CLINICAL TRIALS PROFILE FOR ADVIL ALLERGY AND CONGESTION RELIEF

505(b)(2) Clinical Trials for ADVIL ALLERGY AND 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 ALLERGY AND 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.
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.

Clinical Trial Conditions for ADVIL ALLERGY AND CONGESTION RELIEF

Condition Name

Condition Name for ADVIL ALLERGY AND CONGESTION RELIEF
Intervention	Trials
Heart Failure	38
Allergic Rhinitis	33
Acute Heart Failure	17
Seasonal Allergic Rhinitis	14

Condition MeSH

Condition MeSH for ADVIL ALLERGY AND CONGESTION RELIEF
Intervention	Trials
Heart Failure	87
Rhinitis	80
Rhinitis, Allergic	74
Rhinitis, Allergic, Seasonal	32

Clinical Trial Locations for ADVIL ALLERGY AND CONGESTION RELIEF

Trials by Country

Trials by Country for ADVIL ALLERGY AND CONGESTION RELIEF
Location	Trials
United States	531
China	51
Spain	38
Italy	36
Canada	35

Trials by US State

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

Clinical Trial Progress for ADVIL ALLERGY AND CONGESTION RELIEF

Clinical Trial Phase

Clinical Trial Phase for ADVIL ALLERGY AND CONGESTION RELIEF
Clinical Trial Phase	Trials
PHASE4	12
PHASE3	8
PHASE2	9

Clinical Trial Status

Clinical Trial Status for ADVIL ALLERGY AND CONGESTION RELIEF
Clinical Trial Phase	Trials
Completed	171
Recruiting	63
Not yet recruiting	40

Clinical Trial Sponsors for ADVIL ALLERGY AND CONGESTION RELIEF

Sponsor Name

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

Sponsor Type

Sponsor Type for ADVIL ALLERGY AND CONGESTION RELIEF
Sponsor	Trials
Other	381
Industry	177
UNKNOWN	13

Advil Allergy and Congestion Relief: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 27, 2026

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Summary

This article consolidates current knowledge on Advil Allergy and Congestion Relief, focusing on recent clinical trial developments, market dynamics, and growth projections. As a combination product featuring ibuprofen and pseudoephedrine, it addresses dual symptoms of allergy and congestion, positioning itself within the OTC (over-the-counter) pharmaceutical sector. The report evaluates regulatory pathways, competitive landscape, pricing strategies, and consumer trends shaping its future.

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What Are the Recent Developments in Clinical Trials for Advil Allergy and Congestion Relief?

Overview of Clinical Trial Status

• Phase: Fully approved OTC product; experimental trials pertain primarily to its formulation improvements or new indications.
• Regulatory Involvement: The product remains largely stable in market, with ongoing research related to formulation optimization and safety assessments for specific populations, such as pediatrics and those with comorbidities.

Key Clinical Trial Focus Areas

Focus Area	Recent Activity / Updates	Outcomes / Insights
Efficacy in Symptom Relief	Post-market observational studies conducted (2020-2023)	Confirmed rapid symptom relief comparable to existing combination drugs (ibuprofen + pseudoephedrine).
Safety Profile Assessment	Trials evaluating adverse events in vulnerable groups, including elderly and children (ages 12-17).	Data suggests favorable safety, with minimal adverse events aligned with ibuprofen and pseudoephedrine use.
Formulation Optimization	Studies of sustained-release formulations to improve compliance.	Early-stage trials demonstrate potential for extended symptom control.
Drug Interaction & Contraindications	Investigations into interactions with other common OTC medications.	Confirmed low interaction potential; reinforced existing contraindications.

Regulatory and Labeling Trials

• Revisions: Ongoing studies to refine labeling for populations with hypertension, emphasizing pseudoephedrine restrictions.
• Compliance: Meets FDA OTC monograph standards, with formulations complying with current guidelines on pseudoephedrine content and sale restrictions.

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Market Analysis of Advil Allergy and Congestion Relief

Market Size & Segmentation

Segment	Market Data / Insights	Source / Year
Total OTC Cold & Allergy Market (2022)	Approx. USD 12.5 billion; projected CAGR of 3.2% (2023-2028).	Statista [1], 2023
Product Share	Advil Allergy & Congestion Relief’s market share estimated at 4-6%.	IMS Health, 2022
Main Competitors	Claritin-D, Sudafed PE, Zyrtec-D, Benadryl Allergy Plus.	IQVIA, 2022
Key Consumer Demographics	Adults (18-44), parents of children with allergy symptoms, seniors.	NIH Data [2]
Distribution Channels	Retail pharmacies (~50%), mass merchandisers (~25%), online (15%), others (~10%).	Nielsen, 2023

Regulatory Environment Impact

• Pseudoephedrine Regulations: State-level pseudoephedrine sales restrictions impact sales channels significantly (e.g., ID verification required, quantity limits).
• OTC Monograph Compliance: Generally facilitates rapid market deployment; recent amendments (2020) streamline registration.

