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aripiprazole lauroxil

Generic: ARIPIPRAZOLE LAUROXIL·Brand: ARISTADA, ARISTADA INITIO KIT, Aristada

aripiprazole lauroxil: sourced relationships with 1 company · 1 clinical trial tracked · 2 FDA decisions.

aripiprazole lauroxil evidence translation

What we can confirm

2 FDA records · 1 tracked trial

What it means

Source-backed records connect aripiprazole lauroxil to ALKS; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could aripiprazole lauroxil → ALKS affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence3 indications · 0 study sponsors

Related indications

Treatment of schizophreniaInitiation of ARISTADA for the treatment of schizophrenia in adults (when combined with a single 30 mg dose of oral aripiprazole)Schizophrenia

Study sponsors

No additional listed-company sponsor is linked.

Dated Pipeline Records (2)
CompanyDated record stage
Alkermes plc. (ALKS)
owner · Reported 2025-02-12 · Current development: unknownSource
Treatment of schizophrenia
Approved
Alkermes plc. (ALKS)
owner · Reported 2025-02-12 · Current development: unknownSource
Initiation of ARISTADA for the treatment of schizophrenia in…
Approved
Clinical Trial Registry Records (1)

Comprehensive Treatment of Early Course Schizophrenia: A Nonrandomized Study of Long Acting Injectable Antipsychotic Medication Combined With Cognitive and Functional Skills Training

NCT05662306Registry updated 2026-02-06·Phase 4
Terminated

Primary endpoint: The Percentage of Participants Who Develop Sustained Remission of Symptoms of Schizophrenia as Measured as Having a Score of 3 or Less on All 6 Critical Items From the Positive and Negative Syndrome Scale (PANSS)

Interventionalopen1 enrolledStarted 2024-01Completion 2025-031 site · United StatesUniversity of Miami
FDA Decisions2 records
Approval(ALKS)FDA ↗
NDA209830Type 5 - New Formulation or New ManufacturerStandardSubcutaneousSuspension, Extended Release
Approval1 INDICATIONS AND USAGE ARISTADA is indicated for the treatment of schizophrenia in adults [see Clinical Studies ( 14 )]. ARISTADA is an atypical antipsychotic indicated for the treatment of schizophrenia in adults ( 1 ).(ALKS)FDA ↗
NDA207533Type 1 - New Molecular EntityStandardSubcutaneousSuspension, Extended Release

Frequently asked questions

Which companies have sourced relationships with aripiprazole lauroxil?

aripiprazole lauroxil has dated SEC/FDA relationship records for Alkermes plc..

How many clinical trials involve aripiprazole lauroxil?

BioSniper tracks 1 clinical trial involving aripiprazole lauroxil.

What is aripiprazole lauroxil's latest FDA decision?

The most recent tracked FDA decision for aripiprazole lauroxil is Approval, dated June 29, 2018.