CLINICAL TRIALS PROFILE FOR VICKS FORMULA 44

505(b)(2) Clinical Trials for VICKS FORMULA 44

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	NCT00125281 ↗	SAMe to Treat Biliary Cirrhosis Symptoms	Terminated	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2	2005-07-25	This study will examine the effect of S-adenosyl methionine (SAMe) on itching and fatigue in patients with primary biliary cirrhosis, a disease of the small bile ducts in the liver. Ursodiol, the only currently available treatment for biliary cirrhosis, does not cure the disease, and many people continue to have symptoms or liver test abnormalities despite treatment. SAMe is a naturally occurring substance found in most cells of the body. The highest levels of the substance are produced by the liver, where it helps to rid the body of toxins and breakdown products of metabolism. Studies in Europe suggest that SAMe may help to: 1) decrease the fatigue and itching that are common in persons with liver problems, and 2) decrease levels of liver enzymes in the blood, suggesting that it may decrease the amount of liver injury. Patients 21 years of age or older with primary biliary cirrhosis who are taking ursodiol and have symptoms of itching or fatigue may be eligible for this study. Candidates are screened with a medical history, physical examination, review of medical records, routine blood tests, and a symptoms rating scale. Participants stop all medications for itching 4 weeks before starting the study, but continue to take ursodiol during the 42-week trial. On entering the study, patients are assigned to take either SAMe or placebo tablets twice a day for 12 weeks. While taking the medications, they are followed in the clinic every 2 weeks for the first month and then every 4 weeks to fill out symptoms questionnaires and have a short medical evaluation and blood tests. At the end of 12 weeks, treatment is interrupted for a 2-week "wash-out" period, after which patients begin a 12-week crossover treatment; that is, patients who were taking SAMe are switched to placebo, and those who were taking placebo are switched to SAMe. After completing the second 12-week treatment course, patients come to the clinic at 4, 8, and 12 weeks to fill out symptoms questionnaires and have a medical evaluation and blood tests. At the last visit, patients are told which type of tablet they received during the two courses of treatment. SAMe is available without prescription in many forms as an over-the-counter medication.
New Formulation	NCT00490932 ↗	New Hypo-Osmolar ORS (Recommended by WHO) for Routine Use in the Diarrhea Management- Surveillance Study for Adverse Effects	Completed	Society for Applied Studies	Phase 4	2005-03-01	For more than 25 years WHO and UNICEF have recommended a single formulation of glucose-based Oral Rehydration Salts (ORS) to prevent or treat dehydration from diarrhoea irrespective of the cause or age group affected. This product has proven effective and contributed substantially to the dramatic global reduction in mortality from diarrhoeal disease during the period. Based on more than two decades of research and recommendations by an expert group, WHO and UNICEF reviewed the effectiveness of a new ORS formula with reduced concentration of glucose and salts. Because of the improved effectiveness of this new ORS solution WHO and UNICEF recommended that countries use and manufacture this new formulation in place of the old one. While recommending this new ORS the experts also recommended that further monitoring is desirable to better assess the risk, if any of symptomatic hyponatraemia (low blood level of sodium salt). This is a surveillance study to evaluate adverse effect of routinely using the new ORS in a hospital admitting over 20,000 patients with diarrhea of all ages including cholera. If the new ORS is found safe, it will provide added confidence in its global use.
OTC	NCT01451918 ↗	Regulation of Intestinal and Hepatic Lipoprotein Secretion by Resveratrol	Completed	Canadian Institutes of Health Research (CIHR)	Phase 2	2011-10-01	Resveratrol, an ingredient of red wine and available in Canada in highly purified form as an over-the-counter health supplement, has been shown to have a number of health benefits. Data from in vitro and animal studies suggest that it has beneficial effects on insulin sensitivity and lipid lowering. The investigators are not aware, however, of any mechanistic studies that have examined the effect of highly purified resveratrol in vivo on lipoprotein metabolism in humans. Given the potential therapeutic benefit of resveratrol in correcting the metabolic abnormalities of insulin resistant individuals the investigators plan to examine the effects of resveratrol on intestinal and hepatic lipoprotein production in humans.
OTC	NCT01451918 ↗	Regulation of Intestinal and Hepatic Lipoprotein Secretion by Resveratrol	Completed	University Health Network, Toronto	Phase 2	2011-10-01	Resveratrol, an ingredient of red wine and available in Canada in highly purified form as an over-the-counter health supplement, has been shown to have a number of health benefits. Data from in vitro and animal studies suggest that it has beneficial effects on insulin sensitivity and lipid lowering. The investigators are not aware, however, of any mechanistic studies that have examined the effect of highly purified resveratrol in vivo on lipoprotein metabolism in humans. Given the potential therapeutic benefit of resveratrol in correcting the metabolic abnormalities of insulin resistant individuals the investigators plan to examine the effects of resveratrol on intestinal and hepatic lipoprotein production in humans.

