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Abilify (aripiprazole)
Third-generation antipsychotic that acts as a partial agonist at D2 and 5-HT1A receptors, stabilizing dopamine activity rather than simply blocking it.
Aripiprazole (Abilify) is a third-generation antipsychotic with a unique partial agonist mechanism, developed by Otsuka and approved in 2002. Less metabolic disruption than other atypicals. Available generically.
At a glance
| Generic name | aripiprazole |
|---|---|
| Also known as | Abilify, Abilify Maintena, Aristada |
| Sponsor | Generic (originally Otsuka/BMS) |
| Drug class | Third-generation antipsychotic (D2 partial agonist) |
| Target | 5-hydroxytryptamine receptor 1E, 5-hydroxytryptamine receptor 5A, 5-hydroxytryptamine receptor 6 |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2002-11-15 (United States) |
| Annual revenue | 3000 |
Mechanism of action
Aripiprazole has a unique mechanism as a dopamine partial agonist — it stabilizes dopamine transmission by acting as an agonist where dopamine is low (negative symptoms) and antagonist where dopamine is high (positive symptoms). This \
Approved indications
- Agitation associated with Bipolar Mania
- Agitation associated with Schizophrenia
- Bipolar affective disorder, current episode manic
- Bipolar disorder in remission
- Depression Treatment Adjunct
- Infantile autism
- Mixed bipolar I disorder
- Schizophrenia
Common side effects
- Headache
- Nausea
- Constipation
- Vomiting
- Dyspepsia
- Akathisia
- Fatigue
- Dry Mouth
- Musculoskeletal Stiffness
- Pain in Extremity
- Toothache
- Blurred Vision
Key clinical trials
- A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole as Maintenance Treat (Phase 3)
- A 2-year, Prospective, Blinded-rater, Open-label, Active-controlled, Multicenter, Randomized Study of Long-term Efficacy and Effectiveness Comparing Risperdal® Consta® and Abilify® (Aripiprazole) in A (Phase 4)
- Evaluating the Effects of Adjunctive Aripiprazole on Weight and Metabolic Outcomes in Females Receiving Atypical Antipsychotics: A Randomized Clinical Trial (Phase 4)
- A Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Patients With Major Depressive Disorder (Phase 3)
- An Open-label, Multiple Dose, Safety and Tolerability Study of Aripiprazole IM Depot Administered in the Deltoid Muscle in Adult Subjects With Schizophrenia (Phase 1)
- A Phase 2, 6-Week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 Once Daily and Aripiprazole Once Daily for Treat (Phase 2)
- A Short-term Administration Study of Aripiprazole in Children and Adolescents (Age: 6 to 17 Years) With Autistic Disorder (Phase 3)
- The Role of Antidepressants or Antipsychotics in Preventing Psychosis (NA)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 8759350 | 2027-03-02 | Method of Use |
| 9125939 | 2026-07-28 | Method of Use |
| 8945005 | 2029-08-19 | Formulation |
| 8956288 | 2029-07-06 | Formulation |
| 8547248 | 2030-12-18 | Formulation |
| 9268909 | 2033-10-15 | Formulation |
| 8674825 | 2029-04-09 | Formulation |
| 8847766 | 2030-03-29 | Formulation |
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:
- Abilify CI brief — competitive landscape report
- Abilify updates RSS · CI watch RSS
- Generic (originally Otsuka/BMS) portfolio CI