CLINICAL TRIALS PROFILE FOR ADVIL CONGESTION RELIEF

505(b)(2) Clinical Trials for ADVIL CONGESTION RELIEF

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
OTC	NCT00487032 ↗	Differential Adrenoreceptor Mediated Tachyphylaxis and Upregulation	Completed	Brian J Lipworth	Phase 4	2008-05-01	The investigators wish to evaluate the onset of tolerance to nasal decongestants like oxymetazoline (available over the counter) and the mechanism of tolerance particularly with differential effects on alpha 1 and alpha 2 adrenoreceptors on the nose. The investigators will 'tease' out by using an alpha 1 blocker called Prazosin. The investigators hypothesize that alpha 1 receptors mediate arterial constriction and this will be captured by measuring nasal blood flow. The investigators also hypothesize that alpha 2 receptors mediate venous sinusoid constriction and this the investigators will capture by airflow parameters like Peak Nasal Inspiratory Flow, Rhinomanometry, Oscillometric indices etc.
OTC	NCT01448057 ↗	Evaluation of Efficacy and Safety of Tablets of Paracetamol, Dimethindene Maleate and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu	Completed	Novartis	Phase 3	2013-07-01	The study is a clinical evaluation of an over the counter (OTC) combination product containing paracetamol (500 mg), dimethindene maleate (1 mg), phenylephrine hydrochloride (10 mg) compared to paracetamol (500 mg) alone in the treatment of nasal congestion, rhinorrhea, sneezing and other symptoms due to upper respiratory tract infection (URTI).
New Formulation	NCT03339726 ↗	Randomized, Double-blind, Placebo-Controlled, Efficacy Study of a New Formulation of Phenylephrine HCL in the Common Cold	Terminated	Johnson & Johnson Consumer Inc. (J&JCI)	Phase 2	2017-11-30	This will be a randomized, double-blind, placebo controlled, parallel-group Phase 2 study to evaluate the efficacy of a new formulation of phenylephrine HCl and a currently marketed phenylephrine HCl for relief of nasal congestion in subjects with naturally occurring cold symptoms.

All Clinical Trials for ADVIL CONGESTION RELIEF

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00115622 ↗	Study In Adults And Adolescents With Seasonal Allergic Rhinitis	Completed	GlaxoSmithKline	Phase 3	2004-12-01	The purpose of the study is to compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray in the treatment of seasonal allergic rhinitis. Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly referred to as "hay fever", it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.
NCT00118729 ↗	Study In Adolescent And Adult Subjects 12 Years Of Age And Older With Seasonal Allergic Rhinitis To Assess Onset of Action	Completed	GlaxoSmithKline	Phase 3	2005-04-01	Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly referred to as "hay fever", it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes. The purpose of this study is to evaluate the onset of action of an investigational nasal spray, GW685698X aqueous nasal spray, versus vehicle placebo nasal spray in the treatment of seasonal allergic rhinitis caused by ragweed following a single dose of treatment in controlled pollen concentrations in an allergen challenge chamber.
NCT00124137 ↗	Ultrafiltration Versus Intravenous (IV) Diuretics for Patients Hospitalized for Acute Decompensated Heart Failure: (UNLOAD)	Completed	CHF Solutions	N/A	2004-04-01	The purpose of this study is to compare patients who are suffering from heart failure and who are fluid overloaded to determine if ultrafiltration (UF) can remove more of the extra fluid as measured by weight loss while in the hospital and improve the patient's breathing.
NCT00124137 ↗	Ultrafiltration Versus Intravenous (IV) Diuretics for Patients Hospitalized for Acute Decompensated Heart Failure: (UNLOAD)	Completed	Nuwellis, Inc.	N/A	2004-04-01	The purpose of this study is to compare patients who are suffering from heart failure and who are fluid overloaded to determine if ultrafiltration (UF) can remove more of the extra fluid as measured by weight loss while in the hospital and improve the patient's breathing.
NCT00197262 ↗	Once-Daily Investigational Nasal Spray In Adults And Adolescents With Seasonal Allergic Rhinitis (SAR)	Completed	GlaxoSmithKline	Phase 3	2005-08-01	Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly referred to as (hay fever), it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes. The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with seasonal allergic rhinitis (SAR) caused by ragweed pollen.

