NDAINTRAMUSCULARSUSPENSION, EXTENDED RELEASE
Approved
Oct 2015
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
6
Data completeness
6/8 — Strong
ARISTADA (aripiprazole lauroxil) by Alkermes is aripiprazole. First approved in 2015.
Drug data last refreshed 13h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ARISTADA (aripiprazole lauroxil) is an extended-release intramuscular injection for schizophrenia approved in 2015. The drug works as a partial agonist at dopamine D2 and serotonin 5-HT1A receptors while antagonizing 5-HT2A receptors, providing sustained antipsychotic activity. It is administered via IM injection, converting to active aripiprazole through enzyme-mediated hydrolysis.
$0.273BPart D
Peak12.8 years to LOEProduct is at peak lifecycle with $273M in Part D spending, indicating stable commercial infrastructure and established field teams.
Mechanism 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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (6)
Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode
Started Dec 2019
15 enrolled
SchizophreniaSchizoaffective Disorder, Depressive TypeSchizophreniform Disorder
A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia
Started Nov 2017
200 enrolled
Schizophrenia
A Study of Aripiprazole Lauroxil in Subjects With Schizophrenia or Schizoaffective Disorder
Started Dec 2015
47 enrolled
SchizophreniaSchizoaffective Disorder
A Study of Aripiprazole Lauroxil (Also Known as ARISTADA TM) in Subjects With Schizophrenia
Started Dec 2015
51 enrolled
Schizophrenia
An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia
Started Dec 2014
140 enrolled
Schizophrenia
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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.