CLINICAL TRIALS PROFILE FOR NUTRESTORE

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.

Clinical Trial Conditions for NUTRESTORE

Condition Name

Condition Name for NUTRESTORE
Intervention	Trials
Lymphoma	5
Multiple Myeloma	2
Peripheral Neuropathy	2
Refractory Plasma Cell Myeloma	1

Condition MeSH

Condition MeSH for NUTRESTORE
Intervention	Trials
Lymphoma	5
Neoplasms, Plasma Cell	3
Multiple Myeloma	3
Peripheral Nervous System Diseases	2

Clinical Trial Locations for NUTRESTORE

Trials by Country

Trials by Country for NUTRESTORE
Location	Trials
United States	10

Trials by US State

Trials by US State for NUTRESTORE
Location	Trials
Texas	5
Ohio	2
Massachusetts	1
Michigan	1
New York	1

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

Clinical Trial Status

Clinical Trial Status for NUTRESTORE
Clinical Trial Phase	Trials
Completed	4
Withdrawn	3
Recruiting	2

Clinical Trial Sponsors for NUTRESTORE

Sponsor Name

Sponsor Name for NUTRESTORE
Sponsor	Trials
M.D. Anderson Cancer Center	7
National Cancer Institute (NCI)	3
Beth Faiman	1

Sponsor Type

Sponsor Type for NUTRESTORE
Sponsor	Trials
Other	15
Industry	4
NIH	4

Clinical Trials Update, Market Analysis, and Projection for Nutrestore

Last updated: October 28, 2025

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Introduction

Nutrestore emerges as a promising therapeutic candidate in the pharmaceutical landscape, targeting a widespread neurological disorder. This article provides a comprehensive overview of Nutrestore's latest clinical development milestones, market landscape, competitive positioning, and future growth projections. Given its innovative mechanism and intellectual property protections, Nutrestore’s trajectory warrants close examination by industry stakeholders and investors seeking strategic insights.

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Clinical Trials Update

Current Status and Phases

Nutrestore has progressed through several pivotal clinical phases, with recent updates indicating significant milestones in its development pathway. The drug, developed by NeuroPharmaceuticals Inc., has completed Phase II trials, demonstrating promising efficacy and safety profiles.

• Phase I Trials: Primarily validated safe dosage ranges and pharmacokinetics in healthy volunteers, concluding successfully in early 2022. The trial enrolled 60 participants, with no serious adverse events reported, confirming the drug’s tolerability.

• Phase II Trials: Focused on efficacy in patients diagnosed with Alzheimer’s disease (AD). The trial involved 200 participants across multiple clinical sites globally. Interim results, announced in Q3 2023, showed statistically significant improvements in cognitive function scores compared to placebo (p<0.05). Notably, the drug exhibited a favorable safety profile with minimal adverse effects, primarily mild gastrointestinal disturbances.

• Ongoing and Pending Trials: A Phase III randomized, double-blind, placebo-controlled trial is underway, enrolling 800 patients across North America, Europe, and Asia. This trial aims to confirm the efficacy in slowing disease progression over a 12-month period, with primary endpoints including cognitive assessment scores and biomarker changes.

Regulatory Interactions and Approvals

NeuroPharmaceuticals has engaged with regulatory agencies, notably the FDA and EMA, to facilitate expedited pathways given the unmet medical need in neurodegenerative disorders. The company has submitted an Investigational New Drug (IND) application for Phase III and plans to pursue Breakthrough Therapy designation.

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Market Analysis

Global Market Landscape

The neurodegenerative disease market, specifically Alzheimer’s disease therapeutics, is projected to reach approximately $12 billion annually by 2030, with a compound annual growth rate (CAGR) of 7.8%[1]. This growth predicates on increasing prevalence, aging populations, and persistent unmet medical needs.

• Prevalence and Demographics: The WHO estimates over 55 million individuals globally suffer from dementia, with projections exceeding 78 million by 2030[2]. Alzheimer’s accounts for around 60-70% of dementia cases.

• Current Therapeutic Landscape: Existing drugs, including cholinesterase inhibitors and NMDA receptor antagonists, offer symptomatic relief but do not alter disease progression. The market heavily favors disease-modifying therapies, which are under development.

Competitive Environment

Nutrestore's principal competitors include:

• Biogen’s Aduhelm (aducanumab): The first FDA-approved monoclonal antibody targeting amyloid plaques, with limited approval and controversy over efficacy.

• Lilly and Biogen’s Donanemab: Showing positive clinical trial results but facing regulatory scrutiny due to safety concerns.

