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 37 indications[4].[1]

Abilify is one of 457 small molecule programs targeting Schizophrenia. It is currently in Approved.

Indications

268

Total Trials

Active Trials

456

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

SchizophreniaUnknown status

AripiprazoleUnknown status

TrichotillomaniaActive, not recruiting

Tourette SyndromeActive, not recruiting

HyperprolactinemiaActive, not recruiting

Aggressive BehaviorActive, not recruiting

Attention Deficit Hyperactivity DisorderApproved

Alzheimer DiseaseApproved

Asperger SyndromeApproved

Hair-PullingApproved

SchizophreniaApproved

Unknown status

AripiprazoleApproved

Unknown status

TrichotillomaniaPreclinical

Active, not recruiting

Tourette SyndromeApproved

Active, not recruiting

HyperprolactinemiaPreclinical

Active, not recruiting

Aggressive BehaviorApproved

Active, not recruiting

Attention Deficit Hyperactivity DisorderApproved

Approved

Alzheimer DiseaseApproved

Approved

Asperger SyndromeApproved

Approved

Hair-PullingApproved

Approved

Showing 10 of 36 indications

Competition

Competitive Landscape

174 competitors in Schizophrenia

#DrugCompanyPhaseTrials

Abilify

Otsuka

Approved

70 2

Ozempic

Novo Nordisk

Preclinical

1 3

Resotran

Takeda

Preclinical

1 4

Inapsine

Jazz Pharmaceuticals

Preclinical

1 5

Depakote

Lunesta

3 7

Luvox

SSolvay Pharmaceuticals

Preclinical

1 8

Catapres

Boehringer Ingelheim

Preclinical

1 9

Rapamune

PPrism Pharmaceuticals

Preclinical

1 10

Persantine

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

Phase 2Not yet recruiting

Aripiprazole

NCT05545891

Post-ApprovalNot yet recruiting

Adolescent

NCT07011693

Clinical

Trials by Indication[1]

Schizophrenia51 trials

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

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

Show 48 more trials

The Impact of Aripiprazole Long-acting on Myelin and Cognition in the Onset of Schizophrenia

Completed·FFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico·Phase 4·NCT05322031·15 enrolled

An Open-Label, Multicenter, Rollover, Long-term Study of Aripiprazole Intramuscular Depot in Participants With Schizophrenia

Completed· Otsuka logo

Otsuka·Phase 3·NCT01129882·709 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

Safety and Efficacy of Cariprazine in Patients With Schizophrenia

Completed·FForest Laboratories·Phase 3·NCT01104766·617 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

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

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

Safety and Efficacy of Brexpiprazole in the Treatment of Schizophrenia

Completed· Otsuka logo

Otsuka·Phase 3·NCT03874494·371 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

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

Completed· Otsuka logo

Otsuka·Phase 4·NCT00392197·111 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

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

Terminated·LLouisiana State University Health Sciences Center Shreveport·N/A·NCT00211380·8 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

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

Schizophrenia Trial of Aripiprazole

Completed· Otsuka logo

Otsuka·Phase 3·NCT00237913·700 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

Pan European Collaboration on Antipsychotic Naïve Schizophrenia II

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

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

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

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

Metabolic Signatures and Biomarkers in Schizophrenia

Completed·—·Phase 1·NCT00466310·71 enrolled

Pan European Collaboration on Antipsychotic Naive Schizophrenia (PECANS)

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

Study of Olanzapine vs. Aripiprazole in the Treatment of Schizophrenia

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00088049·560 enrolled

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

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

Antipsychotic Effects on Brain Function in Schizophrenia

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

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

Completed· Otsuka logo

Otsuka·Phase 3·NCT00292409·400 enrolled

Effect of Switch to Aripiprazole on Health and Smoking Parameters in Patients With Schizophrenia: A Pilot Study

Completed·VVeterans Medical Research Foundation·Phase 4·NCT00167817·15 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

