ABILIFY (aripiprazole)
ABILIFY (aripiprazole) Tablets are indicated for the treatment of: Schizophrenia Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder Adjunctive Treatment of Major Depressive Disorder Irritability Associated with Autistic Disorder Treatment of Tourette's Disorder ABILIFY is an atypical antipsychotic.
Details
- Status
- Prescription
- First Approved
- 2002-11-15
- Patent Cliff
- 2027
- Routes
- ORAL, INTRAMUSCULAR
- Dosage Forms
- TABLET, TABLET, ORALLY DISINTEGRATING, SOLUTION, INJECTABLE
ABILIFY Approval History
What ABILIFY Treats
15 FDA approvalsOriginally approved for its first indication in 2002 . Covers 15 distinct patient populations.
- Other (15)
Other
(15 approvals)- • Approved indication (Nov 2002)Label Letter
- • Approved indication (Aug 2003)Label Letter
- • Approved indication (Sep 2004)Label Letter
- • Approved indication (Dec 2004)Label Letter
- • Approved indication (Mar 2005)Label Letter
- • Approved indication (Jun 2006)Label Letter
- • Approved indication (Sep 2006)Label Letter
- • Approved indication (Oct 2007) PriorityLabel Letter
- • Approved indication (Nov 2007) PriorityLabel Letter
- • Approved indication (Feb 2008) PriorityLabel Letter
- • Approved indication (May 2008)Letter
- • Approved indication (Nov 2009)Label Letter
- • Approved indication (Feb 2011)Label Letter
- • Approved indication (Jun 2014)Label Letter
- • Approved indication (Dec 2014)Label Letter
ABILIFY Boxed Warning
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT DRUGS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1) ] . Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-te...
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT DRUGS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1) ] . Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24 years; there was a reduction in risk with antidepressant use in patients aged 65 years and older [see Warnings and Precautions (5.3) ] . In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.3) ] . WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT DRUGS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY is not approved for the treatment of patients with dementia-related psychosis. ( 5.1 ) Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants. Monitor for worsening and emergence of suicidal thoughts and behaviors. ( 5.3 )
Clinical Trial Registry
95 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07565428 | MIN-101C19 | Ph 3 | recruiting | 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 |
| NCT06969755 BEEST | BEEST 1R01MH134883-01A1 | Ph 4 | recruiting | Biomarkers to Enhance Early Schizophrenia Treatment |
| NCT07550387 | HS-10380-202 | Ph 2 | completed | A Study Assessing the Efficacy and Safety of HS-10380 in Hospitalized Adults With Acute Schizophrenia |
| NCT03485417 | SToP-S | Ph 2, Ph 3 | completed | Substance Misuse To Psychosis for Stimulants |
| NCT05814640 STAR-AD | 1stChongqingMU--ZXY | Ph 1, Ph 2 | recruiting | Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD) |
| NCT06236451 | PGThesis/2023-24/100 | Ph 4 | completed | Atypical Antipsychotic-induced Mitochondrial Dysfunction in Patients With Schizophrenia |
| NCT05545891 | IRB22-0616 | Ph 2 | not yet recruiting | Aripiprazole in Body Focused Repetitive Behaviors |
| NCT02634463 | CR108047 CODX0001-NAP-1004 | Ph 1 | completed | Whole Blood and Plasma Sample Collection for the Development of Antipsychotic Immunoassays From Participants Taking Aripiprazole, Olanzapine, Paliperidone, or Risperidone |
| NCT01490086 REFRESH results posted | RVP-20-001 | Ph 2 | completed | RP5063 in Subjects With Schizophrenia or Schizoaffective Disorder |
| NCT07011693 SMART-I | 1stChongqingCQMU | Ph 4 | not yet recruiting | Switching Medication and Augmentation Strategies for SSRI-Resistant Adolescent Depression（SMART-I) |
| NCT02431702 DREaM results posted | CR106193 R092670SCH3013 | Ph 3 | completed | 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 |
| NCT03874494 | 331-403-00027 | Ph 3 | completed | Safety and Efficacy of Brexpiprazole in the Treatment of Schizophrenia |
| NCT01119014 TEA | TEAprotocolversion5-11 03 2010 2009-016715-38 | Ph 4 | completed | Tolerance and Effect of Antipsychotics in Children and Adolescents With Psychosis |
| NCT05322031 | ARIANNA | Ph 4 | completed | The Impact of Aripiprazole Long-acting on Myelin and Cognition in the Onset of Schizophrenia |
| NCT03557931 results posted | 4345-CL-0015 | Ph 2 | completed | 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 |
| NCT02918370 results posted | 102015-062 | Ph 3 | completed | Aripiprazole for Bipolar Disorder and Alcohol Use Disorder |
| NCT01617460 results posted | 031-11-003 | Ph 3 | completed | A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder |
| NCT05554627 VAST-D II | KEP-002-20S | Ph 4 | withdrawn | VA Aripiprazole vs Esketamine for Treatment Resistant Depression |
| NCT03198078 results posted | 331-10-234 2017-001447-12 | Ph 3 | completed | Trial to Evaluate the Short-term Safety & Efficacy of Brexpiprazole Monotherapy in the Treatment of Adolescents With Schizophrenia |
| NCT04030143 results posted | 031-201-00181 | Ph 1, Ph 2 | completed | A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder |
