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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

Clinical Trials

Phase 4
Recruiting
Posted: 2024/02/01
Sponsor:
All India Institute ...
Not yet recruiting
Posted: 2023/11/13
Sponsor:
Peking University
Phase 1
Recruiting
Posted: 2023/04/18
Sponsor:
First Affiliated Hos...

FDA Approved Products

Aripiprazole
Manufacturer:XLCare Pharmaceuticals, Inc.
Route:ORAL
Strength:10 mg in 1 1
Approved: 2023/01/16
NDC:72865-155
Aripiprazole
Manufacturer:American Health Packaging
Route:ORAL
Strength:5 mg in 1 1
Approved: 2023/12/07
NDC:60687-168
ABILIFY
Manufacturer:Otsuka America Pharmaceutical, Inc.
Route:ORAL
Strength:20 mg in 1 1
Approved: 2022/11/30
NDC:59148-010
Aripiprazole
Manufacturer:Bryant Ranch Prepack
Route:ORAL
Strength:2 mg in 1 1
Approved: 2021/06/18
NDC:71335-1892
Aripiprazole
Manufacturer:AvPAK
Route:ORAL
Strength:5 mg in 1 1
Approved: 2024/01/09
NDC:50268-088

Singapore Approved Products

ABILIFY TABLET 5 mg
Manufacturer:OTSUKA PHARMACEUTICAL CO. LTD., Bristol-Myers Squibb Manufacturing Company {Humacao], Abdi Ibrahim IIaç San. Ve Tic. A.Ş.
Form:TABLET
Strength:5.0 mg
Online:Yes
Approved: 2004/04/14
Approval:SIN13006P
ARIPRIP 15 TABLET 15MG
Manufacturer:Ind-Swift Limited
Form:TABLET
Strength:15.00mg
Online:Yes
Approved: 2022/09/06
Approval:SIN16595P
ARIPDON Tablets 5mg
Manufacturer:PHARMATHEN INTERNATIONAL S.A, Pharmathen S.A. (Primary and Secondary Packager)
Form:TABLET
Strength:5.00mg
Online:Yes
Approved: 2023/02/13
Approval:SIN16688P
ABILIFY TABLET 2MG
Manufacturer:Korea Otsuka Pharmaceutical Co., Ltd.
Form:TABLET
Strength:2mg
Online:Yes
Approved: 2021/03/10
Approval:SIN16119P
ABILIFY MAINTENA POWDER AND SOLVENT FOR PROLONGED RELEASE SUSPENSION FOR INJECTION IN PFS 400mg
Manufacturer:OTSUKA PHARMACEUTICAL CO., LTD. (Finished Product Manufacturer)
Form:INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE
Strength:400mg/syringe
Online:Yes
Approved: 2023/08/14
Approval:SIN16832P

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