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.
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.

Clinical Trial Conditions for Mometasone Furoate

Condition Name

Condition Name for Mometasone Furoate
Intervention	Trials
Asthma	36
Seasonal Allergic Rhinitis	15
Nasal Polyps	11
Allergic Rhinitis	9

Condition MeSH

Condition MeSH for Mometasone Furoate
Intervention	Trials
Rhinitis, Allergic	48
Rhinitis	48
Asthma	35
Rhinitis, Allergic, Seasonal	25

Clinical Trial Locations for Mometasone Furoate

Trials by Country

Trials by Country for Mometasone Furoate
Location	Trials
United States	255
Japan	38
China	36
Korea, Republic of	24
India	23

Trials by US State

Trials by US State for Mometasone Furoate
Location	Trials
California	15
Florida	13
Texas	13
New York	13
North Carolina	11

Clinical Trial Progress for Mometasone Furoate

Clinical Trial Phase

Clinical Trial Phase for Mometasone Furoate
Clinical Trial Phase	Trials
Phase 4	30
Phase 3	60
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Mometasone Furoate
Clinical Trial Phase	Trials
Completed	106
Not yet recruiting	13
Recruiting	8

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	140
Other	35
NIH	3

Mometasone Furoate: Clinical Trials, Market Analysis, and Projections

Introduction

Mometasone furoate is a synthetic corticosteroid widely used in the treatment of various respiratory and dermatological conditions. This article delves into the recent clinical trials, market analysis, and projections for this drug, providing a comprehensive overview of its efficacy, safety, and market dynamics.

Clinical Trials: Efficacy and Safety

Seasonal Allergic Rhinitis

A recent multicenter, randomized, double-blind, placebo and active controlled parallel-group trial (EudraCT Number 2021-004050-31) evaluated the efficacy and safety of a fixed combination medicinal product containing mometasone furoate and azelastine hydrochloride nasal spray in patients with seasonal allergic rhinitis. The trial aimed to assess the benefit of this treatment on nasal symptoms. The results, published in January 2024, indicated significant improvements in nasal symptoms, highlighting the efficacy of mometasone furoate in combination with azelastine hydrochloride for this condition[1].

Nasal Polyposis

Another significant trial published in the JAMA Otolaryngology journal evaluated the efficacy and safety of mometasone furoate nasal spray (NS) in patients with nasal polyposis. The study found that 200 μg doses of mometasone furoate NS administered once or twice daily produced statistically superior improvements in congestion and/or obstruction scores compared to placebo. The treatment was well tolerated, with most adverse events being mild or moderate in intensity[3].

Sickle Cell Disease

The IMPROVE-II trial, a randomized, placebo-controlled trial, assessed the effects of mometasone furoate in non-asthmatic patients with sickle cell disease (SCD) who experience episodic cough or wheeze (ECW). The trial showed that treatment with mometasone furoate over a longer period significantly reduced daily pain, markers of hemolysis, and soluble vascular cell adhesion molecule (sVCAM) levels compared to placebo. This indicates the potential of mometasone furoate in managing complications associated with SCD[5].

Market Analysis

Current Market Size

As of 2023, the global mometasone furoate market was valued at USD 1 billion. This market is driven by the increasing prevalence of uncontrolled asthmatic conditions, which affect both children and adults. According to the CDC, about 44% of children and 60% of adults have uncontrolled asthma, contributing significantly to the demand for mometasone furoate[4].

Growth Projections

The market is expected to experience exponential growth, reaching USD 3 billion by the end of 2036, with a projected CAGR of 7% during the forecast period from 2024 to 2036. This growth is attributed to several factors, including the rising awareness and focus on skincare and overall well-being, as well as the expansion of the aging population worldwide[4].

Market Dynamics

The mometasone furoate market is characterized by robust growth rates driven by internal factors such as increasing demand for dermatological treatments and external factors like market opportunities and challenges. The market analysis encompasses various segments, scrutinizing patterns and essential elements shaping the market. Drivers include the growing need for effective treatments for respiratory and dermatological conditions, while restraints may include regulatory hurdles and competition from other corticosteroids[2].

