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Last Updated: March 21, 2025

CLINICAL TRIALS PROFILE FOR ZAFIRLUKAST


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All Clinical Trials for Zafirlukast

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00406861 ↗ Montelukast in ENL Reaction Unknown status The Leprosy Mission Bangladesh N/A 2006-12-01 Objective of the trial is to assess the safety and efficacy of Montelukast in treatment of Erythema Nodosum leprosum (ENL) reaction in multibacillary leprosy patients either in combination with prednisolone or alone. Hypothesis is that montelukast will reduce the severity of ENL reaction in Multibacillary leprosy patients without causing an unacceptably high incidence of adverse effects. Design is a multicentre hospital-based single-blind prospective trial for leprosy patients with ENL reaction. prior written consent will be taken from the patients who will undergo the trial. Endpoints are decrease in severity of ENL and absence of new nerve function impairment
NCT01283061 ↗ Bioequivalence Study of Zafirlukast Tablets 20 mg of Dr. Reddy's Laboratories Limited Under Fasting Condition Completed Dr. Reddy's Laboratories Limited Phase 1 2007-12-01 The objective of this study was to compare the relative bioavailability of zafirlukast tablets 20 mg with that of 'ACCOLATE®' tablets 20 mg (zafirlukast tablets 20 mg) in healthy, adult, human, subjects under fasting conditions and to monitor safety of subjects.
NCT02017197 ↗ Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil Completed Fundação de Amparo à Pesquisa do Estado de São Paulo Phase 4 2014-08-01 The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Zafirlukast

Condition Name

Condition Name for Zafirlukast
Intervention Trials
Healthy 1
Leprosy 1
Moderate Covid19 1
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Condition MeSH

Condition MeSH for Zafirlukast
Intervention Trials
Contracture 1
Atrial Fibrillation 1
Leprosy 1
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Clinical Trial Locations for Zafirlukast

Trials by Country

Trials by Country for Zafirlukast
Location Trials
United States 2
Brazil 1
India 1
Saudi Arabia 1
Bangladesh 1
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Trials by US State

Trials by US State for Zafirlukast
Location Trials
Massachusetts 1
California 1
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Clinical Trial Progress for Zafirlukast

Clinical Trial Phase

Clinical Trial Phase for Zafirlukast
Clinical Trial Phase Trials
Phase 4 1
Phase 3 1
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Zafirlukast
Clinical Trial Phase Trials
Recruiting 2
Completed 2
Terminated 1
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Clinical Trial Sponsors for Zafirlukast

Sponsor Name

Sponsor Name for Zafirlukast
Sponsor Trials
University of California, San Francisco 1
National Institutes of Health (NIH) 1
Dana-Farber Cancer Institute 1
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Sponsor Type

Sponsor Type for Zafirlukast
Sponsor Trials
Other 7
NIH 1
Industry 1
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Zafirlukast: Clinical Trials, Market Analysis, and Projections

Introduction to Zafirlukast

Zafirlukast is an orally active and selective cysteinyl leukotriene (cysLT) receptor antagonist, primarily used for the prophylaxis and treatment of chronic asthma. It works by blocking the effects of leukotrienes, which are chemicals that cause inflammation in the airways.

Clinical Trials and Efficacy

Mechanism of Action

Zafirlukast antagonizes the effects of exogenously administered LTD4 and cysLTs released endogenously in response to physical and chemical stimuli. It inhibits LTD4-induced bronchoconstriction, with effects still evident 12 hours after drug administration[3][4].

Clinical Outcomes

In multicenter trials involving patients with chronic, stable asthma, zafirlukast has been shown to reduce asthma symptoms, decrease the use of as-needed beta-agonist therapy, and improve pulmonary function. These improvements were observed without an increase in adverse events[3][4].

Comparative Studies

Zafirlukast has been compared to other treatments in clinical studies. It was found to be as effective as doubling the dosage of inhaled corticosteroids and similar in efficacy to pranlukast 225 mg twice daily. However, inhaled fluticasone propionate and salmeterol have shown greater clinical improvement than zafirlukast in some studies[1].

Safety Profile

Clinical trials have demonstrated that zafirlukast has an adverse event profile similar to that of placebo. However, isolated reports of hepatic dysfunction in a small number of patients have been noted, and recommendations for monitoring patients are in place. There is no established causal relationship between zafirlukast and Churg-Strauss Syndrome, but patients undergoing corticosteroid dosage reductions require careful surveillance[1].

