Aristada

(Aripiprazole Lauroxil)

ApprovedSmall molecule

AAlkermes, Inc.

Aristada is one of 41 small molecule programs targeting Schizophrenia. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

SchizophreniaTerminated

SchizophreniaApproved

Terminated

Competition

Competitive Landscape

174 competitors in Schizophrenia

#DrugCompanyPhaseTrials

Aristada

AAlkermes, Inc.

Approved

4 2

Ozempic

Novo Nordisk

Preclinical

1 3

Resotran

Takeda

Preclinical

1 4

Inapsine

Jazz Pharmaceuticals

Preclinical

1 5

Depakote

Ibrance

Lunesta

3 8

Luvox

SSolvay Pharmaceuticals

Preclinical

1 9

Catapres

Boehringer Ingelheim

Preclinical

1 10

Rapamune

PPrism Pharmaceuticals

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Schizophrenia4 trials

Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode

Terminated·UUniversity of California, Los Angeles·Phase 4·NCT04203056·15 enrolled

A Study of Aripiprazole Lauroxil (Also Known as ARISTADA TM) in Subjects With Schizophrenia

Completed·AAlkermes, Inc.·Phase 4·NCT02634320·51 enrolled

C-Cog in Early Course Schizophrenia Study

Terminated·UUniversity of Miami·Phase 4·NCT05662306·1 enrolled

Show 1 more trial

An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia

Completed·AAlkermes, Inc.·Phase 1·NCT02320032·140 enrolled

Schizoaffective Disorder1 trial

A Study of Aripiprazole Lauroxil in Subjects With Schizophrenia or Schizoaffective Disorder

Completed·AAlkermes, Inc.·Phase 1·NCT02636842·47 enrolled

Regulatory

FDA Approval Timeline[4]

Oct 5, 2015

ARISTADA

NDA NDA207533

Jun 29, 2018

ARISTADA INITIO KIT

NDA NDA209830

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for Aripiprazole Lauroxil. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Aripiprazole Lauroxil compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Aripiprazole Lauroxil. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA209830). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Aristada. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Alkermes, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: AAlkermes, Inc.

Patent Landscape[5]

Patent Cliff

Jun 24, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8796276Jun 24, 2030

10112903Jun 24, 2030

8431576Oct 26, 2030

10226458Mar 19, 2032

9034867Nov 7, 2032

17 more patents

12629366Dec 5, 2032

12311027Sep 19, 2033

9193685Oct 24, 2033

11969469Oct 24, 2033

11097006Oct 24, 2033

12653822Mar 18, 2035

10813928Mar 19, 2035

10238651Mar 19, 2035

9452131Mar 19, 2035

11406632Mar 19, 2035

9526726Mar 19, 2035

11154552Aug 17, 2035

10688091Aug 17, 2035

10849894Aug 17, 2035

10016415Sep 8, 2035

12251381Apr 6, 2039

11273158Apr 6, 2039

Aristada

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Schizophrenia4 trials

Schizoaffective Disorder1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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