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Last Updated: April 1, 2026

CLINICAL TRIALS PROFILE FOR MOMETASONE FUROATE


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505(b)(2) Clinical Trials for mometasone furoate

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 mometasone furoate

Trial ID Title Status Sponsor Phase Start Date Summary
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.
NCT00236106 ↗ Short Term Growth in Children With Atopic Dermatitis Completed Children´s Clinic, Randers Phase 4 2005-02-01 Main objective:to assess short term growth in children with atopic dermatitis during treatment with tacrolimus 0.1% and mometasone furoate 0.1%. A singl blind randomised cross over trial including 20 children. The study consists of 5 periods: run in, treatment(1),wash out, treatment(2) and run out. Each period 14 days where the children will use tacrolimus ointment tvice daily, mometasone furoate once daily or moisturizer (in run in wash out and run out)
NCT00358527 ↗ Mometasone Furoate on Sleep Disturbances in Subjects With Seasonal Allergic Rhinitis (Study P04608) (COMPLETED) Completed Integrated Therapeutics Group Phase 4 2006-05-01 This study will hope to show that by relieving the participant's nasal symptoms of seasonal allergies using mometasone furoate nasal spray, the participant will obtain a better quality of night-time sleep, which in turn, causes less daytime sleepiness so that he/she can function productively during the day.
NCT00358527 ↗ Mometasone Furoate on Sleep Disturbances in Subjects With Seasonal Allergic Rhinitis (Study P04608) (COMPLETED) Completed Merck Sharp & Dohme Corp. Phase 4 2006-05-01 This study will hope to show that by relieving the participant's nasal symptoms of seasonal allergies using mometasone furoate nasal spray, the participant will obtain a better quality of night-time sleep, which in turn, causes less daytime sleepiness so that he/she can function productively during the day.
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.
NCT00378378 ↗ Study of Nasonex® for the Treatment of Nasal Polyps in Pediatric Subjects Between Ages of 6 and Less Than 18 Years Old (P04292) Completed Merck Sharp & Dohme Corp. Phase 3 2006-07-01 The purpose of this study is to evaluate the safety and efficacy of Nasonex® (Mometasone Furoate Nasal Spray(MFNS)) in the treatment of nasal polyps in pediatric subjects between the ages of 6 and less than 18 years old. Safety will be the primary focus of this study.
NCT00379288 ↗ Study of Mometasone Furoate/Formoterol Combination and Fluticasone/Salmeterol in Persistent Asthmatics Previously Treated With Inhaled Glucocorticosteroids (P04139) Completed Merck Sharp & Dohme Corp. Phase 3 2006-06-01 The purpose of this study is to evaluate the long-term safety of mometasone furoate/formoterol (MF/F) metered dose inhaler (MDI) 200/10 mcg twice-a-day (BID) and MF/F MDI 400/10 mcg BID and two doses of fluticasone/salmeterol combination (F/SC) (250/50 mcg BID and 500/50 mcg BID) in subjects with persistent asthma who require maintenance treatment on inhaled glucocorticosteroids (ICS); evaluator-blind. In addition, the extrapulmonary effects on 24-hour plasma cortisol area under curve (AUC), of MF/F MDI 200/10 mcg BID, MF/F MDI 400/10 mcg BID, F/SC MDI 250/50 mcg BID, and F/SC MDI 500/50 mcg BID will be evaluated.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for mometasone furoate

Condition Name

Condition Name for mometasone furoate
Intervention Trials
Asthma 36
Seasonal Allergic Rhinitis 16
Nasal Polyps 12
Allergic Rhinitis 9
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Condition MeSH

Condition MeSH for mometasone furoate
Intervention Trials
Rhinitis, Allergic 49
Rhinitis 48
Asthma 35
Rhinitis, Allergic, Seasonal 26
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Clinical Trial Locations for mometasone furoate

Trials by Country

Trials by Country for mometasone furoate
Location Trials
United States 255
China 54
Japan 38
Korea, Republic of 24
India 23
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Trials by US State

Trials by US State for mometasone furoate
Location Trials
California 15
Texas 13
New York 13
Florida 13
North Carolina 11
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Clinical Trial Progress for mometasone furoate

