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Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR ARIPIPRAZOLE LAUROXIL


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All Clinical Trials for Aripiprazole Lauroxil

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01469039 ↗ A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With Schizophrenia Completed Alkermes, Inc. Phase 3 2011-12-01 The study will determine the efficacy of ALKS 9072 (also known as aripiprazole lauroxil or ALKS 9070) for the treatment of schizophrenia in subjects experiencing an acute exacerbation.
NCT02320032 ↗ An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia Completed Alkermes, Inc. Phase 1 2014-12-01 This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of various doses and dosing intervals of aripiprazole lauroxil.
NCT02634320 ↗ A Study of Aripiprazole Lauroxil (Also Known as ARISTADA TM) in Subjects With Schizophrenia Completed Alkermes, Inc. Phase 4 2015-12-01 This study will evaluate the safety and tolerability of aripiprazole lauroxil (also known as ARISTADA, ALKS 9070).
NCT02636842 ↗ A Study of Aripiprazole Lauroxil in Subjects With Schizophrenia or Schizoaffective Disorder Completed Alkermes, Inc. Phase 1 2015-12-01 The study will determine the safety, tolerability, and pharmacokinetics of aripiprazole lauroxil in adults with schizophrenia or schizoaffective disorder.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Aripiprazole Lauroxil

Condition Name

Condition Name for Aripiprazole Lauroxil
Intervention Trials
Schizophrenia 7
Schizoaffective Disorder 1
Schizoaffective Disorder, Depressive Type 1
Schizophreniform Disorder 1
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Condition MeSH

Condition MeSH for Aripiprazole Lauroxil
Intervention Trials
Schizophrenia 7
Psychotic Disorders 2
Disease 2
Depressive Disorder 1
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Clinical Trial Locations for Aripiprazole Lauroxil

Trials by Country

Trials by Country for Aripiprazole Lauroxil
Location Trials
United States 46
Russian Federation 5
Ukraine 2
Romania 2
Philippines 2
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Trials by US State

Trials by US State for Aripiprazole Lauroxil
Location Trials
California 6
Texas 5
Illinois 5
Missouri 4
Florida 4
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Clinical Trial Progress for Aripiprazole Lauroxil

Clinical Trial Phase

Clinical Trial Phase for Aripiprazole Lauroxil
Clinical Trial Phase Trials
Phase 4 3
Phase 3 2
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for Aripiprazole Lauroxil
Clinical Trial Phase Trials
Completed 5
Not yet recruiting 1
Recruiting 1
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Clinical Trial Sponsors for Aripiprazole Lauroxil

Sponsor Name

Sponsor Name for Aripiprazole Lauroxil
Sponsor Trials
Alkermes, Inc. 7
University of California, Los Angeles 1
University of Miami 1
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Sponsor Type

Sponsor Type for Aripiprazole Lauroxil
Sponsor Trials
Industry 7
Other 2
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Aripiprazole Lauroxil: Clinical Trials, Market Analysis, and Projections

Introduction

Aripiprazole lauroxil, marketed under the brand name ARISTADA, is an extended-release injectable atypical antipsychotic developed for the treatment of schizophrenia. This article provides an update on the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Phase 3 Studies

The pivotal Phase 3 study for aripiprazole lauroxil was a randomized, multicenter, double-blind, placebo-controlled trial designed to assess the efficacy, safety, and tolerability of the drug in patients with acute exacerbation of schizophrenia. The study included 623 patients who received either 441 mg or 882 mg of aripiprazole lauroxil or a placebo once monthly for 12 weeks. Key findings included:

  • Efficacy: Both doses of aripiprazole lauroxil demonstrated statistically and clinically significant reductions in Positive and Negative Syndrome Scale (PANSS) total scores compared to placebo. The mean reductions were -10.9 points for the 441 mg dose and -11.9 points for the 882 mg dose, both with p<0.001[1][3].
  • Secondary Endpoints: The study met all prespecified secondary endpoints, including improvement on the Clinical Global Impression – Improvement (CGI-I) scale at Week 12[1][3].
  • Safety and Tolerability: Aripiprazole lauroxil was generally well tolerated, with a safety profile similar to that of oral aripiprazole. Common adverse events included insomnia, akathisia, and headache[1][3].

Post-Marketing Studies

The ALPINE post-marketing study evaluated the efficacy and safety of the ARISTADA INITIO regimen and the 2-month dose of ARISTADA (1064 mg). This study focused on adult patients hospitalized for an acute exacerbation of schizophrenia and assessed the treatment during the first 4 weeks. The results supported the efficacy and safety of the ARISTADA INITIO regimen and the 2-month dose, aligning with previous findings[2].

