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.
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
Research Report
A Comprehensive Monograph on Aripiprazole (DB01238)
Part I: Foundational Profile of Aripiprazole
1. Introduction and Drug Classification
Executive Summary
Aripiprazole is a quinolinone derivative classified as a third-generation, or "atypical," antipsychotic medication.[1] Marketed under brand names including Abilify, Abilify Maintena, and Aristada, it holds a unique position in psychopharmacology due to its novel mechanism of action.[1] Aripiprazole was the first agent approved by the U.S. Food and Drug Administration (FDA) that functions as a partial agonist at the dopamine D2 receptor, earning it the designation of a "dopamine-system stabilizer" (DSS).[4] This distinct pharmacological profile differentiates it from first-generation ("typical") antipsychotics, which are pure D2 receptor antagonists, and most second-generation ("atypical") antipsychotics, which are primarily serotonin-dopamine antagonists.[5] Its primary indications include the treatment of schizophrenia, bipolar I disorder, as an adjunctive therapy for major depressive disorder (MDD), and for managing irritability associated with autistic disorder and tics in Tourette syndrome.[1]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/10 | Phase 4 | Not yet recruiting | Xinyu Zhou | ||
2025/05/14 | Phase 4 | Not yet recruiting | |||
2025/04/22 | Not Applicable | Not yet recruiting | N/A | ||
2024/09/10 | Phase 3 | Not yet recruiting | Chengdu Kanghong Pharmaceutical Group Co., Ltd. | ||
2024/07/15 | Phase 4 | Not yet recruiting | All India Institute of Medical Sciences, Bhubaneswar | ||
2024/04/17 | Not Applicable | Completed | |||
2024/02/01 | Phase 4 | Recruiting | All India Institute of Medical Sciences, Bhubaneswar | ||
2023/11/13 | N/A | Not yet recruiting | Peking University | ||
2023/09/29 | Phase 4 | Not yet recruiting | Consorcio Centro de Investigación Biomédica en Red (CIBER) | ||
2023/05/22 | Not Applicable | Not yet recruiting | All India Institute of Medical Sciences, Bhubaneswar |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Major Pharmaceuticals | 0904-7366 | ORAL | 2 mg in 1 1 | 10/11/2023 | |
| Safecor Health, LLC | 48433-115 | ORAL | 2 mg in 1 1 | 11/21/2019 | |
| ScieGen Pharmaceuticals Inc | 50228-331 | ORAL | 15 mg in 1 1 | 11/10/2023 | |
| Camber Pharmaceuticals, Inc. | 31722-922 | ORAL | 15 mg in 1 1 | 2/20/2023 | |
| Ajanta Pharma USA Inc. | 27241-056 | ORAL | 30 mg in 1 1 | 7/20/2023 | |
| ScieGen Pharmaceuticals Inc | 50228-328 | ORAL | 20 mg in 1 1 | 3/7/2020 | |
| ScieGen Pharmaceuticals Inc | 50228-476 | ORAL | 5 mg in 1 1 | 2/20/2023 | |
| XLCare Pharmaceuticals, Inc. | 72865-184 | ORAL | 20 mg in 1 1 | 6/16/2023 | |
| Camber Pharmaceuticals, Inc. | 31722-924 | ORAL | 30 mg in 1 1 | 2/20/2023 | |
| NuCare Pharmaceuticals,Inc. | 68071-2394 | ORAL | 10 mg in 1 1 | 4/29/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/15/2015 | ||
Authorised | 11/14/2013 | ||
Authorised | 6/4/2004 | ||
Authorised | 6/25/2015 | ||
Authorised | 6/25/2015 | ||
Authorised | 6/30/2015 | ||
Authorised | 8/20/2015 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ARIPRIP 5 TABLET 5MG | SIN16593P | TABLET | 5.00mg | 9/6/2022 | |
