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Last Updated: December 12, 2025

CLINICAL TRIALS PROFILE FOR ADVIL MIGRAINE LIQUI-GELS


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505(b)(2) Clinical Trials for ADVIL MIGRAINE LIQUI-GELS

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 NCT01687101 ↗ STOPAIN in the Treatment of a Single Migraine Attack Completed Thomas Jefferson University N/A 2012-05-01 This is an open label pilot study of 25 subjects with a diagnosis of episodic migraine with or without aura. STOPAIN is an over-the-counter product that is used for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains. We plan to have subjects apply the product during a single migraine attack to see if it will alleviate the headache pain and associated symptoms.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for ADVIL MIGRAINE LIQUI-GELS

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00004654 ↗ Phase III Randomized, Placebo-Controlled, Crossover Study of Soy Protein Isolate for Hereditary Hemorrhagic Telangiectasia Completed Yale University Phase 3 1996-01-01 OBJECTIVES: I. Evaluate migraine prophylaxis with soy protein isolate in patients with hereditary hemorrhagic telangiectasia. II. Assess whether soy protein isolate reduces the frequency and severity of epistaxis and gastrointestinal bleeding in these patients.
NCT00004654 ↗ Phase III Randomized, Placebo-Controlled, Crossover Study of Soy Protein Isolate for Hereditary Hemorrhagic Telangiectasia Completed National Center for Research Resources (NCRR) Phase 3 1996-01-01 OBJECTIVES: I. Evaluate migraine prophylaxis with soy protein isolate in patients with hereditary hemorrhagic telangiectasia. II. Assess whether soy protein isolate reduces the frequency and severity of epistaxis and gastrointestinal bleeding in these patients.
NCT00055484 ↗ A Study to Measure the Safety and Effectiveness of Zonisamide in Subjects With Migraine Headache Completed Elan Pharmaceuticals Phase 2 2002-03-01 The purpose of this study is to determine if zonisamide is effective as a preventative medication for individuals with migraine headache.
NCT00069355 ↗ Propranolol for the Treatment of Acute Stress Disorder Completed National Institute of Mental Health (NIMH) Phase 2 2003-09-01 This 10-week study will examine whether propranolol, a medication that blocks the activity of the stress hormones adrenaline and noradrenaline, can relieve acute stress disorder (ASD) and symptoms from persisting long-term. ASD is a condition that some people develop soon after exposure to trauma. They may be anxious, depressed, have trouble sleeping, startle easily, have difficulties concentrating, and feel as though the event is happening again. Propranolol has been used for many years to treat high blood pressure and heart disease, and has been found useful in treating anxiety states such as social phobia and migraine. Men and women between 18 and 65 years of age who were recently exposed to trauma (between 1 and 3 weeks of evaluation in this study) may be eligible for this study. Candidates must be diagnosed with ASD and must have been mentally healthy before the traumatic event. They will be screened for the study with a medical and psychiatric interview, physical examination, electrocardiogram (EKG), and blood and urine tests. Participants will be evaluated with the following procedures: - Neuropsychological tests using pen-and-paper and computer tests to evaluate cognitive function, particularly memory, learning, attention and concentration, and vocabulary and naming. - Emotion-related performance tasks to determine if the study medication can weaken emotionally arousing information by blocking the activity of adrenaline and noradrenaline. Subjects perform emotion-related and neutral tasks, such as looking at pictures with neutral, pleasant, or unpleasant content, both before and after treatment with the study medication (see below). - Traumatic script exposure: Subjects recount the traumatic event that caused them to develop ASD. The description is summarized, recorded, and played back to the subject. During the playback, physiological responses, such as heart rate and skin conductance (sweating), are recorded using electrodes taped to the hand and chest. - Fear conditioning to evaluate the response to an unpleasant stimulus: Several mild electrical shocks are delivered to the wrists while the subject looks at colored squares. Heart rate and skin conductance are measured. - Magnetic resonance imaging (MRI) to examine brain structure. The subject lies on a table that is moved into the MRI scanner (a narrow cylinder containing a strong magnetic field) and must remain still during the actual scanning. Earplugs are worn to muffle loud noises caused by electrical switching of radio frequency circuits used in the scanning process. After the evaluation, participants are randomly assigned to receive either propranolol or placebo (a look-alike pill with no active ingredient) for 8 weeks During this time they are seen by a doctor once a week for 4 weeks and then once every other week for the rest of the study. At the end of the 8-week treatment period, participants undergo the same evaluation they had before beginning treatment (see above). The decision to continue treatment will then be decided based on the individual's clinical condition and whether he or she received propranolol or placebo.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ADVIL MIGRAINE LIQUI-GELS

Condition Name

Condition Name for ADVIL MIGRAINE LIQUI-GELS
Intervention Trials
Migraine 353
Migraine Disorders 89
Chronic Migraine 47
Migraine Headache 47
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Condition MeSH

Condition MeSH for ADVIL MIGRAINE LIQUI-GELS
Intervention Trials
Migraine Disorders 688
Headache 237
Migraine without Aura 56
Migraine with Aura 55
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Clinical Trial Locations for ADVIL MIGRAINE LIQUI-GELS

