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 22h ago · AI intelligence enriched 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ARISTADA is an extended-release intramuscular suspension of aripiprazole lauroxil approved for schizophrenia treatment. The prodrug is hydrolyzed in vivo to aripiprazole, which exerts efficacy through partial agonism at dopamine D2 and serotonin 5-HT1A receptors and antagonism at 5-HT2A receptors. This long-acting injectable formulation enables reduced dosing frequency compared to oral antipsychotics.
$0.273BPart D
PeakStable
12.5 years to LOEStable peak-stage product with 90K+ annual claims indicates mature commercial infrastructure supporting field sales, medical affairs, and account management roles.
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.