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 7m ago · AI intelligence enriched 7m ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ABILIFY ASIMTUFII is an extended-release intramuscular suspension formulation of aripiprazole, an atypical antipsychotic indicated for schizophrenia and bipolar disorder. It works as a dopamine D2 receptor partial agonist to modulate neurotransmission in psychotic conditions. The extended-release depot formulation provides sustained antipsychotic coverage with less frequent dosing than oral alternatives.
$0.013BPart D
Peak6.6 years to LOEEarly-peak product with modest current penetration ($13M spending, 2,410 claims in 2023) suggests active commercial expansion phase with growing team investment.
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.