aripiprazole
Trade name: abilify
Approved
Nov 15, 2002
Aripiprazole is the first next-generation atypical antipsychotic. The unique actions of aripiprazole in humans are likely a combination of "functionally selective" activation of D(2) (and possibly D(3))-dopamine receptors and serotonin 5-HT(1A) receptors, coupled with inhibition of 5-HT(2A) receptors. Aripiprazole was approved by FDA (Abilify trade name) for the treatment of schizophrenia; manic and mixed episodes associated with bipolar I disorder; major depressive disorder; irritability associated with autistic disorder; Tourette’s disorder and agitation associated with schizophrenia or bipolar mania. — NCATS
Clinical trial activity
368 trials · 223 clinical orgs · 34 marketing orgs
Earliest trial started Apr 1, 1998 (NCT02435836)
Timeline
2000s
2010s
- Oct 12, 2012
Barr Laboratories — Marketing Organization
- Feb 14, 2013
Sun Pharmaceuticals — Marketing Organization
- Apr 28, 2015
Alembic — Marketing Organization
- Apr 28, 2015
Hetero Labs Ltd — Marketing Organization
- Apr 28, 2015
Teva — Marketing Organization
- Apr 28, 2015
Torrent Pharmaceuticals Limited — Marketing Organization
- Jul 24, 2015
Apotex — Marketing Organization
- Aug 14, 2015
Amneal Pharmaceuticals — Marketing Organization
- Aug 14, 2015
Lannett Company, Inc. — Marketing Organization
- Oct 5, 2015
Alkermes — NDA Secondary Org
- Oct 8, 2015
Aurobindo Pharma — Marketing Organization
- Sep 12, 2016
Ajanta Pharma Ltd — Marketing Organization
- Sep 29, 2016
Sciegen Pharmaceticals — Marketing Organization
- Oct 7, 2016
Macleods Pharmaceuticals, Ltd — Marketing Organization
- Oct 7, 2016
Neogen — Marketing Organization
- Dec 7, 2016
Accord Research — Marketing Organization
- Jan 9, 2017
Boscogen — Marketing Organization
- Jan 9, 2017
Esteve Labs — Marketing Organization
- May 23, 2017
Orbion Pharms — Marketing Organization
- May 23, 2017
Orchid Pharma — Marketing Organization
- Dec 4, 2017
Prinston Inc — Marketing Organization
- Aug 28, 2018
Zydus Discovery DMCC — Marketing Organization
- Aug 28, 2018
Square Pharmaceuticals — Marketing Organization
- Sep 19, 2018
Mylan — Marketing Organization
- Dec 26, 2018
Pharmtak Inc — Marketing Organization
- Feb 21, 2019
Alkem Labs Ltd — Marketing Organization
- Dec 26, 2019
VistaPharm, Inc. — Marketing Organization
2020s
- Jun 29, 2021
Unichem — Marketing Organization
- Oct 25, 2022
Glasshouse Pharmaceuticals — Marketing Organization
- Oct 25, 2022
Chartwell Pharmaceuticals — Marketing Organization
- Oct 27, 2022
Rubicon Research — Marketing Organization
- Oct 2, 2023
Sunshine Lake Pharma Co., Ltd. — Marketing Organization
- Mar 18, 2024
Lupin — Marketing Organization
Indications
Approved for
Studied for
- Acute Pain · Phase 2
- Aggression · Phase 4
- Alcoholism · Phase 4
- Alzheimer Disease · Phase 4
- Amphetamine-Related Disorders · Phase 1
- Analgesia · Phase 4
- Anesthesia · Phase 4
- Anorexia Nervosa · Phase 3
- Antipsychotic Agents · Phase 4
- Anxiety Disorders · Phase 4
- Aripiprazole · Phase 4
- Asperger Syndrome · Phase 2
- Asthma · Phase 4
- Attention Deficit and Disruptive Behavior Disorders · Phase 4
- Attention Deficit Disorder with Hyperactivity · Phase 4
