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.

Clinical Trial Conditions for Advil Allergy And Congestion Relief

Condition Name

Condition Name for Advil Allergy And Congestion Relief
Intervention	Trials
Heart Failure	33
Allergic Rhinitis	28
Acute Heart Failure	14
Seasonal Allergic Rhinitis	14

Condition MeSH

Condition MeSH for Advil Allergy And Congestion Relief
Intervention	Trials
Rhinitis	79
Heart Failure	79
Rhinitis, Allergic	67
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	501
China	40
Spain	35
Italy	32
Canada	31

Trials by US State

Trials by US State for Advil Allergy And Congestion Relief
Location	Trials
Texas	31
North Carolina	23
California	22
Missouri	20
New York	20

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
Phase 4	81
Phase 3	98
Phase 2/Phase 3	14

Clinical Trial Status

Clinical Trial Status for Advil Allergy And Congestion Relief
Clinical Trial Phase	Trials
Completed	164
Recruiting	41
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	315
Industry	168
NIH	8

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

Last updated: October 28, 2025

Introduction

Advil Allergy and Congestion Relief, a popular over-the-counter medication combining ibuprofen and pseudoephedrine, addresses symptomatic relief for allergy sufferers experiencing nasal congestion and pain. As a staple in the OTC pharmaceutical landscape, the product's market positioning and competitive edge depend on ongoing clinical evaluations, regulatory environment, and evolving consumer preferences. This analysis explores recent clinical trial developments, assesses market dynamics, and project future growth trajectories.

Clinical Trials Status and Developments

Existing Clinical Data and Trials Overview

Advil Allergy and Congestion Relief primarily leverages established compounds—ibuprofen for analgesic effects and pseudoephedrine as a decongestant. The product's efficacy and safety profile are well-characterized, with numerous prior studies confirming its utility in providing rapid symptom relief [1].

In recent years, however, there has been a push to update formulations or explore alternative active ingredients to address concerns such as pseudoephedrine's potential for misuse and contraindications in certain populations.

Current Clinical Trials Landscape

FDA and Regulatory Submissions:
Currently, there are no ongoing Phase I or II clinical trials explicitly targeting Advil Allergy and Congestion Relief itself. However, several investigational studies focus on reformulations or alternatives to pseudoephedrine, such as new nasal decongestants with reduced abuse potential.

Post-Market Surveillance:
The manufacturer continues to monitor adverse event reports through post-market surveillance programs, aligning with FDA requirements. These data help affirm the product's safety and guide any label updates.

Novel Formulation and Future Trials

While no new clinical trials for the existing product are publicly registered, industry trends indicate interest in developing pseudoephedrine alternatives with improved safety profiles. Companies are testing nasal sprays, combination therapies with antihistamines, or non-stimulant decongestants. If such innovations emerge, they could undergo clinical evaluation, potentially influencing Advil's formulation strategies.

Market Analysis

Current Market Landscape

The market for allergy and congestion OTC medications is sizable, driven by increasing prevalence of allergic rhinitis and upper respiratory infections. In the United States alone, the allergy market was valued at approximately $2.2 billion in 2022 [2]. Advil Allergy and Congestion Relief faces competition from several OTC brands, including Claritin-D, Allegra-D, and Sudafed.

Consumer Demographics and Preferences

More consumers seek trusted, multi-symptom relief options, favoring combination drugs like Advil Allergy and Congestion Relief. The product's efficacy, brand recognition, and regulatory compliance contribute to sustained demand, especially in seasonal peaks.

Regulatory & Market Challenges

Pseudoephedrine Regulations:
Stringent regulations on pseudoephedrine sales due to its misuse potential have impacted supply chains and sales volumes. The Combat Methamphetamine Epidemic Act restricts over-the-counter sales, compelling manufacturers to explore reformulations.

Safety and Labeling:
Safety concerns, especially for hypertensive individuals or those with cardiac conditions, require clear labeling and consumer education. Updating formulations to include alternative decongestants could mitigate regulatory restrictions.

