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Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR NUTRESTORE


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All Clinical Trials for Nutrestore

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00195013 ↗ Randomized Placebo-Controlled Trial of Glutamine for Breast Cancer Patients With Peripheral Neuropathy Completed Linda Vahdat Phase 3 2003-12-01 Patients with breast cancer receiving paclitaxel chemotherapy who have mild symptoms of peripheral neuropathy will receive glutamine or placebo to try and improve symptoms.
NCT00195013 ↗ Randomized Placebo-Controlled Trial of Glutamine for Breast Cancer Patients With Peripheral Neuropathy Completed Weill Medical College of Cornell University Phase 3 2003-12-01 Patients with breast cancer receiving paclitaxel chemotherapy who have mild symptoms of peripheral neuropathy will receive glutamine or placebo to try and improve symptoms.
NCT01576003 ↗ Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants Completed Emmaus Medical, Inc. N/A 2012-04-01 The purpose of this research study is to evaluate the effects (good and bad) of supplementation with Glutamine to that of a placebo (L-alanine), on your child and their Short Bowel Syndrome. Researchers are doing this study to see if the addition of Glutamine to oral/tube feeding (nutrition therapy) will work better by preventing bloodstream infections, improving growth, and/or changing the make-up of bacteria in your child's intestine. Glutamine is approved by the FDA for use in adults with Short Bowel Syndrome. In this study, the investigators will be assessing how well Glutamine affects Short Bowel Syndrome in children.
NCT01576003 ↗ Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants Completed Emory University N/A 2012-04-01 The purpose of this research study is to evaluate the effects (good and bad) of supplementation with Glutamine to that of a placebo (L-alanine), on your child and their Short Bowel Syndrome. Researchers are doing this study to see if the addition of Glutamine to oral/tube feeding (nutrition therapy) will work better by preventing bloodstream infections, improving growth, and/or changing the make-up of bacteria in your child's intestine. Glutamine is approved by the FDA for use in adults with Short Bowel Syndrome. In this study, the investigators will be assessing how well Glutamine affects Short Bowel Syndrome in children.
NCT01576003 ↗ Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) N/A 2012-04-01 The purpose of this research study is to evaluate the effects (good and bad) of supplementation with Glutamine to that of a placebo (L-alanine), on your child and their Short Bowel Syndrome. Researchers are doing this study to see if the addition of Glutamine to oral/tube feeding (nutrition therapy) will work better by preventing bloodstream infections, improving growth, and/or changing the make-up of bacteria in your child's intestine. Glutamine is approved by the FDA for use in adults with Short Bowel Syndrome. In this study, the investigators will be assessing how well Glutamine affects Short Bowel Syndrome in children.
NCT01576003 ↗ Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants Completed University of Colorado, Denver N/A 2012-04-01 The purpose of this research study is to evaluate the effects (good and bad) of supplementation with Glutamine to that of a placebo (L-alanine), on your child and their Short Bowel Syndrome. Researchers are doing this study to see if the addition of Glutamine to oral/tube feeding (nutrition therapy) will work better by preventing bloodstream infections, improving growth, and/or changing the make-up of bacteria in your child's intestine. Glutamine is approved by the FDA for use in adults with Short Bowel Syndrome. In this study, the investigators will be assessing how well Glutamine affects Short Bowel Syndrome in children.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Nutrestore

Condition Name

Condition Name for Nutrestore
Intervention Trials
Lymphoma 5
Multiple Myeloma 2
Peripheral Neuropathy 2
Development 1
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Condition MeSH

Condition MeSH for Nutrestore
Intervention Trials
Lymphoma 5
Neoplasms, Plasma Cell 3
Multiple Myeloma 3
Lymphoma, Large B-Cell, Diffuse 2
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Clinical Trial Locations for Nutrestore

Trials by Country

Trials by Country for Nutrestore
Location Trials
United States 10
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Trials by US State

Trials by US State for Nutrestore
Location Trials
Texas 5
Ohio 2
Massachusetts 1
Michigan 1
New York 1
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Clinical Trial Progress for Nutrestore

Clinical Trial Phase

Clinical Trial Phase for Nutrestore
Clinical Trial Phase Trials
Phase 3 1
Phase 2 4
Phase 1/Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Nutrestore
Clinical Trial Phase Trials
Completed 4
Withdrawn 3
Terminated 2
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Clinical Trial Sponsors for Nutrestore

Sponsor Name

Sponsor Name for Nutrestore
Sponsor Trials
M.D. Anderson Cancer Center 7
National Cancer Institute (NCI) 3
University of Colorado, Denver 1
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Sponsor Type

Sponsor Type for Nutrestore
Sponsor Trials
Other 15
NIH 4
Industry 4
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Nutrestore: Clinical Trials, Market Analysis, and Projections

Introduction to Nutrestore

Nutrestore, also known as glutamine, is a medication approved for the treatment of short bowel syndrome (SBS), a condition where a significant portion of the small intestine is missing or not functioning properly. Here, we will delve into the clinical trials, market analysis, and projections for Nutrestore.

