NDAORALFILM
Approved
Jul 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
OPIPZA (aripiprazole) by Otsuka is indications, is unclear. Approved for schizophrenia, bipolar disorder, schizoaffective disorder and 1 more indications. First approved in 2024.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OPIPZA is an oral film formulation of aripiprazole, an atypical antipsychotic approved July 2024 for schizophrenia, bipolar disorder, schizoaffective disorder, and autism spectrum disorder. It works through partial agonist activity at dopamine D2 and serotonin 5-HT1A receptors combined with antagonist activity at 5-HT2A receptors.
Growth15.6 years to LOE
Early-stage NDA launch offers opportunity to build market presence in a crowded antipsychotic category; commercial teams will focus on differentiation through formulation convenience and patient compliance.
Mechanism of Action
indications, is 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.
Pharmacologic Class:
Atypical Antipsychotic
Indications (4)
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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.