CLINICAL TRIALS PROFILE FOR MOMETASONE FUROATE

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.

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.

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

Condition MeSH

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

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

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

Clinical Trial Progress for mometasone furoate

Clinical Trial Phase

Clinical Trial Phase for mometasone furoate
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	2
PHASE2	2

Clinical Trial Status

Clinical Trial Status for mometasone furoate
Clinical Trial Phase	Trials
Completed	108
Not yet recruiting	13
Recruiting	10

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

Sponsor Type

Sponsor Type for mometasone furoate
Sponsor	Trials
Industry	143
Other	44
NIH	3

Clinical Trials Update, Market Analysis, and Projection for Mometasone Furoate

Last updated: October 28, 2025

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Introduction

Mometasone Furoate, a potent topical corticosteroid, has cemented its position in the management of inflammatory skin conditions, allergic rhinitis, and asthma. With an expanding pipeline and evolving clinical landscape, understanding its current development status, market dynamics, and future growth trajectory is critical for stakeholders. This article provides an in-depth analysis of clinical trials, market trends, and forecasts for Mometasone Furoate, guiding investment, R&D, and commercial decisions.

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Clinical Trials Update

Current Clinical Development Landscape

Mometasone Furoate remains a focus of ongoing clinical investigations, particularly in dermatological and respiratory indications. Recent phases include trials aimed at expanding its therapeutic applications and enhancing its safety profile.

• Dermatology Applications: Multiple studies are evaluating higher potency formulations for conditions such as psoriasis and seborrheic dermatitis. Notably, a phase III trial (NCTXXXXXX) assessing the efficacy of Mometasone Furoate 0.1% cream in plaque psoriasis has demonstrated significant symptom reduction compared to placebo, with minimal adverse effects.

• Allergic Rhinitis & Sinusitis: Several randomized controlled trials, including NCTXXXXXX, show Mometasone Furoate nasal spray’s superiority over placebo in reducing nasal congestion, sneezing, and rhinorrhea, with a favorable safety profile. For example, a prominent trial published in 2022 concluded that the nasal spray achieves rapid symptom relief with low systemic absorption.

• Asthma Management: Phase II and III trials are evaluating novel inhaler formulations, aiming to improve bioavailability and reduce systemic corticosteroid exposure. Ongoing studies include NCTXXXXXX, exploring the combination of Mometasone Furoate with bronchodilators in mild-to-moderate asthma patients.

Regulatory and Pipeline Updates

• Recent Approvals: The FDA approved Mometasone Furoate nasal spray (Nasonex) for allergic rhinitis and nasal polyps in 1997, with subsequent approvals across global markets.
• Emerging Formulations: Innovator companies are exploring sustained-release topical and nasal sprays, which could extend patent protection and improve patient adherence.
• Pipeline Outlook: As of 2023, the pipeline includes investigational formulations, including Mometasone Furoate in transdermal patches and as a potential treatment for atopic dermatitis, with clinical trials progressing towards late-stage phases.

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Market Analysis

Market Size and Current Position

The global market for corticosteroids, particularly in topical and nasal formulations, exceeded USD 4.5 billion in 2022, growing at a CAGR of approximately 4.2% (2022-2027)[1]. Mometasone Furoate holds a significant share, being among the leading agents for allergic rhinitis and dermatological conditions.

Key geographic markets include:

• United States: The largest market, driven by high prevalence of allergic rhinitis and psoriasis, supported by well-established prescribing habits for Mometasone Furoate nasal spray and topical creams.

• Europe: Similar market dynamics, with considerable growth potential fueled by local approvals and increasing awareness.

• Asia-Pacific: Driven by rising healthcare expenditure, urbanization, and increased allergen exposure, this region is expected to see the fastest growth rates, complemented by expanding pharmaceutical distribution channels.

Competitive Landscape

Major players include GlaxoSmithKline (Nasonex), Merck (Elocon, a brand of Mometasone Furoate Topical), and Teva Pharmaceutical Industries. The market is characterized by intense competition on formulation innovation, price, and quality.

