NDAINTRAMUSCULARSUSPENSION, EXTENDED RELEASE
Approved
Jun 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
7
Data completeness
5/8 — Partial
ARISTADA INITIO KIT (aripiprazole lauroxil) by Alkermes is aripiprazole. First approved in 2018.
Drug data last refreshed 14h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ARISTADA INITIO KIT is an extended-release intramuscular suspension of aripiprazole lauroxil indicated for schizophrenia. Following injection, the compound undergoes enzyme-mediated hydrolysis to release aripiprazole, which acts as a partial agonist at dopamine D2 and serotonin 5-HT1A receptors and antagonist at 5-HT2A receptors. This mechanism addresses both positive and negative symptoms of psychotic disorders through multi-receptor modulation.
Peak12.8 years to LOE
Product is at peak market penetration with established commercial infrastructure; team focus shifts toward defending market share against emerging competitors and managing pricing pressure.
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 unclear. However, efficacy could be…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
C-Cog in Early Course Schizophrenia Study
Started Jan 2024
1 enrolled
Schizophrenia
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 (Also Known as ARISTADA TM) in Subjects With Schizophrenia
Started Dec 2015
51 enrolled
Schizophrenia
A Study of Aripiprazole Lauroxil in Subjects With Schizophrenia or Schizoaffective Disorder
Started Dec 2015
47 enrolled
SchizophreniaSchizoaffective Disorder
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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.