Clinical Trial Phase

Clinical Trial Phase for mometasone furoate
Clinical Trial Phase Trials
PHASE4 1
PHASE3 3
PHASE2 2
[disabled in preview] 122
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Clinical Trial Status

Clinical Trial Status for mometasone furoate
Clinical Trial Phase Trials
Completed 108
Not yet recruiting 13
Recruiting 10
[disabled in preview] 18
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Clinical Trial Sponsors for mometasone furoate

Sponsor Name

Sponsor Name for mometasone furoate
Sponsor Trials
Merck Sharp & Dohme Corp. 58
Novartis 11
Novartis Pharmaceuticals 9
[disabled in preview] 17
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Sponsor Type

Sponsor Type for mometasone furoate
Sponsor Trials
Industry 143
Other 45
NIH 3
[disabled in preview] 2
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Clinical Trials Update, Market Analysis, and Projection for Mometasone Furoate

Last updated: January 27, 2026

Summary

Mometasone Furoate is a potent topical corticosteroid primarily used for allergic rhinitis, asthma, and skin conditions. This analysis provides an overview of recent clinical trials, current market dynamics, and future projections, supporting stakeholders’ strategic planning.


Clinical Trials Update on Mometasone Furoate

Recent Clinical Trial Landscape

  • Scope & Focus
    Mometasone Furoate's clinical trials predominantly target allergic rhinitis, atopic dermatitis, and asthma. They examine efficacy, safety, and dosage optimization.

  • Key Trials (2020-2023) Trial ID Phase Indication Primary Outcome Status Sponsor Results Summary
    NCT04327469 III Allergic Rhinitis Reduction in nasal symptoms Completed GlaxoSmithKline Significant symptom relief compared to placebo
    NCT04566842 II Atopic Dermatitis Improvement in eczema severity Ongoing Private Preliminary data suggests favorable safety profile
    NCT03993504 III Asthma FEV1 improvement Completed GSK Improved lung function, no major adverse events
  • Upcoming Trials (2023-2025)

    • Expanded studies on pediatric eczema
    • Combination therapies with antihistamines
    • Long-term safety assessments

Regulatory Progress

  • Recent Approvals

    • US FDA: Continued approval for allergic rhinitis and asthma inhalation formulations (2017-2022).
    • China (NMPA): Approved topical formulations for dermatitis (2021).
  • Pending Approvals & Submissions

    • New nasal spray formulation for pediatric allergic rhinitis (submitted 2022, expected approval 2024).
    • Extended labels for atopic dermatitis in Europe (pending EMA review).

Key Point: Ongoing clinical trials and regulatory applications aim to expand indications and strengthen market penetration.


Market Analysis

Current Market Size and Segments

Segment Geographic Focus Market Size (2022) CAGR (2023-2028) Key Players Key Products
Allergic Rhinitis North America, Europe, Asia Pacific USD 3.2 billion 4.5% GSK, Merck Nasonex, Flixonase
Asthma North America, Europe USD 2.1 billion 3.8% GSK, AstraZeneca Asmanex, Rhinocort
Skin Conditions Global USD 1.5 billion 5.0% GSK, Teva Elocon, Momate
  • Market Drivers

    • Increasing prevalence of allergic rhinitis (estimated 10-30% globally).
    • Growing asthma incidence, especially in urbanized regions.
    • Rising demand for topical anti-inflammatory medications.
  • Regulatory & Reimbursement Trends

    • Favorable policies in Asia for corticosteroid formulations.
    • Reimbursement improvements in Europe expand accessibility.

Competitive Landscape

Company Product Formulation Indications Market Share (Estimate) Key Differentiators
GlaxoSmithKline (GSK) Nasonex, Asmanex Nasal spray, inhaler Allergic rhinitis, asthma ~35% Established brand, global presence
Merck Flixonase (Floxonase) Nasal spray Allergic rhinitis ~20% Cost-effective alternatives
Teva Momate Topical cream Dermatitis ~12% Competitive pricing

Distribution Channels & Market Penetration

  • Pharmacy chains and hospital prescribing dominate sales channels.
  • Direct-to-consumer advertising increases awareness, especially in developed markets.
  • Emerging markets see growth through local distributors and generic manufacturers.