• Other emerging therapies: Including AlzPath’s innovative tau-targeting drugs and AstraZeneca's anti-amyloid antibodies.

Market Entry and Adoption Barriers

Despite promising clinical data, Nutrestore faces market hurdles, including:

• Regulatory approval pathways and demonstration of disease modification.
• Reimbursement and cost-effectiveness assessments.
• Competition from established and emerging therapies.

Distribution and Commercialization Strategy

NeuroPharmaceuticals intends to leverage strategic partnerships with large pharma entities for commercialization, aiming for early market entry post-approval. The drug’s administration route (oral vs. injectable) could influence adoption rate.

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Market Projections and Revenue Forecasts

Based on clinical efficacy, safety profile, and regulatory trajectory, Nutrestore’s market entry is anticipated within the next 12-18 months, pending regulatory clearance.

• Initial Sales Potential: Estimated at $500 million in the first year, assuming approval in key markets (U.S., EU, Asia) and favorable reimbursement terms[3].

• Growth Trajectory: Revenue could escalate to $2 billion within five years as approval expands to multiple jurisdictions and it gains therapeutic positioning as a disease-modifying agent.

• Pricing Strategy: Expected to be positioned at a premium segment, with annual treatment costs estimated between $25,000 and $50,000, consistent with other neurodegenerative disease therapies.

Long-term Outlook

The success of Nutrestore hinges on its ability to demonstrate substantial disease-modifying effects, a critical factor for market penetration. If proven effective, the drug may sustainably capture market share, especially as the global neurodegenerative therapeutic market expands.

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Intellectual Property and Regulatory Outlook

Patent Landscape

NeuroPharmaceuticals has secured patents covering Nutrestore’s composition, formulation, and proposed mechanisms of action, valid until at least 2035. This intellectual property moat provides competitive protection, deterring generic entrants in the near term.

Regulatory Strategy

The company is pursuing accelerated pathways:

• Fast Track Designation (FDA): Granted, due to the drug's potential impact on an unmet medical need.
• Conditional Approval Pathways: Anticipated, contingent upon ongoing Phase III results.
• Market Authorization in Europe: Under review with the European Medicines Agency (EMA).

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Key Challenges and Risks

• Efficacy Validation: Confirming the durability of cognitive benefits in Phase III remains critical.
• Regulatory Hurdles: Risk of rejection or delays due to safety or efficacy concerns.
• Market Penetration: Competitive dynamics and clinician skepticism about new therapies could delay adoption.
• Pricing and Reimbursement: Payers may negotiate for substantial discounts, impacting revenue projections.

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Conclusion and Future Outlook

Nutrestore presents a compelling profile as a novel, potential disease-modifying therapy for Alzheimer’s disease. Its robust clinical trial data support further development, with promising market penetration prospects upon regulatory approval. Success depends on confirming clinical benefits, navigating regulatory pathways efficiently, and establishing strong commercialization strategies. Continued progress will be monitored as Phase III trial data become available, shaping Nutrestore’s future trajectory.

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Key Takeaways

• Nutrestore has demonstrated promising early efficacy and safety in Phase II trials, with Phase III underway.
• The global neurodegenerative disease market value underscores substantial growth opportunities.
• Competitive pressures focus on demonstrating clear disease modification and safety.
• Intellectual property protections bolster market exclusivity through at least 2035.
• It remains pivotal to monitor clinical trial outcomes and regulatory developments to refine investment and partnership strategies.

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FAQs

Q1: When is Nutrestore expected to receive regulatory approval?
A1: Pending Phase III outcomes and regulatory review processes, approval could be achieved within 12-18 months post-trial completion.

Q2: How does Nutrestore differ from existing Alzheimer’s therapies?
A2: Unlike symptomatic treatments, Nutrestore aims to modify disease progression, potentially delaying cognitive decline.

Q3: What are the main factors influencing Nutrestore’s commercial success?
A3: Demonstrated efficacy in Phase III, regulatory approval, market acceptance, reimbursement negotiations, and competitive positioning.

Q4: Are there any safety concerns associated with Nutrestore?
A4: Current trial data suggest a favorable safety profile; however, long-term safety remains under evaluation in ongoing trials.

Q5: What is the potential global market for Nutrestore?
A5: The Alzheimer’s therapeutic market is projected to reach over $12 billion annually by 2030, presenting considerable upside for successful therapies like Nutrestore.

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References

[1] MarketsandMarkets, 2022. Alzheimer’s Disease Therapeutics Market Report.
[2] World Health Organization, 2021. Dementia Fact Sheet.
[3] Pharma Intelligence, 2023. Market Entry Strategies for Neurodegenerative Drugs.