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Last Updated: March 27, 2025

CLINICAL TRIALS PROFILE FOR MANNITOL 15%


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All Clinical Trials for MANNITOL 15%

Trial IDTitleStatusSponsorPhaseStart DateSummary
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.
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 4 of 4 entries

Clinical Trial Conditions for MANNITOL 15%

Condition Name

2010760-20246810121416182022AsthmaCystic FibrosisHealthyTraumatic Brain Injury[disabled in preview]
Condition Name for MANNITOL 15%
Intervention Trials
Asthma 20
Cystic Fibrosis 10
Healthy 7
Traumatic Brain Injury 6
[disabled in preview] 0
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Condition MeSH

231210100-2024681012141618202224AsthmaIntracranial HypertensionCystic FibrosisBrain Neoplasms[disabled in preview]
Condition MeSH for MANNITOL 15%
Intervention Trials
Asthma 23
Intracranial Hypertension 12
Cystic Fibrosis 10
Brain Neoplasms 10
[disabled in preview] 0
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Clinical Trial Locations for MANNITOL 15%

Trials by Country

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Trials by Country for MANNITOL 15%
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 15%
Location Trials
New York 19
Massachusetts 12
Minnesota 9
Oregon 8
Ohio 7
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Clinical Trial Progress for MANNITOL 15%

Clinical Trial Phase

30.3%27.9%8.2%33.6%010152025303540Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for MANNITOL 15%
Clinical Trial Phase Trials
Phase 4 37
Phase 3 34
Phase 2/Phase 3 10
[disabled in preview] 41
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Clinical Trial Status

68.0%13.9%9.3%8.8%020406080100120140CompletedUnknown statusNot yet recruiting[disabled in preview]
Clinical Trial Status for MANNITOL 15%
Clinical Trial Phase Trials
Completed 132
Unknown status 27
Not yet recruiting 18
[disabled in preview] 17
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Clinical Trial Sponsors for MANNITOL 15%

Sponsor Name

trials02468101214161820PharmaxisNorthwell HealthAin Shams University[disabled in preview]
Sponsor Name for MANNITOL 15%
Sponsor Trials
Pharmaxis 19
Northwell Health 7
Ain Shams University 6
[disabled in preview] 6
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Sponsor Type

81.0%14.2%0050100150200250300350400OtherIndustryNIH[disabled in preview]
Sponsor Type for MANNITOL 15%
Sponsor Trials
Other 366
Industry 64
NIH 17
[disabled in preview] 5
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Mannitol 15%: Clinical Trials, Market Analysis, and Projections

Introduction to Mannitol 15%

Mannitol is a sugar alcohol widely used in medical and industrial applications. In the medical field, it is particularly notable for its use in managing increased intracranial pressure, treating glaucoma, and promoting diuresis. Here, we will delve into recent clinical trials, market analysis, and future projections for mannitol, especially focusing on the 15% solution.

Clinical Trials and Safety

Recent Clinical Trials on Mannitol

A recent clinical trial published in Frontiers in Neurology investigated the safety and tolerability of oral mannitol in patients with Parkinson's disease. This phase IIa, randomized, double-blind, placebo-controlled study involved dose escalations up to 18 g per day of oral mannitol. The primary outcome was the safety of oral mannitol, assessed by adverse events and abnormal laboratory results. The study concluded that long-term use of 18 g per day of oral mannitol is safe, although gastrointestinal symptoms limited dose escalation in some participants[1].

Another study compared the efficacy and safety of 7.2% hypertonic saline hydroxyethyl starch 200/0.5 with 15% mannitol in treating increased intracranial pressure (ICP). This prospective randomized clinical study found that both treatments were effective in reducing ICP, but it highlighted the need for further research to determine the optimal infusion rates and doses[3].

Safety and Tolerability

The safety profile of mannitol, particularly the 15% solution, is well-established. However, it is crucial to monitor patients for potential side effects. In the context of ICP management, mannitol is generally safe when used appropriately, but it can cause osmotic shifts and dehydration if not managed carefully. The study comparing hypertonic saline and mannitol did not report significant adverse events related to mannitol, reinforcing its safety when used as directed[3].

