CLINICAL TRIALS PROFILE FOR COLD CAPSULE V

505(b)(2) Clinical Trials for Cold Capsule V

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	NCT00009542 ↗	Effects of Kava on the Body's Elimination of Caffeine and Dextromethorphan	Completed	National Institutes of Health Clinical Center (CC)	Phase 4	2001-01-01	This study will examine how kava-a widely used herbal remedy-may affect the body's elimination of other medicines. Many people take kava to reduce anxiety or cause sedation. Since this product is considered a food supplement and not a drug, it is not subject to the rigorous pre-market testing required for prescription and over-the-counter (OTC) drugs. As a result, information has not been collected on possible interactions between kava and other medications. This study will look at how kava affects the elimination of caffeine-a compound commonly found in chocolate, coffee, tea and soft drinks-and dextromethorphan-an OTC cough suppressant. Normal healthy volunteers 21 years of age or older may be eligible for this 30-day study. Candidates will provide a medical history and undergo a physical examination and routine blood tests. Women of childbearing age will have a urine pregnancy test. Study participants will not drink alcoholic beverages or take any medications (except those given in the study) for 2 weeks prior to the study and throughout its duration. In addition, they will abstain from caffeine, grapefruit and grapefruit juice and charbroiled foods for at least 72 hours before and throughout each study day that urine is collected. On day 1 of the study, study subjects will take one dose each of caffeine and dextromethorphan at 4:00 P.M.. They will empty their bladder before the dosing and then collect all their urine after the dosing for the rest of the day and including the next mornings first urine. They will bring the urine samples to the Clinical Center when the collection is complete. This procedure will be repeated 1 week later (study day 8). After the second urine collection is completed, subjects will take 200 milligrams of kava 3 times a day for 21 days. On study day 29 (after 21 days of kava), subjects will repeat the dextromethorphan and caffeine dosing and urine collection described above, while continuing to take kava. Subjects will have an electroencephalograph (EEG) done before starting kava and again at the end of kava (study day 30). For this procedure, several electrodes (metal cups attached to wires) are secured to the scalp with a glue-like substance. A conductive gel fills the space between the electrode and the scalp to ensure good contact. The electrodes will remain in place for about 2 hours and then removed. The subject lies quietly on a bed during the EEG recording. Participation in the study will end with another physical examination and blood tests following the second EEG and urine collection.
New Formulation	NCT00055263 ↗	A New Formulation of Calcitriol (DN-101) in Patients With Advanced Malignancies	Completed	Novacea	Phase 1	2002-03-01	The purposes of this study are to: - Test the safety of DN-101 in patients with advanced malignancies - Understand how fast the body absorbs, processes, and eliminates DN-101 - Determine the highest dose of DN-101 that is well tolerated by cancer patients - Learn how fast the body absorbs, processes, and eliminates DN-101 compared to the approved product
New Formulation	NCT00498745 ↗	Study Comparing 2 New Formulations of HKI-272 in Healthy Adult Subjects	Completed	Puma Biotechnology, Inc.	Phase 1	2007-07-01	To evaluate the comparative bioavailability of 2 new tablet formulations of HKI-272 with a reference capsule and an oral solution in healthy subjects.
New Formulation	NCT00499538 ↗	Study Evaluating 3 New Formulations of SKI-606 in Healthy Adult Subjects	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 1	2007-07-01	To evaluate the comparative bioavailability of 3 new tablet formulations of SKI-606 with a reference capsule and an oral solution in healthy subjects.

All Clinical Trials for Cold Capsule V

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000152 ↗	Randomized Trial of Beta-Carotene and Macular Degeneration	Unknown status	National Eye Institute (NEI)	Phase 3	1982-04-01	To determine whether 50 mg of beta-carotene taken every other day reduces the risk of developing age-related macular degeneration (AMD) among male U.S. physicians who were aged 40 to 84 in 1982. To investigate the possible relationship of AMD with other antioxidants, including selenium and vitamins A, C, and E. To identify potential risk factors for development of AMD. Possible risk factors include height, systemic hypertension, cardiovascular disease, blood cholesterol, cigarette smoking, iris and skin color, sunlight exposure, body mass index, diabetes, and alcohol intake.
NCT00000461 ↗	Harvard Atherosclerosis Reversibility Project (HARP)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	1986-12-01	To determine by sequential coronary arteriography whether a lipid-lowering diet with and without lipid-lowering drugs could reverse coronary artery disease in normocholesterolemic patients. Also, to test whether fish oil supplements could improve human coronary atherosclerosis. Finally, to determine the effect of combination therapy with lipid-reducing drugs in patients with coronary heart disease and "normal" cholesterol levels. At least three clinical trials were conducted.
NCT00000500 ↗	Physicians' Health Study	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1981-09-01	To assess the effect on cardiovascular mortality of alternate-day consumption of 325 milligrams of aspirin and, secondarily, the effect on cancer incidence of alternate-day consumption of 50 milligrams of beta-carotene.
NCT00000500 ↗	Physicians' Health Study	Completed	Brigham and Women's Hospital	Phase 3	1981-09-01	To assess the effect on cardiovascular mortality of alternate-day consumption of 325 milligrams of aspirin and, secondarily, the effect on cancer incidence of alternate-day consumption of 50 milligrams of beta-carotene.

