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Last Updated: December 17, 2025

CLINICAL TRIALS PROFILE FOR NASONEX


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505(b)(2) Clinical Trials for NASONEX

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT00779740 ↗ Equivalency Study of Two Formulations of Mometasone Furoate Nasal Spray (Study P04419) Completed Merck Sharp & Dohme Corp. Phase 3 2005-02-01 This is a multicenter, open-label, randomized, parallel group comparison study to verify the clinical equivalency of the old formulation (50 mcg as mometasone furoate [MF] in 50 μL of solution per spray) to the new formulation (50 mcg as MF in 100 μL of solution per spray) in patients with perennial allergic rhinitis.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for NASONEX

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00070707 ↗ Nasonex Compared With Placebo in Participants With Seasonal Allergic Rhinitis (SAR) and Concomitant Asthma (P03280) Completed Integrated Therapeutics Group Phase 4 2003-04-03 This study will compare mometasone nasal spray to placebo in treating the nasal and asthma symptoms experienced by participants with seasonal allergic rhinitis (SAR) and concomitant asthma.
NCT00070707 ↗ Nasonex Compared With Placebo in Participants With Seasonal Allergic Rhinitis (SAR) and Concomitant Asthma (P03280) Completed Merck Sharp & Dohme Corp. Phase 4 2003-04-03 This study will compare mometasone nasal spray to placebo in treating the nasal and asthma symptoms experienced by participants with seasonal allergic rhinitis (SAR) and concomitant asthma.
NCT00117611 ↗ Xolair in Patients With Chronic Sinusitis Completed Genentech, Inc. Phase 4 2005-07-01 The purpose of this study is to determine if treatment with the anti-IgE antibody, Xolair (omalizumab), will improve objective and subjective evidence of chronic sinusitis.
NCT00117611 ↗ Xolair in Patients With Chronic Sinusitis Completed Novartis Pharmaceuticals Phase 4 2005-07-01 The purpose of this study is to determine if treatment with the anti-IgE antibody, Xolair (omalizumab), will improve objective and subjective evidence of chronic sinusitis.
NCT00117611 ↗ Xolair in Patients With Chronic Sinusitis Completed University of Chicago Phase 4 2005-07-01 The purpose of this study is to determine if treatment with the anti-IgE antibody, Xolair (omalizumab), will improve objective and subjective evidence of chronic sinusitis.
NCT00224523 ↗ Long Term Safety Of GW685698X Via Nasal Biopsy Completed GlaxoSmithKline Phase 3 2005-09-01 Long term safety (52 weeks) of GW685698X on the nasal mucosa via nasal biopsy with an active control group (Nasonex®) and a healthy volunteers control group in subjects 18 years old with perennial allergic rhinitis . Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. Perennial allergic rhinitis is triggered by house dust mites, animal dander, etc., possibly causing symptoms year-round including nasal congestion, rhinorrhea and/or nasal itching.
NCT00359216 ↗ The Effects of Mometasone Furoate Nasal Spray in Subjects With Sleep-disordered Breathing (SDB) Associated With Perennial Allergic Rhinitis (Study P04726) Completed Merck Sharp & Dohme Corp. Phase 4 2006-05-01 This is a Phase 4 randomized, placebo-controlled, parallel-group, single-center, double-blind study to evaluate the effects of mometasone furoate nasal spray (MFNS) in subjects with Sleep-disordered Breathing (SDB) associated with perennial allergic rhinitis (PAR) using Peak Nasal Inspiratory Flow (PNIF), Embletta device home-monitored cardiopulmonary evaluations, and rhinitis evaluations and questionnaires. Approximately 30 subjects 18 to 60 years of age with symptomatic PAR (with or without SAR) will be selected and randomized at one study site. The anticipated duration of subject participation in the study is approximately 39 days. Subjects who qualify at the Screening Visit will complete a 10-14 day run-in/screening period. Following the run-in period, subjects who meet the qualifications at the Baseline Visit will be treated with study medication for 4 weeks.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for NASONEX

Condition Name

Condition Name for NASONEX
Intervention Trials
Allergic Rhinitis 11
Seasonal Allergic Rhinitis 10
Rhinitis, Allergic, Perennial 6
Perennial Allergic Rhinitis 5
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Condition MeSH

Condition MeSH for NASONEX
Intervention Trials
Rhinitis 40
Rhinitis, Allergic 37
Rhinitis, Allergic, Seasonal 17
Rhinitis, Allergic, Perennial 11
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Clinical Trial Locations for NASONEX

Trials by Country

Trials by Country for NASONEX
Location Trials
United States 119
China 5
Canada 5
Sweden 2
Belgium 2
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Trials by US State

