ARIPIPRAZOLE

Post-LOESM

aripiprazole

Aurobindo Pharma

ANDAORALTABLET, ORALLY DISINTEGRATING1 Generic Approved

Approved

Feb 2026

Lifecycle

Post-LOE

Competitive Pressure

45/100

Clinical Trials

Data completeness

3/8 — Basic

ARIPIPRAZOLE (aripiprazole) by Aurobindo Pharma. Approved for atypical antipsychotic [epc]. First approved in 2026.

Drug data last refreshed 19h ago

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)

NCT06589817Phase 3Not Yet Recruiting

A Double-Blind, Randomized Comparative Study of Carliprazine and Aripiprazole in Patients with Acute Schizophrenia

Started Oct 2024

376 enrolled

Acute Schizophrenia

NCT04907279N/AUnknown

Aripiprazole Once-Monthly in Hospitalized Patients (INITIATE)

Started Nov 2021

200 enrolled

SchizophreniaSchizo Affective DisorderBipolar I Disorder

NCT04203056Phase 4Terminated

Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode

Started Dec 2019

15 enrolled

SchizophreniaSchizoaffective Disorder, Depressive TypeSchizophreniform Disorder

NCT04030143Phase 1/2Completed

A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder

Started Aug 2019

266 enrolled

SchizophreniaBipolar I Disorder

NCT03881449Phase 4Unknown

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.