NDAINTRAMUSCULARFOR SUSPENSION, EXTENDED RELEASE
Approved
Feb 2013
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
ABILIFY MAINTENA KIT (aripiprazole) by Otsuka is unknown. Approved for schizophrenia, bipolar disorder. First approved in 2013.
Drug data last refreshed 23h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ABILIFY MAINTENA KIT is an extended-release intramuscular suspension of aripiprazole, an atypical antipsychotic approved in 2013. It treats schizophrenia, bipolar disorder, schizoaffective disorder, major depressive disorder, autism spectrum disorder, Tourette's disorder, OCD, and other psychiatric and neurological conditions. The mechanism involves partial agonist activity at dopamine D2 and serotonin 5-HT1A receptors combined with antagonist activity at 5-HT2A receptors.
Peak7.9 years to LOE
Peak lifecycle product with stable market position; brand teams typically maintain established commercial infrastructure focused on market defense rather than aggressive growth.
Mechanism of Action
unknown. The efficacy of aripiprazole could be mediated through a combination of partial agonist activity at dopamine D 2 and serotonin 5-HT 1A receptors and antagonist activity at 5-HT 2A receptors.
Indications (2)
Clinical Trials (20)
A Double-Blind, Randomized Comparative Study of Carliprazine and Aripiprazole in Patients with Acute Schizophrenia
Started Oct 2024
376 enrolled
Acute Schizophrenia
Aripiprazole Once-Monthly in Hospitalized Patients (INITIATE)
Started Nov 2021
200 enrolled
SchizophreniaSchizo Affective DisorderBipolar I Disorder
Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode
Started Dec 2019
15 enrolled
SchizophreniaSchizoaffective Disorder, Depressive TypeSchizophreniform Disorder
A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder
Started Aug 2019
266 enrolled
SchizophreniaBipolar I Disorder
DIMES - DIgital MEdicine Study for Adults With Schizophrenia, Bipolar I Disorder, or Major Depression Currently Using Aripiprazole
Started Apr 2019
46 enrolled
SchizophreniaMajor Depressive DisorderBi-Polar Disorder+1 more
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.