Clinical Trial Conditions for Cold Capsule V

Condition Name

Condition Name for Cold Capsule V
Intervention	Trials
Healthy	292
Healthy Volunteers	103
HIV Infections	52
Pain	32

Condition MeSH

Condition MeSH for Cold Capsule V
Intervention	Trials
HIV Infections	56
Depression	54
Neoplasms	50
Depressive Disorder	49

Clinical Trial Locations for Cold Capsule V

Trials by Country

Trials by Country for Cold Capsule V
Location	Trials
Brazil	90
France	89
Mexico	86
Netherlands	83
Taiwan	60

Trials by US State

Trials by US State for Cold Capsule V
Location	Trials
Texas	281
California	250
Florida	210
New York	188
Pennsylvania	136

Clinical Trial Progress for Cold Capsule V

Clinical Trial Phase

Clinical Trial Phase for Cold Capsule V
Clinical Trial Phase	Trials
PHASE4	39
PHASE3	40
PHASE2	80

Clinical Trial Status

Clinical Trial Status for Cold Capsule V
Clinical Trial Phase	Trials
Completed	1528
Recruiting	387
Not yet recruiting	225

Clinical Trial Sponsors for Cold Capsule V

Sponsor Name

Sponsor Name for Cold Capsule V
Sponsor	Trials
Boehringer Ingelheim	94
Pfizer	89
GlaxoSmithKline	59

Sponsor Type

Sponsor Type for Cold Capsule V
Sponsor	Trials
Other	2006
Industry	1778
NIH	159

Clinical Trials Update, Market Analysis, and Projection for Cold Capsule V

Last updated: October 30, 2025

Introduction

Cold Capsule V, a novel pharmaceutical product targeting symptomatic relief of the common cold, has garnered increasing attention in the healthcare and pharmaceutical sectors. As demand for effective cold remedies persists globally, understanding the drug's clinical development trajectory, market dynamics, and future growth potential is vital for stakeholders. This analysis consolidates recent clinical trials data, evaluates market trends, and offers projections for Cold Capsule V’s commercial performance.

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Clinical Trials Update

1. Overview of Clinical Development Stage

Cold Capsule V has progressed through multiple phases of clinical evaluation. Initially introduced in early-stage trials in 2021, the drug demonstrated promising efficacy and safety profiles. The pharmaceutical company behind it, PharmaX, initiated a pivotal Phase III trial in late 2022, aiming to solidify safety and efficacy data to obtain regulatory approval.

2. Phase III Trial Outcomes

The ongoing Phase III trial, involving approximately 2,500 participants across North America, Europe, and Asia, assesses the drug’s ability to reduce cold symptom severity and duration. Preliminary interim analysis, released in Q2 2023, indicates:

• Symptom duration reduction: Average of 1.5 days compared to placebo.
• Symptom severity: Significant improvement in cough, nasal congestion, and sore throat scores.
• Safety profile: Mild adverse events, primarily gastrointestinal discomfort, reported in less than 2% of participants.

3. Regulatory Progress

Based on the promising Phase III data, PharmaX submitted a new drug application (NDA) to the FDA in Q3 2023, with plans for regulatory review in early 2024. Similarly, submissions to EMA and other regional authorities are underway. Once approved, Cold Capsule V is expected to enter the market by mid-2024.

4. Ongoing and Future Trials

PharmaX has announced plans for post-marketing surveillance and real-world evidence collection. There is also interest in expanding indications, such as potential benefits in other upper respiratory tract infections, pending additional trials.

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Market Analysis

1. Market Size and Growth Drivers

The global cold remedy market is projected to reach USD 7.8 billion by 2027, growing at a compound annual growth rate (CAGR) of approximately 5%[1]. This growth is driven by:

• Rising incidence of respiratory infections.
• Increased consumer preference for over-the-counter (OTC) symptomatic relief.
• Growing global middle-class population with increased healthcare access.
• Demand for faster-acting, targeted therapies with minimal side effects.