Trials by Country

Trials by Country for ADVIL MIGRAINE LIQUI-GELS
Location Trials
Italy 87
France 64
India 52
Belgium 52
Czechia 52
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Trials by US State

Trials by US State for ADVIL MIGRAINE LIQUI-GELS
Location Trials
California 186
New York 181
Florida 170
Missouri 157
Texas 152
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Clinical Trial Progress for ADVIL MIGRAINE LIQUI-GELS

Clinical Trial Phase

Clinical Trial Phase for ADVIL MIGRAINE LIQUI-GELS
Clinical Trial Phase Trials
PHASE4 15
PHASE3 21
PHASE2 16
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Clinical Trial Status

Clinical Trial Status for ADVIL MIGRAINE LIQUI-GELS
Clinical Trial Phase Trials
Completed 478
Recruiting 171
Not yet recruiting 82
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Clinical Trial Sponsors for ADVIL MIGRAINE LIQUI-GELS

Sponsor Name

Sponsor Name for ADVIL MIGRAINE LIQUI-GELS
Sponsor Trials
Danish Headache Center 56
GlaxoSmithKline 39
Eli Lilly and Company 37
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Sponsor Type

Sponsor Type for ADVIL MIGRAINE LIQUI-GELS
Sponsor Trials
Other 699
Industry 554
U.S. Fed 24
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Clinical Trials Update, Market Analysis, and Projection for Advil Migraine Liqui-Gels

Last updated: October 28, 2025

Introduction

Advil Migraine Liqui-Gels, a leading over-the-counter (OTC) medication formulated with ibuprofen, addresses acute migraine pain relief. As a prominent product under the Johnson & Johnson portfolio, it combines fast-acting liquid gel technology with proven analgesic efficacy. This comprehensive analysis explores recent clinical trials, assesses current market dynamics, and projects future growth prospects for Advil Migraine Liqui-Gels.


Clinical Trials Update

Recent and Ongoing Clinical Evidence

Advil Migraine Liqui-Gels’ formulation leverages the well-established safety and efficacy profile of ibuprofen, supplemented by advances in drug delivery technology. Historically, ibuprofen’s efficacy in migraine relief has been validated through multiple clinical studies conducted by various organizations, affirming its status as a first-line OTC option.

Recently, there have been minimal dedicated clinical trials specific to the Liqui-Gels formulation. However, ongoing research emphasizes the advantages of liquid gel delivery over traditional tablets, particularly in rapid absorption and onset of action, crucial in migraine management.

Key Findings from Related Pharmacokinetic Studies

Pharmacokinetic studies demonstrate that Liqui-Gel formats facilitate quicker gastric absorption, leading to faster onset of analgesia. A published study illustrates that Liqui-Gels achieve peak plasma concentrations approximately 30 minutes post-administration, compared to 45-60 minutes for tablets [1]. This translates into quicker pain relief, aligning with patient expectations for OTC migraine medications.

Regulatory and Safety Considerations

Johnson & Johnson maintains the safety profile of Advil Migraine Liqui-Gels, supported by post-marketing surveillance and adverse event reporting. The product complies with FDA regulations, with no significant recent updates or clinical trial relaxations. Notably, the safety profile remains consistent with that of standard ibuprofen formulations, with gastrointestinal, cardiovascular, and renal effects closely monitored.


Market Analysis of Advil Migraine Liqui-Gels

Market Landscape and Competitive Position

The OTC migraine market has experienced sustained growth driven by increasing migraine prevalence—estimated at approximately 15% worldwide, predominantly affecting women aged 20-50 years [2]. Advil Migraine Liqui-Gels occupies a premium segment, characterized by fast-acting relief and convenience, distinctly positioning itself from competitors like Excedrin Migraine, Tylenol Migraine, and generics.

The global OTC analgesics market was valued at approximately USD 23 billion in 2022 and is projected to grow at a CAGR of 4.2% through 2030 [3]. Within this, migraine-specific segments have seen increased innovation, emphasizing rapid onset and targeted relief. Advil’s brand recognition, backed by Johnson & Johnson’s marketing prowess, sustains its dominant position.

Consumer Preferences and Behavioral Trends

Modern consumers favor fast-acting, portable, and non-prescription options, especially amid a rising awareness of migraine triggers and prevalence. The advent of Liqui-Gel technology aligns with these preferences, offering quicker relief, ease of swallowing, and suitability for on-the-go use.

Additionally, an increasing focus on safety and minimal side effects influences consumer choices, favoring products with well-documented safety profiles like ibuprofen-based Advil.

Distribution Channels and Market Penetration

Advil Migraine Liqui-Gels predominantly reach consumers through retail pharmacies, grocery stores, and online platforms. E-commerce channels have gained traction, especially post-pandemic, accounting for roughly 30% of OTC analgesic sales [4].

In particular, online direct-to-consumer (DTC) platforms, including Amazon and Johnson & Johnson’s own e-commerce, position the product for targeted marketing and rapid distribution, supporting higher sales volumes.

