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Last Updated: January 13, 2025

CLINICAL TRIALS PROFILE FOR MANNITOL 5%


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All Clinical Trials for MANNITOL 5%

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00117182 ↗ Aridol Challenge as a Tool to Predict Treatment Response to Inhaled Corticosteroids in COPD Completed Pharmaxis Phase 2 2005-07-01 The purpose of this study is to determine whether the Aridol (mannitol) challenge test can predict response to treatment with inhaled corticosteroids in COPD subjects. Subjects will undergo an Aridol test and then 3 months of treatment with inhaled corticosteroids. The effect on lung function and quality of life will then be measured and correlated with the Aridol test result.
NCT00113854 ↗ Mannitol as Adjunct Therapy for Childhood Cerebral Malaria Unknown status Makerere University Phase 3 2004-10-01 Cerebral malaria is a life-threatening complication of Plasmodium falciparum infection in African children and nonimmune travellers despite availability of quinine, the current drug of choice. Several reports have suggested that raised intracranial pressure (ICP) is a major cause of death among children with cerebral malaria. Mannitol, an osmotic diuretic, effectively lowers ICP and is used to treat post traumatic raised ICP. There have been some case reports of reduction in mortality and morbidity in African children with cerebral malaria following administration of mannitol, but as these were not randomized controlled trials it is difficult to evaluate their significance. This study seeks to establish whether a single dose of intravenous mannitol given to children with cerebral malaria will significantly reduce the coma recovery time.
NCT00111956 ↗ Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome Completed Massachusetts General Hospital Phase 2/Phase 3 2004-04-01 Metabolic syndrome is associated with increased inflammatory cytokines and reduced adiponectin, that may be mediated in part by TNF production from abdominal fat. We reasoned that an anti-TNF agent would reduce C-reactive protein (CRP) and increase adiponectin, improving the inflammatory milieu associated with metabolic syndrome.
NCT00111956 ↗ Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2/Phase 3 2004-04-01 Metabolic syndrome is associated with increased inflammatory cytokines and reduced adiponectin, that may be mediated in part by TNF production from abdominal fat. We reasoned that an anti-TNF agent would reduce C-reactive protein (CRP) and increase adiponectin, improving the inflammatory milieu associated with metabolic syndrome.
NCT00003062 ↗ Temozolomide in Patients With Progressive or Recurrent Non-small Cell Lung Cancer Completed European Organisation for Research and Treatment of Cancer - EORTC Phase 2 1997-07-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effect of temozolomide in patients with progressive or recurrent stage IV non-small cell lung cancer, with or without brain metastases, who have not been treated for metastatic disease with chemotherapy.
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 7 of 7 entries

Clinical Trial Conditions for MANNITOL 5%

Condition Name

2010760-20246810121416182022AsthmaCystic FibrosisHealthyGlioblastoma Multiforme[disabled in preview]
Condition Name for MANNITOL 5%
Intervention Trials
Asthma 20
Cystic Fibrosis 10
Healthy 7
Glioblastoma Multiforme 6
[disabled in preview] 0
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Condition MeSH

231210100-2024681012141618202224AsthmaIntracranial HypertensionFibrosisCystic Fibrosis[disabled in preview]
Condition MeSH for MANNITOL 5%
Intervention Trials
Asthma 23
Intracranial Hypertension 12
Fibrosis 10
Cystic Fibrosis 10
[disabled in preview] 0
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Clinical Trial Locations for MANNITOL 5%

Trials by Country

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Trials by Country for MANNITOL 5%
Location Trials
United States 137
Canada 38
United Kingdom 35
Australia 34
Italy 20
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Trials by US State

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Trials by US State for MANNITOL 5%
Location Trials
New York 19
Massachusetts 12
Minnesota 9
Oregon 8
Ohio 7
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Clinical Trial Progress for MANNITOL 5%

Clinical Trial Phase

17.4%16.0%62.0%0020406080100120140Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for MANNITOL 5%
Clinical Trial Phase Trials
Phase 4 37
Phase 3 34
Phase 2/Phase 3 10
[disabled in preview] 132
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Clinical Trial Status

59.7%12.2%8.1%19.9%020406080100120140CompletedUnknown statusNot yet recruiting[disabled in preview]
Clinical Trial Status for MANNITOL 5%
Clinical Trial Phase Trials
Completed 132
Unknown status 27
Not yet recruiting 18
[disabled in preview] 44
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Clinical Trial Sponsors for MANNITOL 5%

Sponsor Name

trials0246810121416182022PharmaxisNorthwell HealthAin Shams University[disabled in preview]
Sponsor Name for MANNITOL 5%
Sponsor Trials
Pharmaxis 19
Northwell Health 7
Ain Shams University 6
[disabled in preview] 21
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Sponsor Type

81.0%14.2%0050100150200250300350400OtherIndustryNIH[disabled in preview]
Sponsor Type for MANNITOL 5%
Sponsor Trials
Other 366
Industry 64
NIH 17
[disabled in preview] 5
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MANNITOL 5% Market Analysis and Financial Projection

Mannitol 5%: Clinical Trials, Market Analysis, and Projections

Clinical Uses and Trials of Mannitol

Mannitol is a versatile compound widely used in medical and non-medical applications. Here, we focus on its clinical uses, particularly in managing raised intracranial pressure (ICP) and the latest clinical trial updates.

