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
New Formulation	NCT01052883 ↗	TMC114-TiDP3-C182 - A Study to Compare the Oral Bioavailability of a 800 mg Prototype Tablet Formulation of Darunivar (DRV) to That of the 400 mg Commercial Tablet Formulation in the Presence of Low Dose Ritonavir, Under Fasted and Fed Conditions	Completed	Tibotec Pharmaceuticals, Ireland	Phase 1	2010-03-01	The purpose of this study is to compare the drug levels of darunavir obtained after administration of a single administration of the 800 mg tablet (new formulation) to that following administration of two 400 mg commercial tablets formulation when administered under fed and fasted conditions to those also taking low-dose ritonavir. Darunavir is marketed for the treatment of HIV. The short-term safety and tolerability of darunavir following administration of a single 800 mg dose of darunavir given to healthy volunteers taking taking low-dose ritonavir will also be assessed.
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.
New Combination	NCT00620828 ↗	The Role of Intra-Operative Intracapsular Blocks in Post-Operative Pain Management Following Total Knee Arthroplasty	Completed	Pfizer	Phase 4	2007-05-01	The purpose of this study is to use a new combination of anesthesia techniques in an attempt to minimize early pain after surgery and improve the patient's ability to participate more fully with physical therapy. Total knee replacement patients who participate will receive the standard anesthesia. This includes a spinal nerve block as well as a femoral nerve block. The study is looking at the added benefits of including an injection of numbing medication (Bupivicaine) to the back of the knee. This injection occurs during surgery. In order to compare the outcomes we will also have a group of patients who will receive a saline injection as opposed to the numbing medication. Patients are randomly assigned to a group. Outcomes are measured up until twenty-four hours following the surgery.
New Combination	NCT00620828 ↗	The Role of Intra-Operative Intracapsular Blocks in Post-Operative Pain Management Following Total Knee Arthroplasty	Completed	Duke University	Phase 4	2007-05-01	The purpose of this study is to use a new combination of anesthesia techniques in an attempt to minimize early pain after surgery and improve the patient's ability to participate more fully with physical therapy. Total knee replacement patients who participate will receive the standard anesthesia. This includes a spinal nerve block as well as a femoral nerve block. The study is looking at the added benefits of including an injection of numbing medication (Bupivicaine) to the back of the knee. This injection occurs during surgery. In order to compare the outcomes we will also have a group of patients who will receive a saline injection as opposed to the numbing medication. Patients are randomly assigned to a group. Outcomes are measured up until twenty-four hours following the surgery.
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
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.

All Clinical Trials for COLD CAPSULE V

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
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.
NCT00000687 ↗	Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To determine the safety and effectiveness of combining zidovudine (AZT) and interferon alfa-2a (IFN-A2a) in a treatment for Kaposi's sarcoma (KS) in patients who have AIDS. It is hoped with the present study to define the rate at which the treatment affects the tumors and also to assess any toxic effects of the combination treatment over a period of time. In a recent study, the combination of IFN-A2a and AZT in the treatment of patients with AIDS-associated KS was evaluated and safe doses of both AZT and IFN-A2a were determined. In addition, it appeared that there was a substantial reduction in KS lesions with this therapy. Potential benefits of this combined therapy include resolution of KS lesions, prolonged survival, a decrease in the frequency and severity of opportunistic infections, improvement in CD4 cells, and a decrease in serum p24 antigens.
NCT00000696 ↗	A Phase I/II Open Label Study To Evaluate the Antiviral Potential of Combination Low-Dose Therapy With Zidovudine and Interferon-Alpha 2A in Patients With Symptomatic HIV Disease	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To evaluate the anti-HIV effect of single agent versus combination therapy with zidovudine (AZT) and interferon alfa-2a (IFN-A2a), as measured by p24 protein expression, viral growth and infectivity in patients with symptomatic HIV disease. To assess the safety of low dose schedules of AZT and IFN-A2a, alone and in combination, as measured by neutrophil counts and hepatic transaminase levels. To evaluate the comparative effects of single agent versus combination therapy with AZT and IFN-A2a on CD4 cell counts and skin test reactivity. AZT is known to be an effective treatment for HIV infection. However, patients may develop reactions to AZT when it is administered for long periods of time. Combining AZT with another drug at lower doses might reduce toxicity in patients and prevent the development of drug resistant strains. IFN-A2a can reduce the growth of HIV in test tube experiments and recent studies have shown that when AZT and IFN-A2a are used together they reduce the growth of HIV more effectively than when either drug is used alone. This study will examine the effectiveness and safety of these drugs when they are given together and compare these results with the effectiveness and safety of the drugs when they are used alone.
NCT00000727 ↗	A Controlled Comparative Trial of Sulfamethoxazole-Trimethoprim Versus Aerosolized Pentamidine for Secondary Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients Receiving Azidothymidine (AZT)	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	To determine if the drug combination sulfamethoxazole-trimethoprim (SMX-TMP), given by mouth, and the drug pentamidine (PEN), given by inhaled aerosol, are effective in preventing a relapse of Pneumocystis carinii pneumonia (PCP) when they are given to patients who have recovered from a first episode of PCP and are being given zidovudine (AZT) to treat primary HIV infection. AZT prolongs survival in patients with AIDS and decreases the occurrence of opportunistic infections such as PCP. However, PCP recurs in about 43 percent of patients receiving AZT, indicating a need for other treatments to reduce the relapse rate. The two medications to be tested in this study, SMX/TMP and aerosolized PEN, have also been partially effective in preventing recurrence of PCP. It is hoped that the combination of AZT with these medications will be more effective than AZT or one of the medications alone.

