CLINICAL TRIALS PROFILE FOR NASONEX

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.

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.

Clinical Trial Conditions for NASONEX

Condition Name

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

Condition MeSH

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

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

Trials by US State

Trials by US State for NASONEX
Location	Trials
Texas	8
Illinois	7
Maryland	5
North Carolina	5
New York	5

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

Clinical Trial Status

Clinical Trial Status for NASONEX
Clinical Trial Phase	Trials
Completed	44
Terminated	6
Withdrawn	4

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

Sponsor Type

Sponsor Type for NASONEX
Sponsor	Trials
Industry	58
Other	20
NIH	2

NASONEX Market Analysis and Financial Projection

Last updated: April 26, 2026

Nasonex (mometasone furoate) Clinical Trials Update, Market Analysis and Projections

What is Nasonex and what is its current commercial posture?

Nasonex is intranasal mometasone furoate (GSK brand). In markets where it is approved, it is used primarily for allergic rhinitis and nasal polyps (depending on jurisdiction and label). The product is mature, off-patent in most regions for its core active ingredient, and competition is driven by:

• Entrenched brand and pharmacy channel share
• Shelf positioning among intranasal corticosteroids (INCS)
• Switching behavior around formulary decisions and generic availability
• Margin pressure from multi-source competition

For business planning, Nasonex should be treated as a base-case “franchise maintenance” asset unless a label expansion or delivery-technology differentiation is pursued.

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Which clinical-trial updates matter for Nasonex now?

No “fresh” pivotal phase-3 readouts change the commercial thesis in the way they would for a new-generation candidate. Current trial activity for Nasonex, where present, is typically in these buckets:

• Pediatric or special-population bridging (dose, safety, growth)
• Comparative effectiveness studies vs other INCS and/or antihistamines
• Formulation and device-change studies (where applicable)
• Real-world evidence studies and post-marketing safety monitoring

From a patent-and-pipeline perspective, Nasonex is not in the same category as reformulations with meaningful IP barriers. Most ongoing studies do not create new exclusivity for the active ingredient and generally do not reset market share trajectories.

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What endpoints define the practical value of intranasal steroid trials for Nasonex?

Across allergic rhinitis and nasal polyps, the clinical endpoints that typically drive label positioning and prescriber confidence are:

Allergic rhinitis

• Change from baseline in Total Nasal Symptom Score (TNSS)
• Individual symptom subscores (congestion, rhinorrhea, sneezing, itching)
• Time to onset (often reported as earlier relief versus comparators)
• Proportion achieving symptom control thresholds

Nasal polyps

• Change in nasal polyp score (endoscopic grade)
• Nasal congestion symptom scores
• Quality-of-life measures tied to nasal symptoms
• Durability across treatment periods

In market terms, these endpoints mostly affect formulary decisions by strengthening “clinical equivalence” against competitors rather than creating new clinical-differentiation tiers.

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How does Nasonex fit versus the competitive INCS landscape?

Nasonex competes in the intranasal corticosteroid class, where positioning is usually anchored by:

• Onset and symptom control consistency
• Device preference (spray delivery, patient adherence)
• Insurance coverage and net price
• Brand familiarity and clinician prescribing habits

The key market dynamic is class substitution. If a payer pushes lower-cost INCS (including generics), Nasonex loses on price unless it maintains a favorable net settlement or has differentiated contracting.

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What is the market structure for intranasal corticosteroids where Nasonex is sold?

The relevant demand pool is the chronic care market for:

• Allergic rhinitis (seasonal and perennial)
• Chronic rhinosinusitis with nasal polyps (CRSwNP), depending on local approvals

Where Nasonex tends to perform best

• High adherence settings where prescribers favor known products
• Formulary tiers that still keep branded options accessible via contracts
• Patient segments with stable prescriber routines

Where Nasonex tends to face share erosion

• Broad generic coverage across the class
• Aggressive pharmacy switching programs
• Payer preference for specific INCS with lower acquisition costs

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How should investors model Nasonex revenue under generic pressure?

A pragmatic revenue model for Nasonex should assume:

• Continued erosion from class generics
• Periodic stabilization from payer contracting and brand loyalty
• Limited upside unless the company executes new label or device-based differentiation

The core variables are:

• Net price (post rebates/discounts)
• Prescription volume (class switching)
• Channel mix (retail vs mail, specialty vs general)
• Region-by-region generic penetration and tender behavior

Because Nasonex is a legacy product, projections are most sensitive to net price and formulary status.

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What are the projection ranges for Nasonex-style INCS franchises (base-case, downside, upside)?

Given the absence of a proprietary late-stage catalyst and the mature nature of the active ingredient market, projections should be modeled on a “decline with stabilization” pattern rather than growth. Below are scenario templates that reflect typical behavior for legacy branded INCS under ongoing generic substitution:

Scenario	Net price trend	Prescription volume trend	Revenue trend (directional)	Business interpretation
Base-case	Low single-digit annual declines	Flat to low single-digit declines	Flat to modest decline	Maintains formulary presence through contracting
Downside	Mid single-digit annual declines	Low to mid single-digit declines	Moderate decline	Loses payer share to generics or competitor INCS
Upside	Small net-price erosion or partial reimbursement gains	Low single-digit growth	Low growth or stabilization	Better than expected formulary retention and adherence

For high-stakes forecasting, the operational target is to keep “net price minus rebates” from falling faster than volume can offset.

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What commercialization levers still move Nasonex performance?

1. Contracting strategy: defend access on payer formularies and pharmacy benefit manager (PBM) tiers.
2. Patient adherence programs: refill persistence and device usability support.
3. Lifecycle management: ensure label-appropriate switching controls for each indication.
4. Competitive negotiation: manage net price pressure against the specific lowest-cost INCS in each region.

These levers influence volume and net price more than new clinical evidence does in a mature INCS franchise.

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Key Takeaways

• Nasonex is a mature intranasal corticosteroid franchise with competitive pressure dominated by class substitution and net price erosion from generics.
• Clinical trial activity, where ongoing, typically supports bridging, comparative reassurance, or post-marketing surveillance rather than creating new exclusivity or major market-shifting efficacy differentiation.
• Market projections should be modeled as “decline with stabilization,” with sensitivity concentrated in net price (post rebates) and formulary retention.
• The highest ROI actions for stakeholders are contracting and adherence execution, because they counteract generic-driven switching more effectively than incremental evidence.

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FAQs

1) Is Nasonex expected to deliver major growth from late-stage clinical results?
No. The commercial engine is mature; typical trial activity does not reset IP-driven exclusivity or re-anchor the market on a new standard-of-care.

2) What is the biggest driver of Nasonex revenue change?
Net price after rebates and formulary access, followed by prescription volume lost to class substitution.

3) How do intranasal steroid trials influence payer decisions?
They mainly support comparative equivalence and symptom-control consistency used in formulary placement and switching protocols.

4) Which indication carries the most long-term commercial relevance?
Allergic rhinitis in broad primary-care use is usually the largest routine demand pool; nasal polyps is important where label coverage and access persist.

5) What is the correct market framing for investors?
A legacy franchise model: declining branded share under generic penetration with stabilization potential via contracting and adherence.

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References

[1] U.S. Food and Drug Administration (FDA). Nasonex (mometasone furoate) prescribing information and label information. FDA Labeling. https://www.accessdata.fda.gov/
[2] European Medicines Agency (EMA). Nasonex EPAR and product information (mometasone furoate). https://www.ema.europa.eu/
[3] ClinicalTrials.gov. Search results for “mometasone furoate” and “Nasonex” (study listings, statuses, and results). https://clinicaltrials.gov/