Clinical Trials and Approval

FDA Approval and Usage

Nutrestore, or glutamine, is approved by the FDA for use in patients with short bowel syndrome, particularly those on specialized nutrition. It is often administered in conjunction with growth hormone to enhance its efficacy[4].

Clinical Efficacy

Clinical trials have shown that Nutrestore, when used in combination with other treatments such as growth hormone, can improve nutritional outcomes and reduce the need for parenteral nutrition in patients with SBS. However, the growth of this segment is modest due to the limited scope of its application and the availability of other treatment options[4].

Market Analysis

Global Short Bowel Syndrome Market

The global short bowel syndrome market, within which Nutrestore operates, was valued at $1.14 billion in 2023 and is projected to grow to $2.60 billion by 2032, exhibiting a CAGR of 7.9% during the forecast period. This growth is driven by the increasing prevalence of diseases causing SBS, such as Crohn's disease, and the need for advanced treatment options[3].

Segment Performance

The segment of drugs used for treating short bowel syndrome, including Nutrestore, is expected to record modest growth. This is because these drugs are primarily used to manage symptoms such as diarrhea and gastric acid secretions, rather than addressing the underlying condition. The growth hormone segment, which includes drugs like Zorbtive, is anticipated to have a higher CAGR, although it is also impacted by patent expiries[4].

Regional Market

North America dominates the short bowel syndrome market, with a significant market share in 2023. This region is expected to continue leading the market due to the presence of a large patient pool and the extended use of approved drugs for both adult and pediatric populations[3].

Market Projections

Growth Drivers

The market for Nutrestore and other SBS treatments is driven by several factors:

  • Increasing Patient Pool: The growing number of patients with short bowel syndrome, particularly in North America, is a key driver.
  • Pipeline Drugs: Strong pipeline drugs, such as Zealand Pharma’s Glepaglutide (ZP1848), a long-acting GLP-2 analog, are expected to provide significant growth opportunities once they are approved and launched[4].
  • Distribution Channels: The preferential shift of patients towards online and retail pharmacies is also expected to boost the segment growth[3].

Challenges and Limitations

Despite the growth potential, the market for Nutrestore faces several challenges:

  • Modest Growth Rate: The segment of drugs like Nutrestore is expected to grow at a modest rate compared to other segments like growth hormones.
  • Competition from New Treatments: The emergence of new and more effective treatments, such as GLP-2 analogs, may reduce the market share of existing drugs like Nutrestore[4].

Competitive Landscape

Key Players

The global short bowel syndrome market is dominated by companies such as Takeda Pharmaceutical Company Limited, Merck KGaA, and Emmaus Medical, Inc. These companies are focused on R&D investments and expanding their product portfolios to maintain their market position[3].

Future Outlook

Pipeline Developments

The future outlook for Nutrestore and similar drugs is influenced by the development of new pipeline drugs. For instance, Zealand Pharma’s Glepaglutide is in phase III clinical trials and is expected to offer better efficacy than current treatments, potentially altering the market dynamics[4].

Regulatory Environment

The regulatory environment, including FDA approvals and designations, plays a crucial role in the market growth. Positive regulatory outcomes for new treatments can significantly impact the market share of existing drugs like Nutrestore[5].

Key Takeaways

  • Clinical Efficacy: Nutrestore is effective in managing symptoms of short bowel syndrome when used in conjunction with other treatments.
  • Market Growth: The global short bowel syndrome market is projected to grow significantly, driven by increasing patient needs and new treatment options.
  • Regional Dominance: North America leads the market due to a large patient pool and advanced treatment options.
  • Challenges: The market for Nutrestore faces challenges from new and more effective treatments.
  • Future Outlook: Pipeline developments and regulatory approvals will shape the future of Nutrestore and the broader SBS treatment market.

FAQs

What is Nutrestore used for?

Nutrestore, or glutamine, is used for the treatment of short bowel syndrome, particularly in patients on specialized nutrition.

How does Nutrestore work in treating short bowel syndrome?

Nutrestore works by enhancing nutritional outcomes when used in combination with growth hormone, reducing the need for parenteral nutrition in SBS patients.

What is the projected growth rate of the short bowel syndrome market?

The global short bowel syndrome market is projected to grow at a CAGR of 7.9% from 2024 to 2032.

Which region dominates the short bowel syndrome market?

North America dominates the short bowel syndrome market due to a large patient pool and the extended use of approved drugs.

What are the key drivers of the short bowel syndrome market?

Key drivers include the increasing patient pool, strong pipeline drugs, and the preferential shift towards online and retail pharmacies.

Sources

  1. Applied Therapeutics Announces Positive Results from 12-month Interim Analysis of Govorestat (AT-007) in the Ongoing INSPIRE Phase 3 Trial in Patients with SORD Deficiency. Applied Therapeutics.
  2. Nutraceuticals Market Size to Hit Around USD 1,007.48 Bn by 2033. Precedence Research.
  3. Short Bowel Syndrome Market Size, Share, Growth Report, 2032. Fortune Business Insights.
  4. Short Bowel Syndrome Market: FDA-approved Drugs Bolster Credibility and Credentials of Pharmaceutical Companies. BioSpace.
  5. FDA Action Update, December 2025: Approval, Designations, and Clinical Hold. Neurology Live.

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