CLINICAL TRIALS PROFILE FOR TROPHAMINE 10%

All Clinical Trials for TROPHAMINE 10%

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00005889 ↗	Gluconeogenesis in Very Low Birth Weight Infants Who Are Receiving Nutrition By Intravenous Infusion	Unknown status	Baylor College of Medicine	N/A	1999-10-01	RATIONALE: Very low birth weight infants have problems maintaining normal blood sugar levels. Gluconeogenesis is the production of sugar from amino acids and fats. The best combination of amino acids, fat, and sugar to help very low birth weigh infants maintain normal blood sugar levels is not yet known. PURPOSE: Clinical trial to study how very low birth weight infants break down amino acids, fat, and sugar given by intravenous infusion, and the effect of different combinations of nutrients on the infants' ability to maintain normal blood sugar levels.
NCT00005889 ↗	Gluconeogenesis in Very Low Birth Weight Infants Who Are Receiving Nutrition By Intravenous Infusion	Unknown status	National Center for Research Resources (NCRR)	N/A	1999-10-01	RATIONALE: Very low birth weight infants have problems maintaining normal blood sugar levels. Gluconeogenesis is the production of sugar from amino acids and fats. The best combination of amino acids, fat, and sugar to help very low birth weigh infants maintain normal blood sugar levels is not yet known. PURPOSE: Clinical trial to study how very low birth weight infants break down amino acids, fat, and sugar given by intravenous infusion, and the effect of different combinations of nutrients on the infants' ability to maintain normal blood sugar levels.
NCT00005775 ↗	Glutamine Supplementation to Prevent Death or Infection in Extremely Premature Infants	Completed	National Center for Research Resources (NCRR)	Phase 3	1999-07-01	This large multicenter double-masked clinical trial tested whether supplementation of standard neonatal parenteral nutrition with glutamine would reduce the risk of death or late-onset sepsis in extremely-low-birth-weight (ELBW, less than or equal to 1000 gm) infants. Neonates with birth weights of 401-1000gm were randomized to standard TrophAmine or TrophAmine supplemented with glutamine before 72 hours and continued until the infants are tolerating full enteral feedings.
NCT00005775 ↗	Glutamine Supplementation to Prevent Death or Infection in Extremely Premature Infants	Completed	NICHD Neonatal Research Network	Phase 3	1999-07-01	This large multicenter double-masked clinical trial tested whether supplementation of standard neonatal parenteral nutrition with glutamine would reduce the risk of death or late-onset sepsis in extremely-low-birth-weight (ELBW, less than or equal to 1000 gm) infants. Neonates with birth weights of 401-1000gm were randomized to standard TrophAmine or TrophAmine supplemented with glutamine before 72 hours and continued until the infants are tolerating full enteral feedings.

Clinical Trial Conditions for TROPHAMINE 10%

Condition Name

Condition Name for TROPHAMINE 10%
Intervention	Trials
Infant, Low Birth Weight	2
Hyperglycemia	1
Infant, Newborn	1
Infant, Premature	1

Condition MeSH

Condition MeSH for TROPHAMINE 10%
Intervention	Trials
Birth Weight	2
Premature Birth	1
Hyperglycemia	1
Body Weight	1

Clinical Trial Locations for TROPHAMINE 10%

Trials by Country

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Trials by Country for TROPHAMINE 10%
Location	Trials
United States	13

Trials by US State

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Trials by US State for TROPHAMINE 10%
Location	Trials
Texas	2
Rhode Island	1
Ohio	1
North Carolina	1
New Mexico	1

Clinical Trial Progress for TROPHAMINE 10%

Clinical Trial Phase

Clinical Trial Phase for TROPHAMINE 10%
Clinical Trial Phase	Trials
Phase 3	1
N/A	1

Clinical Trial Status

Clinical Trial Status for TROPHAMINE 10%
Clinical Trial Phase	Trials
Completed	1
Unknown status	1

Clinical Trial Sponsors for TROPHAMINE 10%

Sponsor Name

Sponsor Name for TROPHAMINE 10%
Sponsor	Trials
National Center for Research Resources (NCRR)	2
NICHD Neonatal Research Network	1
Baylor College of Medicine	1

Sponsor Type

Sponsor Type for TROPHAMINE 10%
Sponsor	Trials
NIH	2
Other	2

TrophAmine 10%: Clinical Trials, Market Analysis, and Projections

Introduction

TrophAmine 10% is a sterile, nonpyrogenic, hypertonic solution containing crystalline amino acids, designed for the nutritional support of infants and young pediatric patients. Here, we will delve into the current clinical trials, market analysis, and future projections for this critical nutritional therapy.

