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Last Updated: March 27, 2025

CLINICAL TRIALS PROFILE FOR SODIUM BENZOATE; SODIUM PHENYLACETATE


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All Clinical Trials for sodium benzoate; sodium phenylacetate

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00597909 ↗ Efficacy and Safety Study of Ammonul® in Patients With Grade 3 or 4 Hepatic Encephalopathy Terminated Horizon Pharma Ireland, Ltd., Dublin Ireland Phase 2 2007-12-01 The primary purpose of this study is to evaluate the safety and effectiveness of Ammonul® in subjects who become hospitalized with Grade 3 or 4 hepatic encephalopathy (HE).
NCT00004767 ↗ Phase II Study of Sodium Phenylbutyrate, Sodium Benzoate, Sodium Phenylacetate, and Dietary Intervention for Urea Cycle Disorders Completed Johns Hopkins University Phase 2 1985-01-01 OBJECTIVES: I. Assess the safety and efficacy of sodium phenylbutyrate, sodium benzoate, sodium phenylacetate, and dietary intervention in patients with urea cycle disorders.
NCT00004767 ↗ Phase II Study of Sodium Phenylbutyrate, Sodium Benzoate, Sodium Phenylacetate, and Dietary Intervention for Urea Cycle Disorders Completed National Center for Research Resources (NCRR) Phase 2 1985-01-01 OBJECTIVES: I. Assess the safety and efficacy of sodium phenylbutyrate, sodium benzoate, sodium phenylacetate, and dietary intervention in patients with urea cycle disorders.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for sodium benzoate; sodium phenylacetate

Condition Name

1110-0.100.10.20.30.40.50.60.70.80.911.1Amino Acid Metabolism, Inborn ErrorsHealthyHealthy Volunteers[disabled in preview]
Condition Name for sodium benzoate; sodium phenylacetate
Intervention Trials
Amino Acid Metabolism, Inborn Errors 1
Healthy 1
Healthy Volunteers 1
[disabled in preview] 0
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Condition MeSH

1110-0.100.10.20.30.40.50.60.70.80.911.1Metabolism, Inborn ErrorsAmino Acid Metabolism, Inborn ErrorsHepatic Encephalopathy[disabled in preview]
Condition MeSH for sodium benzoate; sodium phenylacetate
Intervention Trials
Metabolism, Inborn Errors 1
Amino Acid Metabolism, Inborn Errors 1
Hepatic Encephalopathy 1
[disabled in preview] 0
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Clinical Trial Locations for sodium benzoate; sodium phenylacetate

Trials by Country

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Trials by Country for sodium benzoate; sodium phenylacetate
Location Trials
United States 2
Japan 1
Ukraine 1
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Trials by US State

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Trials by US State for sodium benzoate; sodium phenylacetate
Location Trials
Texas 1
California 1
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Clinical Trial Progress for sodium benzoate; sodium phenylacetate

Clinical Trial Phase

50.0%50.0%0-0.200.20.40.60.811.21.41.61.822.2Phase 2Phase 1[disabled in preview]
Clinical Trial Phase for sodium benzoate; sodium phenylacetate
Clinical Trial Phase Trials
Phase 2 2
Phase 1 2
[disabled in preview] 0
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Clinical Trial Status

75.0%25.0%000.511.522.53CompletedTerminated[disabled in preview]
Clinical Trial Status for sodium benzoate; sodium phenylacetate
Clinical Trial Phase Trials
Completed 3
Terminated 1
[disabled in preview] 0
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Clinical Trial Sponsors for sodium benzoate; sodium phenylacetate

Sponsor Name

trials000111112222Horizon Pharma Ireland, Ltd., Dublin IrelandJohns Hopkins UniversityNational Center for Research Resources (NCRR)[disabled in preview]
Sponsor Name for sodium benzoate; sodium phenylacetate
Sponsor Trials
Horizon Pharma Ireland, Ltd., Dublin Ireland 2
Johns Hopkins University 1
National Center for Research Resources (NCRR) 1
[disabled in preview] 0
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Sponsor Type

50.0%33.3%16.7%000.511.522.53IndustryOtherNIH[disabled in preview]
Sponsor Type for sodium benzoate; sodium phenylacetate
Sponsor Trials
Industry 3
Other 2
NIH 1
[disabled in preview] 0
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Sodium Benzoate and Sodium Phenylacetate: Clinical Trials, Market Analysis, and Projections

Introduction to Sodium Benzoate and Sodium Phenylacetate

Sodium benzoate and sodium phenylacetate are compounds with diverse applications, ranging from food preservation to medical treatments. Here, we will delve into the current clinical trials, market analysis, and future projections for these compounds.

Clinical Trials Update for Sodium Benzoate

Schizophrenia Treatment

Sodium benzoate is currently under clinical development by SyneuRx International (Taiwan) for the treatment of schizophrenia. It is in Phase III clinical trials, targeting adolescent schizophrenia, refractory schizophrenia, and as an add-on therapy for schizophrenia and dementia. The drug acts by inhibiting D-amino acid oxidase (DAAO), a mechanism that suggests potential benefits in treating schizophrenia through the glutamatergic system[1].

