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ALK3831
ALK3831 is a long-acting injectable formulation of aripiprazole designed to provide sustained dopamine D2/D3 receptor antagonism for antipsychotic effect.
ALK3831 is a long-acting injectable formulation of aripiprazole designed to provide sustained dopamine D2/D3 receptor antagonism for antipsychotic effect. Used for Schizophrenia (maintenance treatment), Bipolar I disorder (maintenance treatment).
At a glance
| Generic name | ALK3831 |
|---|---|
| Sponsor | Alkermes, Inc. |
| Drug class | Atypical antipsychotic (long-acting injectable) |
| Target | Dopamine D2/D3 receptors |
| Modality | Small molecule |
| Therapeutic area | Psychiatry/Neurology |
| Phase | Phase 3 |
Mechanism of action
ALK3831 is a depot formulation of aripiprazole, a partial dopamine D2/D3 receptor agonist, administered via intramuscular injection to provide extended therapeutic coverage over weeks or months. This extended-release approach aims to improve medication adherence and maintain stable antipsychotic efficacy in patients with schizophrenia or bipolar disorder. The sustained delivery reduces the need for frequent dosing while maintaining consistent plasma levels of the active agent.
Approved indications
- Schizophrenia (maintenance treatment)
- Bipolar I disorder (maintenance treatment)
Common side effects
- Injection site reactions
- Akathisia
- Extrapyramidal symptoms
- Weight gain
- Sedation
Key clinical trials
- A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study) (PHASE3)
- A Phase 1 Safety Study in Adults With Schizophrenia (PHASE1)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ALK3831 CI brief — competitive landscape report
- ALK3831 updates RSS · CI watch RSS
- Alkermes, Inc. portfolio CI