Aripiprazole Augmentation for Clozapine-Treated Patients With Refractory Schizophrenia

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

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

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

Estimating and Reducing the Cardiovascular Risk of Patients With Schizophrenia Drugs From Lipid Measures and Ischemic Electrocardiographic Changes

Terminated·NNorthwestern University·Phase 3·NCT00288353·48 enrolled

Family Intervention in Recent Onset Schizophrenia Treatment (FIRST)

Completed· Johnson & Johnson logo

Johnson & Johnson··NCT02600741·296 enrolled

Aripiprazole31 trials

A Study of Adjunctive Treatment of Aripiprazole in Schizophrenic Patients

Completed· Otsuka logo

Otsuka·Phase 4·NCT00300846·200 enrolled

Comparison of Aripiprazole Versus Risperidone on Brain Morphology Using MRI

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

Trial of Aripiprazole in the Treatment of CD in Adolescents

Completed·UUniversity of Iowa·Phase 4·NCT00250705·12 enrolled

Show 28 more trials

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

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

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

Aripiprazole in Body Focused Repetitive Behaviors

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

Aripiprazole to Reduce Cocaine Relapse

Completed·CCraig Rush·Phase 1·NCT00276874·41 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

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

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

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

Study of Aripiprazole in Subjects With Alcoholism

Completed· Otsuka logo

Otsuka·Phase 4·NCT00082199·400 enrolled

Drug Interaction Study Between AZD3480 and Aripiprazole in Healthy Subjects

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT00689559·52 enrolled

Study of Aripiprazole in Patients With Acute Bipolar Mania

Completed· Otsuka logo

Otsuka·Phase 3·NCT00097266·615 enrolled

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

Completed· Otsuka logo

Otsuka·Phase 3·NCT01416441·170 enrolled

Oral Aripiprazole Open-Label Rollover Study

Completed· Otsuka logo

Otsuka·Phase 3·NCT01001702·85 enrolled

Effects of Aripiprazole and Haloperidol on Mesolimbic System Functioning

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

Safety and Tolerability of Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

Completed· Otsuka logo

Otsuka·Phase 3·NCT01727713·110 enrolled

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

Completed· Otsuka logo

Otsuka·Phase 2/3·NCT00036127

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

Aripiprazole Treatment of Prodromal Patients

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

Bipolar Disorder15 trials

Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies

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

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

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

Show 12 more trials

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

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

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

ABLE: Abilify in Bipolar Disorder for Long-term Effectiveness

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

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

Completed· Otsuka logo

Otsuka·Phase 3·NCT00046384

A Multicenter, Placebo-controlled, Double-blind Investigative Extension Trial of the Safety and Efficacy of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode

Completed· Otsuka logo

Otsuka·Phase 3·NCT00606177·99 enrolled

Aripiprazole for Bipolar Disorder and Alcohol Use Disorder

Completed·UUniversity of Texas Southwestern Medical Center·Phase 3·NCT02918370·75 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

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

Study of Aripiprazole to Reduce Medical Risks in Bipolar Disorder

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

Psychosis14 trials

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

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

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

Show 11 more trials

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

Aripiprazole in Patients With Psychosis Associated With Parkinson's Disease

Completed· Otsuka logo

Otsuka·Phase 4·NCT00095810·50 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

Substance Misuse To Psychosis for Stimulants

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

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

Tolerance and Effect of Antipsychotics in Children and Adolescents With Psychosis

Completed·AAnne Katrine Pagsberg·Phase 4·NCT01119014·300 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 Disorder7 trials

Aripiprazole in Children and Adolescents With Bipolar I Disorder

Completed· Otsuka logo

Otsuka·Phase 3·NCT00110461·296 enrolled

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

Show 4 more trials

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

Completed· Otsuka logo

Otsuka·Phase 3·NCT00080314·400 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

