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Aristada (ARIPIPRAZOLE LAUROXIL)
Aristada works by blocking dopamine receptors in the brain to help regulate abnormal thought and behavior patterns.
Aristada (Aripiprazole Lauroxil) is a small molecule medication developed by Alkermes Inc, targeting the D(2) dopamine receptor. It is used to treat schizophrenia and was FDA approved in 2015. Aristada is a patented medication with no generic manufacturers available. Key safety considerations include monitoring for extrapyramidal symptoms and potential interactions with other medications. As a long-acting injectable, it provides sustained release of the active ingredient.
At a glance
| Generic name | ARIPIPRAZOLE LAUROXIL |
|---|---|
| Sponsor | Alkermes Inc |
| Target | D(2) dopamine receptor |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2015 |
| Annual revenue | 500 |
Mechanism of action
Aripiprazole lauroxil is prodrug of 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 mediated through combination of partial agonist activity at dopamine D2 and serotonin 5-HT1A receptors and antagonist activity at 5-HT2A receptors.
Approved indications
- Schizophrenia
Boxed warnings
- 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 )
Common side effects
- Akathisia
- Injection site pain
- Increased weight
- Increased blood creatinine phosphokinase
- Headache
- Insomnia
- Restlessness
- Dystonia
- Cardiac angina pectoris
- Tachycardia
- Palpitations
- Constipation
Key clinical trials
- C-Cog in Early Course Schizophrenia Study (PHASE4)
- National Pregnancy Registry for Psychiatric Medications
- VA Aripiprazole vs Esketamine for Treatment Resistant Depression (PHASE4)
- Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode (PHASE4)
- Observational Study of Long Acting Injectable Medications (LAIs) in Schizophrenia (OASIS)
- A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia (PHASE3)
- A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With Schizophrenia (PHASE3)
- A Study of Aripiprazole Lauroxil (Also Known as ARISTADA TM) in Subjects With Schizophrenia (PHASE4)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Aristada CI brief — competitive landscape report
- Aristada updates RSS · CI watch RSS
- Alkermes Inc portfolio CI