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Aripiprazole and aripiprazole once-monthly
Aripiprazole and aripiprazole once-monthly is a Atypical antipsychotic Small molecule drug developed by H. Lundbeck A/S. It is currently in Phase 3 development for Schizophrenia, Bipolar I disorder (acute manic or mixed episodes), Major depressive disorder (adjunctive treatment). Also known as: Aripiprazole: Abilify®, Aripiprazole (extended-release injectable suspension): Abilify Maintena®.
Aripiprazole is a partial agonist at dopamine D2 and serotonin 5-HT1A receptors, and an antagonist at serotonin 5-HT2A receptors, which stabilizes dopamine and serotonin neurotransmission in the brain.
Aripiprazole is a partial agonist at dopamine D2 and serotonin 5-HT1A receptors, and an antagonist at serotonin 5-HT2A receptors, which stabilizes dopamine and serotonin neurotransmission in the brain. Used for Schizophrenia, Bipolar I disorder (acute manic or mixed episodes), Major depressive disorder (adjunctive treatment).
At a glance
| Generic name | Aripiprazole and aripiprazole once-monthly |
|---|---|
| Also known as | Aripiprazole: Abilify®, Aripiprazole (extended-release injectable suspension): Abilify Maintena® |
| Sponsor | H. Lundbeck A/S |
| Drug class | Atypical antipsychotic |
| Target | Dopamine D2 receptor (partial agonist), serotonin 5-HT1A receptor (partial agonist), serotonin 5-HT2A receptor (antagonist) |
| Modality | Small molecule |
| Therapeutic area | Psychiatry |
| Phase | Phase 3 |
Mechanism of action
Aripiprazole differs from typical antipsychotics by acting as a partial agonist rather than a full antagonist at dopamine D2 receptors. This mechanism allows it to modulate dopamine activity—increasing it when levels are low and decreasing it when levels are high—while also affecting serotonergic pathways. The once-monthly formulation is a long-acting injectable depot form that provides sustained therapeutic levels over an extended period.
Approved indications
- Schizophrenia
- Bipolar I disorder (acute manic or mixed episodes)
- Major depressive disorder (adjunctive treatment)
- Irritability associated with autism spectrum disorder
Common side effects
- Akathisia
- Headache
- Anxiety
- Insomnia
- Nausea
- Weight gain
- Tremor
- Injection site pain (once-monthly formulation)
Key clinical trials
- A Study to Compare Disease Progression and Modification Following Treatment With Paliperidone Palmitate Long-Acting Injection or Oral Antipsychotics in Participant's With Recent-onset Schizophrenia or Schizophreniform (PHASE3)
- Impact of Aripiprazole Once Monthly Medications on Changes in Brain Structure and Metabolism (PHASE4)
- Aripiprazole Once-Monthly in Hospitalized Patients (INITIATE)
- Effectiveness of Aripiprazole Long-acting Injection in Recent Onset and Chronic Schizophrenia Patients (PHASE4)
- Comparison of a Long-acting Injectable Antipsychotic vs Clinician's Choice Early in Treatment to Break the Cycle of Relapse in Early Phase Schizophrenics (PHASE4)
- European Long-acting Antipsychotics in Schizophrenia Trial (PHASE4)
- Aripiprazole, Abilify Maintena Collaborative Clinical Protocol (PHASE4)
- Efficacy, Safety, and Tolerability of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Bipolar I Patients (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:
- Aripiprazole and aripiprazole once-monthly CI brief — competitive landscape report
- Aripiprazole and aripiprazole once-monthly updates RSS · CI watch RSS
- H. Lundbeck A/S portfolio CI
Frequently asked questions about Aripiprazole and aripiprazole once-monthly
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Related
- Drug class: All Atypical antipsychotic drugs
- Target: All drugs targeting Dopamine D2 receptor (partial agonist), serotonin 5-HT1A receptor (partial agonist), serotonin 5-HT2A receptor (antagonist)
- Manufacturer: H. Lundbeck A/S — full pipeline
- Therapeutic area: All drugs in Psychiatry
- Indication: Drugs for Schizophrenia
- Indication: Drugs for Bipolar I disorder (acute manic or mixed episodes)
- Indication: Drugs for Major depressive disorder (adjunctive treatment)
- Also known as: Aripiprazole: Abilify®, Aripiprazole (extended-release injectable suspension): Abilify Maintena®
- Compare: Aripiprazole and aripiprazole once-monthly vs similar drugs
- Pricing: Aripiprazole and aripiprazole once-monthly cost, discount & access