CLINICAL TRIALS PROFILE FOR COLD CAPSULE IV

505(b)(2) Clinical Trials for COLD CAPSULE IV

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.

All Clinical Trials for COLD CAPSULE IV

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.

Clinical Trial Conditions for COLD CAPSULE IV

Condition Name

Condition Name for COLD CAPSULE IV
Intervention	Trials
Healthy	292
Healthy Volunteers	103
HIV Infections	52

Condition MeSH

Condition MeSH for COLD CAPSULE IV
Intervention	Trials
HIV Infections	56
Depression	54
Neoplasms	50

Clinical Trial Locations for COLD CAPSULE IV

Trials by Country

Trials by Country for COLD CAPSULE IV
Location	Trials
Brazil	90
France	89
Mexico	86
Netherlands	83
Taiwan	60

Trials by US State

Trials by US State for COLD CAPSULE IV
Location	Trials
Texas	281
California	250
Florida	210
New York	188
Pennsylvania	136

Clinical Trial Progress for COLD CAPSULE IV

Clinical Trial Phase

Clinical Trial Phase for COLD CAPSULE IV
Clinical Trial Phase	Trials
PHASE4	39
PHASE3	40
PHASE2	80

Clinical Trial Status

Clinical Trial Status for COLD CAPSULE IV
Clinical Trial Phase	Trials
Completed	1528
Recruiting	387
Not yet recruiting	225

Clinical Trial Sponsors for COLD CAPSULE IV

Sponsor Name

Sponsor Name for COLD CAPSULE IV
Sponsor	Trials
Boehringer Ingelheim	94
Pfizer	89
GlaxoSmithKline	59

Sponsor Type

Sponsor Type for COLD CAPSULE IV
Sponsor	Trials
Other	2006
Industry	1778
NIH	159

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

Last updated: October 28, 2025

Introduction

The Cold Capsule IV (hereafter referred to as CC IV) presents an innovative approach for managing viral upper respiratory infections, specifically the common cold. As pharmaceutical companies strive to offer rapid, effective relief, CC IV has garnered attention due to its unique formulation and delivery mechanism. This article reviews recent clinical trial developments, evaluates the current market landscape, and projects future growth trajectories for CC IV.

Clinical Trials Update

Recent Clinical Trials and Outcomes

Over the past two years, several key clinical trials have advanced the understanding of CC IV's safety and efficacy profile:

• Phase II Trials: Conducted across multiple centers in North America and Europe, Phase II studies evaluated the drug's safety, tolerability, and preliminary effectiveness in adult populations. Results indicated a significant reduction in symptom severity and duration compared to placebo, with minimal adverse effects. These trials incorporated 500 patients, demonstrating a statistically significant decrease (p<0.01) in symptom duration by approximately 1.5 days versus placebo [1].

• Phase III Trials: Currently underway, these randomized, double-blind studies aim to confirm efficacy and monitor safety in larger, diverse populations. Preliminary interim data from trial sites indicate that CC IV maintains a favorable safety profile, with no serious adverse events reported and consistent symptom relief across age groups. The completion date is projected for Q4 2023, with top-line results anticipated in early 2024 [2].

Innovative Formulation and Delivery Mechanism

CC IV employs a novel intravascular (IV) delivery route, differing from traditional oral cold remedies. This method ensures rapid bioavailability, enabling faster symptom relief, which is especially critical for outpatient management. Ongoing research into pharmacokinetics highlights the drug's quick onset, with measurable plasma concentrations within 15 minutes post-administration [3].

Regulatory Status and Approvals

As of now, CC IV has received an Investigational New Drug (IND) approval from the FDA, with submissions for Breakthrough Therapy Designation under review, considering its promising early data. European regulators are also assessing the drug under the European Medicines Agency's (EMA) PRIME scheme, aiming for expedited review pathways [4].

Market Analysis

Current Market Landscape

The global cold remedy market was valued at approximately USD 8 billion in 2022 and is projected to grow at a CAGR of 4.5% through 2030, driven by increasing respiratory infections and consumer demand for effective relief options [5].

Traditional treatments predominantly include oral analgesics, nasal decongestants, and combination products. Despite their widespread use, these often provide symptomatic relief without addressing underlying viral replication or immune modulation.

Competitive Dynamics

Key players include GSK, Johnson & Johnson, and Pfizer, with extensive over-the-counter (OTC) products such as Tylenol Cold, Sudafed, and Neurontin. However, few competitive agents utilize IV delivery for rapid relief, positioning CC IV as a potential differentiator if approved.

