NDAINTRAMUSCULARSUSPENSION, EXTENDED RELEASE
Approved
Oct 2015
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
6
Data completeness
7/8 — Comprehensive
ARISTADA (aripiprazole lauroxil) by Alkermes is aripiprazole. Approved for schizophrenia, schizoaffective disorder. First approved in 2015.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ARISTADA (aripiprazole lauroxil) is an extended-release intramuscular suspension antipsychotic approved in 2015 for the treatment of schizophrenia in adults. It functions as a dopamine D2 and serotonin 5-HT1A partial agonist with 5-HT2A antagonist activity, mechanisms believed to mediate efficacy in schizophrenia. Following intramuscular injection, the lauroxil ester is enzymatically hydrolyzed to active aripiprazole, providing sustained therapeutic levels. ARISTADA occupies a niche in the long-acting injectable antipsychotic market, competing primarily against paliperidone palmitate formulations.
$0.3BPart D
12.9 years to LOEMechanism of Action
aripiprazole. Following intramuscular injection, aripiprazole lauroxil is likely converted by enzyme-mediated hydrolysis to N-hydroxymethyl aripiprazole, which is then hydrolyzed to aripiprazole. The mechanism of action of aripiprazole in schizophrenia is unknown. However, efficacy could be…
Indications (2)
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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.