CLINICAL TRIALS PROFILE FOR GLUTAMINE

All Clinical Trials for Glutamine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000925 ↗	A Study to Evaluate High Protein Supplementation in HIV-Positive Patients With Stable Weight Loss	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1999-05-01	The purpose of this study is to determine whether a high-quality protein food supplement will help HIV-positive patients maintain, and possibly gain, muscle mass. Many HIV-positive patients lose weight that they are then unable to regain. This may be because patients are not eating enough protein or are not eating the right kinds of protein. The protein eaten in foods (such as meat, eggs, or beans) may not be able to make up for the amount of protein lost due to HIV infection. This study gives patients high-quality protein food supplements to help them maintain and/or gain weight.
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.
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.

Clinical Trial Conditions for Glutamine

Condition Name

Condition Name for Glutamine
Intervention	Trials
Lymphoma	9
Bipolar Depression	7
Critical Illness	6
Schizophrenia	5

Condition MeSH

Condition MeSH for Glutamine
Intervention	Trials
Depression	13
Depressive Disorder	11
Mucositis	9
Bipolar Disorder	9

Clinical Trial Locations for Glutamine

Trials by Country

Trials by Country for Glutamine
Location	Trials
United States	276
China	10
India	8
Egypt	7
Canada	6

Trials by US State

Trials by US State for Glutamine
Location	Trials
Texas	26
New York	17
California	17
Massachusetts	14
Pennsylvania	12

Clinical Trial Progress for Glutamine

Clinical Trial Phase

Clinical Trial Phase for Glutamine
Clinical Trial Phase	Trials
Phase 4	25
Phase 3	33
Phase 2/Phase 3	13

Clinical Trial Status

Clinical Trial Status for Glutamine
Clinical Trial Phase	Trials
Completed	82
Recruiting	28
Terminated	26

Clinical Trial Sponsors for Glutamine

Sponsor Name

Sponsor Name for Glutamine
Sponsor	Trials
M.D. Anderson Cancer Center	14
National Cancer Institute (NCI)	9
Emmaus Medical, Inc.	7

Sponsor Type

Sponsor Type for Glutamine
Sponsor	Trials
Other	248
Industry	51
NIH	41

The Role of Glutamine in Clinical Trials, Market Analysis, and Projections

Introduction to Glutamine

Glutamine is an amino acid and a derivative of glutamic acid, playing a crucial role in various biological processes, including the synthesis of amino acids, nucleotides, and the tricarboxylic acid (TCA) cycle. Its significance extends across multiple industries, including pharmaceuticals, dietary supplements, and cosmetics.

Clinical Trials: Targeting Glutamine Metabolism in Cancer

The Significance of Glutamine in Cancer Cells

Cancer cells have a high dependency on glutamine for their rapid growth and survival. This dependency is being exploited in clinical trials to develop effective cancer treatments. Glutamine serves as a critical nitrogen and carbon source for cancer cells, making it a viable target for therapeutic interventions[4].

Current Clinical Trials

Several clinical trials are underway to target glutamine metabolism in cancer treatment. One notable example is the use of DRP-104, a glutamine antagonist, in combination with durvalumab for patients with advanced-stage fibrolamellar carcinoma. This trial, conducted at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, has recently been updated to allow patients to self-administer the drug at home, reducing the need for frequent clinic visits[1].

Another promising drug is CB-839 (Telaglenastat), which inhibits glutaminase, an enzyme crucial for glutamine metabolism. CB-839 has been tested in various clinical trials for cancers such as colorectal, triple-negative breast, renal cell carcinoma, and melanoma. The combination of CB-839 with other drugs, like metformin, has shown significant therapeutic effects in inhibiting tumor growth and metastasis[4].

Future Directions in Glutamine-Targeting Therapies

The future of glutamine-targeting therapies looks promising, with ongoing research focusing on combination therapies to overcome tumor resistance. For instance, combining glutaminase inhibitors with other metabolic inhibitors or immunotherapies is being explored to enhance treatment efficacy. These strategies aim to exploit the metabolic vulnerabilities of cancer cells, offering new hope for cancer patients[4].

