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Data updated: May 26, 2026

ABILIFY MYCITE KIT (aripiprazole)

CNS Approved 2017-11-13
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
8
Years on Market

Details

Status
Discontinued
First Approved
2017-11-13
Patent Cliff
2033

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Routes
ORAL
Dosage Forms
TABLET

Companies

OTSUKA
Active Ingredient: ARIPIPRAZOLE

ABILIFY MYCITE KIT Approval History

2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
42 FDA actions from 2017 to 2025
Jan 2025 SUPPL
Label · Labeling
FDA Letter Label
Nov 2022 SUPPL
Label · Labeling
FDA Letter Label
Dec 2020 SUPPL
Mfg · Manufacturing (CMC)
Label

What ABILIFY MYCITE KIT Treats

1 FDA approvals

Originally approved for its first indication in 2017 .

  • Other (1)
📋

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

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Key Completed Trials

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Trial Timeline

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Full development history with FDA approval milestones

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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 MYCITE KIT FDA Label Details

View full patent landscape →
27 OB patents · 15 families · 529 international docs across 40 countries

ABILIFY MYCITE KIT Patents & Exclusivity

Latest Patent: Oct 2033

Patents (27 active)

US9268909 Expires Oct 15, 2033
US10517507 Expires Jun 13, 2032
US9320455 Expires Dec 15, 2031
US11229378 Expires Jul 11, 2031
US8547248 Expires Dec 18, 2030
US8258962 Expires Nov 25, 2030
US8961412 Expires Nov 17, 2030
US9941931 Expires Nov 4, 2030
US11464423 Expires Sep 15, 2030
US8114021 Expires Jun 21, 2030
US8545402 Expires Apr 27, 2030
US8847766 Expires Mar 29, 2030
US9149577 Expires Dec 15, 2029
US8718193 Expires Dec 5, 2029
US9433371 Expires Sep 15, 2029
US8945005 Expires Aug 19, 2029
US10441194 Expires Jul 26, 2029
US8956288 Expires Jul 6, 2029
US8674825 Expires Apr 9, 2029
US9060708 Expires Mar 5, 2029
US9258035 Expires Mar 5, 2029
US9119554 Expires Dec 16, 2028
US9444503 Expires Nov 19, 2027
US8759350 Expires Mar 2, 2027
US7978064 Expires Sep 14, 2026
US9125939 Expires Jul 28, 2026
US11476952 Expires Apr 28, 2026
Source: FDA Orange Book

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Patent Timeline

  • • Cliff: 2033
  • • 972 active patents

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Data Sources

FDA Approval: NDA207202 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.