Regulatory and Competitive Dynamics

Regulatory agencies remain cautious regarding OTC analgesics, emphasizing safety and appropriate labeling. Recent updates have emphasized age restrictions and dosing guidelines but have not significantly altered the OTC landscape for ibuprofen-based formulations.

Competition is intensifying, with formulations like Fast-Acting Excedrin and new OTC combinations entering the market. Yet, Advil’s longstanding reputation and proven efficacy serve as barriers to market erosion.


Market Projection and Growth Potential

Forecast Overview

Based on current market trends, Advil Migraine Liqui-Gels is positioned for continued growth. The compound annual growth rate (CAGR) for OTC migraine products is estimated at 5-6% through 2030, driven by rising migraine diagnoses and consumer preference for rapid relief solutions.

Driving Factors

  • Increasing Prevalence of Migraines: Global survey data estimates that 1 billion people experience migraines worldwide, with rising awareness fostering higher OTC adoption [2].

  • Advances in Delivery Technology: The Liqui-Gel format's superior absorption profile will sustain demand, especially among consumers seeking immediate relief.

  • Consumer Shift Toward Self-Medication: The COVID-19 pandemic accelerated self-care practices, favoring OTC options like Advil Liqui-Gels.

  • Expanding Distribution and Digital Outreach: Strategic online marketing increases product penetration, especially among younger demographics.

Risks and Challenges

  • Regulatory Changes: Stricter regulations on NSAID products could impact sales volume or labeling requirements.

  • Competitive Innovations: Emergence of novel formulations, including prescription-like targeted therapies, might challenge OTC dominance.

  • Safety Concerns: Increased awareness of NSAID-related adverse effects, such as gastrointestinal issues, could influence consumer confidence.

Revenue Projections

Assuming steady market penetration and brand loyalty, Johnson & Johnson’s Advil Migraine Liqui-Gels could see a compound revenue growth of approximately 7% annually over the next five years. Market expansion into emerging economies, increased online sales, and product line extensions could further augment revenues.


Conclusion

Advil Migraine Liqui-Gels stand at the nexus of proven pharmacology and innovative delivery technology, offering rapid migraine relief that aligns with evolving consumer preferences. While clinical trial data specific to Liqui-Gels are minimal, existing pharmacokinetic evidence supports its efficacy advantage over traditional tablets. Market prospects remain robust amid growing migraine prevalence, consumer demand for fast-acting OTC options, and strategic marketing.

To capitalize on these opportunities, Johnson & Johnson should continue monitoring regulatory developments, innovate through product line extensions, and harness digital channels for marketing and distribution.


Key Takeaways

  • Clinical efficacy of Advil Migraine Liqui-Gels is supported by pharmacokinetic studies indicating faster absorption and onset of action compared to traditional tablets.

  • Market growth is driven by rising migraine prevalence, consumer demand for convenience, and technological advantages of Liqui-Gel formulations.

  • Competitive landscape favors brands emphasizing rapid relief, with Advil maintaining a strong market share through brand visibility and efficacy.

  • Future projections anticipate a CAGR of 5-6% for OTC migraine segment growth, with Advil Liqui-Gels positioned to capture an increasing share.

  • Strategic focus on online distribution, product innovation, and consumer education will be critical for sustaining growth amid evolving industry dynamics.


FAQs

Q1: Are there any recent clinical trials specifically evaluating the efficacy of Advil Migraine Liqui-Gels?
A1: No recent dedicated clinical trials for Liqui-Gels have been published. However, pharmacokinetic studies demonstrate faster absorption rates, supporting its rapid relief capabilities.

Q2: How does Advil Migraine Liqui-Gels compare to other OTC migraine medications in terms of onset of relief?
A2: Liqui-Gels typically achieve peak plasma concentrations around 30 minutes, offering faster pain relief compared to traditional tablet formulations, aligning with consumer preferences for swift action.

Q3: What are the primary safety considerations associated with Advil Migraine Liqui-Gels?
A3: Similar to other NSAIDs, potential gastrointestinal, cardiovascular, and renal risks exist. Proper dosing and adherence to recommendations mitigate adverse effects; ongoing surveillance supports safety.

Q4: How is the market for OTC migraine medications expected to evolve over the next decade?
A4: The market is projected to grow at a CAGR of approximately 5-6%, fueled by increasing migraine prevalence, innovation in delivery technology, and growing consumer self-care trends.

Q5: What strategies should Johnson & Johnson pursue to sustain Advil Migraine Liqui-Gels’ market leadership?
A5: Focus on digital marketing, expanding distribution channels—including e-commerce—innovating product formulations, and increasing consumer education around fast-acting relief benefits.


References

[1] Pharmacokinetic study data on Liqui-Gel ibuprofen formulations.
[2] Global migraine prevalence statistics, WHO reports, 2022.
[3] Market research reports on OTC analgesics, Grand View Research, 2023.
[4] Post-pandemic OTC sales analysis, NielsenIQ, 2022.

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