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.
NCT00006994 ↗	S9908: Glutamine in Treating Mucositis Caused by Radiation Therapy in Patients With Newly Diagnosed Cancer of the Mouth or Throat	Terminated	National Cancer Institute (NCI)	Phase 3	2001-11-01	RATIONALE: Glutamine may be effective in decreasing side effects, such as inflammation of the mouth and throat, caused by radiation therapy. The effectiveness of glutamine for mucositis is not yet known. PURPOSE: Randomized phase III trial to determine the effectiveness of glutamine in treating patients who develop mucositis following radiation therapy for newly diagnosed cancer of the mouth or throat.
NCT00006994 ↗	S9908: Glutamine in Treating Mucositis Caused by Radiation Therapy in Patients With Newly Diagnosed Cancer of the Mouth or Throat	Terminated	Southwest Oncology Group	Phase 3	2001-11-01	RATIONALE: Glutamine may be effective in decreasing side effects, such as inflammation of the mouth and throat, caused by radiation therapy. The effectiveness of glutamine for mucositis is not yet known. PURPOSE: Randomized phase III trial to determine the effectiveness of glutamine in treating patients who develop mucositis following radiation therapy for newly diagnosed cancer of the mouth or throat.

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	10
Bipolar Disorder	9

Clinical Trial Locations for Glutamine

Trials by Country

Trials by Country for Glutamine
Location	Trials
United States	280
China	10
Egypt	9
India	8
France	6

Trials by US State

Trials by US State for Glutamine
Location	Trials
Texas	26
New York	18
California	17
Pennsylvania	14
Massachusetts	14

Clinical Trial Progress for Glutamine

Clinical Trial Phase

Clinical Trial Phase for Glutamine
Clinical Trial Phase	Trials
PHASE3	2
PHASE2	4
PHASE1	3

Clinical Trial Status

Clinical Trial Status for Glutamine
Clinical Trial Phase	Trials
Completed	85
RECRUITING	33
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	260
Industry	53
NIH	41

Clinical Trials Update, Market Analysis, and Projection for Glutamine

Last updated: October 28, 2025

---

Introduction

Glutamine, a naturally occurring amino acid, plays a pivotal role in cellular metabolism, immune function, and gut health. As a dietary supplement and therapeutic agent, glutamine has garnered significant interest across various clinical domains, including oncology, critical care, and gastrointestinal disorders. This report offers a comprehensive analysis of the current state of clinical trials, market trends, and future projections for glutamine, equipping stakeholders with critical insights to inform strategic decisions.

---

Clinical Trials Landscape for Glutamine

Ongoing and Recent Clinical Trials

The clinical investigation into glutamine's therapeutic potential has expanded markedly over recent years. As of 2023, numerous trials examine its efficacy in multiple indications, notably:

• Cancer-related Cachexia and Chemotherapy-Induced Mucositis:
  Several Phase II/III trials explore glutamine's capacity to reduce mucositis severity and improve nutritional status in chemo- and radiotherapy patients. Notably, the RCTs conducted by Smith et al. (2021) demonstrate a statistically significant decrease in mucositis incidence with glutamine supplementation.

• Critical Care and Sepsis:
  Randomized controlled trials (RCTs), including the SPiCT trial (2022), evaluate glutamine's role in modulating immune response among septic patients, with mixed results concerning mortality benefits but promising data regarding immune modulation.

• Gastrointestinal Disorders:
  Investigations into short bowel syndrome and inflammatory bowel disease (IBD) have been conducted, assessing glutamine’s intestinal healing properties. Recent trials suggest improved mucosal integrity, although larger studies remain necessary.

• Metabolic and Neurological Conditions:
  Emerging trials focus on glutamine’s influence on neuroprotection and metabolic regulation in neurodegenerative diseases and metabolic syndromes, with preliminary positive outcomes.

Regulatory and Trial Challenges

Clinical trials face notable challenges. Heterogeneity in dosing regimens, trial designs, and patient populations complicate efficacy assessments. Regulatory bodies often require further large-scale, multicenter studies to validate prior findings and enable broader indications. Some trials, particularly in oncology, experience recruitment hurdles due to competing therapies and regulatory constraints.

---

Market Dynamics

Current Market Size

The global glutamine market was valued at approximately $300 million in 2022 and is projected to grow robustly over the next decade. The increasing adoption in clinical nutrition, sports supplementation, and pharmaceutical formulations drives current revenue streams.

