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IM aripiprazole once monthly
Aripiprazole is a dopamine D2/D3 receptor partial agonist that modulates dopaminergic and serotonergic neurotransmission to treat schizophrenia and bipolar disorder.
Aripiprazole is a dopamine D2/D3 receptor partial agonist that modulates dopaminergic and serotonergic neurotransmission to treat schizophrenia and bipolar disorder. Used for Schizophrenia, Bipolar I disorder (maintenance treatment), Agitation associated with schizophrenia or bipolar disorder.
At a glance
| Generic name | IM aripiprazole once monthly |
|---|---|
| Sponsor | University of Utah |
| Drug class | Atypical antipsychotic |
| Target | Dopamine D2 receptor, Dopamine D3 receptor |
| Modality | Small molecule |
| Therapeutic area | Psychiatry |
| Phase | FDA-approved |
Mechanism of action
Aripiprazole acts as a partial agonist at dopamine D2 and D3 receptors, providing dopaminergic stabilization rather than pure antagonism. This mechanism reduces excessive dopamine signaling in hyperactive pathways while maintaining adequate dopamine function in hypoactive pathways. The intramuscular once-monthly formulation provides sustained drug delivery for improved medication adherence in psychiatric patients.
Approved indications
- Schizophrenia
- Bipolar I disorder (maintenance treatment)
- Agitation associated with schizophrenia or bipolar disorder
Common side effects
- Injection site pain
- Akathisia
- Headache
- Anxiety
- Insomnia
- Weight gain
- Nausea
Key clinical trials
- Impact of Aripiprazole Once Monthly Medications on Changes in Brain Structure and Metabolism (PHASE4)
- Effectiveness of Aripiprazole Long-acting Injection in Recent Onset and Chronic Schizophrenia Patients (PHASE4)
- European Long-acting Antipsychotics in Schizophrenia Trial (PHASE4)
- Effects of Aripiprazole (LAI) on Phychosocial/Cognitive Functioning, pt Reported AcceptabilityofTreatment in Sch (PHASE4)
- Efficacy, Safety, and Tolerability of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Bipolar I Patients (PHASE3)
- Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients With Schizophrenia (PHASE3)
- Aripiprazole Once-monthly in Patients With Schizophrenia (PHASE3)
- Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients With Schizophrenia (PHASE3)
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:
- IM aripiprazole once monthly CI brief — competitive landscape report
- IM aripiprazole once monthly updates RSS · CI watch RSS
- University of Utah portfolio CI