All Clinical Trials for VICKS FORMULA 44

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000574 ↗	Ibuprofen in Sepsis Study	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1990-09-01	To determine the effects of ibuprofen on mortality, development and reversal of shock, and adult respiratory distress syndrome, and on Lung Parenchymal Injury Score in adult patients with serious infection.
NCT00000574 ↗	Ibuprofen in Sepsis Study	Completed	Vanderbilt University	Phase 3	1990-09-01	To determine the effects of ibuprofen on mortality, development and reversal of shock, and adult respiratory distress syndrome, and on Lung Parenchymal Injury Score in adult patients with serious infection.
NCT00000574 ↗	Ibuprofen in Sepsis Study	Completed	Vanderbilt University Medical Center	Phase 3	1990-09-01	To determine the effects of ibuprofen on mortality, development and reversal of shock, and adult respiratory distress syndrome, and on Lung Parenchymal Injury Score in adult patients with serious infection.
NCT00000873 ↗	A Study on the Effect of High-Calorie Infant Formula on Growth and Nutrition in HIV-Infected Infants	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	N/A	1969-12-31	This study examines the effects of an infant formula containing increased calories, as compared to commercial formulas, when given during the first 6 months of life. It will examine effects on growth, disease progress, immune system, and quality of life of infected infants. HIV disease in infants often leads to nutritional deficiencies. Providing increased nutrition early in their lives may help the quality of life of children who contract HIV from their mothers.

Clinical Trial Conditions for VICKS FORMULA 44

Condition Name

Condition Name for VICKS FORMULA 44
Intervention	Trials
Obesity	13
COVID19	10
HIV Infections	10
Healthy	8

Condition MeSH

Condition MeSH for VICKS FORMULA 44
Intervention	Trials
Syndrome	36
Kidney Diseases	25
Diabetes Mellitus	24
Infections	22

Clinical Trial Locations for VICKS FORMULA 44

Trials by Country

Trials by Country for VICKS FORMULA 44
Location	Trials
United States	554
China	214
Egypt	41
Taiwan	36
Canada	35

Trials by US State

Trials by US State for VICKS FORMULA 44
Location	Trials
California	37
New York	34
Texas	31
Illinois	29
Florida	28

Clinical Trial Progress for VICKS FORMULA 44

Clinical Trial Phase

Clinical Trial Phase for VICKS FORMULA 44
Clinical Trial Phase	Trials
PHASE4	21
PHASE3	12
PHASE2	28

Clinical Trial Status

Clinical Trial Status for VICKS FORMULA 44
Clinical Trial Phase	Trials
Completed	436
Recruiting	152
Unknown status	109

Clinical Trial Sponsors for VICKS FORMULA 44

Sponsor Name

Sponsor Name for VICKS FORMULA 44
Sponsor	Trials
Chinese University of Hong Kong	21
Hoosier Cancer Research Network	19
Chang Gung Memorial Hospital	13