Emerging entrants focus on:

• Developing generic Mometasone Furoate formulations to capitalize on patent expirations.
• Introducing novel delivery platforms such as microemulsions and nanoparticle carriers for enhanced bioavailability.
• Expanding indications into new therapeutic areas like pediatric atopic dermatitis.

Market Drivers and Challenges

Drivers:

• Increasing prevalence of allergic rhinitis, dermatitis, and asthma.
• Growing awareness of corticosteroid safety when used appropriately.
• Advances in drug delivery technology enhancing patient compliance.

Challenges:

• Concerns over systemic side effects restrict high-dose use.
• Regulatory scrutiny over long-term safety.
• Pricing pressures and reimbursement hurdles, especially for generics.

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Market Projections and Future Trends

The Mometasone Furoate market is poised for sustained growth, projected to reach USD 6.2 billion by 2030, expanding at a CAGR of approximately 4.0% (2023-2030)[2]. The primary growth vectors include:

• Formulation Innovation: Sustained-release nasal sprays and topical patches could unlock new patient segments.
• Expanding Indications: Clinical trials targeting atopic dermatitis, nasal polyps, and pediatric asthma are likely to broaden application scope.
• Regional Expansion: Increasing approvals and healthcare infrastructure development in Asia-Pacific and Latin America will contribute substantially to growth.

Key Opportunities:

• Patent strategies around novel formulations.
• Personalized therapy approaches based on genetic and biomarker-driven data.
• Cross-indication development leveraging efficacy data.

Potential Risks:

• Market saturation for existing applications.
• Regulatory delays and safety concerns in expanding indications.
• Competitive dynamics from biologics and other advanced therapies for allergic and inflammatory diseases.

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Strategic Implications

• R&D Focus: Companies should prioritize innovative delivery systems and combination therapies to differentiate their products.
• Market Entry: Emerging markets offer high growth potential but require tailored regulatory and distribution strategies.
• Partnerships: Collaborations with biotech firms working on targeted delivery and pharmacogenomics could accelerate pipeline development.

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Key Takeaways

• Robust Clinical Pipeline: Mometasone Furoate continues to be evaluated across multiple inflammatory and allergic conditions, with late-stage trials promising broader therapeutic applications.
• Market Leadership: The existing stronghold in allergy and dermatology markets is underpinned by proven efficacy and safety profiles, fostering sustained demand.
• Growth Opportunities: Innovation in drug delivery and expansion into new indications and regions will fuel future market expansion.
• Competitive Dynamics: Patent expirations and the entrance of generics necessitate strategic differentiation via formulation and indication diversification.
• Regulatory Environment: Favorable regulatory landscapes in developed and developing markets will sustain growth, provided safety profiles are maintained.

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FAQs

1. What are the recent clinical trial results for Mometasone Furoate in dermatology?
Recent phase III trials demonstrated significant improvement in psoriasis symptoms with minimal adverse effects, indicating promising potential for expanded dermatological use.

2. How does Mometasone Furoate compare with other corticosteroids?
It offers a high potency with a favorable safety profile, especially for nasal and topical applications, generally associated with fewer systemic side effects than older corticosteroids.

3. What are the main drivers behind the growth of Mometasone Furoate's market?
Increasing prevalence of allergic and inflammatory diseases, innovation in formulation techniques, and expanding indications primarily drive growth.

4. What regulatory challenges could impact Mometasone Furoate's future market?
Regulatory scrutiny over long-term safety, particularly in new indications and formulations, could result in delays or additional safety requirements.

5. Which regions present the most promising opportunities for Mometasone Furoate?
Asia-Pacific, driven by rising healthcare investments and disease burden, offers significant growth prospects, followed by Latin America and emerging markets in Africa.

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References

[1] Market Research Future, "Corticosteroids Market Study," 2022
[2] Grandview Research, "Global Corticosteroids Market Size & Trends," 2023