NDAORALFILM
Approved
Apr 2025
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
MEZOFY (aripiprazole) by Otsuka is unclear. Approved for schizophrenia, bipolar disorder, schizoaffective disorder and 2 more indications. First approved in 2025.
Drug data last refreshed 3d ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MEZOFY is an oral aripiprazole film formulation approved by the FDA in April 2025 for schizophrenia, bipolar disorder, schizoaffective disorder, major depressive disorder, and autistic disorder. The drug functions as a partial agonist at dopamine D2 and serotonin 5-HT1A receptors while antagonizing 5-HT2A receptors, though its exact mechanism of action remains incompletely understood.
Launch7.3 years to LOE
As a freshly launched product with no direct Part D spending data yet, the brand team will focus on market penetration and awareness-building in a highly competitive antipsychotic landscape dominated by long-acting injectables and established oral competitors.
Mechanism of Action
unclear. However, the efficacy of aripiprazole in the listed indications could be mediated through a combination of partial agonist activity at D 2 and 5-HT 1A receptors and antagonist activity at 5-HT 2A receptors.
Indications (5)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.