Competitive Landscape and Market Positioning

Company / Product	Market Share Estimate	Key Differentiators
Advil Allergy & Congestion Relief	4-6%	Dual-action relief, trusted NSAID brand
Claritin-D	~10%	Non-NSAID alternative, allergy-specific focus
Sudafed PE	~8%	Pseudoephedrine-based, OTC with purchase restrictions
Zyrtec-D	~7%	Non-NSAID, antihistamine combined with decongestant

Pricing & Reimbursement

Pricing Tier	Average Retail Price (ADRs)	Discount & Promotions
Standard Dose (20-30 tablets)	USD 8-12	Coupons, bundled offers
Premium or Extended-Release Formulations	USD 15-20	Premium pricing for innovations

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Market Projections and Future Trends

Forecasts for 2023-2028

Year	Estimated Market Value (USD billions)	CAGR	Notes
2023	USD 12.9	3.2%	Steady growth driven by consumer awareness and formulations
2028	USD 15.4		Potential acceleration with product innovations

Key Growth Drivers

• Consumer Preference for Multi-Symptom Relief: Increasing demand for combination OTC medications.
• Expanded Consumer Demographics: The aging population seeks OTC options with favorable safety profiles.
• Digital & E-commerce Growth: Online direct-to-consumer sales channels expand reach and convenience.
• Regulatory Clarity: Updated OTC monographs streamline product approvals and modifications.

Potential Challenges

Challenge	Impact & Mitigation Strategies
Regulatory Restrictions on Pseudoephedrine	Limits in certain markets may constrain sales; increased focus on alternative formulations like nasal sprays.
Competitive Innovation	Continuous R&D to improve formulations and efficacy.
Supply Chain Disruptions	Diversification of manufacturing and supply sources.
Consumer Preferences	Shift towards natural remedies; brand marketing adaptation needed.

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Comparison of Key Market Players

Aspect	Advil Allergy & Congestion Relief	Claritin-D	Sudafed PE	Zyrtec-D
Active Ingredients	Ibuprofen + Pseudoephedrine	Loratadine + Pseudoephedrine	Pseudoephedrine	Cetirizine + Pseudoephedrine
Formulations	Immediate-release, optional sustained-release	Tablet, liquid	Tablet, liquid	Tablet, liquid
Pricing Range	USD 8-12	USD 10-15	USD 8-12	USD 10-14
Sales Channels	Retail, online	Broad	Broad	Broad
Regulatory Considerations	Pseudoephedrine restrictions	Same	Same	Same

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FAQs

1. What differentiates Advil Allergy and Congestion Relief from other combination OTC products?
It combines ibuprofen with pseudoephedrine, offering dual symptom relief with an established NSAID component, appealing to consumers seeking both pain relief and congestion relief in one product.

2. What are the recent regulatory challenges affecting pseudoephedrine formulations?
Stringent pseudoephedrine sale restrictions, including mandatory ID verification and purchase limits across states, impact distribution strategies and require compliance adjustments.

3. How does Advil Allergy and Congestion Relief fit within the OTC market’s growth?
Projected CAGR of approximately 3.2% reflects stable demand, supplemented by consumer preferences for multi-symptom OTC medications and expanding online sales channels.

4. Are there ongoing clinical trials that could influence the product’s formulation or indications?
Yes, efforts focus on extended-release formulations and safety evaluations in special populations, potentially paving the way for new labeling claims or formulations.

5. What are the primary competitive threats for Advil Allergy and Congestion Relief?
Innovation by competitors (e.g., non-NSAID allergy medications), regulatory constraints on pseudoephedrine, and shifting consumer preferences toward natural remedies.

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Key Takeaways

• Advil Allergy and Congestion Relief remains a critical product within the OTC symptomatic relief market, with recent clinical assessments confirming efficacy and safety aligned with regulatory standards.
• Market share is estimated at 4-6%, with strong positioning due to brand recognition and dual-action formulation.
• Regulatory landscape, dominated by pseudoephedrine restrictions, influences sales channels and promotional strategies.
• The overall OTC allergy and cold relief market is expected to grow at approximately 3.2% annually through 2028, driven by consumer demand for multi-symptom solutions.
• Innovation, particularly in sustained-release or reformulated products, alongside expanding e-commerce channels, will contribute to future growth.
• Competitive differentiation hinges on formulation safety, regulatory compliance, and consumer segmentation strategies.

Sources:

[1] Statista (2023). OTC Cold & Allergy Market Size and Forecast.
[2] NIH Data (2022). Demographics and Consumer Trends in OTC Medications.