Clinical Trial Conditions for ADVIL CONGESTION RELIEF

Condition Name

Condition Name for ADVIL CONGESTION RELIEF
Intervention	Trials
Heart Failure	37
Allergic Rhinitis	33
Acute Heart Failure	16
Seasonal Allergic Rhinitis	14

Condition MeSH

Condition MeSH for ADVIL CONGESTION RELIEF
Intervention	Trials
Heart Failure	86
Rhinitis	80
Rhinitis, Allergic	74
Rhinitis, Allergic, Seasonal	32

Clinical Trial Locations for ADVIL CONGESTION RELIEF

Trials by Country

Trials by Country for ADVIL CONGESTION RELIEF
Location	Trials
United States	531
China	50
Spain	38
Canada	35
Italy	34

Trials by US State

Trials by US State for ADVIL CONGESTION RELIEF
Location	Trials
Texas	33
California	24
North Carolina	23
Missouri	22
New York	21

Clinical Trial Progress for ADVIL CONGESTION RELIEF

Clinical Trial Phase

Clinical Trial Phase for ADVIL CONGESTION RELIEF
Clinical Trial Phase	Trials
PHASE4	9
PHASE3	7
PHASE2	9

Clinical Trial Status

Clinical Trial Status for ADVIL CONGESTION RELIEF
Clinical Trial Phase	Trials
Completed	171
Recruiting	60
Not yet recruiting	40

Clinical Trial Sponsors for ADVIL CONGESTION RELIEF

Sponsor Name

Sponsor Name for ADVIL CONGESTION RELIEF
Sponsor	Trials
GlaxoSmithKline	17
Merck Sharp & Dohme Corp.	15
Bayer	9

Sponsor Type

Sponsor Type for ADVIL CONGESTION RELIEF
Sponsor	Trials
Other	375
Industry	177
UNKNOWN	13

Clinical Trials Update, Market Analysis, and Projection for Advil Congestion Relief

Last updated: October 28, 2025

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Introduction

Advil Congestion Relief, an over-the-counter (OTC) medication developed by Pfizer Inc., combines ibuprofen with a nasal decongestant to provide comprehensive relief for cold and flu symptoms. As the landscape of OTC therapeutics evolves, understanding its clinical trial progress, market dynamics, and future outlook becomes critical for stakeholders. This report synthesizes recent developments, analyzes market positioning, and offers projections to inform strategic decisions.

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Clinical Trial Update

Recent Developments in Clinical Research

Although Advil Congestion Relief primarily targets adult consumers seeking symptomatic relief for cold and flu, its clinical development phase has largely focused on confirming its efficacy, safety, and tolerability. The product has historically relied on existing evidence supporting the individual components:

• Ibuprofen: Well-established analgesic and anti-inflammatory agent with extensive clinical data supporting its safety profile at OTC doses [1].

• Nasal Decongestants: Sympathomimetic agents like pseudoephedrine, with a long history of efficacy but associated with cardiovascular considerations [2].

In recent years, Pfizer has focused on formulation optimization and packaging innovation to enhance user experience and compliance. However, there have been no recent public disclosures of dedicated new-phase clinical trials specific to Advil Congestion Relief, suggesting that the product’s clinical development phase is primarily concluded, and the current efforts are related to post-market surveillance and real-world effectiveness studies.

Regulatory Status

FDA approvals of combination OTC products like Advil Congestion Relief are generally based on established safety and efficacy profiles of their components, with the submission focusing on formulation stability, manufacturing consistency, and labeling. The product was approved as part of Pfizer’s OTC portfolio, with no recent indications of regulatory hurdles or clinical setbacks.

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Market Analysis

Market Size and Segmentation

The OTC cold and flu medication market, estimated at approximately USD 9 billion globally in 2022, is segmented into various product classes including analgesics, decongestants, antitussives, and combination therapies [3]. Advil Congestion Relief targets a specific niche within the adult OTC cold remedy market, competing primarily with brands like Sudafed PE Congestion, Tylenol Cold + Congestion, and Mucinex Sinus-Max.

Key segments include:

• Adult consumers (18+): Predominant demographic, seeking rapid relief.
• Analgesic and decongestant combination users: Consumers preferring single-dose solutions for multiple symptoms.

Competitive Landscape

Market leaders leverage brand recognition, effective formulations, and wide distribution channels. Pfizer’s longstanding brand equity with Advil enhances consumer trust, providing a competitive edge. Nevertheless, the segment faces challenges from:

• Generic proliferation: Multiple formulations offering similar active ingredients at lower prices.
• Natural/alternative remedies: Rising consumer interest in herbal and natural approaches to cold relief.
• Regulatory scrutiny: Increasing emphasis on cardiovascular risks associated with decongestants.