Sponsor Type

Sponsor Type for VICKS FORMULA 44
Sponsor	Trials
Other	1377
Industry	216
NIH	59

Clinical Trials Update, Market Analysis, and Projection for Vicks Formula 44

Last updated: October 31, 2025

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Introduction

Vicks Formula 44, a well-recognized over-the-counter (OTC) medication used primarily for cough suppression and cold symptom relief, has historically commanded a significant share within the OTC healthcare segment. Increasingly, pharmaceutical stakeholders and investors seek updated insights into its clinical development status, market dynamics, and future growth potential amid evolving consumer preferences and regulatory landscapes. This comprehensive overview consolidates recent clinical trial activities, assesses current market positioning, and projects future trends for Vicks Formula 44.

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Clinical Trials Update

Clinical Development Status

As of 2023, Vicks Formula 44 remains predominantly an OTC product, with minimal ongoing clinical trials dedicated explicitly to this formulation. Historically, its active ingredients—primarily dextromethorphan and possibly guaifenesin—have undergone extensive validation, ensuring established safety and efficacy profiles.

However, recent developments suggest an emerging interest in reformulating or enhancing traditional cough medicines, including Vicks Formula 44, through clinical investigations targeting new delivery mechanisms, alternative active compounds, or combination therapies. Notably:

• Reformulation Studies: Several ongoing trials aim to evaluate bioavailability and patient compliance for novel formulations of cough suppressants, some of which might influence Vicks' formulation strategizes indirectly (e.g., through market adaptation).
• Safety Profiling of Alternatives: Trials examining safer, non-addictive formulations of dextromethorphan derivatives are underway, with preliminary results indicating promising safety profiles, potentially underpinning future reformulations.
• Extended Indications: Investigations into broader respiratory conditions, such as chronic cough or post-viral cough syndromes, remain at early stages, with no current clinical trials directly targeting Vicks Formula 44.

Regulatory and Post-Market Surveillance

While no recent high-profile clinical trials have been conducted specifically for Vicks Formula 44, post-market surveillance continuously assesses its safety, especially considering concerns over dextromethorphan misuse. Regulatory agencies, including the FDA, monitor adverse events and abuse potential, prompting ongoing pharmacovigilance rather than formal trials.

Implications

The paucity of new clinical trials directly involving Vicks Formula 44 reflects its established status as a proven OTC remedy. Future clinical development likely hinges on reformulation efforts or expanded therapeutic indications, driven by consumer demand for safer, more effective cough remedies.

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Market Analysis

Current Market Landscape

The global OTC cough and cold medicines market was valued at approximately USD 10 billion in 2022, with North America accounting for around 40% of the share [1]. Vicks, as a leading brand under Procter & Gamble (P&G), secures a substantial portion within this segment, largely due to brand recognition, extensive distribution channels, and consumer trust.

Market Drivers include:

• Rising Cold Incidence: Seasonal variations and increased respiratory infections, especially post-pandemic, sustain product demand.
• Consumer Preference: Preference for proven OTC remedies over prescription drugs for minor ailments persists.
• Product Accessibility: Wide distribution in retail and online channels enhances consumer reach.

Market Challenges include:

• Regulatory Scrutiny: Concerns over safety, particularly regarding dextromethorphan misuse, influence market positioning.
• Competitive Innovation: Emergence of natural, herbal, or alternative remedies caters to health-conscious consumers.
• Generic Competition: Numerous OTC cough suppressants with similar compositions dilute market share.

Competitor Landscape

Major competitors include Robitussin (Johnson & Johnson), Mucinex (Bayer), and store-brand equivalents, with innovation driven by formulations targeting specific demographics, such as pediatric or elderly markets. These competitors introduce variations with enhanced flavors, formulations for persistent coughs, or combination therapies, challenging Vicks Formula 44's dominance.

Consumer Trends and Preferences

The shift toward natural ingredients and concern over potential abuse of dextromethorphan pose both threats and opportunities. Consumers increasingly favor products that are perceived as safer, organic, or herbal. Accordingly, Vicks is exploring reformulation opportunities to align with these trends, maintaining market relevance.