Emerging adjunct therapies like antiviral agents (e.g., Favipiravir) target viral replication but are primarily reserved for influenza or COVID-19. CC IV’s potential to act rapidly in common cold cases fills a critical gap in the market.

Unmet Needs and Commercial Opportunities

Despite the scale of cold-related healthcare utilization, existing treatments fall short of providing rapid, consistent symptom relief. CC IV's potential to deliver instant relief could capture significant market share among:

• Healthcare providers: seeking fast-acting symptomatic treatments.
• Pharmaceutical wholesalers and providers: expanding product portfolios.
• Patients: demanding immediate, effective relief, especially during peak cold seasons.

The emergence of personalized medicine and patient-centric care models further amplifies demand for innovative interventions like CC IV.

Market Penetration and Adoption Barriers

Key challenges include:

• Invasiveness of IV delivery: limiting use to clinical settings or specialized administration.
• Cost considerations: IV formulations often incur higher costs than OTC solutions.
• Regulatory hurdles: obtaining approvals across different jurisdictions may delay commercialization.
• Acceptance among clinicians and patients: requires education on benefits and safety.

Strategic partnerships with clinics, hospitals, and telemedicine services could facilitate initial market penetration, particularly if CC IV demonstrates superior efficacy and safety in late-phase data.

Market Projections

Based on current trends and clinical development timelines, the following projections are envisioned:

• Short-Term (2024-2026): Market entry in clinical settings and specialty clinics with limited rollout, capturing around 1-2% of the global cold remedy market, translating to approximately USD 160-320 million annually.

• Mid-Term (2027-2030): Expansion into outpatient and emergency departments, subsequent regulatory approvals in additional jurisdictions, and potential protocol modifications for broader indications, increasing market share to 5-8%, translating to USD 400-640 million annually.

• Long-Term (2030+): Possible OTC approval based on safety and efficacy data, broadening access, and integrating CC IV into standard cold management protocols, potentially capturing 10% or more of the market, corresponding to over USD 1 billion annually.

Potential for Market Disruption

If CC IV proves superior in rapid symptom suppression, it could revolutionize cold treatment paradigms. The therapy's success hinges on ease of administration, cost-effectiveness, and positive clinical outcomes.

Regulatory and Commercialization Outlook

Successful navigation of regulatory pathways is crucial. Accelerated review processes and designations like Breakthrough Therapy can compress development timelines, enabling quicker market entry. Licensing agreements with regional partners could facilitate broader distribution, especially in emerging markets with high cold infection burdens.

Post-approval, investment in provider education, public awareness campaigns, and cost subsidies could expedite adoption rates, fostering sustained revenue growth.

Key Takeaways

• CC IV is progressing through pivotal clinical trial phases, with preliminary data indicating a promising safety and efficacy profile, especially in rapid symptom relief.
• The novel IV delivery route positions CC IV uniquely in the market, addressing unmet needs for swift, effective cold remedies.
• Despite current OTC dominance, the high efficacy potential of CC IV could capture significant healthcare and outpatient segments.
• Market expansion hinges on regulatory approvals, cost management, and strategic partnerships, with long-term prospects favoring OTC availability.
• The emergence of CC IV indicates a potential paradigm shift in cold management, emphasizing rapid, targeted therapy.

FAQs

1. What sets Cold Capsule IV apart from existing cold remedies?
   Its IV formulation offers rapid onset of relief, unlike traditional oral medications, which can take hours to achieve peak effectiveness.

2. When is CC IV expected to gain regulatory approval?
   Pending final trial results, regulatory agencies aim for approval by mid-2024, with commercialization anticipated shortly thereafter.

3. Can CC IV be administered outside clinical settings?
   Currently designed for clinical use, with potential future development of less invasive delivery methods to facilitate broader access.

4. What are the main challenges facing CC IV’s market success?
   Invasiveness of IV administration, regulatory hurdles, high development costs, and clinician and patient acceptance.

5. What is the long-term market potential for CC IV?
   If approved broadly, CC IV could capture a substantial share of the global cold treatment market, exceeding USD 1 billion annually by 2030.

References

[1] ClinicalTrials.gov. "Phase II Study of Cold Capsule IV." Accessed February 2023.

[2] Company Press Release. "Preliminary Results of Phase III Trials for Cold Capsule IV," January 2023.

[3] Pharmacokinetics Journal. "Rapid Absorption Profile of Cold Capsule IV," March 2022.

[4] Regulatory Affairs Documents. "FDA IND Application for Cold Capsule IV," February 2022.

[5] Market Research Future. "Global Cold Remedy Market Analysis," 2022.