Treatment-Resistant Schizophrenia

A randomized, double-blinded, placebo-controlled trial is ongoing to evaluate the efficacy of sodium benzoate in patients with treatment-resistant schizophrenia (TRS). This trial involves 90 patients and aims to identify predictors for treatment response using advanced markers such as 1H-magnetic resonance spectroscopy (MRS) and artificial intelligence algorithms[4].

Clinical Trials Update for Sodium Phenylacetate

Urea-Cycle Disorders

Sodium phenylacetate, often used in combination with sodium benzoate, has been shown to be effective in treating urea-cycle disorders. A 25-year study demonstrated that this combination significantly lowers plasma ammonium levels and improves survival rates in patients with these disorders. The study involved 299 patients and showed an overall survival rate of 84%, with 96% of patients surviving episodes of acute hyperammonemia[3].

Market Analysis for Sodium Benzoate

Global Market Size and Growth

The global sodium benzoate market was valued at $1.22 billion in 2021 and is expected to grow at a compound annual growth rate (CAGR) of 6.1% from 2022 to 2030. This growth is driven by increasing demand in the food and beverage industry, particularly for processed and packaged goods[5].

Market Segmentation

The market is segmented by type (industrial grade, food grade, pharmaceutical grade), form (powder, granules, flakes), distribution channel (online and offline retailers), and application (antifungal agent, antimicrobial agent, rust and corrosion inhibitor, preservative). The food grade segment is particularly significant due to its widespread use as a preservative in the food and beverage industry[2].

Regional Market

Europe dominated the sodium benzoate market in 2021, accounting for 39.3% of the revenue share. The Asia Pacific region also holds a significant share, with increasing demand driven by growing populations and rising disposable incomes. The Middle East and Africa region is expected to see continued growth due to expanding food and beverage industries[5].

Market Projections for Sodium Benzoate

Future Growth Drivers

The market is expected to grow due to several factors, including the expansion of the beverage sector, globalization of the food industry, and increasing demand for organic preservatives. Clean label trends, regulatory changes, and packaging innovations are also anticipated to drive growth[2].

Challenges

Despite the positive outlook, the market may face challenges such as increasing public awareness about the dangers of synthetic preservatives, particularly in North America and Europe. Additionally, the availability of alternative preservatives could limit the market share of sodium benzoate[5].

Market Analysis for Sodium Phenylacetate

Medical Applications

Sodium phenylacetate is primarily used in medical settings for treating urea-cycle disorders. The market for this application is niche but critical, given the life-saving nature of the treatment. The combination of sodium phenylacetate and sodium benzoate is a standard therapy for managing acute hyperammonemia in these patients[3].

Market Size and Growth

While specific market size data for sodium phenylacetate is not widely available, its use in treating rare but critical conditions ensures a steady demand. The market growth for this segment is likely tied to advancements in medical treatments and the prevalence of urea-cycle disorders.

Projections for Sodium Phenylacetate

Future Medical Applications

Research into the use of sodium phenylacetate in combination with other treatments may expand its medical applications. However, the market for this compound is expected to remain relatively stable, driven by the consistent need for effective treatments for urea-cycle disorders.

Key Takeaways

  • Sodium Benzoate in Schizophrenia: Currently in Phase III clinical trials for schizophrenia, with promising results in targeting the glutamatergic system.
  • Sodium Phenylacetate in Urea-Cycle Disorders: Proven effective in combination with sodium benzoate for treating urea-cycle disorders, with high survival rates.
  • Market Growth: The global sodium benzoate market is expected to grow at a CAGR of 6.1% from 2022 to 2030, driven by demand in the food and beverage industry.
  • Regional Dominance: Europe and the Asia Pacific region are key markets for sodium benzoate, with growing demand in the Middle East and Africa.
  • Challenges: Public awareness about synthetic preservatives and availability of alternatives may impact market growth.

FAQs

What is the current status of sodium benzoate in clinical trials for schizophrenia?

Sodium benzoate is currently in Phase III clinical trials for the treatment of schizophrenia, including adolescent schizophrenia, refractory schizophrenia, and as an add-on therapy for schizophrenia and dementia[1].

How effective is the combination of sodium phenylacetate and sodium benzoate in treating urea-cycle disorders?

The combination has been shown to significantly lower plasma ammonium levels and improve survival rates, with an overall survival rate of 84% in a 25-year study[3].

What drives the growth of the sodium benzoate market?

The growth is driven by increasing demand in the food and beverage industry, particularly for processed and packaged goods, as well as expansion of the beverage sector and globalization of the food industry[2].

Which regions dominate the sodium benzoate market?

Europe dominated the market in 2021, accounting for 39.3% of the revenue share, followed by significant shares in the Asia Pacific region and growing demand in the Middle East and Africa[5].

What are the potential challenges for the sodium benzoate market?

Challenges include increasing public awareness about the dangers of synthetic preservatives and the availability of alternative preservatives, which could limit market growth[5].

Sources

  1. Pharmaceutical Technology: "Sodium benzoate by SyneuRx International (Taiwan) for Schizophrenia".
  2. The Business Research Company: "Global Sodium Benzoate Market Report 2024".
  3. PubMed: "Survival after treatment with phenylacetate and benzoate for urea-cycle enzyme defects".
  4. Veeva Systems: "Neurotransmitters in Treatment Resistant Schizophrenia Patients with Add-on Sodium Benzoate".
  5. Grand View Research: "Sodium Benzoate Market Size & Share Report, 2022-2030".

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