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Abilify Maintena
Abilify Maintena is a long-acting intramuscular injection of aripiprazole that acts as a dopamine D2 receptor partial agonist to treat schizophrenia and bipolar disorder.
Abilify Maintena is a long-acting injectable antipsychotic that blocks dopamine D2 receptors in the brain to reduce psychotic symptoms and stabilize mood. Used for Schizophrenia (maintenance treatment), Bipolar I disorder (maintenance treatment).
At a glance
| Generic name | Abilify Maintena |
|---|---|
| Also known as | Aripiprazole, long-acting injectable aripiprazole, aripiprazole |
| Sponsor | Gazda, Thomas D., M.D., PC |
| Drug class | Atypical antipsychotic |
| Target | Dopamine D2 receptor (partial agonist); serotonin 5-HT1A receptor |
| Modality | Small molecule |
| Therapeutic area | Psychiatry |
| Phase | FDA-approved |
Mechanism of action
Aripiprazole functions as a partial agonist at dopamine D2 receptors, which helps stabilize dopamine neurotransmission in the brain. The Maintena formulation uses microsphere technology to provide sustained drug release over 4 weeks, improving medication adherence in patients with psychotic disorders. This mechanism reduces both positive symptoms (hallucinations, delusions) and negative symptoms of schizophrenia and mania in bipolar disorder.
Approved indications
- Schizophrenia (maintenance treatment)
- Bipolar I disorder (maintenance treatment of acute manic and mixed episodes)
Common side effects
- Akathisia
- Tremor
- Headache
- Anxiety
- Insomnia
- Weight gain
- Injection site pain
Key clinical trials
- Sequential Multiple Assignment Randomized Trial for Bipolar Depression (PHASE4)
- National Pregnancy Registry for Psychiatric Medications
- Estimating and Reducing the Cardiovascular Risk of Patients With Schizophrenia Drugs From Lipid Measures and Ischemic Electrocardiographic Changes (PHASE3)
- Aripiprazole in Body Focused Repetitive Behaviors (PHASE2)
- RP5063 in Subjects With Schizophrenia or Schizoaffective Disorder (PHASE2)
- Real-life Assessment of Abilify Maintena + Rexult in Schizophrenia
- Specified Drug-use Survey on Abilify Prolonged Release Aqueous Suspension for IM Injection (Prevention of Relapse of Mood Episodes in BP)
- Impact of Aripiprazole Once Monthly Medications on Changes in Brain Structure and Metabolism (PHASE4)
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:
- Abilify Maintena CI brief — competitive landscape report
- Abilify Maintena updates RSS · CI watch RSS
- Gazda, Thomas D., M.D., PC portfolio CI