Clinical Indications and Usage

TrophAmine 10% is indicated for the nutritional support of infants, including those of low birth weight, and young pediatric patients who require total parenteral nutrition (TPN) via either central or peripheral infusion routes. It is used to prevent nitrogen and weight loss or treat negative nitrogen balance in patients where the alimentary tract cannot or should not be used, or when gastrointestinal absorption of protein is impaired[5].

Clinical Trials and Studies

While there are no ongoing phase 3 trials specifically focused on TrophAmine 10% as of the latest updates, several clinical studies have been conducted to establish its efficacy and safety.

• Previous Clinical Studies: These studies have shown that infusion of TrophAmine 10% with cysteine hydrochloride results in the normalization of plasma amino acid concentrations, consistent with those of a breast-fed infant. These studies also demonstrated weight gains, improved nitrogen balance, and serum protein concentrations, indicating an improving nutritional status[4][5].

Market Analysis

Current Market Position

TrophAmine 10% holds a significant position in the market for parenteral nutrition solutions, particularly for pediatric patients. Its formulation, which includes a mixture of essential and nonessential amino acids, taurine, and a soluble form of tyrosine (N-Acetyl-L-Tyrosine), makes it a well-tolerated nitrogen source.

Competitors

The market for parenteral nutrition solutions is competitive, with other amino acid injections available. However, TrophAmine 10% stands out due to its specific formulation designed to meet the nutritional needs of infants and young pediatric patients.

Market Trends

There is a growing demand for advanced nutritional therapies, especially in pediatric care. The increasing awareness of the importance of nutritional support in patient recovery and the advancement in parenteral nutrition formulations are driving the market growth.

Market Projections

Growth Potential

The market for parenteral nutrition is expected to grow due to the increasing need for specialized nutritional support, particularly in pediatric and neonatal care. TrophAmine 10% is poised to benefit from this trend, given its established efficacy and safety profile.

Regulatory Environment

The regulatory environment remains favorable, with TrophAmine 10% already approved and widely used. Any future updates or expansions in indications could further enhance its market position.

Financial Projections

Revenue

Given the stable demand and the lack of significant competition specifically targeting the pediatric segment, TrophAmine 10% is expected to maintain a steady revenue stream. The exact financial projections would depend on market dynamics, pricing strategies, and any potential new indications or formulations.

Cost and Pricing

The cost of TrophAmine 10% is influenced by factors such as production costs, market competition, and regulatory approvals. The pricing strategy will need to balance profitability with affordability to ensure continued market presence.

Future Developments

Potential New Indications

While there are no current phase 3 trials for new indications of TrophAmine 10%, future research could explore its use in other patient populations or conditions where advanced nutritional support is necessary.

Formulation Enhancements

Continuous improvements in the formulation, such as enhancing the stability or ease of administration, could further solidify TrophAmine 10%'s position in the market.

Key Takeaways

• Established Efficacy: TrophAmine 10% has been shown to normalize plasma amino acid concentrations and improve nutritional status in infants and young pediatric patients.
• Market Position: It holds a significant position in the parenteral nutrition market, particularly for pediatric care.
• Growth Potential: The market for parenteral nutrition is expected to grow, driven by increasing demand for specialized nutritional therapies.
• Regulatory Favorability: The product is already approved, and any future updates could enhance its market position.
• Financial Stability: Expected to maintain a steady revenue stream due to stable demand and lack of significant competition.

FAQs

What is TrophAmine 10% used for?

TrophAmine 10% is used for the nutritional support of infants and young pediatric patients requiring total parenteral nutrition (TPN) via either central or peripheral infusion routes.

What are the key components of TrophAmine 10%?

TrophAmine 10% contains a mixture of essential and nonessential amino acids, taurine, and a soluble form of tyrosine (N-Acetyl-L-Tyrosine).

What are the clinical benefits of TrophAmine 10%?

Clinical studies have shown that TrophAmine 10% normalizes plasma amino acid concentrations, leads to weight gains, improves nitrogen balance, and increases serum protein concentrations.

Is TrophAmine 10% approved by regulatory authorities?

Yes, TrophAmine 10% is approved for use in infants and young pediatric patients requiring TPN.

What is the market outlook for TrophAmine 10%?

The market for parenteral nutrition solutions is expected to grow, and TrophAmine 10% is poised to benefit from this trend due to its established efficacy and safety profile.

Sources

1. TrophAmine® in a Flexible Container, 500 mL - B. Braun Medical Inc.
2. TrophAmine® (Amino Acid Injection) - DailyMed
3. Table of Contents TrophAmine® (Amino Acid Injection) - FDA
4. Clinical studies in infants and young pediatric patients who required TPN therapy - FDA
5. TrophAmine® (Amino Acid Injection) - DailyMed