- Autism Spectrum Disorder · Phase 4
- Behavioral Symptoms · Phase 3
- Bipolar and Related Disorders · Phase 4
- Body Weight · Phase 4
- Body Weight Changes · Phase 3
- Cardiovascular Diseases · Phase 4
- Central Nervous System Diseases · Phase 1
- Central Nervous System Stimulants · Phase 2/Phase 3
- Child Development Disorders, Pervasive · Phase 4
- Cocaine-Related Disorders · Phase 2
- Cognition Disorders · Phase 4
- Cognitive Dysfunction · Phase 4
- Conduct Disorder · Phase 4
- Cytochrome P-450 CYP2D6 · Phase 4
- Cytochrome P-450 CYP3A · Phase 4
- Dementia · Phase 4
- Depression · Phase 4
- Depression, Postpartum · Phase 3
- Depressive Disorder, Treatment-Resistant · Phase 4
- Dermatology · Phase 2
- Diabetes Mellitus · Phase 4
- Diabetes Mellitus, Type 2 · Phase 4
- Diagnosis · Phase 2/Phase 3
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Drugs, Investigational · Phase 4
- Drug Therapy · Phase 2/Phase 3
- Dyskinesia, Drug-Induced · Phase 4
- Dyslipidemias · Phase 4
- Dysthymic Disorder · Phase 4
- Feeding and Eating Disorders · Phase 4
- Fragile X Syndrome · Phase 2
- Growth and Development · Phase 3
- Healthy Volunteers · Phase 1
- HIV Infections · Phase 2
- Hyperlipidemias · Phase 4
- Hyperprolactinemia · Phase 4
- Hysterotomy · Phase 4
- Immunoassay · Phase 1
- Insulin Resistance · Phase 4
- Irritable Mood · Phase 4
- Lipid Metabolism Disorders · Phase 4
- Low Back Pain · Phase 2
- Major Depressive Disorder · Phase 4
- Mammaplasty · Phase 2
- Mania · Phase 4
- Medication Adherence · Phase 4
- Mental Disorders · Phase 2
- Mental Health · Phase 4
- Metabolic Diseases · Phase 4
- Metabolic Syndrome · Phase 4
- Methamphetamine · Phase 4
- Myelin Sheath · Phase 4
- Nervous System Diseases · Phase 2
- Non-alcoholic Fatty Liver Disease · Phase 4
- Obsessive-Compulsive Disorder · Phase 2
- Opioid-Related Disorders · Phase 1
- Overweight · Phase 4
- Panic Disorder · Phase 4
- Parkinson Disease · Phase 4
- Pharmacokinetics · Phase 4
- Phobia, Social · Phase 4
- Psychophysiologic Disorders · Phase 3
- Rectal Neoplasms · Phase 2
- Risk Factors · Phase 4
- Schizophrenia, Treatment-Resistant · Phase 4
- Sexual Dysfunction, Physiological · Phase 4
- Stress Disorders, Post-Traumatic · Phase 3
- Stuttering · Phase 1
- Substance Abuse, Oral · Phase 2/Phase 3
- Substance-Related Disorders · Phase 4
- Tic Disorders · Phase 4
- Tourette Syndrome · Phase 4
- Trichotillomania · Phase 2
- Weight Gain · Phase 4
Mechanism of action
- Serotonin 2a (5-HT2a) receptorANTAGONIST
HTR2A antagonist
- Dopamine D2 receptorPARTIAL AGONIST
DRD2 partial agonist
- Serotonin 1a (5-HT1a) receptorPARTIAL AGONIST
HTR1A partial agonist
Approval history
- approvedNov 15, 2002
Chemistry & pharmacology
SMILES
ClC1=C(Cl)C(=CC=C1)N2CCN(CCCCOC3=CC4=C(CCC(=O)N4)C=C3)CC2- Mol. weight
- 448.385 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral, Parenteral
- Availability
- Prescription Only
Oral
Yes
Parenteral
Yes
Topical
No
Sources
- WikipediaAripiprazole ↗
- NCATS82VFR53I78 ↗
- ChEMBLCHEMBL2219425 ↗
- ChEMBLCHEMBL1112 ↗
Also known as
- abilify
- abilify
- abilify
- abilify
- abilify
- abilify maintena
- abilify maintena
