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
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
PHASE4	1
PHASE3	3
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	45
NIH	3

MOMETASONE FUROATE Market Analysis and Financial Projection

Last updated: April 28, 2026

Mometasone Furoate: Clinical Trial Update, Market Analysis, and Revenue Projection

What clinical-trial activity is visible for mometasone furoate?

Mometasone furoate is an established corticosteroid used primarily for allergic rhinitis, nasal polyps (in some jurisdictions), asthma controller regimens (inhaled forms), and other inflammatory indications depending on formulation (e.g., topical dermatology and ophthalmic uses). The clinical-trial picture for mometasone furoate is dominated by (1) formulation development and (2) label-expanding or competitive bridging studies rather than novel mechanism breakthroughs.

Trial activity patterns that typically dominate for marketed mometasone furoate

• Nasal formulations (allergic rhinitis): comparative efficacy and safety studies, device and dosing regimen studies, and pharmacokinetic or bioequivalence work for generic or improved delivery systems.
• Ophthalmic formulations: safety and efficacy studies in allergic conjunctivitis and postoperative inflammation.
• Topical dermatology: vehicle comparisons and pediatric or site-of-disease label expansions.
• Inhaled forms (asthma): regimen optimization, comparative inhaler-device outcomes, and post-authorization observational commitments.

Where to anchor the update (public sources) A complete, auditable “clinical trials update” should be grounded in a registry query and a cut of trial statuses by sponsor and date. The sources below are the standard registry reference points used to support status determinations:

• ClinicalTrials.gov search interface and study records (industry and academic trials, global entries). [1]
• EU Clinical Trials Register entries (Europe-focused trial visibility). [2]
• WHO ICTRP (aggregated trial listings feeding national registries). [3]

Key limitation for this deliverable A precise, date-stamped update by phase (Phase 2/3), indication, sponsor, enrollment size, and current status requires a registry pull with a defined query (mometasone furoate, related brand/formulations) and a cutoff date. That registry extraction is not contained in the provided context, so no complete and accurate trial-by-trial status table can be produced here without fabricating details.

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What is the market structure for mometasone furoate and where is demand concentrated?

Mometasone furoate is sold as multiple dosage forms and across geographies, with a market structure that typically looks like:

• Core demand in allergic rhinitis via intranasal products (highest share among non-dermatology indications in many markets).
• Secondary demand in dermatology (topical creams/ointments and compounded/combination variants in some regions).
• Smaller but stable demand in ophthalmic anti-inflammatory and in asthma controller uses when inhaled formulations are positioned.

Competitive landscape

• Brand originator + generics: after patent expiries, intranasal and topical products typically transition to generic competition in most major markets.
• Differentiation shifts from molecule novelty to device usability, formulation performance, and payer contracting.
• Substitution risk is high because corticosteroids in the same class compete on symptom control and formulary placement.

Commercial implications

• Long-run growth tends to track population with chronic allergic conditions, formulary access, and switching within the class, not new patient creation from a new mechanism.

Where revenue is most likely to concentrate

• Intranasal allergic rhinitis is the dominant anchor product category for mometasone furoate revenue in many markets.
• Topical dermatology is material and can offset volatility in rhinitis depending on competitive intensity and formulation penetration.
• Ophthalmic and inhaled tend to be smaller relative pools unless a specific branded formulation sustains premium positioning.

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How should revenue be projected for mometasone furoate (method and baseline logic)?

Because mometasone furoate is an established molecule with multiple marketed formulations, projections must treat the market as formulation- and territory-specific with pricing pressure from generics. Without a verified registry pull for trial timelines and without a specified SKU/territory revenue baseline, a projection can only be expressed as a framework rather than a numeric forecast.

A projection framework that is consistent with how pharma investors model established topical and intranasal corticosteroids:

1) Segment the revenue pool by product form

• Intranasal rhinitis (primary)
• Topical dermatology
• Ophthalmic anti-inflammatory
• Inhaled asthma controller (if applicable in your target territory set)

2) Apply a unit growth rate

• Base unit growth tracks allergic rhinitis prevalence and adoption.
• Adjust downward for generic erosion and formulary substitution dynamics.

3) Apply net price erosion

• Generic competition typically drives multi-year declines.
• Brand retention matters; device upgrades can slow erosion but rarely reverse it.

4) Stress-test competition

• Competitive entries from generics or authorized alternatives often cause step changes rather than smooth declines.
• Channel contracting can change faster than underlying symptom prevalence.

5) Incorporate clinical impact only where new differentiation exists

• If a late-stage program adds a unique benefit (new delivery device, new dosing regimen with adherence improvement, new indication), you model uptake.
• If activity is largely bridging or reformulation, you model limited incremental uptake and focus on price and share.

Data requirement to generate an audited numeric forecast A numeric “revenue projection” requires, at minimum:

• Current global and/or territory revenue by product form (or at least a validated market size baseline).
• Expected pricing decline and generic entry timing by geography and SKU.
• Confirmed clinical-stage events that are likely to impact launch or label acceptance.

Those inputs are not present in the provided context. Producing numbers without them would be fabrication.

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What is the actionable outlook for R&D and investment decisions?

Even without a numeric forecast, mometasone furoate presents a predictable decision profile:

For R&D

• Competitive advantage is most likely to come from delivery technology, dosing convenience, and adherence rather than from new mechanism science.
• Development spend should target areas where payer or clinician behavior changes with improved regimen simplicity or reduced dosing frequency.

For investment

• The biggest driver of shareholder outcomes is typically net price and share, not new clinical differentiation.
• Watch for:
  • Generic substitution waves in intranasal and topical segments
  • Formulary changes by major payers
  • Regulatory label tightening or expansion by country

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Key Takeaways

• Mometasone furoate demand is structurally anchored in allergic rhinitis (intranasal) and supported by topical dermatology and smaller ophthalmic/asthma pools.
• Clinical-trial activity for mometasone furoate is generally reformulation, device, bridging, or label-context work, not mechanism-defining innovation.
• A numeric market projection cannot be produced accurately without an auditable baseline (revenue and pricing by form/territory) and a registry-driven trial timeline extract.
• Business outcomes for mometasone furoate are primarily driven by generic pricing erosion and formulary share, with clinical impact relevant mainly where it changes dosing adherence or access.

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FAQs

1. Is mometasone furoate still actively studied in clinical trials?
   Yes, but activity typically centers on comparative, formulation, device, and label-context studies rather than new mechanism breakthroughs. Registry sources include ClinicalTrials.gov and EU registers. [1,2]

2. Which formulation category drives most mometasone furoate revenue?
   Intranasal corticosteroid products for allergic rhinitis are typically the largest category, with topical dermatology a major secondary pool.

3. What creates downside risk for revenue of mometasone furoate?
   Generic substitution, payer formulary pressure, and net price erosion across intranasal and topical products.

4. What creates upside potential?
   A formulation that improves adherence or reduces dosing friction can win formulary favor, and label expansion can unlock incremental use where it is clinically and commercially credible.

5. How should investors model mometasone furoate long term?
   Use a segment-by-form model with unit growth assumptions and explicit net price erosion, and treat clinical trial updates as modifiers only when they change differentiated access or adoption.

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References

[1] U.S. National Library of Medicine. ClinicalTrials.gov. https://clinicaltrials.gov/
[2] European Medicines Agency. EU Clinical Trials Register. https://www.clinicaltrialsregister.eu/
[3] World Health Organization. International Clinical Trials Registry Platform (ICTRP). https://trialsearch.who.int/