ABILIFY
LOE ApproachingNDAINTRAMUSCULARINJECTABLE
Approved
Sep 2006
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
ABILIFY by Otsuka is unknown. First approved in 2006.
Drug data last refreshed 7h ago · AI intelligence enriched 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ABILIFY (aripiprazole) is an injectable atypical antipsychotic approved in 2006 for intramuscular administration. It works through partial agonist activity at dopamine D2 and serotonin 5-HT1A receptors, combined with antagonist activity at 5-HT2A receptors. The product is indicated for psychiatric conditions treated with antipsychotics, delivered as a long-acting injectable formulation.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), indicating potential team contraction and shift toward lifecycle management or transition roles.
Mechanism of Action
unknown. The efficacy of aripiprazole could be mediated through a combination of partial agonist activity at dopamine D 2 and serotonin 5-HT 1A receptors and antagonist activity at 5-HT 2A receptors.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Specified Drug-use Survey on Abilify Prolonged Release Aqueous Suspension for IM Injection (Prevention of Relapse of Mood Episodes in BP)
Started Apr 2021
535 enrolled
Bipolar Disorder I
A Trial in Adult Participants With Schizophrenia Treated Prospectively for 6-months With Abilify MyCite®
Started Apr 2019
277 enrolled
Schizophrenia
A Trial to Measure the Difference in All-cause Hospitalizations for Participants Who Are Using Abilify MyCite Versus Virtual Matched Controls in Adults With Schizophrenia, Bipolar 1 Disorder, and Major Depressive Disorder
Started Jun 2018
2 enrolled
SchizophreniaBipolar 1 DisorderMajor Depressive Disorder
A Study of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Bipolar Depression
Started Feb 2018
390 enrolled
Depression, Bipolar
Bioequivalence Study of Bosiqing and ABILIFY Under Fasting/Fed Condition
Started Jun 2017
66 enrolled
Bioequivalence
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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.