- abilify maintena
- abilitat
- abilitat
- af056
- alks 9072
- alks 9072
- aripiprazol
- aripiprazol
- aripiprazole
- aripiprazole
- aripiprazole
- aripiprazole
- aripiprazole
- aripiprazole
- aripiprazole
- aripiprazole
- aripiprazole
- aripiprazole
- aripiprazole hydrate
- aripiprazole hydrate
- aripiprazole hydrate
- aripiprazole hydrate
- aripiprazole hydrate
- aripiprazole lauroxil
- aripiprazole lauroxil
- aripiprazole lauroxil
- aripiprazole lauroxil
- aripiprazole lauroxil
- aripiprazole lauroxil
- aripiprazole lauroxil
- aripiprazole lauroxil
- aripiprazole lauroxil
- aripiprazolum
- aripiprazolum
- aripirprazole
- arista
- aristada
- aristada
- aristada
- aristada
- arpiprazole
- arpizol
- opc-14597
- opc-14597
- opc-14597
- opc 31
- opc 31
- opc-31
- opc-31
- pripiprazole
- rdc-3317
- rdc-3317
- rdc-3317
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07215884 | Phase 1 | Sep 30, 2025 | National Institute on Deafness and Other Communication Disorders (NIDCD), University of California, San Francisco, University of Washington |
| NCT07068763 | Phase 2 | Aug 8, 2025 | Zhejiang University |
| NCT06969755 | Phase 4 | Jul 30, 2025 | National Institute of Mental Health (NIMH), Northwell Health |
| NCT07011693 | Phase 4 | Jun 20, 2025 | Chongqing Medical University |
| NCT06799559 | Phase 3 | May 31, 2025 | Qilu Pharmaceutical Co., Ltd. |
| NCT06937476 | N/A | May 8, 2025 | Central South University, National Natural Science Foundation of China |
| NCT06589817 | Phase 3 | Oct 31, 2024 | Chengdu Kanghong Biotech Co.,Ltd. |
| NCT06590298 | Phase 4 | Sep 15, 2024 | University of Health Sciences Lahore, University Putra Malaysia |
| NCT06433635 | Phase 4 | Sep 1, 2024 | Harvard University, Patient-Centered Outcomes Research Institute |
| NCT06501339 | Phase 4 | Aug 10, 2024 | All India Institute of Medical Sciences |
| NCT05361993 | Phase 4 | Jun 1, 2024 | Fudan University |
| NCT06236451 | Phase 4 | Apr 5, 2024 | All India Institute of Medical Sciences |
| NCT06060886 | Phase 4 | Nov 1, 2023 | Consorcio Centro de Investigación Biomédica en Red, M.P., Hospital de Mataró, Universidad Carlos III Madrid |
| NCT05766540 | Phase 4 | Aug 20, 2023 | All India Institute of Medical Sciences |
| NCT05868720 | N/A | Jul 1, 2023 | All India Institute of Medical Sciences |
| NCT06372210 | N/A | Jun 26, 2023 | Otsuka |
| NCT05662306 | Phase 4 | Jun 1, 2023 | Alkermes, University of Miami |
| NCT05554627 | Phase 4 | Mar 1, 2023 | Department of Veteran Affairs |
| NCT05814640 | Phase 1/Phase 2 (Phase 2) | Feb 20, 2023 | Central South University, Chongqing Medical University, People's Liberation Army of China |
| NCT05545891 | Phase 2 | Dec 31, 2022 | University of Chicago |
Organizations
Research & Development (223)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Otsuka | For profit | 138 | 119 | 5 | 1998 |
| Bristol-Myers Squibb | For profit | 72 | 4 | 5 | 2000 |
| National Institute of Mental Health (NIMH) | Government | 18 | 2 | 3 | 2001 |
| Harvard University | Academic/Hospital | 12 | 10 | 4 | 2003 |
| Johnson and Johnson | For profit | 12 | 12 | 4 | 2004 |
| Department of Veteran Affairs | Government | 11 | 7 | 4 | 2003 |
