NDAORALFILM
Approved
Jul 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
4/8 — Partial
OPIPZA (aripiprazole) by Otsuka is indications, is unclear. First approved in 2024.
Drug data last refreshed 10h 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 by the FDA in July 2024. It works through partial agonist activity at D2 and 5-HT1A receptors combined with antagonist activity at 5-HT2A receptors. The specific indications are not provided in available data, but aripiprazole is typically used to treat schizophrenia, bipolar disorder, and major depressive disorder.
Growth15.5 years to LOE
Early-stage growth product with potential to build commercial infrastructure in antipsychotic market; team expansion likely in sales and marketing.
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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Double-Blind, Randomized Comparative Study of Carliprazine and Aripiprazole in Patients with Acute Schizophrenia
Started Oct 2024
376 enrolled
Acute Schizophrenia
Aripiprazole Once-Monthly in Hospitalized Patients (INITIATE)
Started Nov 2021
200 enrolled
SchizophreniaSchizo Affective DisorderBipolar I Disorder
Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode
Started Dec 2019
15 enrolled
SchizophreniaSchizoaffective Disorder, Depressive TypeSchizophreniform Disorder
A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder
Started Aug 2019
266 enrolled
SchizophreniaBipolar I Disorder
DIMES - DIgital MEdicine Study for Adults With Schizophrenia, Bipolar I Disorder, or Major Depression Currently Using Aripiprazole
Started Apr 2019
46 enrolled
SchizophreniaMajor Depressive DisorderBi-Polar Disorder+1 more
Worked on OPIPZA at Otsuka? Share your interview experience or compensation data (+7 days Pro)
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.