CLINICAL TRIALS PROFILE FOR TRAVASOL 4.25% IN DEXTROSE 5% IN PLASTIC CONTAINER

All Clinical Trials for TRAVASOL 4.25% IN DEXTROSE 5% IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02032953 ↗	Enhancing the Anabolic Effect of Perioperative Nutrition With Insulin While Maintaining Normoglycemia	Active, not recruiting	Canadian Institutes of Health Research (CIHR)	Phase 4	2013-12-01	The purpose of this study is to find out whether adding insulin after current colorectal cancer surgery promotes making and keeping proteins in the body, and to find out whether or not this effect can be further increased by increasing the amount of protein given.
NCT02032953 ↗	Enhancing the Anabolic Effect of Perioperative Nutrition With Insulin While Maintaining Normoglycemia	Active, not recruiting	McGill University Health Center	Phase 4	2013-12-01	The purpose of this study is to find out whether adding insulin after current colorectal cancer surgery promotes making and keeping proteins in the body, and to find out whether or not this effect can be further increased by increasing the amount of protein given.
NCT00313807 ↗	Study of Intravenous Amino Acid Infusion to Prevent Contrast Dye Mediated Renal Damage	Withdrawn	Queen's University	Phase 2	2005-11-01	Exposure to radiographic contrast dye during coronary angiography is well known to cause either transient decreases in renal function or acute renal failure. Although the overall incidence is low, acute renal failure occurs most frequently in patients with both diabetes and chronic renal failure where the average reported incidence is upwards of 20%. The etiology of contrast-induced nephropathy is related to acute decline in renal blood flow following dye exposure resulting in ischemic injury at the level of the medulla. The development of acute renal failure following radiocontrast dye administration is significant because it contributes to morbidity and mortality in patients at risk. The administration of amino acids, either through intravenous infusion or a protein meal, results in a substantial increase in renal plasma flow (RPF) and glomerular filtration rate (GFR). In both healthy subjects and in those with chronic renal failure, an amino acid infusion produces a 20% rise in GFR and effective RPF. We hypothesize that the 20% rise in effective RPF and GFR following an amino acid infusion will counteract the radiocontrast dye-induced vasoconstriction and reduce the renal toxicity of contrast medium in a group of high-risk patients.

Clinical Trial Conditions for TRAVASOL 4.25% IN DEXTROSE 5% IN PLASTIC CONTAINER

Condition Name

Condition Name for TRAVASOL 4.25% IN DEXTROSE 5% IN PLASTIC CONTAINER
Intervention	Trials
Colorectal Cancer	1
Contrast Nephropathy	1
Renal Failure	1

Condition MeSH

Condition MeSH for TRAVASOL 4.25% IN DEXTROSE 5% IN PLASTIC CONTAINER
Intervention	Trials
Colorectal Neoplasms	1
Renal Insufficiency	1
Kidney Diseases	1

Clinical Trial Locations for TRAVASOL 4.25% IN DEXTROSE 5% IN PLASTIC CONTAINER

Trials by Country

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Trials by Country for TRAVASOL 4.25% IN DEXTROSE 5% IN PLASTIC CONTAINER
Location	Trials
Canada	1

Clinical Trial Progress for TRAVASOL 4.25% IN DEXTROSE 5% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for TRAVASOL 4.25% IN DEXTROSE 5% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for TRAVASOL 4.25% IN DEXTROSE 5% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Withdrawn	1
Active, not recruiting	1

Clinical Trial Sponsors for TRAVASOL 4.25% IN DEXTROSE 5% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for TRAVASOL 4.25% IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor	Trials
McGill University Health Centre/Research Institute of the McGill University Health Centre	1
Queen's University	1
Canadian Institutes of Health Research (CIHR)	1

Sponsor Type

Sponsor Type for TRAVASOL 4.25% IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor	Trials
Other	4

Clinical Trials Update, Market Analysis, and Projections for Travasol 4.25% in Dextrose 5%

Introduction

Travasol, a formulation of amino acids with electrolytes in dextrose, is a critical component in parenteral nutrition, providing essential nutrients to patients who cannot receive them through the digestive system. Here, we will delve into the current status of clinical trials, market analysis, and future projections for Travasol 4.25% in Dextrose 5%.

Clinical Trials and Regulatory Status

Current Regulatory Status

Travasol, including the 4.25% amino acid formulation in 5% dextrose, is already approved by regulatory bodies such as the U.S. Food and Drug Administration (FDA). The approval is based on extensive clinical data demonstrating its safety and efficacy in providing parenteral nutrition[2].