| NCT02357849 FACT results posted | 11-199 | Ph 4 | terminated | Fluoxetine vs Aripiprazole Comparative Trial (FACT) |
| NCT00845026 results posted | 12648 H8Y-MC-HBBR | Ph 2 | completed | A Safety Study Comparing LY2140023 to Atypical Antipsychotic Standard Treatment in Schizophrenic Patients |
| NCT01354353 results posted | 13565 H8Y-MC-HBDB | Ph 1 | completed | A Study of Safety and Tolerability in Subjects With Schizophrenia |
| NCT01328093 results posted | 14211 H8Y-MC-HBDE | Ph 3 | terminated | A Comparison Study of LY2140023 and Aripiprazole in Schizophrenia Patients |
| NCT02977299 ASCERTAINTRD | 2015P002430 | Ph 4 | completed | Comparative Effectiveness Research Trial for Antidepressant Incomplete and Non-responders With TRD |
| NCT01123707 results posted | 31-08-257 2010-018860-17 | Ph 3 | terminated | To Assess the Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD) |
| NCT01111565 results posted | 31-08-263 2010-018859-97 | Ph 3 | terminated | Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD) |
| NCT01111552 results posted | 31-08-256 2010-018858-12 | Ph 3 | terminated | Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD) |
| NCT01111539 results posted | 31-08-255 2010-018796-21 | Ph 3 | terminated | Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD) |
| NCT01416441 results posted | 31-10-274 2011-000469-11 | Ph 3 | completed | Safety and Tolerability Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder |
| NCT01418352 results posted | 31-10-273 | Ph 3 | completed | Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder (TD) |
| NCT01418339 results posted | 31-10-272 2011-000467-27 | Ph 3 | completed | Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder |
| NCT02949752 | 518-2015 | Ph 4 | completed | Aripiprazole as an Adjunct to Atypical Antipsychotics for Weight Reduction and Improvement in Metabolic Profile |
| NCT02339844 PECANSII | H-3-2013-149 | Ph 4 | completed | Pan European Collaboration on Antipsychotic Naïve Schizophrenia II |
| NCT03661983 results posted | 31-14-204 2018-002270-48 | Ph 4 | terminated | Trial to Evaluate the Long-term Efficacy of Oral Aripiprazole in the Treatment of Pediatric Participants With Tourette's Disorder |
| NCT03289026 | 320-57-1706-1101-0001 | Ph 4 | completed | Pharmacologic Treatment of Acute Episode of Schizophrenia: a Real World Study |
| NCT03854409 | 031-201-00279 | Ph 1 | completed | A Trial of Single- and Multiple-doses of Aripiprazole in Adult Subjects With Schizophrenia or Bipolar I Disorder |
| NCT02146547 EULAST | ABR49490 | Ph 4 | completed | European Long-acting Antipsychotics in Schizophrenia Trial |
| NCT00895921 results posted | R21MH082805 R21MH082805, DATR A5-ETSE | Ph 4 | completed | Examining the Effects of Antipsychotic Medications on Insulin Sensitivity |
| NCT03568500 results posted | 031-201-00186 | Ph 4 | completed | 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 |
| NCT01446328 BP2 | 2010/3387 11/01070, 2010-022307-22 | Ph 4 | completed | Bergen Psychosis Project 2 - The Best Intro Study |
| NCT02574741 PIII | 12-000726 | Ph 2 | completed | Combination Treatment for Augmenting Language in Children With ASD |
| NCT01913327 APD results posted | 2010489 | Ph 4 | terminated | Antipsychotic Effects on Brain Function in Schizophrenia |
| NCT01129882 ASPIRE results posted | 31-10-270 | Ph 3 | completed | An Open-Label, Multicenter, Rollover, Long-term Study of Aripiprazole Intramuscular Depot in Participants With Schizophrenia |
| NCT01942187 | #6627 | Ph 4 | withdrawn | A Comparison of Medication Augmentation and PST in the Treatment of Depression in Older Adults |
| NCT01104766 results posted | RGH-MD-04 | Ph 3 | completed | Safety and Efficacy of Cariprazine in Patients With Schizophrenia |
| NCT01333072 BAART results posted | R01HD062550-01A1 | Ph 4 | completed | Biomarkers in Autism of Aripiprazole and Risperidone Treatment (BAART) |
| NCT01710709 ATLAS results posted | 31-08-252 | Ph 3 | completed | Open-label Study to Evaluate the Effectiveness of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Bipolar I Disorder |
| NCT03150771 | 031-201-00104 | Ph 1 | completed | Study to Determine the Pharmacokinetics, Safety & Tolerability of Aripiprazole in Adults With Schizophrenia |
| NCT01655706 CAN-BIND-1 | 11-0917-A | Ph 3 | completed | Canadian Biomarker Integration Network for Depression Study |
Showing 50 of 95 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ABILIFY FDA Label Details
Indications & Usage
FDA Label (PDF)ABILIFY (aripiprazole) Tablets are indicated for the treatment of: Schizophrenia Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder Adjunctive Treatment of Major Depressive Disorder Irritability Associated with Autistic Disorder Treatment of Tourette's Disorder ABILIFY is an atypical antipsychotic. ABILIFY is indicated for: Schizophrenia Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder Adjunctive Treatment of Major Depressive Disorder Irritability Associated with Autistic Disorder Treatment of Tourette's Disorder
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT DRUGS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY is not approved for the treatmen...
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Patent Timeline
- • Cliff: 2027
- • 89 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.