Key Drivers of Market Growth

Increasing Prevalence of Respiratory Conditions

The rising incidence of uncontrolled asthma and other respiratory conditions is a significant driver of the mometasone furoate market. As more people seek effective treatments, the demand for this drug is expected to increase[4].

Growing Awareness of Skincare

There is a growing awareness and focus on skincare and overall well-being, leading to an increased demand for dermatological treatments, including mometasone furoate. This trend is expected to continue, contributing to the market's growth[4].

Aging Population

The expansion of the aging population worldwide is another factor driving the growth of the mometasone furoate market. Older adults are more likely to experience skin and respiratory conditions, thereby increasing the demand for this drug[4].

Challenges and Opportunities

Regulatory Challenges

One of the challenges facing the mometasone furoate market is regulatory hurdles. Strict regulations and the need for extensive clinical trials can slow down the approval process for new formulations and indications[2].

Competitive Landscape

The market for corticosteroids is competitive, with several other drugs available for similar indications. However, the efficacy and safety profile of mometasone furoate, as demonstrated in clinical trials, positions it favorably in the market[3].

Emerging Indications

The potential use of mometasone furoate in managing complications associated with sickle cell disease, as seen in the IMPROVE-II trial, presents an opportunity for market expansion into new therapeutic areas[5].

Conclusion

Mometasone furoate is a versatile and effective corticosteroid with a strong presence in the market for treating various respiratory and dermatological conditions. Recent clinical trials have reinforced its efficacy and safety, particularly in seasonal allergic rhinitis, nasal polyposis, and potentially in managing complications of sickle cell disease.

Key Takeaways

• Efficacy in Respiratory Conditions: Mometasone furoate has shown significant efficacy in treating seasonal allergic rhinitis and nasal polyposis.
• Market Growth: The global mometasone furoate market is projected to grow from USD 1 billion in 2023 to USD 3 billion by 2036.
• Drivers: Increasing prevalence of respiratory conditions, growing awareness of skincare, and the expanding aging population are key drivers of market growth.
• Challenges and Opportunities: Regulatory challenges and competition are balanced by emerging indications and a strong safety and efficacy profile.

FAQs

Q: What are the primary indications for mometasone furoate?

A: Mometasone furoate is primarily used for treating seasonal allergic rhinitis, nasal polyposis, and various dermatological conditions.

Q: What are the key findings from recent clinical trials on mometasone furoate?

A: Recent trials have shown that mometasone furoate significantly improves nasal symptoms in seasonal allergic rhinitis, reduces congestion and/or obstruction scores in nasal polyposis, and may manage complications associated with sickle cell disease.

Q: What is the projected market size for mometasone furoate by 2036?

A: The global mometasone furoate market is expected to reach USD 3 billion by the end of 2036.

Q: What are the main drivers of the mometasone furoate market growth?

A: The main drivers include the increasing prevalence of respiratory conditions, growing awareness of skincare, and the expansion of the aging population.

Q: Are there any emerging indications for mometasone furoate?

A: Yes, there is potential for its use in managing complications associated with sickle cell disease, as indicated by the IMPROVE-II trial.

Sources

1. Clinical Trial Results: EudraCT Number 2021-004050-31 - Clinical trial results.
2. Global Mometasone Furoate Market: Market Research Intellect - Global Mometasone Furoate Market Size, Trends and Projections.
3. Randomized Controlled Trial: JAMA Otolaryngology - A Randomized Controlled Trial of Mometasone Furoate Nasal Spray.
4. Market Size and Projections: Research Nester - Mometasone Furoate Market Size.
5. Clinical Results of IMPROVE-II Trial: Blood - Clinical Results of a Randomized Placebo Controlled Trial of Mometasone Furoate.

Last updated: 2025-01-01