CLINICAL TRIALS PROFILE FOR TROPHAMINE

All Clinical Trials for TROPHAMINE

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

Condition Name

Condition Name for TROPHAMINE
Intervention	Trials
Infant, Low Birth Weight	2
Infant, Premature	1
Infant, Small for Gestational Age	1
Sepsis	1

Condition MeSH

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

Clinical Trial Locations for TROPHAMINE

Trials by Country

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Trials by Country for TROPHAMINE
Location	Trials
United States	13

Trials by US State

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−

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

Clinical Trial Progress for TROPHAMINE

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for TROPHAMINE

Sponsor Name

Sponsor Name for TROPHAMINE
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
Sponsor	Trials
NIH	2
Other	2

TrophAmine®: Clinical Trials, Market Analysis, and Projections

Introduction to TrophAmine®

TrophAmine® is an amino acid injection specifically formulated to provide a well-tolerated nitrogen source for nutritional support and therapy, particularly in infants and young pediatric patients. It is designed to normalize plasma amino acid concentrations when used in conjunction with cysteine hydrochloride, mimicking the amino acid profile of a breast-fed infant[1].

Clinical Trials and Outcomes

Early Amino Acid Administration in Preterm Infants

A significant clinical trial involving TrophAmine® focused on the administration of amino acids in extremely preterm infants. This multi-center, double-blind, randomized control trial investigated whether higher parenteral protein administration in the first 5 days of life would improve neurodevelopmental outcomes at 2 years of corrected gestational age.

• Design and Methodology: Infants were randomized to receive either 8.5% TrophAmine containing 1 gram of amino acids or 0.45% saline. The intervention was administered via umbilical arterial catheter (UAC) for 120 hours or until the UAC was removed.
• Outcomes: The study found that higher parenteral protein administration did not significantly improve neurodevelopmental outcomes at 2 years. However, it highlighted the importance of early amino acid administration in maintaining nutritional status and supporting growth in preterm infants[4].

Nutritional Support and Therapy

Clinical studies have shown that TrophAmine® with cysteine hydrochloride results in the normalization of plasma amino acid concentrations, consistent with those of a breast-fed infant. This formulation has been associated with improved weight gains, nitrogen balance, and serum protein concentrations, indicating an improving nutritional status in infants and young pediatric patients[1].

Market Analysis

Current Market Size and Growth

The amino acid metabolism disorders treatment market, which includes products like TrophAmine®, is experiencing significant growth. As of 2022, the market size was valued at over $814.27 million and is projected to reach $1.39 billion by 2032, reflecting a Compound Annual Growth Rate (CAGR) of 6.2%[5].

Regional Market Analysis

• North America: This region currently holds the largest market share for amino acid metabolism disorders treatments, driven by the availability of treatments and well-established healthcare infrastructure. It is expected to maintain its lead during the forecast period[2].
• Asia-Pacific: This region is anticipated to register the highest CAGR of 5.5% from 2022 to 2031, driven by an increase in the prevalence of amino acid metabolism disorders and rising healthcare expenditure[2].

Product Segment Review

The market is segmented by product type, with sapropterin and betaine being key segments. While sapropterin exhibited high growth in 2021 due to its demand in treating phenylketonuria, the betaine segment is expected to register the highest CAGR of 5.4% from 2022 to 2031 due to increased product offerings by key market players[2].

Distribution Channel Analysis

The market is also segmented by distribution channels, with drug stores and retail pharmacies dominating the market share in 2021. However, online providers are expected to register the highest CAGR of 6.0% from 2022 to 2031, driven by the shift in patient preference towards online purchases post-COVID-19 pandemic[2].

Market Projections

Growth Drivers

• Increasing Prevalence: The rise in prevalence of amino acid metabolism disorders such as maple syrup urine disease, phenylketonuria, and citrullinemia is a significant driver of market growth[2].
• Research and Development: Increased research and development activities focused on treating these disorders are also contributing to market expansion[2].
• Healthcare Infrastructure: Development of healthcare infrastructure and increased disposable income in developing countries are additional factors driving growth[2].

Challenges

• High Treatment Costs: The high cost of treatments and amino acid supplements is a significant challenge for market growth[2].
• Lack of Awareness: Limited awareness about amino acid metabolism disorders and their associated treatments also hampers market expansion[2].

Key Takeaways

• Clinical Trials: TrophAmine® has been shown to normalize plasma amino acid concentrations and support nutritional status in infants and young pediatric patients.
• Market Growth: The amino acid metabolism disorders treatment market is projected to grow significantly, reaching $1.39 billion by 2032.
• Regional Dominance: North America currently leads the market, while Asia-Pacific is expected to show the highest growth rate.
• Product Segments: Sapropterin and betaine are key product segments, with betaine expected to show the highest CAGR.
• Distribution Channels: Online providers are expected to grow significantly due to increased online purchases.

FAQs

What is TrophAmine® used for?

TrophAmine® is used for nutritional support and therapy in infants and young pediatric patients, particularly those requiring total parenteral nutrition (TPN).

What are the key components of TrophAmine®?

TrophAmine® is an amino acid injection that, when used with cysteine hydrochloride, normalizes plasma amino acid concentrations to a profile consistent with that of a breast-fed infant.

What is the current market size for amino acid metabolism disorders treatments?

As of 2022, the market size was valued at over $814.27 million.

Which region is expected to show the highest growth rate in the amino acid metabolism disorders treatment market?

The Asia-Pacific region is expected to register the highest CAGR of 5.5% from 2022 to 2031.

What are the main challenges facing the amino acid metabolism disorders treatment market?

High treatment costs, lack of awareness about amino acid metabolism disorders, and associated side effects of treatments are significant challenges.

Sources

1. FDA Label: TrophAmine® (Amino Acid Injection) Label.
2. Allied Market Research: Amino Acid Metabolism Disorders Treatment Market Forecast - 2031.
3. Marinus Pharmaceuticals: Update on the Phase 3 RAISE Trial (Note: This source is not directly related to TrophAmine® but provides context on clinical trials and market dynamics).
4. EBNEO: Early Amino Acids in Extremely Preterm Infants and Neurodisability Outcomes.
5. PharmiWeb: Amino Acid Metabolism Disorders Treatment Market is expected to reach US$1.39 Billion by 2032.