Another post hoc analysis of a 25-week trial further characterized the safety of aripiprazole lauroxil 1064 mg administered every 2 months, initiated with the ARISTADA INITIO formulation plus 30 mg of oral aripiprazole. This study found no new safety concerns and confirmed the known safety profile of aripiprazole lauroxil[4].

Market Analysis

Approval and Launch

Aripiprazole lauroxil received FDA approval on October 5, 2015, for the treatment of schizophrenia. The drug is intended to be administered by healthcare providers and is available in various formulations, including once-monthly and two-month injections[5].

Market Position

Aripiprazole lauroxil has carved out a niche in the antipsychotic market by offering a long-acting injectable option, which is particularly beneficial for patients who have difficulty with oral medication compliance. The drug's ability to provide clinically meaningful symptom control and its favorable safety profile have contributed to its market presence.

Competitive Landscape

The antipsychotic market is competitive, with several oral and injectable options available. However, aripiprazole lauroxil's unique formulation and administration schedule set it apart. Competitors include other long-acting injectables like paliperidone palmitate, but aripiprazole lauroxil's profile, particularly its initiation regimen and dosing flexibility, makes it an attractive option for both patients and healthcare providers.

Projections and Future Outlook

Market Growth

The global antipsychotic market is expected to grow, driven by increasing prevalence of mental health disorders and the need for effective treatment options. Aripiprazole lauroxil is poised to benefit from this trend, especially as it continues to demonstrate its efficacy and safety in real-world settings.

New Formulations and Initiatives

The introduction of the ARISTADA INITIO formulation, which simplifies the treatment initiation regimen, is expected to enhance patient compliance and satisfaction. This new formulation reduces the need for concurrent oral medication to a single dose, making the treatment process more streamlined[5].

Expansion into New Markets

Alkermes, the developer of aripiprazole lauroxil, is likely to pursue expansion into new markets, both geographically and in terms of indications. While currently approved for schizophrenia, there may be potential for exploring its use in other psychiatric conditions.

Safety and Tolerability

Long-Term Safety

The long-term safety and durability of effect of aripiprazole lauroxil have been assessed in extension phases of clinical trials. These studies have shown that the drug maintains its efficacy and safety profile over extended periods, supporting its use as a long-term treatment option[1][3].

Adverse Events

Common adverse events associated with aripiprazole lauroxil include insomnia, akathisia, and headache. Injection site reactions and motor adverse events are also noted but are generally mild or moderate in severity[1][3][4].

Patient Compliance and Adherence

Importance of Compliance

Patient compliance is a critical factor in the management of schizophrenia. Aripiprazole lauroxil's long-acting injectable formulation helps address the issue of non-adherence, which is common with oral medications. The once-monthly or two-monthly dosing schedule reduces the burden on patients to remember daily medication, thereby improving treatment outcomes.

Key Takeaways

  • Efficacy: Aripiprazole lauroxil has demonstrated statistically and clinically significant reductions in PANSS total scores and improvement on the CGI-I scale.
  • Safety: The drug is generally well tolerated, with a safety profile similar to oral aripiprazole.
  • Market Position: Aripiprazole lauroxil offers a unique long-acting injectable option, beneficial for patients with compliance issues.
  • Future Outlook: The drug is expected to grow in the market, driven by its efficacy, safety, and new formulations that simplify treatment initiation.

FAQs

Q: What is aripiprazole lauroxil used for?

A: Aripiprazole lauroxil is used for the treatment of schizophrenia, particularly for patients experiencing acute exacerbation.

Q: How is aripiprazole lauroxil administered?

A: Aripiprazole lauroxil is administered via intramuscular injection, available in once-monthly and two-month formulations.

Q: What are the common adverse events associated with aripiprazole lauroxil?

A: Common adverse events include insomnia, akathisia, headache, and injection site reactions.

Q: How does aripiprazole lauroxil improve patient compliance?

A: The long-acting injectable formulation reduces the need for daily oral medication, improving adherence and treatment outcomes.

Q: Is aripiprazole lauroxil approved for other psychiatric conditions?

A: Currently, aripiprazole lauroxil is approved only for schizophrenia, but there may be potential for exploring its use in other psychiatric conditions in the future.

Sources

  1. Alkermes Presents Phase 3 Data From Successful Pivotal Study of Aripiprazole Lauroxil. Investor.Alkermes.
  2. ALPINE Study of ARISTADA® (aripiprazole lauroxil). Aristadahcp.
  3. Alkermes Announces Positive Topline Results From Pivotal Phase 3 Study of Aripiprazole Lauroxil. Investor.Alkermes.
  4. Safety and Tolerability of Starting Aripiprazole Lauroxil 1064 mg Every 2 Months Following Initiation Using the AL NanoCrystal Dispersion Formulation Plus 30-mg Oral Aripiprazole. PubMed.
  5. Summary Review(s) - Aripiprazole Lauroxil. FDA.

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