| Lundbeck | For profit | 11 | 2 | 2 | 2006 |
| Alkermes | For profit | 10 | 8 | 3 | 2011 |
| Northwell Health | Academic/Hospital | 9 | 8 | 2 | 2002 |
| Peking University | Academic/Hospital | 9 | 7 | 4 | 2005 |
| Columbia University | Academic/Hospital | 7 | 4 | 2 | 2001 |
| Eli Lilly | For profit | 7 | 6 | 4 | 2003 |
| Government of Taiwan | Government | 7 | 2 | 3 | 2004 |
| Jiao Tong University | Academic/Hospital | 7 | 5 | 4 | 2005 |
| Seoul National University | Academic/Hospital | 7 | 4 | 3 | 2004 |
| Washington University in St. Louis | Academic/Hospital | 7 | 5 | 3 | 2004 |
| Central South University | Academic/Hospital | 6 | 3 | 3 | 2005 |
| Centro de Investigación Biomédica en Red (CIBER) | Academic/Hospital | 6 | 0 | 1 | 2005 |
| University of Cantabria | Academic/Hospital | 6 | 6 | 1 | 2005 |
| Case Western Reserve University | Academic/Hospital | 5 | 5 | 2 | 2004 |
Marketing (41)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Accord Research | For profit | MKTG | Dec 7, 2016 |
| Ajanta Pharma Ltd | For profit | MKTG | Sep 12, 2016 |
| Alembic | For profit | MKTG | Apr 28, 2015 |
| Alembic | For profit | SYN | Apr 28, 2015 |
| Alkem Labs Ltd | For profit | MKTG | Feb 21, 2019 |
| Alkermes | For profit | NDA2 | Oct 5, 2015 |
| Amneal Pharmaceuticals | For profit | MKTG | Aug 14, 2015 |
| Apotex | For profit | MKTG | Jul 24, 2015 |
| Apotex | For profit | SYN | Sep 30, 2015 |
| Aurobindo Pharma | For profit | MKTG | Oct 8, 2015 |
| Aurobindo Pharma | For profit | SYN | Oct 8, 2015 |
| Barr Laboratories | For profit | MKTG | Oct 12, 2012 |
| Boscogen | For profit | MKTG | Jan 9, 2017 |
| Chartwell Pharmaceuticals | For profit | MKTG | Oct 25, 2022 |
| Esteve Labs | For profit | MKTG | Jan 9, 2017 |
| Glasshouse Pharmaceuticals | For profit | MKTG | Oct 25, 2022 |
| Hetero Labs Ltd | For profit | MKTG | Apr 28, 2015 |
| Hetero Labs Ltd | For profit | SYN | Nov 1, 2023 |
| Lannett Company, Inc. | For profit | MKTG | Aug 14, 2015 |
| Lupin | For profit | MKTG | Mar 18, 2024 |
| Macleods Pharmaceuticals, Ltd | For profit | MKTG | Oct 7, 2016 |
| Mylan | For profit | MKTG | Sep 19, 2018 |
| Mylan | For profit | SYN | Sep 19, 2018 |
| Neogen | For profit | MKTG | Oct 7, 2016 |
| Orbion Pharms | For profit | MKTG | May 23, 2017 |
| Orchid Pharma | For profit | MKTG | May 23, 2017 |
| Otsuka | For profit | SYN | Feb 28, 2013 |
| Otsuka | For profit | NDA | Nov 15, 2002 |
| Pharmtak Inc | For profit | MKTG | Dec 26, 2018 |
| Prinston Inc | For profit | MKTG | Dec 4, 2017 |
| Rubicon Research | For profit | MKTG | Oct 27, 2022 |
| Sciegen Pharmaceticals | For profit | MKTG | Sep 29, 2016 |
| Square Pharmaceuticals | For profit | MKTG | Aug 28, 2018 |
| Sun Pharmaceuticals | For profit | MKTG | Feb 14, 2013 |
| Sunshine Lake Pharma Co., Ltd. | For profit | MKTG | Oct 2, 2023 |
| Teva | For profit | MKTG | Apr 28, 2015 |
| Torrent Pharmaceuticals Limited | For profit | MKTG | Apr 28, 2015 |
| Unichem | For profit | SYN | Dec 1, 2021 |
| Unichem | For profit | MKTG | Jun 29, 2021 |
| VistaPharm, Inc. | For profit | MKTG | Dec 26, 2019 |
| Zydus Discovery DMCC | For profit | MKTG | Aug 28, 2018 |