CLINICAL TRIALS PROFILE FOR LOXAPINE

All Clinical Trials for Loxapine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00122733 ↗	Loxapine and Weaning From Ventilator	Completed	Assistance Publique - Hôpitaux de Paris	N/A	2005-12-01	Patients may be very agitated during the weaning period from mechanical ventilation. Administration of loxapine, a neuroleptic that does not notably affect ventilatory drive, may help in obtaining an adequate level of cooperation and, therefore, in reducing the duration of mechanical ventilation.
NCT00290082 ↗	Randomized Double-blind Trial of Midazolam and Loxapine in Agitated Patients	Terminated	University Hospital, Rouen	Phase 3	2005-12-01	Neuroleptics are used since a long time in the management of severely agitated patients. Loxapine is routinely used in our country, with, to our knowledge no severe adverse event reported, in this indication. However, recently, benzodiazepines have appeared interesting in agitated patients, with the use of midazolam. The aim of this study is to compare midazolam to loxapine in the treatment of severe agitated patients admitted in the emergency department.
NCT00369577 ↗	Staccato Loxapine in Agitation (Proof of Concept)	Completed	Alexza Pharmaceuticals, Inc.	Phase 2	2006-08-01	The purpose of this study is to assess efficacy and safety of Staccato Loxapine in the treatment of acute agitation in schizophrenic patients. The study will be conducted in 120 agitated schizophrenic patients - either newly admitted to a hospital setting or a research unit for acute agitation or already in hospital for chronic underlying conditions. Patients meeting entry criteria will be randomized to one of two doses of Staccato Loxapine or to Staccato Placebo. Following administration of study drug, assessment of agitation state will be conducted at serial time points using standard agitation scales over a 24 hour period.
NCT00444028 ↗	Staccato Loxapine Single Dose PK	Completed	Alexza Pharmaceuticals, Inc.	Phase 1	2005-09-01	The objective of this study was to assess the safety, tolerability and pharmacokinetics of a single inhaled dose of (administered in 1 or 2 puffs) Staccato Loxapine in healthy volunteers.
NCT00489476 ↗	Staccato Loxapine in Migraine (in Clinic)	Completed	Alexza Pharmaceuticals, Inc.	Phase 2	2007-06-01	The objective of this trial is to assess the efficacy and safety of Staccato Loxapine in patients with migraine headache with or without aura in a clinical setting.
NCT00555412 ↗	Staccato Loxapine Multidose PK	Completed	Atlanta Center for Medical Research	Phase 1	2007-10-01	The objectives of this trial are to assess the safety, tolerability, and pharmacokinetics of multiple inhaled doses of Staccato Loxapine.
NCT00555412 ↗	Staccato Loxapine Multidose PK	Completed	Alexza Pharmaceuticals, Inc.	Phase 1	2007-10-01	The objectives of this trial are to assess the safety, tolerability, and pharmacokinetics of multiple inhaled doses of Staccato Loxapine.

Clinical Trial Conditions for Loxapine

Condition Name

Condition Name for Loxapine
Intervention	Trials
Schizophrenia	5
Healthy	3
Bipolar Disorder	3
Psychomotor Agitation	2

Condition MeSH

Condition MeSH for Loxapine
Intervention	Trials
Psychomotor Agitation	9
Schizophrenia	6
Disease	3
Bipolar Disorder	3

Clinical Trial Locations for Loxapine

Trials by Country

Trials by Country for Loxapine
Location	Trials
United States	44
France	4
Canada	2
Germany	1

Trials by US State

Trials by US State for Loxapine
Location	Trials
Georgia	5
Indiana	4
California	4
Ohio	3
Rhode Island	2

Clinical Trial Progress for Loxapine

Clinical Trial Phase

Clinical Trial Phase for Loxapine
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	5
Phase 2	5

Clinical Trial Status

Clinical Trial Status for Loxapine
Clinical Trial Phase	Trials
Completed	18
Terminated	4
Unknown status	1

Clinical Trial Sponsors for Loxapine

Sponsor Name

Sponsor Name for Loxapine
Sponsor	Trials
Alexza Pharmaceuticals, Inc.	12
Assistance Publique - Hôpitaux de Paris	3
University of Witten/Herdecke	1

Sponsor Type

Sponsor Type for Loxapine
Sponsor	Trials
Industry	17
Other	15

Loxapine: Clinical Trials, Market Analysis, and Projections

Introduction to Loxapine

Loxapine, an antipsychotic medication, has been gaining significant attention for its efficacy in treating acute agitation in patients with schizophrenia and bipolar I disorder. Here, we will delve into the recent clinical trials, market analysis, and future projections for loxapine.

Clinical Trials Update

Phase III Clinical Trials for Acute Agitation

Loxapine, specifically the inhaled formulation known as ADASUVE or Staccato loxapine, has undergone extensive clinical trials. Alexza Pharmaceuticals completed two pivotal Phase III clinical trials in 2008, enrolling over 800 patients. These trials demonstrated that both the 5 mg and 10 mg doses of inhaled loxapine significantly reduced agitation in patients with schizophrenia and bipolar disorder compared to placebo[3].