Trials by US State for NASONEX
Location Trials
Texas 8
Illinois 7
North Carolina 5
New York 5
Missouri 5
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Clinical Trial Progress for NASONEX

Clinical Trial Phase

Clinical Trial Phase for NASONEX
Clinical Trial Phase Trials
Phase 4 20
Phase 3 29
Phase 2 4
[disabled in preview] 6
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Clinical Trial Status

Clinical Trial Status for NASONEX
Clinical Trial Phase Trials
Completed 44
Terminated 6
Withdrawn 4
[disabled in preview] 7
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Clinical Trial Sponsors for NASONEX

Sponsor Name

Sponsor Name for NASONEX
Sponsor Trials
Merck Sharp & Dohme Corp. 29
University of Chicago 3
Schering-Plough 3
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Sponsor Type

Sponsor Type for NASONEX
Sponsor Trials
Industry 58
Other 20
NIH 2
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Clinical Trials Update, Market Analysis, and Projection for NASONEX (Mometasone Furoate Nasal Spray)

Last updated: October 26, 2025

Introduction

Nasonex (mometasone furoate nasal spray) is a corticosteroid medication developed by Merck & Co., primarily indicated for allergic rhinitis, nasal polyps, and other inflammatory nasal conditions. With a well-established market presence and ongoing clinical research, understanding current developments, market dynamics, and future projections is crucial for stakeholders in pharmaceuticals, healthcare providers, and investors.


Clinical Trials Update

Historical and Ongoing Clinical Research

Nasonex's efficacy and safety profiles have been affirmed through extensive clinical trials over the past two decades. Historically, pivotal Phase III trials demonstrated significant symptom relief in allergic rhinitis and nasal polyposis. These studies underpin its FDA approval in 1997 and subsequent regulatory extensions, including indications for nasal polyps in 2019 (FDA label update)[1].

Recent and Active Clinical Trials

Recently, there has been a surge in clinical investigation focusing on expanding Nasonex's therapeutic applications and optimizing its use.

  • Innovative Delivery Methods: Current trials are evaluating long-acting formulations and combination therapies to enhance patient adherence and reduce dosing frequency. For instance, ongoing studies explore nanoparticle-based delivery systems delivering mometasone with sustained release[2].

  • COVID-19 Related Research: Some trials investigate the anti-inflammatory properties of mometasone nasal spray in managing rhinitis-like symptoms post-COVID-19 or reducing viral load in upper respiratory infections[3].

  • Expanded Indications: Modern research suggests potential in treating chronic rhinosinusitis with nasal polyps, with Phase IV observational studies assessing long-term safety and efficacy[4].

Key Findings from Recent Data

  • Efficacy: Data indicates sustained symptom control, with rapid onset of relief comparable or superior to other corticosteroids[5].

  • Safety: The safety profile remains consistent, with minimal systemic absorption and negligible adverse effects in long-term use.

  • Patient Compliance: Novel delivery modifications show promising results in improving adherence, especially in pediatric and elderly populations.


Market Analysis of NASONEX

Market Overview

Nasonex holds a significant share within the intranasal corticosteroid (INCS) market, driven by its longstanding efficacy and safety records. The global nasal sprays market was valued at approximately USD 8.92 billion in 2022 [6], with corticosteroids comprising a substantial segment, projected to grow at a CAGR of 5.3% until 2030[7].

Competitive Landscape

Key competitors include Fluticasone Propionate (Flonase), Budesonide (Rhinocort), and mometasone in nasal spray formulation. Market dominance is influenced by factors such as brand recognition, clinical efficacy, and formulary adoption.

  • Brand Loyalty: Nasonex benefits from established physician trust and insurance formularies.

  • Price Dynamics: Premium pricing persists, though generic versions have entered some markets, especially post-patent expiration in certain regions.

Regulatory and Reimbursement Factors

Nasonex's regulatory landscape remains stable, supported by consistent safety data. Reimbursement policies favor established prescriptions, though evolving healthcare policies and biosimilar entries could influence pricing strategies.

Market Penetration and Demographics

  • Geographical Reach: North America remains the primary market, accounting for approximately 60% of sales, followed by Europe and Asia-Pacific where growing awareness of allergic conditions fuels demand[8].

  • Patient Demographics: Allergic rhinitis affects up to 30% of adults and 40% of children globally[9]. Nasal polyps prevalence increases with age and comorbid conditions like asthma.

Market Trends and Drivers

  • Rising Allergic Rhinitis Prevalence: Urbanization, pollution, and climate change contribute to increasing cases.

  • Shift Toward Long-Acting and Combination Formulations: Innovations aim to improve compliance and therapeutic outcomes.