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

45 more indications

Schizoaffective Disorder5 trials

Comparison of Antipsychotics for Metabolic Problems in Schizophrenia or Schizoaffective Disorder

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

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

A Study Comparing the Efficacy and Safety of Ziprasidone and Aripiprazole for the Treatment fo Schizophrenia or Schizoaffective Disorder in Hospitalized Patients

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00634348·256 enrolled

Show 2 more trials

A Trial to Explore Acceptance and Performance of Using a Digital Medicine System With Healthcare Professionals and Adults With Schizophrenia, Schizoaffective Disorder, or First Episode Psychosis on an Oral Atypical Antipsychotic

Completed· Otsuka logo

Otsuka·Phase 4·NCT03568500·44 enrolled

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

Completed· Otsuka logo

Otsuka·Phase 3·NCT00095524·300 enrolled

Antipsychotics5 trials

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

A Study to Compare Capillary and Venous Whole Blood and Plasma Concentrations of Five Antipsychotics

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01607762·31 enrolled

Metabolic Effects of Antipsychotics in Children

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

Show 2 more trials

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

Switch Study of Existing Atypical Antipsychotics to Bifeprunox

Completed·SSolvay Pharmaceuticals·Phase 3·NCT00347425·286 enrolled

Major Depressive Disorder5 trials

Aripiprazole Augmentation Versus Switching to Different Class of Antidepressants in Major Depressive Disorder

Unknown status·KKorea University·N/A·NCT01488266·90 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·NCT01111539·211 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

Show 2 more 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

To Assess the Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)

Terminated· Otsuka logo

Otsuka·Phase 3·NCT01123707·173 enrolled

Autism4 trials

Post-Marketing Surveillance Study of Aripiprazole in Patients With Autism

Completed· Otsuka logo

Otsuka··NCT03179787·528 enrolled

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

Show 1 more trial

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

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

Tic Disorder4 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

Show 1 more trial

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

Completed· Otsuka logo

Otsuka·Phase 3·NCT00332241·98 enrolled

Metabolic Syndrome4 trials

Identification and Treatment Response Prediction of Antipsychotic-Related Metabolic Syndrome

Completed·NNational Taiwan University Hospital·N/A·NCT00956189·132 enrolled

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

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

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

Show 1 more trial

The Effects of Aripiprazole on Patients With Metabolic Syndrome

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

Treatment3 trials

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

Combination Treatment for Augmenting Language in Children With ASD

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

Bipolar Depression3 trials

Aripiprazole in the Treatment of Bipolar Depression

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

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

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

Cognitive Function3 trials

Evaluation of Negative Symptoms and Cognitive Function After Administration of Antipsychotics in Healthy Volunteer

Completed·—··NCT01185418·80 enrolled

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

Methamphetamine Dependence3 trials

Aripiprazole for Methamphetamine Dependence: Double Blind Placebo Trial

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

An Study of Aripiprazole in the Treatment of Methamphetamine Dependence

Terminated·WWei Hao·Phase 4·NCT01813656·10 enrolled

Aripiprazole Treatment for Methamphetamine Dependence Among High-risk Individuals

Completed·SSan Francisco Department of Public Health·Phase 2·NCT00497055·90 enrolled

Depression3 trials

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

Canadian Biomarker Integration Network for Depression Study

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

Adolescent2 trials

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

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

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

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

Autism Spectrum Disorder2 trials

An Open-Label Trial of Aripiprazole in Autism Spectrum Disorders

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

FMRI Brain Activation of Aripiprazole Treatment in Autism Spectrum Disorders

Completed·UUniversity of North Carolina, Chapel Hill·Phase 4·NCT01028820·13 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

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

Major Depressive Episode1 trial

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

Completed· Otsuka logo

Otsuka·Phase 3·NCT00094432·650 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

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

Tourette's Syndrome1 trial

Aripiprazole in the Treatment of Tourette's Syndrome

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

Pediatric1 trial

Long-term Antipsychotic Pediatric Safety Trial

Completed·—··NCT03522168·509 enrolled

Pervasive Developmental Disorder1 trial

A Study of Aripiprazole in Children and Adolescents With Aspergers and Pervasive Developmental Disorder.

