MedPath

Aripiprazole

Generic Name
Aripiprazole
Brand Names
Abilify, Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen), Abilify Maintena, Aripiprazole Accord, Aripiprazole Sandoz, Aripiprazole Zentiva
Drug Type
Small Molecule
Chemical Formula
C23H27Cl2N3O2
CAS Number
129722-12-9
Unique Ingredient Identifier
82VFR53I78

Overview

Aripiprazole is an atypical antipsychotic orally indicated for the treatment of schizophrenia, bipolar I, major depressive disorder, irritability associated with autism, and Tourette's. It is also indicated as an injection for agitation associated with schizophrenia or bipolar mania. Aripiprazole exerts its effects through agonism of dopaminergic and 5-HT1A receptors and antagonism of alpha-adrenergic and 5-HT2A receptors. Aripiprazole was given FDA approval on November 15, 2002.

Background

Aripiprazole is an atypical antipsychotic orally indicated for the treatment of schizophrenia, bipolar I, major depressive disorder, irritability associated with autism, and Tourette's. It is also indicated as an injection for agitation associated with schizophrenia or bipolar mania. Aripiprazole exerts its effects through agonism of dopaminergic and 5-HT1A receptors and antagonism of alpha-adrenergic and 5-HT2A receptors. Aripiprazole was given FDA approval on November 15, 2002.

Indication

Aripiprazole is indicated for the treatment of acute manic and mixed episodes associated with bipolar I disorder, irritability associated with autism spectrum disorder, schizophrenia, and Tourette's disorder. It is also used as an adjunctive treatment of major depressive disorder.[L45859 An injectable formulation of aripiprazole is indicated for agitation associated with schizophrenia or bipolar mania. Finally, an extended-release, bimonthly injection formulation of aripiprazole is indicated for the treatment of adult schizophrenia and maintenance therapy for adult bipolar I disorder.

Associated Conditions

  • Agitation
  • Bipolar 1 Disorder
  • Irritability
  • Major Depressive Disorder (MDD)
  • Mixed manic depressive episode
  • Psychosis
  • Psychotic Depression
  • Schizophrenia
  • Tourette's Disorder (TD)
  • Acute Manic episode

FDA Approved Products

Aripiprazole
Manufacturer:Major Pharmaceuticals
Route:ORAL
Strength:20 mg in 1 1
Approved: 2023/10/11
NDC:0904-7370
ABILIFY
Manufacturer:Carilion Materials Management
Route:ORAL
Strength:15 mg in 1 1
Approved: 2016/01/08
NDC:68151-4461
Abilify MyCite
Manufacturer:Otsuka America Pharmaceutical, Inc.
Route:ORAL
Strength:10 mg in 1 1
Approved: 2023/02/24
NDC:59148-031
Aripiprazole
Manufacturer:Camber Pharmaceuticals, Inc.
Route:ORAL
Strength:1 mg in 1 mL
Approved: 2024/02/15
NDC:31722-684
Aripiprazole
Manufacturer:AvPAK
Route:ORAL
Strength:30 mg in 1 1
Approved: 2024/01/09
NDC:50268-092

Singapore Approved Products

ABILIFY MAINTENA POWDER AND SOLVENT FOR PROLONGED RELEASE SUSPENSION FOR INJECTION 400 MG
Manufacturer:Otsuka Pharmaceutical Co.Ltd, Siegfried Hameln GmbH (Water for Injection), Otsuka Pharmaceutical Co., Ltd.
Form:INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE
Strength:400mg/vial
Online:Yes
Approved: 2017/03/14
Approval:SIN15192P
ARIPIPRAZOLE MEVON TABLETS 10 MG
Manufacturer:Pharmathen International S.A
Form:TABLET
Strength:10 mg
Online:Yes
Approved: 2025/02/18
Approval:SIN17180P
ARIPIPRAZOLE MEVON TABLETS 5 MG
Manufacturer:Pharmathen International S.A
Form:TABLET
Strength:5 mg
Online:Yes
Approved: 2025/02/18
Approval:SIN17182P
ABILIFY ASIMTUFII PROLONGED-RELEASE SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE 960MG/3.2ML
Manufacturer:Otsuka Pharmaceutical Co., Ltd.
Form:INJECTION, SUSPENSION, EXTENDED RELEASE
Strength:960mg /3.2ml
Online:Yes
Approved: 2025/04/22
Approval:SIN17222P
ARIPIPRAZOLE MEVON TABLETS 15 MG
Manufacturer:Pharmathen International S.A
Form:TABLET
Strength:15 mg
Online:Yes
Approved: 2025/02/18
Approval:SIN17181P

Drug Development Updates

Stay informed with timely notifications on clinical trials and research advancements.

© Copyright 2025. All Rights Reserved by MedPath