Market Analysis

Current Market Size and Growth

The global zafirlukast market has experienced rapid growth in recent years and is anticipated to continue this trend from 2023 to 2031. The market is projected to reach significant values, driven by factors such as the increasing prevalence of asthma and chronic obstructive pulmonary disease (COPD), and the growing demand for effective and well-tolerated treatments[2][5].

Market Drivers

Key drivers of the zafirlukast market include:

  • Increasing Prevalence of Asthma and COPD: The rising number of patients with asthma and COPD is driving the demand for effective treatments like zafirlukast[5].
  • Growing Demand for Generic Products: The market is seeing an increase in the demand for generic versions of zafirlukast, which is contributing to its growth[5].
  • Expanding Use in New Therapeutic Areas: Zafirlukast is being explored for use in new therapeutic areas, further expanding its market potential[5].

Market Segmentation

The zafirlukast market is segmented based on factors such as end-use industry, product classification, and geographic regions. The Asia-Pacific region is expected to be the fastest-growing market due to the high prevalence of asthma and allergies in this region[5].

Leading Players

The market is highly competitive, with key players including AstraZeneca Pharmaceuticals, Dr. Reddy's Laboratories, and Camber Pharma. These companies are focusing on developing new formulations, expanding their market reach through strategic partnerships, and geographic expansion, particularly in emerging markets[5].

Market Projections

Growth Rate and Market Size

The global zafirlukast market is expected to grow at a Compound Annual Growth Rate (CAGR) of 4.5% over the next five years. By 2025, the market is projected to reach a value of $2.5 billion[5].

Regional Dominance

The Asia-Pacific region is anticipated to be the fastest-growing market for zafirlukast, driven by the increasing prevalence of asthma and allergies, as well as the growing demand for generic products[5].

Segment Dominance

The hospital segment is expected to account for the largest share of the market by 2025, due to the frequent use of zafirlukast in treating patients with severe asthma and allergies who require hospitalization[5].

Emerging Trends

New and Improved Products

The development of new and improved zafirlukast formulations is a significant trend in the market. Companies are investing in research and development to enhance the efficacy and safety of zafirlukast[5].

Expanding Therapeutic Areas

Zafirlukast is being explored for use in new therapeutic areas beyond asthma, which is expected to further expand its market potential[5].

Growing Adoption of Generic Products

The growing adoption of generic versions of zafirlukast is another emerging trend, driven by cost-effectiveness and similar efficacy to branded products[5].

Key Takeaways

  • Clinical Efficacy: Zafirlukast is effective in reducing asthma symptoms, improving pulmonary function, and decreasing the use of as-needed beta-agonist therapy.
  • Market Growth: The global zafirlukast market is projected to grow significantly from 2023 to 2031, driven by increasing prevalence of asthma and COPD, and growing demand for generic products.
  • Regional Focus: The Asia-Pacific region is expected to be the fastest-growing market due to high prevalence rates and growing demand for generic products.
  • Competitive Landscape: Key players are focusing on developing new formulations, expanding market reach, and geographic expansion.

FAQs

What is zafirlukast used for?

Zafirlukast is used for the prophylaxis and treatment of chronic asthma. It works by blocking the effects of leukotrienes, which cause inflammation in the airways.

How does zafirlukast compare to other asthma treatments?

Zafirlukast is as effective as doubling the dosage of inhaled corticosteroids and similar in efficacy to pranlukast. However, inhaled fluticasone propionate and salmeterol have shown greater clinical improvement in some studies.

What are the common side effects of zafirlukast?

Common side effects include headache, diarrhea, nausea, and abdominal pain.

Which region is expected to be the fastest-growing market for zafirlukast?

The Asia-Pacific region is expected to be the fastest-growing market due to the high prevalence of asthma and allergies and the growing demand for generic products.

What are the key drivers of the zafirlukast market?

Key drivers include the increasing prevalence of asthma and COPD, growing demand for generic products, and the expanding use of zafirlukast in new therapeutic areas.

Sources

  1. Zafirlukast: an update of its pharmacology and therapeutic efficacy in ... - PubMed
  2. Zafirlukast Market Size, Scope And Forecast Report - Market Research Intellect
  3. Summary of clinical trials with zafirlukast - PubMed
  4. Summary of clinical trials with zafirlukast - UTMB Research Experts
  5. Zafirlukast in Emerging Markets: Analysis and Projections 2025-2033 - Data Insights Market

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