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aripiprazole lauroxil

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

aripiprazole lauroxil: developed by 1 company · 2 FDA decisions.

aripiprazole lauroxil evidence translation

What we can confirm

What it means

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

What to watch

Watch for new trials or company disclosures after the FDA record.
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 evidence2 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)

Study sponsors

No additional listed-company sponsor is linked.

Development Pipeline (2)
CompanyPhase
Alkermes plc. (ALKS)
Treatment of schizophrenia
Approved
Alkermes plc. (ALKS)
Initiation of ARISTADA for the treatment of schizophrenia in…
Approved
FDA Decisions2 records
Approval1 INDICATIONS AND USAGE ARISTADA INITIO, in combination with oral aripiprazole, is indicated for the initiation of ARISTADA when used for the treatment of schizophrenia in adults. ARISTADA INITIO, in combination with oral aripiprazole, is indicated for the initiation of ARISTADA ® when used for the treatment of schizophrenia in adults ( 1 ).(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

Who is developing aripiprazole lauroxil?

aripiprazole lauroxil is being developed by Alkermes plc..

What is aripiprazole lauroxil's latest FDA decision?

The most recent tracked FDA decision for aripiprazole lauroxil is Approval for 1 INDICATIONS AND USAGE ARISTADA INITIO, in combination with oral aripiprazole, is indicated for the initiation of ARISTADA when used for the treatment of schizophrenia in adults. ARISTADA INITIO, in combination with oral aripiprazole, is indicated for the initiation of ARISTADA ® when used for the treatment of schizophrenia in adults ( 1 )., dated June 29, 2018.