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Last Updated: April 15, 2026

CLINICAL TRIALS PROFILE FOR GLUTAMINE


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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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Glutamine

Condition Name

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

Condition MeSH for Glutamine
Intervention Trials
Depression 13
Depressive Disorder 11
Mucositis 10
Bipolar Disorder 9
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Clinical Trial Locations for Glutamine

Trials by Country

Trials by Country for Glutamine
Location Trials
United States 280
China 10
Egypt 10
India 8
Canada 6
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Trials by US State

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

Clinical Trial Phase

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

Clinical Trial Status for Glutamine
Clinical Trial Phase Trials
Completed 85
Recruiting 33
Terminated 26
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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
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Sponsor Type

Sponsor Type for Glutamine
Sponsor Trials
Other 260
Industry 53
NIH 41
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Clinical Trials Update, Market Analysis, and Projection for Glutamine

Last updated: January 27, 2026

Summary

Glutamine, a non-essential amino acid, plays critical roles in protein synthesis, immune function, and cellular metabolism. Its therapeutic applications span clinical areas such as gastrointestinal health, oncology, and immune modulation. This report synthesizes recent advances in clinical trials, analyzes current market dynamics, and forecasts future trends.

Introduction to Glutamine

  • Approximate global market size (2022): USD 330 million
  • Expected Compound Annual Growth Rate (CAGR): 6.8% (2023–2030)
  • Primary use: Dietary supplements, clinical nutrition, sports medicine, immune support
  • Key manufacturers: Ajinomoto, FrieslandCampina, Glanbia, and Cargill

What are the Latest Developments in Glutamine Clinical Trials?

Recent Clinical Trial Landscape (2020–2023)

Trial Phase Number of Trials Main Focus Conditions Targeted Notable Outcomes
Phase I/II 15 Safety, tolerability, efficacy Cancer cachexia, GI disorders Promising safety profile; some efficacy signals in mucositis
Phase III 4 Confirm efficacy and safety Burns, Crohn's disease, gastric surgery Mixed results; some trials halted due to lack of efficacy
Observational 8 Nutritional status, immune function ICU patients, athletes Demonstrated improved immune markers; limited clinical endpoints

Key Trials of Note

  • NCT04567491: Evaluating glutamine supplementation in preventing mucositis in chemotherapy patients (Phase II; completed 2021). Results indicated reduced mucositis severity but variability in response.
  • NCT03150984: Investigating glutamine's role in enhancing gut barrier function post-surgery (Phase III; ongoing). Preliminary data suggest improved recovery metrics.
  • NCT04678952: Trial on glutamine in critically ill COVID-19 patients. Early findings show enhanced immune response but no definitive clinical benefit.

Mechanistic Insights from Recent Trials

  • Immune modulation: Glutamine supports lymphocyte proliferation and cytokine production.
  • Gut integrity: Promotes enterocyte health, reducing mucosal damage.
  • Metabolic regulation: Influences amino acid transport and oxidative stress, particularly in cachectic or septic patients.

Market Analysis of Glutamine

Current Market Dynamics (2022–2023)

Segment Market Share Key Trends Drivers Challenges
Dietary Supplements 55% Rising health consciousness; sports nutrition Growing fitness culture; aging population Regulatory concerns on health claims
Pharmaceuticals & Medical Nutrition 30% Clinical nutrition in hospital settings Increased focus on critical care nutrition High manufacturing costs
Food & Beverages 10% Functional foods; fortification Demand for protein-enhanced products Stability issues during processing
Others 5% Animal feed, sports products Expanding applications in livestock and athletes Variable regulations across regions

Geographic Market Breakdown (2022)

Region Market Share (%) Key Trends Growth Drivers
North America 45% High supplement consumption; clinical trials focus Aging population, sports nutrition demand
Europe 25% Regulatory clarity; hospital nutrition growth Healthcare infrastructure, aging demographics
Asia-Pacific 20% Rapid economic growth; increasing health awareness Manufacturing hub; expanding supplement market
Rest of the World 10% Emerging markets' interest in functional foods Dietary shifts, urbanization

Market Projection (2023–2030)

Parameter Forecast Value Growth Rate
Market Size (2023) USD 370 million
Predicted Size (2030) USD 640 million 6.8% CAGR
Key Growth Segments Clinical nutrition, sports supplements

Factors Supporting Growth

  • Increasing prevalence of gastrointestinal and immune-related disorders.
  • Growing geriatric population requiring nutritional support.
  • Expanding research validating glutamine's benefits.
  • Rising adoption in sports nutrition for muscle recovery.

Market Barriers

  • Regulatory uncertainties, especially in functional foods.
  • Competition from alternative amino acids and peptides.
  • Variability in clinical evidence for specific indications.
  • Cost of high-purity manufacturing processes.

Comparative Analysis with Similar Amino Acids

Amino Acid Market Size (2022) Major Applications Clinical Evidence Summary Projected Growth (2023–2030)
Glutamine USD 330 million Immunonutrition, GI health, sports Moderate evidence; promising future data 6.8% CAGR
Arginine USD 250 million Vasodilation, immune modulation Well-established in certain uses 5.2% CAGR
Carnitine USD 150 million Metabolic support, weight management Mixed clinical outcomes 4.5% CAGR

Regulatory Environment and Policy Landscape

  • United States (FDA): Dietary supplement regulation under DSHEA; specific health claim approvals limited.
  • European Union (EFSA): Stringent safety and efficacy reviews; some health claims authorized.
  • Asia-Pacific: Varied regulations; increasing oversight but expanding market access.
  • Global trends: Emphasis on Good Manufacturing Practices (GMP); stringent quality standards impacting supply chain.

Key Challenges and Opportunities

Challenges Opportunities
Limited conclusive evidence in certain indications Growing research pipeline; personalized nutrition applications
Regulatory hurdles Expanding markets in emerging economies
Cost-intensive manufacturing Innovative delivery formats (e.g., encapsulated, powders)
Variability in clinical trial outcomes Collaboration with academic and industry partners

FAQs

1. What are the main clinical indications for glutamine?

Glutamine is primarily studied for gut health (trophic effects on intestinal mucosa), immune support, cancer cachexia management, and recovery from surgical or chemotherapy-induced mucositis.

2. How does the market for glutamine compare with other amino acids?

Compared to amino acids like arginine and carnitine, glutamine boasts a larger market share due to its broader application in clinical nutrition and sports supplements, complemented by ongoing research.

3. Are there any safety concerns associated with glutamine supplementation?

Generally regarded as safe (GRAS) when used within recommended doses. However, caution is advised in certain populations, such as individuals with liver or kidney disease. Clinical trials continue to evaluate long-term safety.

4. What regulatory hurdles impact the commercial development of glutamine-based products?

Regulatory agencies require demonstration of safety and efficacy for health claims, which can delay product approval. Variability in policies across regions complicates global deployment.

5. What is the future outlook for glutamine in clinical and consumer markets?

Enhanced understanding of its therapeutic mechanisms, combined with expanding clinical evidence, is expected to drive market growth, especially in personalized nutrition and medical foods.


Key Takeaways

  • Clinical trial activity indicates promising avenues in GI health, immune modulation, and oncology; however, inconsistent results underscore the need for more targeted research.
  • The global glutamine market is projected to grow at a CAGR of approximately 6.8% through 2030, driven by increased clinical applications and wellness trends.
  • Market expansion faces challenges such as regulatory variability, clinical evidence gaps, and manufacturing costs.
  • Strategic positioning in emerging markets and innovative product formats will be critical for growth.
  • Continuous collaboration between industry stakeholders, regulators, and researchers will shape the future development trajectory.

References

  1. ClinicalTrials.gov Database, 2023
  2. MarketWatch, "Global Glutamine Market Size and Forecast," 2023
  3. EFSA Journal, "Opinion on the safety of amino acids including glutamine," 2022
  4. CPhI Report, "Amino Acids and Nutraceuticals Market Trends," 2022
  5. Ajinomoto Group, "Corporate Overview and Market Strategy," 2023

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