Management of Raised Intracranial Pressure

Mannitol is commonly used to reduce ICP in patients with traumatic brain injury (TBI) and other conditions. Its effectiveness is well-documented, although its role in ongoing TBI management remains somewhat unclear[4].

ADAPT Trial: Hypertonic Saline vs. Mannitol

A significant recent study is the ADAPT trial, published in the JAMA Network Open. This trial compared the effects of hypertonic saline and mannitol on ICP in children with severe TBI. Here are the key findings:

  • Intracranial Pressure Reduction: The study found that hypertonic saline resulted in a 1 mmHg reduction in ICP, while mannitol had a negligible effect of 0.2 mmHg, which was not significant. Both treatments showed a small but significant increase in cerebral perfusion pressure (CPP)[1].
  • Study Design and Outcomes: The trial involved 518 patients and nearly 2,500 boluses of either hypertonic saline or mannitol. Despite the limited effect on ICP, the study provides valuable data that could influence future guidelines on the use of these therapies[1].
  • Limitations and Future Implications: The study highlighted several limitations, including the dominance of data from a few centers and the inability to compare infusion versus bolus administration. However, it is expected to strengthen the confidence in using 3% hypertonic saline boluses and provide guidelines-based support for mannitol use in ICP crisis management[1].

Market Analysis of Mannitol

The market for mannitol is diverse, with applications in pharmaceuticals, food additives, and other industries.

Global Market Size and Growth

  • Current Market Value: As of 2022, the global mannitol market was valued at approximately USD 418.65 million[5].
  • Projected Growth: The market is expected to grow at a Compound Annual Growth Rate (CAGR) of 7.1% from 2023 to 2033, reaching an estimated value of USD 890.31 million by 2033[5].

Regional Market Dynamics

  • Asia Pacific: This region, particularly China and India, dominates the global mannitol market. China accounts for over 52.9% of the Asia Pacific market and is the world's leading producer of sugar alternatives. India, the second-largest producer and largest consumer of sugar, also drives significant demand[5].
  • Emerging Markets: The growing health awareness and increasing prevalence of diabetes, obesity, and heart disorders in emerging countries are driving the demand for low-calorie sweeteners like mannitol[2][5].

Applications and Demand Drivers

  • Pharmaceuticals: Mannitol is used as an excipient in pharmaceutical formulations and for treating brain, kidney, and heart conditions. Its strong water solubility, low moldability, and excellent wetting properties make it a preferred choice[5].
  • Food and Beverages: The demand for mannitol as a food additive, particularly in confectionery products like candies and gums, is increasing due to its low-calorie and non-cariogenic properties. Its cooling effect in mint-based sweets and gums also contributes to its popularity[2][5].

Market Projections and Trends

Future Growth Trajectory

  • Volume Sales: The volume sales of mannitol are expected to rise at a rate of 5.62% in 2023, with shipments reaching 66,998 metric tons in the same year[5].
  • Consumer Health Consciousness: The increasing awareness of health issues among consumers is driving the demand for low-calorie sweeteners, which is expected to continue propelling the market growth over the next decade[5].

Key Factors Influencing Market Growth

  • Rising Diabetic Population: The growing incidence of diabetes, especially in countries like China and India, is a significant factor driving the demand for mannitol as a sugar substitute[5].
  • Urbanization and Lifestyle Changes: Rapid urbanization and changing lifestyles are contributing to the increased consumption of baked goods and confectionery items, further boosting the market[3][5].

Key Takeaways

  • Clinical Trials: The ADAPT trial provides new insights into the comparative effectiveness of hypertonic saline and mannitol in managing ICP in pediatric TBI patients.
  • Market Growth: The global mannitol market is expected to grow significantly, driven by increasing demand in pharmaceuticals, food additives, and the rising health consciousness among consumers.
  • Regional Dynamics: Asia Pacific, particularly China and India, will continue to dominate the market due to their large consumer base and growing health awareness.
  • Applications: Mannitol's versatility in pharmaceutical formulations, confectionery products, and as a sugar substitute will continue to drive its market growth.

FAQs

What are the primary clinical uses of mannitol?

Mannitol is primarily used to manage raised intracranial pressure (ICP) in patients with traumatic brain injury (TBI) and for renal protection in various surgical procedures.

How does the ADAPT trial compare hypertonic saline and mannitol?

The ADAPT trial found that hypertonic saline was more effective than mannitol in reducing ICP in children with severe TBI, although both treatments had a small but significant effect on cerebral perfusion pressure (CPP).

What is the current market size of the global mannitol market?

As of 2022, the global mannitol market was valued at approximately USD 418.65 million.

What is the projected growth rate of the mannitol market from 2023 to 2033?

The market is expected to grow at a CAGR of 7.1% from 2023 to 2033.

Which regions are driving the growth of the mannitol market?

The Asia Pacific region, particularly China and India, is driving the growth of the mannitol market due to increasing health awareness and a growing diabetic population.

Sources

  1. YouTube - World Shared Practice Forum: "Results of Hypertonic Saline or Mannitol Clinical Trial for Treatment..."
  2. Grand View Research: "Mannitol Market Size, Share Analysis | Industry Report, 2024"
  3. IndustryARC: "Mannitol Market 2020 - 2025 - IndustryARC"
  4. BJA Education: "Mannitol: a review of its clinical uses"
  5. Future Market Insights: "Mannitol Market Size, Share, Outlook & Forecast by 2033 | FMI"

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