NDAINTRAMUSCULARSUSPENSION, EXTENDED RELEASE2 Generics Approved
Approved
Apr 2023
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
6/8 — Strong
ABILIFY ASIMTUFII (aripiprazole) by Otsuka. Approved for atypical antipsychotic [epc]. First approved in 2023.
Drug data last refreshed 2d ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ABILIFY ASIMTUFII is an extended-release intramuscular suspension formulation of aripiprazole, an atypical antipsychotic approved in April 2023. It treats schizophrenia, bipolar disorder, and major depressive disorder by modulating dopamine and serotonin neurotransmission. The injectable extended-release formulation provides sustained therapeutic levels with reduced dosing frequency compared to oral alternatives.
$13MPart D
Peak6.8 years to LOEProduct is in peak commercial phase with modest Part D penetration; commercial teams are focused on building market share against established competitors and driving awareness among prescribers.
Mechanism of Action
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
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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.