ABILIFY
LOE ApproachingNDAORALSOLUTION
Approved
Dec 2004
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
20
Data completeness
4/8 — Partial
ABILIFY by Otsuka is unknown. First approved in 2004.
Drug data last refreshed 21h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ABILIFY (aripiprazole) is an oral atypical antipsychotic approved in 2004 that treats schizophrenia, bipolar disorder, major depressive disorder, and related psychiatric conditions. It works through partial agonist activity at dopamine D2 and serotonin 5-HT1A receptors combined with antagonist activity at 5-HT2A receptors. The drug also addresses side effects of other antipsychotics including hyperprolactinemia, sexual dysfunction, weight gain, and dyslipidemia.
LOE Approaching10mo to LOE
Product faces imminent loss of exclusivity (0.9 years remaining), suggesting the brand team is in transition mode with focus on managed decline and generic preparation rather than growth initiatives.
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.