ARISTADA INITIO KIT (aripiprazole lauroxil)
ARISTADA INITIO (aripiprazole lauroxil) is an atypical antipsychotic. It is indicated for the initiation of ARISTADA for the treatment of schizophrenia in adults. Administered as a single intramuscular injection, it is used to provide a rapid start to treatment, typically in combination with a single dose of oral aripiprazole and the first dose of ARISTADA maintenance.
How ARISTADA INITIO KIT Works
Aripiprazole lauroxil is a prodrug of aripiprazole. Following intramuscular injection, it is converted by enzyme-mediated hydrolysis to N-hydroxymethyl aripiprazole, which is then further hydrolyzed to the active molecule, aripiprazole. While the precise mechanism of action in schizophrenia is unknown, its efficacy is thought to be mediated through a combination of partial agonist activity at dopamine D2 and serotonin 5-HT1A receptors and antagonist activity at serotonin 5-HT2A receptors.
Details
- Status
- Prescription
- First Approved
- 2018-06-29
- Patent Cliff
- 2039
- Routes
- INTRAMUSCULAR
- Dosage Forms
- SUSPENSION, EXTENDED RELEASE
ARISTADA INITIO KIT Approval History
What ARISTADA INITIO KIT Treats
1 indicationsARISTADA INITIO KIT is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Schizophrenia
ARISTADA INITIO KIT Boxed Warning
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ARISTADA is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 )] . WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Elderly patients with dementia-related ps...
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ARISTADA is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 )] . WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ( 5.1 ) ARISTADA is not approved for the treatment of patients with dementia-related psychosis. ( 5.1 )
ARISTADA INITIO KIT Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to ARISTADA INITIO KIT
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05662306 results posted | 20211098 | Ph 4 | terminated | C-Cog in Early Course Schizophrenia Study |
| NCT04203056 APPRAISE results posted | PATS 20184225 | Ph 4 | terminated | Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode |
| NCT02634320 results posted | ALK9072-A401 | Ph 4 | completed | A Study of Aripiprazole Lauroxil (Also Known as ARISTADA TM) in Subjects With Schizophrenia |
| NCT02320032 | ALK9072-A105 | Ph 1 | completed | An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia |
| NCT02636842 | ALK9072-A106 | Ph 1 | completed | A Study of Aripiprazole Lauroxil in Subjects With Schizophrenia or Schizoaffective Disorder |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ARISTADA INITIO KIT FDA Label Details
Indications & Usage
FDA Label (PDF)ARISTADA INITIO KIT is indicated for the treatment of Schizophrenia.
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ARISTADA is not approved for the treatment of patients with dementia-related psychosis [see Warnings a...
ARISTADA INITIO KIT Patents & Exclusivity
Patents (9 active)
Pro Intelligence Preview
Deep insights for ARISTADA INITIO KIT
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2039
- • 9 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.