ARISTADA (aripiprazole lauroxil)
ARISTADA is indicated for the treatment of Schizophrenia.
How ARISTADA Works
Following intramuscular injection, ARISTADA is converted via enzyme-mediated hydrolysis into N-hydroxymethyl aripiprazole and then into its active form, aripiprazole. The medication's efficacy is thought to be mediated through a combination of partial agonist activity at dopamine D2 and serotonin 5-HT1A receptors. It also acts as an antagonist at serotonin 5-HT2A receptors. These interactions with specific neurotransmitter receptors are the primary mechanism for treating the symptoms of schizophrenia.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2015-10-05
- Patent Cliff
- 2039
- Routes
- INTRAMUSCULAR
- Dosage Forms
- SUSPENSION, EXTENDED RELEASE
ARISTADA Approval History
What ARISTADA Treats
1 indicationsARISTADA is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Schizophrenia
ARISTADA 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 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
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 FDA Label Details
Indications & Usage
FDA Label (PDF)ARISTADA 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 Patents & Exclusivity
Patents (16 active)
Pro Intelligence Preview
Deep insights for ARISTADA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2039
- • 248 active patents
Trial Analysis
- • 5 total trials
- • Stage: Mature
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.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment