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Last Updated: February 15, 2025

CLINICAL TRIALS PROFILE FOR MANNITOL 25%


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All Clinical Trials for Mannitol 25%

Trial ID Title Status Sponsor Phase Start Date Summary
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

Clinical Trial Conditions for Mannitol 25%

Condition Name

Condition Name for Mannitol 25%
Intervention Trials
Asthma 20
Cystic Fibrosis 10
Healthy 7
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Condition MeSH

Condition MeSH for Mannitol 25%
Intervention Trials
Asthma 23
Intracranial Hypertension 12
Brain Neoplasms 10
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Clinical Trial Locations for Mannitol 25%

Trials by Country

Trials by Country for Mannitol 25%
Location Trials
United States 137
Canada 38
United Kingdom 35
Australia 34
Italy 20
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Trials by US State

Trials by US State for Mannitol 25%
Location Trials
New York 19
Massachusetts 12
Minnesota 9
Oregon 8
Ohio 7
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Clinical Trial Progress for Mannitol 25%

Clinical Trial Phase

Clinical Trial Phase for Mannitol 25%
Clinical Trial Phase Trials
Phase 4 37
Phase 3 34
Phase 2/Phase 3 10
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Clinical Trial Status

Clinical Trial Status for Mannitol 25%
Clinical Trial Phase Trials
Completed 132
Unknown status 27
Not yet recruiting 18
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Clinical Trial Sponsors for Mannitol 25%

Sponsor Name

Sponsor Name for Mannitol 25%
Sponsor Trials
Pharmaxis 19
Northwell Health 7
National Cancer Institute (NCI) 6
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Sponsor Type

Sponsor Type for Mannitol 25%
Sponsor Trials
Other 366
Industry 64
NIH 17
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Mannitol 25%: Clinical Trials, Market Analysis, and Projections

Introduction to Mannitol 25%

Mannitol, a polyol, is widely used in medical and pharmaceutical applications due to its unique properties. The 25% solution of mannitol is particularly significant in clinical settings for managing various medical conditions, including elevated intracranial pressure, cerebral edema, and acute kidney injury.

Clinical Trials and Efficacy

Managing Chronic Post-Thoracotomy Pain (CPTP)

A recent clinical trial aims to evaluate the efficacy and safety of intravenous paracetamol and mannitol in managing chronic post-thoracotomy pain in patients with lung cancer. This prospective double-blind randomized controlled trial will enroll 856 patients and compare the outcomes between the test group (receiving intravenous paracetamol and mannitol) and the control group (receiving normal saline). The primary outcome will be the incidence of CPTP at 3 months. This study highlights the potential of mannitol in combination with other analgesics to prevent and reduce the progression of CPTP[1].

Treatment of Traumatic Brain Injury (TBI)

The ADAPT trial compared the effectiveness of hypertonic saline versus mannitol in lowering intracranial pressure in children with severe traumatic brain injury. While hypertonic saline outperformed mannitol in some aspects, the study provided valuable data supporting the use of mannitol in managing intracranial pressure crises. The trial's findings suggest that mannitol remains a viable option, especially when hypertonic saline is not available or suitable[4].

Market Analysis

Global Market Size and Growth

The global mannitol market, including mannitol 25% solutions, is projected to grow significantly over the next few years. In 2022, the market size was valued at approximately USD 398.62 million and is expected to reach USD 584.47 million by 2030, growing at a CAGR of 4.9% from 2023 to 2030[5].

Market Segmentation

The mannitol market is segmented by product type, with the 20g/100 ml concentration being the largest revenue segment due to its widespread use in treating conditions such as elevated intracranial pressure, glaucoma, and acute kidney injury. However, the 25g/100 ml solution is also significant, particularly in critical care settings[5].

Application and Distribution

Mannitol is used across various applications, including hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies dominate the market due to the frequent use of mannitol in emergency and critical care settings. The demand for sterile mannitol injections is particularly high in hospitals to ensure patient safety and avoid infections[5].

Market Projections

Driving Factors

Several factors are driving the growth of the mannitol market:

  • Aging Population: The increasing global population, especially in North America, is leading to a rise in age-related conditions such as Alzheimer’s disease and chronic renal disease, which often require mannitol treatment[3].
  • Chronic and Neurological Disorders: The rising prevalence of neurological illnesses, such as brain tumors and traumatic brain injuries, is increasing the demand for mannitol to lower intracranial pressure and manage other complications[3].
  • Advances in Healthcare Infrastructure: Improved access to medical treatment in developing countries is boosting the demand for effective drugs like mannitol[3].

Regional Analysis

The Asia Pacific region, particularly countries like China and India, accounts for a significant share of the global mannitol market. This is due to growing health awareness, changing dietary trends, and an increasing prevalence of diabetes and other chronic diseases[2][5].

Challenges and Opportunities

Despite the growth prospects, the mannitol market faces challenges such as the impact of global events like the COVID-19 pandemic and economic recessions. However, opportunities arise from the development of new formulations and delivery mechanisms that could enhance the efficacy and safety of mannitol treatments[5].

Safety and Efficacy

Sterility and Quality Assurance

The emphasis on safety and efficacy is crucial for mannitol injections, particularly in high-risk settings like hospitals. Sterile mannitol injections are essential to avoid infections and ensure patient safety. This focus on quality assurance and adherence to regulatory standards is expected to drive the growth of the sterile mannitol injections segment[3].

Key Takeaways

  • Clinical Efficacy: Mannitol 25% solutions are being evaluated for their efficacy in managing chronic post-thoracotomy pain and traumatic brain injury.
  • Market Growth: The global mannitol market is projected to grow at a CAGR of 4.9% from 2023 to 2030.
  • Driving Factors: The aging population, rising prevalence of neurological disorders, and advances in healthcare infrastructure are key drivers of market growth.
  • Regional Dominance: The Asia Pacific region, especially China and India, dominates the global mannitol market.
  • Safety and Efficacy: Sterile mannitol injections are critical for ensuring patient safety and meeting regulatory standards.

FAQs

What is the primary use of mannitol 25% in clinical settings?

Mannitol 25% is primarily used to lower intracranial pressure, treat cerebral edema, and manage acute kidney injury.

How does the ADAPT trial impact the use of mannitol in TBI?

The ADAPT trial provides data supporting the use of mannitol in managing intracranial pressure crises, although it suggests that hypertonic saline may be more effective in some cases.

What are the key drivers of the global mannitol market growth?

The key drivers include the aging population, rising prevalence of neurological disorders, and advances in healthcare infrastructure.

Why is sterility important for mannitol injections?

Sterility is crucial to avoid infections and ensure patient safety, especially in high-risk settings like hospitals.

What is the projected market size of the global mannitol market by 2030?

The global mannitol market is expected to reach approximately USD 584.47 million by 2030.

Sources

  1. Efficacy of intravenous paracetamol and mannitol in managing chronic post-thoracotomy pain in patients with lung cancer. MedRxiv, 2024.
  2. Mannitol Market Size, Share Analysis | Industry Report, 2024. Grand View Research.
  3. In-Depth Industry Outlook: Mannitol Injection Market Size & Forecast. Verified Market Research.
  4. Results of Hypertonic Saline or Mannitol Clinical Trial for Treatment of Children with Severe TBI. YouTube, World Shared Practice Forum.
  5. Mannitol Market Size & Share Report Forecast 2023-2030. SNS Insider.

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