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Market Projection and Future Outlook

Growth Trajectory

Projections for the OTC cough and cold segment remain optimistic, with a compounded annual growth rate (CAGR) of around 4% through 2030, driven by heightened respiratory illness prevalence and expanding consumer awareness [1].

For Vicks Formula 44 specifically:

• Stability in Core Market: Its entrenched brand loyalty and distribution channels position it favorably.
• Reformulation Potential: Introduction of lower-dose, non-addictive variants or natural ingredients could open new market segments.
• Digital and E-commerce Expansion: Growing online retail platforms facilitate targeted marketing and direct-to-consumer engagement, fostering sales growth.

Innovation and Regulatory Impact

Regulatory agencies' efforts to curb dextromethorphan abuse may shape future formulations, favoring products with reduced psychoactive potential or alternative active ingredients. If successful, these reforms could extend Vicks' market longevity and consumer trust.

Emerging Opportunities:

• Combination Therapy Development: Combining cough suppressant with immune-boosting agents.
• Targeted Delivery Systems: Utilizing inhalers or lozenges to improve efficacy.
• Personalized Medicine Approaches: Custom dosage forms catering to specific demographics.

Risks and Challenges

• Regulatory constraints may restrict certain formulations or require extensive safety testing.
• Market saturation with generic brands could pressure pricing strategies.
• Consumer shift toward natural remedies necessitates innovation to retain market share.

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Key Takeaways

• Clinical Innovation Is Limited: Current clinical trials focus more on reformulation and safety profiling rather than new indications for Vicks Formula 44, signaling reliance on its established safety profile.
• Market Stability but Evolving Competition: While the brand retains a strong position, competition from natural and alternative remedies intensifies, demanding strategic adaptation.
• Regulatory Environment Will Shape Future Formulations: Increasing scrutiny on dextromethorphan may lead to reformulation, presenting both risks and opportunities.
• Growth Prospects Remain Positive: The overall OTC cough and cold market forecast indicates steady growth, with Vicks potentially capitalizing on product innovation and expanded distribution channels.
• Innovation Is Key for Longevity: To sustain relevance, Vicks Formula 44 needs to explore reformulations aligned with consumer preferences and regulatory requirements.

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FAQs

1. Are there any new clinical trials for Vicks Formula 44?
Currently, no clinical trials are specifically ongoing for Vicks Formula 44. The product relies on extensive historical safety data and efficacy profiles from its active ingredients. Future clinical studies are likely focused on reformulations or alternative therapy evaluations.

2. How is the market for cough remedies expected to evolve in the next five years?
The market is projected to grow at around 4% CAGR, driven by increased respiratory illnesses, rising health awareness, and expanding online retail channels. Innovation toward natural and safer formulations will be critical to maintaining market share.

3. What regulatory challenges could impact Vicks Formula 44?
Regulatory agencies are scrutinizing dextromethorphan due to abuse potential, possibly leading to tighter limits or reclassification, which could influence formulation strategies and marketing approaches.

4. Will natural or herbal alternatives threaten Vicks Formula 44's dominance?
Yes, consumer trends favoring natural remedies pose a challenge. Vicks must consider reformulations or new product lines to retain consumer interest and competitiveness.

5. What strategic moves should P&G consider for Vicks Formula 44?
Focus on reformulation to enhance safety and natural appeal, expand digital marketing, explore new delivery formats, and monitor regulatory changes closely for timely adaptation.

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References

[1] Statista. (2022). “OTC cold and cough remedies market size worldwide.”
[2] IBISWorld. (2023). “Over-the-Counter (OTC) Cold and Cough Medicine Manufacturing in the US.”
[3] Grand View Research. (2022). “Cough and Cold Medicine Market Size, Share & Trends.”

(Note: Actual citations should be verified with the latest industry reports and primary sources.)