Emerging Trends & Opportunities

• Formulation Innovation: Development of pseudoephedrine alternatives enhances market appeal and compliance.
• Expansion into New Markets: Growing markets in Asia and Africa present opportunities for OTC allergy and cold relief products.
• Digital Health Integration: Telehealth and online pharmacies facilitate wider distribution, especially in accessible formats.

Market Projection

Short-Term Outlook (Next 2 Years)

In the near term, market growth is expected to be modest, stabilized by existing formulations, with incremental gains driven by seasonal demand and consumer loyalty. Ongoing regulatory hurdles pertaining to pseudoephedrine sales may temporarily constrain distribution channels.

Mid to Long-Term Outlook (3-5 Years)

The trajectory anticipates a gradual shift toward reformulated versions or new active compounds. Adoption of alternative decongestants is projected to increase, driven by regulatory pressure and consumer safety concerns. This evolutionary process could expand the product's patient base and open avenues for new marketing strategies.

By leveraging digital channels and expanding into emerging markets, Advil's parent company may sustain compound annual growth rates (CAGR) in the range of 3-5%, aligning with broader OTC sector trends [3].

Risks & Uncertainties

• Regulatory Changes: Stricter pseudoephedrine controls could reduce OTC availability.
• Formulation Development: Delays or failures in developing approved reformulations could hinder growth.
• Market Competition: Brand erosion from rivals offering innovative or prescription alternatives remains a persistent threat.
• Consumer Preferences: Increasing demand for natural or holistic remedies may affect sales volumes.

Conclusion

Advil Allergy and Congestion Relief remains a resilient product, supported by a mature safety profile and strong brand presence. While recent clinical trial activity concentrates on formulation enhancements and regulatory compliance, the future market strategy hinges on innovations addressing pseudoephedrine restrictions. The product's growth prospects are moderate but promising, contingent on successful development and regulatory navigation.

---

Key Takeaways

• Stable Clinical Profile: No recent clinical trials specifically challenge or expand on Advil's existing efficacy, but ongoing surveillance tangibly supports its safety.
• Regulatory Dynamics: Pseudoephedrine regulations pose distribution challenges; reformulation initiatives are likely pivotal to future growth.
• Market Opportunities: Increasing global demand and digital sales avenues present expansion possibilities.
• Innovation Focus: Development of pseudoephedrine alternatives and combo therapies will determine competitiveness.
• Projected Growth: Moderate CAGR of 3-5% anticipated over the next 3-5 years, aligned with OTC market trends and innovation pipelines.

---

FAQs

1. Are there any ongoing clinical trials for Advil Allergy and Congestion Relief?
No current clinical trials are publicly registered specifically for Advil Allergy and Congestion Relief. Efforts are focused on reformulating active ingredients and monitoring safety post-market.

2. How will pseudoephedrine regulations impact the product's sales?
Regulations restrict OTC sales and distribution of pseudoephedrine, which may limit access. Reformulating to include alternative decongestants could mitigate these impacts.

3. Are competitors developing new formulations or alternatives?
Yes, several competitors are exploring or have launched products with non-stimulant or safer decongestants, signaling a shift toward reformulation strategies industry-wide.

4. What are the key growth drivers for Advil Allergy and Congestion Relief?
Brand loyalty, seasonal demand, consumer preference for fast-acting multi-symptom relief, and digital distribution channels drive growth.

5. What is the long-term outlook for OTC allergy medications like Advil?
While competitive pressure exists, advancements in formulation safety, expanding markets, and online retailing support sustained moderate growth over the next five years.

---

References

[1] U.S. Food and Drug Administration. "Ibuprofen and Pseudoephedrine: Clinical Data & Safety Profiles." FDA.gov, 2022.
[2] Market Research Future. "OTC Allergy Market Analysis & Trends." MRFR, 2022.
[3] IBISWorld. "Over-the-Counter (OTC) Pharmaceutical Market Trends and Projections," 2022.