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Last Updated: February 14, 2025

CLINICAL TRIALS PROFILE FOR XOPENEX


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All Clinical Trials for Xopenex

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00124176 ↗ Continuous Levalbuterol for Treatment of Status Asthmaticus in Children Completed Sunovion Phase 4 2004-04-01 This study will use a randomized, double-blind, controlled trial design in order to assess the safety and efficacy of levalbuterol (LEV) compared to racemic albuterol (RAC) when delivered continuously in a high-dose regimen for children with severe exacerbations of asthma. Primary hypothesis - Children with severe asthma receiving continuous levalbuterol will have a shorter duration of continuous therapy as compared to racemic albuterol. Secondary hypotheses - Children receiving continuous levalbuterol will have improved lung function measured by forced expiratory volume at 1 second (FEV1) as compared to racemic albuterol. - Children receiving continuous levalbuterol will have improved clinical asthma score as compared to racemic albuterol.
NCT00124176 ↗ Continuous Levalbuterol for Treatment of Status Asthmaticus in Children Completed Children's Hospital of Philadelphia Phase 4 2004-04-01 This study will use a randomized, double-blind, controlled trial design in order to assess the safety and efficacy of levalbuterol (LEV) compared to racemic albuterol (RAC) when delivered continuously in a high-dose regimen for children with severe exacerbations of asthma. Primary hypothesis - Children with severe asthma receiving continuous levalbuterol will have a shorter duration of continuous therapy as compared to racemic albuterol. Secondary hypotheses - Children receiving continuous levalbuterol will have improved lung function measured by forced expiratory volume at 1 second (FEV1) as compared to racemic albuterol. - Children receiving continuous levalbuterol will have improved clinical asthma score as compared to racemic albuterol.
NCT00500578 ↗ Intermittent Use of Aerosolized Ribavirin for Treatment of RSV Completed ICN Pharmaceuticals Phase 4 2003-02-01 Primary Objectives: 1. To determine whether aerosolized ribavirin is effective when given at an intermittent dose over 3 hours every 8 hours for therapy of RSV upper respiratory tract infection (URI) and whether it can prevent progression to pneumonia. 2. To determine the effect of this regimen on persistence of viral shedding.
NCT00500578 ↗ Intermittent Use of Aerosolized Ribavirin for Treatment of RSV Completed M.D. Anderson Cancer Center Phase 4 2003-02-01 Primary Objectives: 1. To determine whether aerosolized ribavirin is effective when given at an intermittent dose over 3 hours every 8 hours for therapy of RSV upper respiratory tract infection (URI) and whether it can prevent progression to pneumonia. 2. To determine the effect of this regimen on persistence of viral shedding.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Xopenex

Condition Name

Condition Name for Xopenex
Intervention Trials
Asthma 3
Acute Asthma 1
COPD 1
Hematological Malignancies 1
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Condition MeSH

Condition MeSH for Xopenex
Intervention Trials
Asthma 3
Hematologic Neoplasms 1
Status Asthmaticus 1
Respiratory Tract Infections 1
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Clinical Trial Locations for Xopenex

Trials by Country

Trials by Country for Xopenex
Location Trials
United States 14
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Trials by US State

Trials by US State for Xopenex
Location Trials
Texas 2
Pennsylvania 2
Michigan 2
Oklahoma 1
Illinois 1
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Clinical Trial Progress for Xopenex

Clinical Trial Phase

Clinical Trial Phase for Xopenex
Clinical Trial Phase Trials
Phase 4 5
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Xopenex
Clinical Trial Phase Trials
Completed 5
Terminated 1
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Clinical Trial Sponsors for Xopenex

Sponsor Name

Sponsor Name for Xopenex
Sponsor Trials
Sunovion 3
Children's Hospital of Philadelphia 1
ICN Pharmaceuticals 1
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Sponsor Type

Sponsor Type for Xopenex
Sponsor Trials
Other 7
Industry 4
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XOPENEX: Clinical Trials, Market Analysis, and Projections

Introduction

XOPENEX, also known as levalbuterol tartrate, is a short-acting beta2-adrenergic agonist used for the treatment or prevention of bronchospasm in patients with asthma and other respiratory conditions. Here, we will delve into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Completed Trials

One notable clinical trial with the EudraCT protocol number 2021-002490-26, although not specifically focused on XOPENEX, highlights the rigorous testing process for similar medications. However, for XOPENEX itself, several clinical trials have been conducted to evaluate its efficacy and safety.