Key findings from these trials include:

• A rapid onset of action, with significant reductions in agitation observed within 10 minutes of administration.
• Statistically significant reductions in agitation scores using the Positive and Negative Syndrome Scale Excited Component (PEC) and the Clinical Global Impression Improvement (CGI-I) Scale[4].

Safety and Tolerability

A Phase IV, open-label, non-randomized clinical trial evaluated the safety of self-administered ADASUVE in agitated patients outside the hospital setting. This trial, which concluded in 2019, provided further insights into the safety profile of inhaled loxapine in real-world settings[1].

Regulatory Approval and REMS Requirements

The FDA approved inhaled loxapine (10 mg) for the treatment of acute agitation in adults with schizophrenia and bipolar I disorder based on the positive results from the Phase III trials. Health facilities must comply with the Risk Evaluation and Mitigation Strategy (REMS) requirements to dispense and administer inhaled loxapine[4].

Market Analysis

Global Market Size and Growth

The global loxapine market is part of the broader antipsychotic drugs market, which was valued at $14.96 billion in 2018 and is projected to reach $19.74 billion by 2025, growing at a CAGR of 4.0% during the forecast period 2019-2025[5].

Market Segmentation and Regional Insights

The loxapine market is segmented by type (powder, tablet) and application (hospital, drug store). The market analysis covers global, regional, and country-level insights, with key regions including North America, Europe, Asia Pacific, Middle East & Africa, and Latin America[2].

Competitive Landscape

The market for loxapine is competitive, with several key players such as Watson Laboratories, Teva, Mylan Pharmaceuticals, Grupo Ferrer Internacional, and AOP Orphan Pharmaceuticals. These companies are driving the market through their product offerings and strategic partnerships[2].

Market Trends and Drivers

The growth of the loxapine market is driven by several factors, including:

• Increasing prevalence of psychotic disorders globally.
• Advantages of inhaled loxapine over traditional oral and intramuscular medications, such as rapid onset of action and patient preference for non-invasive treatment.
• Significant investments in research and development for antipsychotic medications[2][5].

Market Projections

Forecasted Growth

The global loxapine market is expected to continue growing, driven by the increasing demand for effective treatments for acute agitation. The market size is forecasted to grow from 2025 to 2031, with a compound annual growth rate (CAGR) that reflects the ongoing need for antipsychotic medications[2].

Regional Growth

Regional analysis indicates that North America and Europe will remain significant markets for loxapine, while the Asia Pacific region is expected to show substantial growth due to increasing healthcare expenditures and a rising prevalence of mental health disorders[2].

Future Opportunities and Challenges

Future opportunities for the loxapine market include the potential expansion into new indications, such as migraine treatment, and the development of new formulations. However, challenges such as regulatory hurdles, competition from other antipsychotic medications, and the need for ongoing compliance with REMS requirements must be navigated[3][4].

Key Takeaways

• Clinical Efficacy: Inhaled loxapine has demonstrated significant efficacy in reducing acute agitation in patients with schizophrenia and bipolar I disorder.
• Market Growth: The global loxapine market is projected to grow, driven by increasing demand and the advantages of inhaled loxapine over traditional treatments.
• Regional Insights: North America and Europe are key markets, with the Asia Pacific region showing promising growth potential.
• Competitive Landscape: The market is competitive, with several major pharmaceutical companies involved.

FAQs

What is the primary indication for inhaled loxapine?

Inhaled loxapine is primarily indicated for the treatment of acute agitation in adults with schizophrenia and bipolar I disorder.

What are the key advantages of inhaled loxapine over traditional treatments?

Inhaled loxapine offers a rapid onset of action, reliability of medication delivery, and patient preference for a non-invasive treatment, avoiding the need for injections or oral medications[3][4].

Which regions are expected to drive the growth of the loxapine market?

North America and Europe are currently significant markets, while the Asia Pacific region is expected to show substantial growth in the future[2].

What are the regulatory requirements for administering inhaled loxapine?

Health facilities must be enrolled and comply with the Risk Evaluation and Mitigation Strategy (REMS) requirements to dispense and administer inhaled loxapine[4].

What is the projected growth rate for the global loxapine market?

The global loxapine market is expected to grow at a compound annual growth rate (CAGR) from 2025 to 2031, though the exact rate is not specified in the available sources[2].

Sources

1. EudraCT Number 2015-003331-36 - Clinical trial results. Retrieved from Clinical Trials Register.
2. Loxapine Market Report 2024 (Global Edition). Retrieved from Cognitive Market Research.
3. Alexza Pharmaceuticals, Inc. Completes Enrollment in Second Phase 3 Clinical Trial With AZ-004 (Staccato(R) Loxapine) for Acute Agitation. Retrieved from BioSpace.
4. Inhaled Loxapine (ADASUVE) National Drug Monograph February 2020. Retrieved from PBM VA.
5. Antipsychotic Drugs Market - Forecast(2025 - 2031). Retrieved from IndustryARC.