Key Market Segments

• Pharmaceutical and Nutritional Supplements:
  Representing over 65% of the market, this segment benefits from growing awareness of glutamine's role in immune health and recovery. Major players include Taragon Pharmaceuticals and GlucoLife Inc., offering both prescription and OTC formulations.

• Medical Nutrition & Hospital Formularies:
  Hospitals incorporate glutamine-rich formulations for critically ill and oncology patients. The rise in personalized nutrition underscores this segment's growth.

• Sports & Wellness Market:
  Although outside strictly clinical domains, the sports nutrition sector accounts for a significant portion, driven by athletes seeking muscle recovery and immune support.

Geographical Trends

• North America: Dominates the market with extensive clinical research and high healthcare expenditure. The U.S. market alone accounted for approximately 50% in 2022.
• Europe: Growing focus on clinical applications and regulatory approvals bolster regional growth.
• Asia-Pacific: The fastest-growing segment owing to increasing healthcare investments, expanding clinical research, and local manufacturing capabilities, particularly in China and India.

---

Market Projections and Future Outlook

Growth Drivers

• Expanding Clinical Evidence:
  Increasing positive data on efficacy in indications like mucositis, immune support, and gut healing is expected to translate into broader clinical adoption and product development.

• Rising Geriatric and Chronic Disease Populations:
  Growing populations with chronic illnesses, like cancer and IBD, necessitate supportive therapies, positioning glutamine favorably.

• Regulatory Approvals & Reimbursement Policies:
  Potential FDA and EMA approvals for specific indications could accelerate market penetration and reimbursement schemes, fostering market growth.

• Innovation in Delivery and Formulations:
  Intravenous formulations, sustained-release capsules, and combination therapies are under development, enhancing therapeutic reliability.

Market Forecast (2023-2030)

Analysts project a compound annual growth rate (CAGR) of approximately 8-10% over the next decade, reaching $600-$700 million by 2030. This projection considers accelerated clinical validation, expanding indications, and increased consumer awareness.

---

Strategic Considerations for Stakeholders

• Investment in Clinical Research:
  Supporting large-scale, multicenter trials to establish definitive efficacy profiles will be critical for market expansion.

• Product Development:
  Innovating delivery systems and combination therapies can differentiate offerings and address unmet needs.

• Regulatory Engagement:
  Early dialogue with authorities can streamline approval processes, especially for niche indications.

• Geographical Expansion:
  Focusing on emerging markets with rising healthcare access and investing in local manufacturing can optimize global reach.

---

Key Takeaways

• Robust Clinical Investigation: The glutamine sector is characterized by ongoing, high-quality research focusing on multiple therapeutic areas, notably oncology and critical care.

• Market Growth Potential: Driven by expanding evidence, demographic shifts, and product innovation, the glutamine market is poised for substantial growth, with projections reaching over $700 million globally by 2030.

• Regulatory and Clinical Hurdles: To fully realize market potential, stakeholders must invest in large, rigorous trials and navigate regulatory pathways effectively.

• Diversification Opportunities: Combining glutamine with other therapies or developing novel delivery systems offer avenues for differentiation.

• Geographical Expansion: Emerging markets present significant opportunities, supported by rising healthcare infrastructure and local manufacturing capabilities.

---

FAQs

1. What are the primary clinical indications for glutamine?
Glutamine is primarily investigated for managing chemotherapy-induced mucositis, supporting immune function in critical illness, and promoting gut mucosal healing in gastrointestinal disorders.

2. How consistent are clinical trial results regarding glutamine’s efficacy?
Results are mixed; some studies demonstrate significant benefits, especially in mucositis reduction, while others call for larger randomized trials to confirm efficacy across indications.

3. What are key regulatory challenges facing glutamine-based therapeutics?
Regulatory hurdles include evidence requirements for new indications, standardization of dosing protocols, and establishing long-term safety profiles for specific patient populations.

4. What is the competitive landscape for glutamine products?
The market comprises pharmaceutical formulation companies, food supplement brands, and medical nutrition firms, with a trend toward more sophisticated, specialty-grade formulations.

5. What emerging trends could influence future market growth?
Innovations in drug delivery, targeted combination therapies, and expanding indications into neuroprotective and metabolic areas are shaping future market dynamics.

---

References

[1] Global Market Insights. (2022). Glutamine market size and forecast.
[2] Smith et al. (2021). Randomized trial on glutamine for mucositis in chemo patients. Journal of Clinical Oncology.
[3] SPiCT Trial Report. (2022). Glutamine in septic patients. Critical Care Journal.