Recent Clinical Trials

Recent clinical trials for XOPENEX include Phase 4 studies conducted by various institutions such as Henry Ford Health System, Fahim Khorfan, MD, and Genesys Regional Medical Center. These trials aim to assess the long-term efficacy and safety of levalbuterol in real-world settings[2].

Adverse Reactions and Safety Profile

Clinical trials have shown that XOPENEX has a generally favorable safety profile, although it is associated with some adverse reactions. These include tremor, nervousness, dizziness, and increased heart rate. The incidence of these systemic beta-adrenergic adverse reactions was slightly less in the XOPENEX Inhalation Solution 0.63 mg group compared to other active treatment groups[4].

Market Analysis

Global Bronchodilators Market

The global bronchodilators market, which includes XOPENEX, was estimated at USD 22.19 billion in 2022. This market is expected to expand at a compound annual growth rate (CAGR) of 3.29% from 2023 to 2030, reaching USD 28.75 billion by 2030[5].

Market Segmentation

Beta-adrenergic bronchodilators, the class to which XOPENEX belongs, dominated the market in 2022 with a revenue share of more than 40.0%. This segment is expected to grow at the fastest CAGR of 3.33% during the forecast period. Major products in this category include levalbuterol (Xopenex HFA) and albuterol (Proair HFA, Proventil HFA, AccuNeb, Ventolin HFA)[5].

Disease Outlook

The asthma segment, which is a primary indication for XOPENEX, accounted for the largest revenue share of 41.9% in the market in 2022. This segment is expected to expand at a CAGR of 3.31% over the forecast period, driven by the increasing prevalence of asthma globally[5].

Market Projections

Revenue Forecast

The global bronchodilators market, including XOPENEX, is projected to grow significantly. The market size is expected to reach USD 22.77 billion in 2023 and USD 28.75 billion by 2030. This growth is driven by the increasing demand for bronchodilators due to rising respiratory diseases and the COVID-19 pandemic's impact on lung health[5].

Regional Outlook

The U.S. market, a significant segment for XOPENEX, is expected to expand at a CAGR of 2.91% from 2022 to 2030. Other regions, including Europe, Asia Pacific, Latin America, and the Middle East and Africa, also show promising growth prospects due to increasing healthcare expenditure and awareness about respiratory diseases[5].

Patent and Generic Landscape

Patent Status

XOPENEX HFA is protected by one patent in the United States and has thirty-six patent family members in eighteen countries. There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data suggest that 63% of patent challenges are decided in favor of the generic patent challenger, and 54% of successful patent challengers promptly launch generic drugs[2].

Key Takeaways

  • Clinical Trials: Recent Phase 4 trials focus on the long-term efficacy and safety of XOPENEX in real-world settings.
  • Market Analysis: The global bronchodilators market, dominated by beta-adrenergic bronchodilators, is expected to grow at a CAGR of 3.29% from 2023 to 2030.
  • Disease Outlook: The asthma segment drives a significant portion of the market, with a CAGR of 3.31% over the forecast period.
  • Revenue Forecast: The market is projected to reach USD 28.75 billion by 2030.
  • Patent and Generic Landscape: XOPENEX faces potential generic competition as patents expire and litigation cases are resolved.

FAQs

What is XOPENEX used for?

XOPENEX (levalbuterol tartrate) is used for the treatment or prevention of bronchospasm in patients with asthma and other respiratory conditions.

What are the common adverse reactions associated with XOPENEX?

Common adverse reactions include tremor, nervousness, dizziness, and increased heart rate.

How is the global bronchodilators market expected to grow?

The global bronchodilators market is expected to grow at a CAGR of 3.29% from 2023 to 2030, reaching USD 28.75 billion by 2030.

Which segment dominates the bronchodilators market?

Beta-adrenergic bronchodilators, which include XOPENEX, dominate the market with a revenue share of more than 40.0%.

What is the impact of the COVID-19 pandemic on the bronchodilators market?

The COVID-19 pandemic has had a positive impact on the market due to the off-label use of bronchodilators for inpatient treatment and the increased susceptibility to lung diseases and viral infections.

Sources

  1. EU Clinical Trials Register - EudraCT Number: 2021-002490-26
  2. DrugPatentWatch - XOPENEX HFA Drug Patent Profile
  3. Tandfonline - Levalbuterol vs. albuterol for hospitalized patients with COPD in China
  4. FDA - XOPENEX® Inhalation Solution Concentrate Label
  5. Grand View Research - Bronchodilators Market Size & Trends Analysis Report, 2030

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