| ARIPRIP 10 TABLET 10MG | SIN16594P | TABLET | 10.00mg | 9/6/2022 | |
| ABILIFY TABLET 15 mg | SIN13008P | TABLET | 15 mg | 4/14/2004 | |
| ABILIFY ORAL SOLUTION 1MG/ML | SIN16120P | SOLUTION | 1.0 mg/ml | 3/10/2021 | |
| ABILIFY TABLET 10 mg | SIN13007P | TABLET | 10.0 mg | 4/14/2004 | |
| ABILIFY TABLET 5 mg | SIN13006P | TABLET | 5.0 mg | 4/14/2004 | |
| ARIPRIP 15 TABLET 15MG | SIN16595P | TABLET | 15.00mg | 9/6/2022 | |
| ARIPDON Tablets 5mg | SIN16688P | TABLET | 5.00mg | 2/13/2023 | |
| ABILIFY TABLET 2MG | SIN16119P | TABLET | 2mg | 3/10/2021 | |
| ABILIFY MAINTENA POWDER AND SOLVENT FOR PROLONGED RELEASE SUSPENSION FOR INJECTION IN PFS 400mg | SIN16832P | INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE | 400mg/syringe | 8/14/2023 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| PMS-ARIPIPRAZOLE TABLETS 2MG | N/A | N/A | N/A | 9/2/2024 | |
| ARIPIPRAZOL STADA TABLETS 5MG | N/A | N/A | N/A | 9/5/2017 | |
| ZYKALOR TABLETS 10MG | N/A | N/A | N/A | 8/16/2024 | |
| ZYKALOR TABLETS 15MG | N/A | N/A | N/A | 8/16/2024 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ARIPIPRAZOLE AN aripiprazole 5 mg tablet bottle | 198198 | Medicine | A | 8/9/2013 | |
| TERRY WHITE CHEMISTS ARIPIPRAZOLE 5 mg aripiprazole tablets blister pack | 152927 | Medicine | A | 7/9/2009 | |
| ARIPIPRAZOLE SANDOZ aripiprazole 30 mg tablet blister pack | 158274 | Medicine | A | 4/18/2010 | |
| ARIPIPRAZOLE SANDOZ aripiprazole 5 mg tablet blister pack | 158282 | Medicine | A | 4/18/2010 | |
| ARIPIPRAZOLE SUN aripiprazole 400 mg powder and diluent for prolonged release suspension for injection vial kit | 444953 | Medicine | A | 2/12/2025 | |
| ABILIFY ASIMTUFII aripiprazole (as monohydrate) 960 mg/3.2 mL prolonged release suspension for injection pre-filled syringe | 410039 | Medicine | A | 2/5/2025 | |
| ARIZOLE 2 aripiprazole 2 mg tablet blister pack | 198211 | Medicine | A | 8/9/2013 | |
| ABILIFY aripiprazole 15mg tablet blister pack | 90998 | Medicine | A | 5/21/2003 | |
| ARIZOLE aripiprazole 15 mg tablet bottle | 198189 | Medicine | A | 8/9/2013 | |
| AURO-ARIPIPRAZOLE 5 aripiprazole 5 mg tablet blister pack | 198185 | Medicine | A | 8/9/2013 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| AG-ARIPIPRAZOLE | angita pharma inc. | 02448181 | Tablet - Oral | 5 MG | N/A |
| APO-ARIPIPRAZOLE DEPOT | 02556286 | Powder For Suspension, Sustained-Release
,
Kit - Intramuscular | 300 MG / VIAL | N/A | |
| TEVA-ARIPIPRAZOLE | teva canada limited | 02464152 | Tablet - Oral | 5 MG | 7/17/2018 |
| TEVA-ARIPIPRAZOLE | teva canada limited | 02464160 | Tablet - Oral | 10 MG | 7/17/2018 |
| APO-ARIPIPRAZOLE | 02471094 | Tablet - Oral | 5 MG | 4/10/2018 | |
| ABILIFY ASIMTUFII | 02554577 | Suspension (Extended-Release) - Intramuscular | 960 MG / 3.2 ML | 3/20/2025 | |
| ABILIFY MAINTENA | 02420872 | Powder For Suspension, Sustained-Release
,
Kit - Intramuscular | 400 MG / VIAL | 3/27/2014 | |
| NRA-ARIPIPRAZOLE | nora pharma inc | 02472244 | Tablet - Oral | 10 MG | 1/23/2024 |
| MINT-ARIPIPRAZOLE | mint pharmaceuticals inc | 02483580 | Tablet - Oral | 15 MG | 4/14/2020 |
| ARIPIPRAZOLE | sanis health inc | 02506718 | Tablet - Oral | 5 MG | 4/23/2021 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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