Clinical Trial Conditions for COLD CAPSULE V

Condition Name

Condition Name for COLD CAPSULE V
Intervention	Trials
Healthy	281
Healthy Volunteers	96
HIV Infections	52
Pain	32

Condition MeSH

Condition MeSH for COLD CAPSULE V
Intervention	Trials
HIV Infections	56
Depression	51
Neoplasms	50
Depressive Disorder	49

Clinical Trial Locations for COLD CAPSULE V

Trials by Country

+

−

Trials by Country for COLD CAPSULE V
Location	Trials
China	916
Belgium	99
Italy	95
Brazil	81
Netherlands	80

Trials by US State

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−

Trials by US State for COLD CAPSULE V
Location	Trials
Texas	267
California	237
Florida	195
New York	179
Pennsylvania	131

Clinical Trial Progress for COLD CAPSULE V

Clinical Trial Phase

Clinical Trial Phase for COLD CAPSULE V
Clinical Trial Phase	Trials
Phase 4	343
Phase 3	349
Phase 2/Phase 3	56

Clinical Trial Status

Clinical Trial Status for COLD CAPSULE V
Clinical Trial Phase	Trials
Completed	1442
Recruiting	283
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	82
GlaxoSmithKline	58

Sponsor Type

Sponsor Type for COLD CAPSULE V
Sponsor	Trials
Other	1764
Industry	1628
NIH	152

Clinical Trials, Market Analysis, and Projections for Innovative Drugs: A Comprehensive Overview

Introduction to Clinical Trials and Market Analysis

In the rapidly evolving pharmaceutical industry, clinical trials and market analysis are crucial for the development, approval, and commercial success of new drugs. Here, we will focus on several innovative drugs and vaccine candidates, highlighting their clinical trial updates, market projections, and the broader industry trends that influence their development and adoption.

Clinical Trials Update

Moderna's Vaccine Candidates

Moderna is at the forefront of vaccine development with several candidates in late-stage clinical trials.

CMV Vaccine (mRNA-1647)

• Moderna's CMV vaccine candidate, mRNA-1647, is in a pivotal Phase 3 trial (CMVictory) evaluating its efficacy, safety, and immunogenicity in women aged 16 to 40 years. The trial is fully enrolled with approximately 7,300 participants and has accrued 50 primary infection cases to date[1].

Shingles Vaccine (mRNA-1468)

• The mRNA-1468 vaccine candidate for shingles has shown promising results in a Phase 1/2 trial, eliciting strong antigen-specific T cell responses and being generally well-tolerated. Moderna is planning for a pivotal Phase 3 trial based on these positive interim results[1].

Norovirus Vaccine (mRNA-1403)

• Moderna's norovirus vaccine candidate, mRNA-1403, has demonstrated a robust immune response with a clinically acceptable safety profile in a Phase 1 trial. The company is advancing this candidate toward a pivotal Phase 3 trial[1].

RSV Vaccine (mRNA-1345)

• The mRNA-1345 vaccine candidate for Respiratory Syncytial Virus (RSV) has shown significant efficacy in a Phase 2/3 trial (ConquerRSV), with a vaccine efficacy of 83.7% against RSV-associated lower respiratory tract disease in adults over 60 years. This vaccine has been granted Breakthrough Therapy designation by the FDA and is awaiting regulatory approvals[1].

Brensocatib for Bronchiectasis

• Insmed's brensocatib, a DPP1 inhibitor, has demonstrated statistically significant and clinically meaningful reductions in pulmonary exacerbations in patients with bronchiectasis in a Phase 3 study (ASPEN). The drug is well-tolerated and has received Breakthrough Therapy designation from the FDA. Insmed plans to file an NDA in the fourth quarter of 2024 and anticipates a U.S. launch in mid-2025[3].