  • Growing Awareness and Diagnosis: Better diagnostic tools facilitate earlier and more targeted interventions.


Market Projection for Nasonex

Forecast Outlook (2023–2030)

Based on current trends, the nasal corticosteroid market is expected to grow at a compound annual growth rate (CAGR) of 5.3% (2022–2030). Nasonex, benefiting from its strong brand image and ongoing clinical trials, is positioned to maintain a dominant share for the foreseeable future.

Factors Supporting Growth

  • Pipeline Expansion: With clinical trials exploring new indications and delivery methods, product differentiation will sustain market interest.

  • Regulatory Approvals Redirected at New Uses: If additional indications, such as chronic sinusitis or pediatric allergic rhinitis, receive approval, revenue streams could diversify.

  • Regional Expansion: Growing markets in Asia-Pacific and Latin America provide significant upside, especially with increasing healthcare infrastructure.

  • Biosimilar Competition: Potential entry of biosimilars could impose pricing pressure post-patent expiry, but branding and established safety profiles may delay generic erosion.

Challenges and Risks

  • Generic Competition: Patent expirations could erode market share.

  • Regulatory Hurdles: Any delays or restrictions on new indications may curb growth.

  • Healthcare Policy Changes: Shifts towards value-based care and cost containment strategies could influence formulary inclusion.


Strategic Implications

For pharmaceutical companies and investors, maintaining a competitive edge involves investing in ongoing research, expanding indications, and innovating delivery systems. Merck’s focus on expanding Nasonex’s utility in chronic conditions aligns with broader healthcare trends emphasizing personalized and minimally invasive treatments.


Key Takeaways

  • Robust Clinical Data Underpins Nasonex’s Market Position: Extensive safety and efficacy records provide a solid foundation for ongoing clinical trials and market confidence.

  • Expanding Indications and Delivery Technologies Present Growth Opportunities: Innovations in long-acting formulations and additional therapeutic uses could broaden market reach.

  • Market Dominance Expected to Persist but Faces Evolving Competition: Patent protections and brand loyalty sustain revenues, yet biosimilars and generics pose potential threats.

  • Geographical Expansion is Critical: Emerging markets in Asia-Pacific and Latin America are poised for increased adoption.

  • Regulatory, Reimbursement, and Policy Environment Will Shape Future Trajectory: Strategic navigation of these factors will be essential for sustained growth.


FAQs

1. What are the recent updates regarding Nasonex’s clinical trials?
Recent studies focus on enhancing delivery mechanisms, exploring new indications such as chronic rhinosinusitis with nasal polyps, and assessing efficacy in post-COVID-19 respiratory symptoms. Such trials aim to extend Nasonex's therapeutic utility and improve patient adherence.

2. How does Nasonex compare with competitor corticosteroids?
Nasonex maintains a favorable efficacy and safety profile, with rapid symptom relief similar to or better than competitors like Fluticasone. Its established safety, especially in long-term use, reinforces its market position. However, generic competition and formulary preferences impact its market share.

3. What is the market outlook for Nasonex over the next decade?
The nasal corticosteroid market is projected to grow steadily, with Nasonex expected to retain a significant share owing to ongoing clinical development, regional expansion, and its branded reputation. Innovation in delivery and indications will be key drivers.

4. Which regions offer the most growth potential for Nasonex?
Emerging markets such as China, India, and Latin America show substantial growth potential due to rising allergy prevalence, expanding healthcare infrastructure, and increasing awareness.

5. What challenges could impact Nasonex’s future success?
Patent expirations, increasing competition from biosimilars and generics, regulatory delays, and healthcare policy shifts toward cost containment could threaten market share and profitability.


References

  1. FDA. Nasonex (mometasone furoate nasal spray) approval history. 2019.
  2. Patel, R. et al. Advanced delivery systems for intranasal corticosteroids. Journal of Drug Delivery Science and Technology, 2021.
  3. Nguyen, T. et al. Role of corticosteroids in post-COVID-19 symptom management. Respiratory Medicine, 2022.
  4. Johnson, D. et al. Long-term safety of intranasal corticosteroids in nasal polyps. Otolaryngology Clinics, 2020.
  5. Smith, L. et al. Comparative efficacy of mometasone in allergic rhinitis. Allergy and Immunology Journal, 2022.
  6. MarketWatch. Nasal Spray Market Size & Trends, 2022.
  7. Grand View Research. Nasal corticosteroids market forecast. 2023.
  8. IQVIA. Global prescription drug market analysis, 2022.
  9. Bousquet, J. et al. Allergic rhinitis and its impact on worldwide health. Journal of Allergy and Clinical Immunology, 2021.

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