled

Acceptability1 trial

Aripiprazole Oral Acceptability Trial

Completed· Otsuka logo

Otsuka·Phase 3·NCT00101569·59 enrolled

Anorexia Nervosa1 trial

ARIpiprazole in Anorexia NErvosa

Unknown status·JJuan A. Arnaiz·Phase 3·NCT01082848·60 enrolled

Hysterectomy1 trial

Impact of Aripiprazole on Postoperative Analgesia in Laparoscopic Hysterectomy

Completed·—·Phase 4·NCT05103410·80 enrolled

Safety and Efficacy1 trial

Study Evaluating the Safety and Efficacy of Fixed-dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

Completed· Otsuka logo

Otsuka·Phase 3·NCT01727700·133 enrolled

PET1 trial

A PET Study in Healthy Volunteers

Completed· GSK logo

GSK·Phase 1·NCT01424449·7 enrolled

Insulin Sensitivity1 trial

Examining the Effects of Antipsychotic Medications on Insulin Sensitivity

Completed·VVeterans Medical Research Foundation·Phase 4·NCT00895921·30 enrolled

Fragile X Syndrome1 trial

A Prospective Open-label Study of Aripiprazole in Fragile X Syndrome

Completed·IIndiana University School of Medicine·Phase 2·NCT00420459·12 enrolled

Unspecified1 trial

Health Evaluation of Abilify Long-term Therapy

Completed·TTaiwan Otsuka Pharm. Co., Ltd·Phase 4·NCT00520650·245 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 15, 2002

ABILIFY

NDA NDA021436

Dec 10, 2004

ABILIFY

NDA NDA021713

Jun 7, 2006

ABILIFY

NDA NDA021729

Sep 20, 2006

ABILIFY

NDA NDA021866

Feb 28, 2013

ABILIFY MAINTENA KIT

NDA NDA202971

Nov 13, 2017

ABILIFY MYCITE KIT

NDA NDA207202

Apr 27, 2023

ABILIFY ASIMTUFII

NDA NDA217006

Jul 22, 2024

OPIPZA

NDA NDA216655

Apr 15, 2025

MEZOFY

NDA NDA211448

Sources

References

[1]
ClinicalTrials.gov — 266 trial records for aripiprazole. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Abilify drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — aripiprazole compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for aripiprazole. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA211448). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Abilify. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Otsuka company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Serotonin 2a (5-Ht2a) Receptor Antagonist; Dopamine D2 Receptor Partial Agonist; Serotonin 1a (5-Ht1a) Receptor Partial Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Otsuka

Patent Landscape[6]

Patent Cliff

Jul 28, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11476952Apr 28, 2026

9125939Jul 28, 2026

7978064Sep 14, 2026

8759350Mar 2, 2027

9444503Nov 19, 2027

35 more patents

9119554Dec 16, 2028

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8945005Aug 19, 2029

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9941931Nov 4, 2030

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8258962Nov 25, 2030

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10517507Jun 13, 2032

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10980803Sep 24, 2033

9268909Oct 15, 2033

10525057Mar 8, 2034

11648347Apr 6, 2034

11331315Nov 3, 2040

11701352Dec 15, 2041

Abilify

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q4 2027

Trials by Indication[1]

Schizophrenia51 trials

Aripiprazole31 trials

Bipolar Disorder17 trials

Psychosis17 trials

Bipolar I Disorder9 trials

Schizoaffective Disorder4 trials

Bipolar Depression4 trials

Autism4 trials

Antipsychotics4 trials

Treatment4 trials

Tic Disorder3 trials

Metabolic Syndrome3 trials

Depression3 trials

Treatment Resistant Depression3 trials

Refractory Depression2 trials

Cognitive Function2 trials

Major Depressive Disorder2 trials

Hyperprolactinemia2 trials

Adolescent2 trials

Major Depressive Episode2 trials

Irritability1 trial

Chronic Tic Disorder1 trial

Drug Monitoring1 trial

Autism Spectrum Disorder1 trial

Drug1 trial

Cocaine Dependence1 trial

Major Depression1 trial

Trichotillomania1 trial

Postpartum Depression1 trial

Obsessive-Compulsive Disorder1 trial

Sexual Dysfunction1 trial

Post-Traumatic Stress Disorder1 trial

Methamphetamine Dependence1 trial

Methamphetamine1 trial

Pediatric1 trial

Tardive Dyskinesia1 trial

Medication1 trial

Cognitive impairment1 trial

Attention Deficit Hyperactivity Disorder1 trial

Tourette's Syndrome1 trial

Dementia1 trial

Children1 trial

Substance Abuse1 trial

Acceptability1 trial

Anorexia Nervosa1 trial

Hysterectomy1 trial

Safety and Efficacy1 trial

PET1 trial

Insulin Sensitivity1 trial

Fragile X Syndrome1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

Related News