NDAINTRAMUSCULARFOR SUSPENSION, EXTENDED RELEASE
Approved
Feb 2013
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
ABILIFY MAINTENA KIT (aripiprazole) by Otsuka is unknown. First approved in 2013.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ABILIFY MAINTENA KIT is an extended-release intramuscular suspension formulation of aripiprazole, an atypical antipsychotic approved in 2013. It works through partial agonist activity at dopamine D2 and serotonin 5-HT1A receptors combined with antagonist activity at 5-HT2A receptors. The product is indicated for maintenance treatment of schizophrenia and bipolar disorder in patients requiring long-acting depot therapy.
Peak7.8 years to LOE
Peak lifecycle positioning indicates stable revenue streams and established commercial infrastructure, though team growth may be limited without new indication expansion.
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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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.