Market Analysis

Current Market Size and Growth

The global mannitol market has been growing steadily. In 2022, the market size was estimated to be around $418.65 million, with a projected growth to $890.31 million by 2033, at a CAGR of 7.1% from 2023 to 2033[2].

Market Drivers

Several factors are driving the growth of the mannitol market:

  • Increasing Demand for Low-Calorie Sweeteners: Mannitol is favored as a sugar substitute due to its low-calorie and non-cariogenic properties, especially in the food and beverages sector[2].
  • Pharmaceutical Applications: Mannitol is used as an excipient in pharmaceutical formulations and for treating various medical conditions, including brain, kidney, and heart problems[2].
  • Consumer Health Consciousness: The rising incidence of diabetes and obesity has led to increased consumer awareness of health issues, driving demand for natural and low-calorie ingredients like mannitol[2].

Market Segments

The mannitol market is segmented by product type and application:

  • Product Type: Solutions such as 5g/100 ml, 10g/100 ml, 15g/100 ml, 20g/100 ml, and 25g/100 ml. The 20g/100 ml solution is expected to represent the largest revenue segment due to its use in treating increased ICP, glaucoma, and promoting diuresis[4].
  • Application: Hospital pharmacies, retail pharmacies, and online pharmacies. The demand from hospital pharmacies is particularly significant due to the medical applications of mannitol[4].

Market Projections

Future Growth

The mannitol market is expected to continue its positive growth trajectory:

  • CAGR: A projected CAGR of 7.1% from 2023 to 2033 indicates robust growth driven by increasing demand for natural sweeteners and pharmaceutical applications[2].
  • Regional Growth: Countries like Brazil are expected to contribute significantly to the market growth, driven by high rates of obesity and diabetes and government initiatives to limit sugar consumption[2].

Challenges and Opportunities

While the market is poised for growth, there are challenges to consider:

  • Competition from Alternatives: Less expensive replacements and other sugar alcohols could pose competition to mannitol[2].
  • Regulatory and Production Costs: High production costs and regulatory hurdles may constrain market growth[2].

However, opportunities abound:

  • Expanding Applications: Increasing use in confectionery, baked goods, and pharmaceuticals will drive demand[2].
  • Health and Wellness Trends: Growing consumer awareness of health issues will continue to boost demand for low-calorie and natural ingredients like mannitol[2].

Key Takeaways

  • Clinical Safety: Mannitol, including the 15% solution, has been shown to be safe and effective in clinical trials, although monitoring for side effects is necessary.
  • Market Growth: The global mannitol market is projected to grow significantly, driven by increasing demand for low-calorie sweeteners and pharmaceutical applications.
  • Segmented Market: The market is segmented by product type and application, with hospital pharmacies being a significant segment.
  • Future Projections: A CAGR of 7.1% from 2023 to 2033 indicates robust growth, with regional markets like Brazil contributing substantially.

FAQs

What are the primary medical uses of mannitol 15%?

Mannitol 15% is primarily used to manage increased intracranial pressure, treat glaucoma, and promote diuresis in patients with renal failure.

What are the key drivers of the mannitol market?

The key drivers include increasing demand for low-calorie sweeteners, pharmaceutical applications, and growing consumer health consciousness.

What are the challenges facing the mannitol market?

Challenges include competition from less expensive replacements, high production costs, and regulatory hurdles.

How is the mannitol market segmented?

The market is segmented by product type (e.g., 5g/100 ml, 10g/100 ml) and application (e.g., hospital pharmacies, retail pharmacies).

What is the projected growth rate of the mannitol market?

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

Sources

  1. Frontiers in Neurology: "Safety and Tolerability, Dose-Escalating, Double-Blind Trial of Oral Mannitol in Parkinson's Disease Patients"[1]
  2. Future Market Insights: "Mannitol Market Size, Share, Outlook & Forecast by 2033"[2]
  3. PubMed: "Efficiency of 7.2% hypertonic saline hydroxyethyl starch 200/0.5 versus 15% mannitol in the treatment of increased intracranial pressure"[3]
  4. SNS Insider: "Mannitol Market Size & Share Report Forecast 2023-2030"[4]

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