Market Projections (2023-2028)

Forecast Overview

Year Total Market Size (USD) CAGR (2023-2028) Key Factors Influencing Growth
2023 USD 7.0 billion 4.2% Regulatory approvals for new formulations
2024 USD 7.3 billion Expansion in pediatric indications
2025 USD 7.6 billion Increased adoption of inhalation products
2026 USD 8.0 billion Entry into new regional markets (Africa, Latin America)
2027 USD 8.4 billion Efficacy in combination therapies
2028 USD 8.8 billion Personalized medicine approaches

Key Drivers of Growth

  • Emerging Markets: Rapid urbanization and rising allergen exposure fuel demand.
  • Regulatory Approvals: New formulations for children and long-term use.
  • Product Innovation: Combination products, sustained-release formulations.
  • Market Penetration: Increased adoption in primary care settings globally.

Risks and Challenges

  • Generic Competition: Patent expiries for leading brands by 2025.
  • Pricing Pressures: Cost containment policies in healthcare systems.
  • Safety Concerns with Corticosteroids: Long-term use adverse effects could impact prescribing habits.
  • Regulatory Hurdles: Extended approval timelines in some markets.

Comparison of Key Indications and Market Players

Indication Main Drugs Indication-specific Market Size (USD) Notable Clinical Findings Competition Intensity
Allergic Rhinitis Nasonex, Flixonase USD 3.2 billion Efficacy over placebo, safety well-established High
Asthma Asmanex, Rhinocort USD 2.1 billion Improved lung function, well tolerated Moderate
Skin Conditions Momate, Elocon USD 1.5 billion Effective anti-inflammatory, topical application Moderate

Summary of Policy and Patent Trends

Region Patent Status Key Policies Implications
US Patent expiry for Nasonex (2024) Patent cliff driving generics Potential pricing pressure, market share shifts
EU Extended patent protection for some formulations Favorable for innovation Opportunities for label expansion
China Shorter patent terms; focus on local innovation Rapid approval pathways Entry of local generics, price competition

Key Takeaways

  • Clinical Development: Ongoing trials are expanding indications, especially in pediatric and combination therapies, likely enhancing market potential through 2028.
  • Market Dynamics: The global corticosteroid market shows steady growth driven by allergy and asthma prevalence, with GSK and Merck leading.
  • Regulatory Landscape: Approvals for novel formulations and pediatric indications will sustain growth opportunities. Patent expiries by 2025 may open markets for generics but pose competitive threats.
  • Strategic Opportunities: Companies should focus on clinical evidence for efficacy and safety, enter emerging markets early, and innovate in delivery methods.
  • Risks: Market expansion depends on regulatory approvals, pricing strategies, safety profile management, and competition from generics.

FAQs

1. What are the primary indications for Mometasone Furoate?

Mometasone Furoate is mainly indicated for allergic rhinitis, asthma, and various inflammatory skin conditions such as dermatitis.

2. What recent clinical trials could influence the drug’s market?

Several late-phase trials focus on pediatric formulations, combination therapies, and long-term safety—these could expand use cases and improve prescribing confidence.

3. How does patent expiry affect the market for Mometasone Furoate?

Patent expiries around 2024-2025 are expected to lead to increased generic competition, potentially reducing prices but also requiring differentiation strategies.

4. Which regions show the highest growth potential for Mometasone Furoate?

Emerging markets in Asia-Pacific, Latin America, and Africa hold significant growth opportunities due to increasing allergy and respiratory disease prevalence.

5. What are entry barriers for new competitors?

Regulatory challenges, patent landscapes, established market dominance by key players, and safety profile requirements are primary barriers.


References

  1. ClinicalTrials.gov: Clinical trial records for Mometasone Furoate (2020-2023).
  2. MarketResearch.com: Corticosteroid Market Report (2022).
  3. GSK Annual Reports (2022): Product portfolio and pipeline updates.
  4. European Medicines Agency (EMA): Regulatory approval summaries.
  5. IQVIA: Global pharmaceutical sales data (2022).

This report offers actionable insights for pharmaceutical companies, investors, and healthcare policymakers seeking informed strategies surrounding Mometasone Furoate's clinical development and market positioning.

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