Completed·IIndiana University School of Medicine·Phase 2·NCT00198055·25 enrolled

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

PET1 trial

A PET Study in Healthy Volunteers

Completed· GSK logo

GSK·Phase 1·NCT01424449·7 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

Obsessive-Compulsive Disorder1 trial

Acceptance and Commitment Therapy in SSRI-Resistant Obsessive Compulsive Disorder

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

Effectiveness1 trial

Broad Effectiveness: Study With Aripiprazole

Completed· Otsuka logo

Otsuka·Phase 3·NCT00036361·444 enrolled

Drug1 trial

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

Completed·OOrganon and Co··NCT01498770·42 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

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

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

Refractory Depression1 trial

Aripiprazole Augmentation of SSRI Therapy in Treatment Refractory Depression

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

Alcohol Drinking1 trial

Aripiprazole Effects on Alcohol Drinking and Craving

Completed·MMedical University of South Carolina·Phase 3·NCT01292057·99 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

Acceptability1 trial

Aripiprazole Oral Acceptability Trial

Completed· Otsuka logo

Otsuka·Phase 3·NCT00101569·59 enrolled

Antidepressants1 trial

Aripiprazole Augmentation of Antidepressants in PTSD

Completed·—·Phase 2·NCT00489866·14 enrolled

Anxiety1 trial

Aripiprazole for the Treatment of Refractory Anxiety

Completed·MMassachusetts General Hospital·Phase 4·NCT00438386

Substance Abuse1 trial

Abilify Therapy for Reducing Comorbid Substance Abuse

Completed·—·Phase 4·NCT00208169·30 enrolled

Anorexia Nervosa1 trial

ARIpiprazole in Anorexia NErvosa

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

Drug Monitoring1 trial

Therapeutic Drug Monitoring in Child and Adolescent Psychiatry

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

Unspecified2 trials

Pharmacovigilance in Gerontopsychiatric Patients

Terminated·HHannover Medical School·Phase 3·NCT02374567·407 enrolled

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 — 268 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

Mar 2, 2027

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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8718193Dec 5, 2029

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11464423Sep 15, 2030

9941931Nov 4, 2030

8961412Nov 17, 2030

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 Disorder15 trials

Psychosis14 trials

Bipolar I Disorder7 trials

Schizoaffective Disorder5 trials

Antipsychotics5 trials

Major Depressive Disorder5 trials

Autism4 trials

Tic Disorder4 trials

Metabolic Syndrome4 trials

Treatment3 trials

Bipolar Depression3 trials

Cognitive Function3 trials

Methamphetamine Dependence3 trials

Depression3 trials

Treatment Resistant Depression3 trials

Adolescent2 trials

Autism Spectrum Disorder2 trials

Hyperprolactinemia2 trials

Tardive Dyskinesia1 trial

Major Depressive Episode1 trial

Attention Deficit Hyperactivity Disorder1 trial

Post-Traumatic Stress Disorder1 trial

Tourette's Syndrome1 trial

Pediatric1 trial

Pervasive Developmental Disorder1 trial

Irritability1 trial

Chronic Tic Disorder1 trial

PET1 trial

Cocaine Dependence1 trial

Major Depression1 trial

Obsessive-Compulsive Disorder1 trial

Effectiveness1 trial

Drug1 trial

Cognitive impairment1 trial

Fragile X Syndrome1 trial

Sexual Dysfunction1 trial

Refractory Depression1 trial

Alcohol Drinking1 trial

Dementia1 trial

Children1 trial

Acceptability1 trial

Antidepressants1 trial

Anxiety1 trial

Substance Abuse1 trial

Anorexia Nervosa1 trial

Medication1 trial

Drug Monitoring1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

Related News