Ongoing and Related Studies

While there are no specific ongoing clinical trials exclusively focused on Travasol 4.25% in Dextrose 5%, the broader category of parenteral nutrition solutions continues to be studied in various clinical contexts. For instance, studies on other nutritional formulations and their impact on patient outcomes can provide indirect insights into the efficacy and safety of Travasol.

Market Analysis

Market Demand

The demand for parenteral nutrition solutions, including Travasol, remains steady due to the ongoing need for nutritional support in hospitalized patients and those with chronic conditions that impair digestive function. The market is driven by the increasing prevalence of malnutrition, particularly in critical care settings, and the growing awareness of the importance of nutritional therapy in patient recovery and outcomes.

Competitive Landscape

The market for parenteral nutrition is competitive, with several manufacturers offering similar formulations. Companies like Baxter, B. Braun, and Fresenius Kabi are key players in this segment. Travasol, with its established reputation and FDA approval, holds a significant market share. However, competition is fierce, and manufacturers must continually innovate and improve their products to maintain market position.

Pricing and Reimbursement

The pricing of Travasol 4.25% in Dextrose 5% is influenced by factors such as production costs, regulatory approvals, and reimbursement policies. In the U.S., reimbursement for parenteral nutrition solutions is typically covered under hospital and outpatient services, with rates set by Medicare and other insurance providers. The cost-effectiveness of Travasol compared to other formulations can be a significant factor in its market adoption.

Market Projections

Growth Trends

The global parenteral nutrition market is expected to grow due to increasing healthcare expenditures, an aging population, and the rising incidence of chronic diseases. According to industry reports, the market is projected to grow at a CAGR of around 5-7% over the next few years.

Technological Advancements

Advancements in formulation technology, such as the development of more stable and convenient packaging (e.g., dual-chamber containers), are expected to enhance the market position of Travasol. These innovations can improve patient safety, reduce errors in administration, and make the product more appealing to healthcare providers.

Geographic Expansion

The market for parenteral nutrition solutions is not limited to developed countries; there is a growing demand in emerging markets where healthcare infrastructure is improving. Companies are likely to focus on expanding their distribution networks and marketing efforts in these regions to capture new market opportunities.

Key Takeaways

• Established Regulatory Approval: Travasol 4.25% in Dextrose 5% is already FDA-approved, ensuring its safety and efficacy.
• Steady Market Demand: The need for parenteral nutrition solutions remains consistent, driven by malnutrition in critical care settings.
• Competitive Market: The market is competitive, with several key players; innovation and cost-effectiveness are crucial for market share.
• Growth Projections: The global parenteral nutrition market is expected to grow, driven by healthcare expenditures and an aging population.
• Technological Advancements: Improvements in formulation and packaging technology will enhance the product's appeal and safety.

FAQs

1. What is Travasol 4.25% in Dextrose 5% used for?

   • Travasol 4.25% in Dextrose 5% is used for parenteral nutrition, providing essential amino acids and electrolytes to patients who cannot receive nutrients through the digestive system.

2. Is Travasol 4.25% in Dextrose 5% FDA-approved?

   • Yes, Travasol 4.25% in Dextrose 5% is FDA-approved for use in parenteral nutrition.

3. What are the key drivers of the parenteral nutrition market?

   • The key drivers include the increasing prevalence of malnutrition, growing healthcare expenditures, and an aging population.

4. Who are the main competitors in the parenteral nutrition market?

   • Key competitors include companies like Baxter, B. Braun, and Fresenius Kabi.

5. What are the future growth prospects for Travasol 4.25% in Dextrose 5%?

   • The product is expected to benefit from the overall growth in the parenteral nutrition market, driven by technological advancements and expanding healthcare needs in emerging markets.

Sources

1. CENTER FOR DRUG EVALUATION AND RESEARCH, "Travasol II” - sulfite free (Amino acids) with Electrolytes in Dextrose with Calcium Injections in Clinimix (PL 2401) Dual Chamber Container."
2. CENTER FOR DRUG EVALUATION AND RESEARCH, "Name of Drug: Travasol II” - sulfite free (Amino acids) with Electrolytes in Dextrose with Calcium Injections in Clinimix (PL 2401) Dual Chamber Container."
3. Travere Therapeutics, "Travere Therapeutics Provides Corporate Update and 2024 Outlook."
4. ClinicalTrials.gov, "NCT05524883."
5. Sanofi, "Tolebrutinib meets primary endpoint in HERCULES phase 3 study."