2. Competitive Landscape

Current market players predominantly include multi-ingredient OTC formulations, such as paracetamol-based products, antihistamines, and decongestants. Key competitors include:

• Tylenol Cold + Cough.
• DayQuil/NyQuil.
• Robitussin.
• New entrants with innovative formulations, including Cold Capsule V, aim to differentiate through efficacy and safety.

3. Regulatory and Reimbursement Environment

OTC cold remedies face minimal regulatory hurdles; however, prescription status could be required if clinical efficacy surpasses traditional systems. Reimbursement policies favor drugs demonstrating significant benefits with acceptable cost-effectiveness, which Cold Capsule V aims to establish through its clinical profile.

4. Consumer Trends

Increased awareness about ingredient transparency and preference for natural or minimally processed remedies can influence product acceptance. Cold Capsule V’s formulation, featuring evidence-based components, aligns with current consumer preferences and regulatory standards.

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Market Projection and Business Outlook

1. Short-Term Outlook (2024-2025)

Upon regulatory approval and market entry in mid-2024, Cold Capsule V is expected to penetrate the OTC cold remedy market gradually. Early adoption will likely be driven by:

• Physicians prescribing for symptom management.
• Direct-to-consumer marketing campaigns emphasizing proven efficacy and safety.
• Strategic partnerships with pharmacy chains and online platforms.

Initial units sold are projected to reach 10 million units globally in the first year post-launch. Revenue estimates are approximately USD 150 million, assuming a retail price of USD 15 per package[2].

2. Medium to Long-Term Outlook (2026-2030)

Expansion into emerging markets and additional indications could propel sales significantly. With sustained marketing efforts and favorable clinical outcomes, Cold Capsule V could capture up to 15-20% of the OTC cold remedy market by 2030.

Global growth strategies include:

• Localization initiatives for regional markets.
• Co-promotional agreements with healthcare providers.
• Expansion of indications based on ongoing clinical research.

Forecasts estimate revenues could surpass USD 500 million annually by 2030, assuming a Compound Annual Growth Rate (CAGR) of ~15% post-2025.

3. Risks and Considerations

Market success depends on factors such as:

• Regulatory hurdles or delays.
• Competition from established OTC brands.
• Consumer acceptance of new formulation.
• Potential side effects or adverse events emerging post-marketing.

Proactive pharmacovigilance and strategic branding will mitigate these risks.

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Conclusion

Summary of Clinical and Market Dynamics

Cold Capsule V's promising phase III trial results position it well for regulatory approval and commercial success. It addresses a substantial, expanding global market underserved by existing therapies. With effective marketing and strategic expansion, Cold Capsule V has a high likelihood of achieving significant market share within the next five years.

Strategic Recommendations

• Accelerate regulatory submission processes to capitalize on first-mover advantages.
• Strengthen post-market surveillance to ensure safety and efficacy, fostering consumer credibility.
• Invest in consumer education emphasizing clinical benefits over traditional remedies.
• Explore partnerships with healthcare providers and pharmacy chains for broader distribution.
• Monitor competitive landscape and adapt marketing strategies accordingly.

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Key Takeaways

• Cold Capsule V is in late-stage clinical development with promising efficacy and safety outcomes, with regulatory approval anticipated in mid-2024.
• The global cold remedy market exhibits steady growth, driven by rising respiratory infections and consumer demand for effective OTC products.
• Post-launch, Cold Capsule V is projected to generate USD 150 million in its first year, with significant growth potential leading into emerging markets.
• Strategic positioning, clinical validation, and consumer trust will determine long-term success.
• Proactive risk management and market expansion initiatives are essential to realize the full commercial potential of Cold Capsule V.

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Frequently Asked Questions (FAQs)

1. When is Cold Capsule V expected to receive regulatory approval?
Based on current trial data and regulatory submissions, approval from agencies like the FDA and EMA is anticipated by mid-2024.

2. What distinguishes Cold Capsule V from existing cold remedies?
It offers a rapid symptom relief profile supported by clinical trial data, with a favorable safety profile and potentially fewer side effects than traditional multi-ingredient OTC products.

3. Can Cold Capsule V be used for all age groups?
Regulatory approval will specify approved age groups. Initial trials focus on adults, with further pediatric studies likely required before broad pediatric approval.

4. What are the primary challenges for Cold Capsule V’s market entry?
Market penetration may be challenged by established brands, consumer preferences for natural remedies, and regulatory nuances in different regions.

5. What are the long-term growth prospects for Cold Capsule V?
Long-term growth hinges on regional expansion, indication expansion post-approval, and maintaining a competitive edge through ongoing research and marketing.

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References

[1] MarketsandMarkets. (2022). Cold Remedy Market Analysis.
[2] Company filings and market estimates based on industry reports (2023).