Distribution and Market Penetration

Advil Congestion Relief is widely distributed through:

• Retail chains (Walgreens, CVS, Walmart)
• Online marketplaces (Amazon, Pfizer’s e-commerce platforms)
• Pharmacy chains and mass merchandisers

The product’s marketing strategy emphasizes trust and efficacy, leveraging Pfizer’s global distribution infrastructure and brand loyalty to capture market share.

Consumer Trends and Behavior

Current consumer tendencies favor multi-symptom relief products, especially among adults managing busy lifestyles. Additionally, increased health awareness post-pandemic has heightened demand for effective OTC cold remedies. The trend toward personalized medicine and self-medication supports sustained demand for OTC combination products like Advil Congestion Relief.

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Market Projection and Future Outlook

Growth Drivers

• Rising prevalence of cold and flu: Seasonal and annual health data indicate consistent demand, especially during winter.
• Product innovation: Enhanced formulations and delivery options (e.g., liquid gels, dissolvables) could stimulate market growth.
• Expanding global markets: Emerging markets with rising disposable incomes and healthcare infrastructure investments present new opportunities.

Challenges and Risks

• Regulatory pressures: Stringent regulations on decongestants concerning cardiovascular safety may limit formulations or usage.
• Competition: The increased availability of natural remedies and private-label brands could erode market share.
• Public health campaigns: Increased emphasis on limiting OTC drug misuse and dependence might impact sales.

Forecast

Based on current trends, the OTC cold and flu segment, including Advil Congestion Relief, is projected to grow at a compound annual growth rate (CAGR) of approximately 3-4% over the next five years. Pfizer is expected to maintain market leadership through extensive marketing, product innovation, and expanding distribution networks.

Potential growth avenues include:

• Geographical expansion into developing markets such as China and India.
• Product line extensions, incorporating multi-action formulations (e.g., analgesic + antihistamine + decongestant).
• Digital marketing initiatives to target younger demographics increasingly seeking OTC solutions online.

Projections Summary:

Year	Market Size (USD billions)	CAGR	Notes
2023	USD 9.5	-	Current market snapshot
2024	USD 9.8	~3.2%	Slight growth driven by seasonal demand
2028	USD 11.5	~3.5%	Product innovation and expansion efforts

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Key Takeaways

• Clinical landscape and regulatory pathways suggest Advil Congestion Relief’s core formulation remains well-supported, with marketing and distribution as primary growth levers.
• The market is mature but expanding, with moderate CAGR driven by seasonal cold prevalence, consumer preferences, and geographic outreach.
• Competition from generics and natural remedies underpins price sensitivity, emphasizing the importance of Pfizer’s brand strength and innovation.
• Regulatory scrutiny on decongestants’ cardiovascular risks could influence future formulations or claims, requiring strategic vigilance.
• Digital transformation and market globalization present significant opportunities to seize new consumer bases and enhance market penetration.

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FAQs

1. What is the primary active ingredient in Advil Congestion Relief?
It combines ibuprofen with a nasal decongestant—typically pseudoephedrine or phenylephrine—to address pain and congestion symptoms [1].

2. Are there any recent clinical trials specific to Advil Congestion Relief?
There are no publicly disclosed recent clinical trials specifically for the product; existing efficacy data support its safety, based on individual component studies. Pfizer’s focus has shifted toward formulation optimization and post-market surveillance [2].

3. How does Advil Congestion Relief compare with competitors?
It benefits from Pfizer’s established brand reputation for Advil, combined with proven formulations. Competition varies on price, formulation options, and consumer preferences, with generic and natural remedies posing ongoing challenges.

4. What regulatory considerations could impact the future of Advil Congestion Relief?
Regulatory agencies scrutinize decongestants for cardiovascular safety, potentially leading to formulation adjustments or usage restrictions. Continuous monitoring and compliance are vital.

5. What growth strategies should Pfizer pursue for Advil Congestion Relief?
Expansion into emerging markets, product line extensions, and digital marketing are key avenues. Emphasizing innovative delivery formats and leveraging brand loyalty can sustain growth.

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References

[1] U.S. Food and Drug Administration (FDA). Ibuprofen Overview. 2021.
[2] FDA. Pseudoephedrine Drug Safety Alert. 2020.
[3] Market Research Future. Over-the-counter (OTC) Cold and Flu Remedies Market Report. 2022.