Market Analysis of Glutamine

Global Market Size and Growth

The global glutamine market is projected to experience steady growth over the coming years. According to market research reports, the global L-glutamine market is expected to reach USD 0.28 billion by 2030, growing at a CAGR of 4.3% during the forecast period of 2024-2030[2].

Market Segmentation

The glutamine market is segmented by type, application, and company. The key types include pharmaceutical grade and nutraceutical grade glutamine. Applications span dietary supplements, sports nutrition, clinical nutrition, and food and beverages. Major players in the market include Ajinomoto, Kyowa Hakko Kirin, Daesang, Meihua, and Fufeng[2].

Pharmaceutical Grade Glutamine Market

The pharmaceutical grade glutamine market is particularly noteworthy, with a valuation of US$ 45 million in 2023 and projected to reach US$ 57 million by 2030, growing at a CAGR of 3.5% during the forecast period. This segment is driven by the increasing demand for glutamine in the production of medicines for various medical conditions, such as sickle cell disease, abdominal pain, and irritable bowel syndrome[5].

Market Drivers and Trends

Increasing Demand in Pharmaceuticals

The pharmaceutical industry is a significant driver of the glutamine market, with glutamine being used in the production of medicines for several conditions. The total production of pharmaceuticals in Europe, for example, was valued at approximately US$354 billion in 2020, indicating a substantial market for pharmaceutical-grade glutamine[3].

Growing Cosmetics and Personal Care Sector

Glutamine is also used in the production of cosmetics and personal care products due to its benefits in skin healing, hydration, and collagen generation. The cosmetics and personal care industry, particularly in regions like South Korea, has seen significant growth, contributing to the increased demand for glutamine[3].

Sports Nutrition and Dietary Supplements

The sports nutrition and dietary supplements sectors are other key drivers of the glutamine market. Glutamine supplements are popular among athletes and fitness enthusiasts due to their role in muscle recovery and immune function. Intense workouts deplete glutamine levels, leading to fatigue and reduced recovery, making supplements a necessity for many[2].

Key Takeaways

• Clinical Trials: Glutamine metabolism is a promising target for cancer therapy, with ongoing clinical trials showing significant therapeutic effects.
• Market Growth: The global glutamine market is expected to grow steadily, driven by increasing demand in pharmaceuticals, cosmetics, and sports nutrition.
• Segmentation: The market is segmented by type, application, and company, with pharmaceutical grade glutamine being a significant segment.
• Market Drivers: The pharmaceutical industry, cosmetics and personal care sector, and sports nutrition market are key drivers of the glutamine market.

FAQs

What is the current status of clinical trials targeting glutamine metabolism in cancer?

Clinical trials are ongoing, with drugs like DRP-104 and CB-839 showing promising results in targeting glutamine metabolism for cancer treatment.

What is the projected growth of the global glutamine market?

The global glutamine market is expected to reach USD 0.28 billion by 2030, growing at a CAGR of 4.3% during the forecast period of 2024-2030.

Which industries are the primary consumers of glutamine?

The primary consumers include the pharmaceutical industry, cosmetics and personal care sector, and the sports nutrition and dietary supplements market.

What are the benefits of glutamine in cosmetics and personal care products?

Glutamine aids in skin healing, hydration, generates more collagen, increases skin cell turnover, and acts as an antioxidant for the skin.

Why is glutamine important for athletes and fitness enthusiasts?

Glutamine is important for muscle recovery and immune function, as intense workouts deplete glutamine levels, leading to fatigue and reduced recovery.

Sources

1. Fibrolamellar Cancer Foundation: "Glutamine antagonist trial update"
2. OpenPR: "L-Glutamine (Gln) Market Growth in 2024-2030: Dynamics"
3. IndustryARC: "Glutamine Market Size Report, 2022-2027"
4. Frontiers in Pharmacology: "Exploiting the Achilles’ heel of cancer: disrupting glutamine metabolism"
5. Valuates Reports: "Global Pharma Grade Glutamine Market Research Report 2024"