LXE408 for Visceral Leishmaniasis

• The Drugs for Neglected Diseases initiative (DNDi) is conducting Phase II clinical trials for LXE408, an oral medicine for visceral leishmaniasis, in Ethiopia and India. This treatment aims to be safer and more patient-friendly compared to current injectable treatments, potentially enabling earlier access to care at primary healthcare levels[4].

Market Analysis and Projections

Cold Chain Market

The cold chain market, crucial for the distribution of vaccines and other temperature-sensitive pharmaceuticals, is expected to grow significantly.

• The global cold chain market is projected to reach $372.0 billion by 2029, growing at a CAGR of 10.3% from 2024. This growth is driven by increasing demand for fresh and organic food, as well as the expansion of the pharmaceutical industry, particularly in the Asia Pacific region[2].

OTC Cough, Cold, and Allergy Medicine Market

The over-the-counter (OTC) cough, cold, and allergy medicine market is also experiencing growth.

• The global OTC cough, cold, and allergy medicine market is expected to grow at a CAGR of 5.5% from 2022 to 2032, reaching $66.54 billion by 2032. The U.S. market, which dominates this sector, is projected to grow at a CAGR of 5.4%, while the Indian market is expected to grow at a CAGR of 5.3% during the same period. Increased product awareness and new product developments are key drivers of this growth[5].

Market Trends and Influencers

Consumer Preferences and Economic Factors

Consumer preferences for organic and fresh food items, as well as the growing emphasis on convenient foods, are driving the demand for cold chain services. Similarly, in the pharmaceutical sector, increased awareness and willingness to spend on OTC medications are boosting the market for cough, cold, and allergy medicines.

Regulatory Approvals and Breakthrough Designations

Regulatory approvals and designations such as Breakthrough Therapy status play a critical role in accelerating the development and commercialization of new drugs. For example, Moderna's mRNA-1345 and Insmed's brensocatib have both received such designations, which can expedite their path to market.

Global Health Needs and Neglected Diseases

The development of treatments for neglected diseases, such as visceral leishmaniasis, is gaining traction. Innovations like LXE408 are crucial for addressing these global health challenges and improving patient outcomes in underserved regions.

Key Takeaways

• Clinical Trials: Moderna's vaccine candidates for CMV, shingles, norovirus, and RSV are in advanced clinical trials, showing promising results.
• Market Growth: The cold chain market is expected to grow significantly due to increased demand for fresh and organic products, while the OTC cough, cold, and allergy medicine market is driven by consumer awareness and new product developments.
• Regulatory Support: Breakthrough Therapy designations and regulatory approvals are critical for the rapid development and commercialization of new drugs.
• Global Health: Innovations in treating neglected diseases like visceral leishmaniasis are essential for improving global health outcomes.

FAQs

What is the current status of Moderna's CMV vaccine candidate?

• Moderna's CMV vaccine candidate, mRNA-1647, is in a pivotal Phase 3 trial (CMVictory) with approximately 7,300 participants enrolled and 50 primary infection cases accrued to date[1].

How effective is Moderna's RSV vaccine candidate?

• Moderna's RSV vaccine candidate, mRNA-1345, has shown a vaccine efficacy of 83.7% against RSV-associated lower respiratory tract disease in adults over 60 years in a Phase 2/3 trial[1].

What is the significance of LXE408 for visceral leishmaniasis?

• LXE408 is an oral medicine in Phase II clinical trials for visceral leishmaniasis, offering a safer and more patient-friendly alternative to current injectable treatments, potentially enabling earlier access to care at primary healthcare levels[4].

What are the growth projections for the cold chain market?

• The global cold chain market is expected to reach $372.0 billion by 2029, growing at a CAGR of 10.3% from 2024[2].

How is the OTC cough, cold, and allergy medicine market expected to grow?

• The global OTC cough, cold, and allergy medicine market is projected to grow at a CAGR of 5.5% from 2022 to 2032, reaching $66.54 billion by 2032[5].

Sources

1. Moderna Advances Multiple Vaccine Programs to Late-Stage Clinical Trials - Moderna Investors.
2. Cold Chain Market Share & Growth Analysis Report - MarketsandMarkets.
3. Insmed Announces Positive Topline Results from Landmark ASPEN Study of Brensocatib in Patients with Bronchiectasis - Insmed Investor.
4. Promising patient-friendly oral drug against visceral leishmaniasis enters Phase II clinical trial in Ethiopia - World Health Organization.
5. OTC Cough, Cold & Allergy Medicine Market 2032 - Fact.MR.