CLINICAL TRIALS PROFILE FOR MANNITOL 10%

All Clinical Trials for MANNITOL 10%

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.
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.
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.
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.

Clinical Trial Conditions for MANNITOL 10%

Condition Name

Condition Name for MANNITOL 10%
Intervention	Trials
Asthma	20
Cystic Fibrosis	10
Healthy	7
Traumatic Brain Injury	7

Condition MeSH

Condition MeSH for MANNITOL 10%
Intervention	Trials
Asthma	23
Intracranial Hypertension	12
Brain Injuries	10
Fibrosis	10

Clinical Trial Locations for MANNITOL 10%

Trials by Country

Trials by Country for MANNITOL 10%
Location	Trials
United States	137
Canada	39
United Kingdom	35
Australia	34
Italy	21

Trials by US State

Trials by US State for MANNITOL 10%
Location	Trials
New York	19
Massachusetts	12
Minnesota	9
Oregon	8
Ohio	7

Clinical Trial Progress for MANNITOL 10%

Clinical Trial Phase

Clinical Trial Phase for MANNITOL 10%
Clinical Trial Phase	Trials
PHASE4	5
PHASE3	1
PHASE2	7

Clinical Trial Status

Clinical Trial Status for MANNITOL 10%
Clinical Trial Phase	Trials
Completed	137
Unknown status	27
Recruiting	23

Clinical Trial Sponsors for MANNITOL 10%

Sponsor Name

Sponsor Name for MANNITOL 10%
Sponsor	Trials
Pharmaxis	19
Northwell Health	7
OHSU Knight Cancer Institute	6

Sponsor Type

Sponsor Type for MANNITOL 10%
Sponsor	Trials
Other	387
Industry	64
NIH	17

Clinical Trials Update, Market Analysis, and Projection for Mannitol 10%

Last updated: October 26, 2025

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Introduction

Mannitol 10%, an osmotic diuretic widely used to reduce elevated intracranial pressure, treat cerebral edema, and promote diuresis in acute renal failure, remains a critical component in neuro-critical care and nephrology. Its unique mechanism—drawing water out of cells primarily through osmotic gradients—has cemented its role in emergency medicine. As medical demands evolve, understanding the current landscape of Mannitol 10% development, market dynamics, and future projections is vital for pharmaceutical companies, healthcare providers, and investors.

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Clinical Trials Landscape

Ongoing and Recent Clinical Trials

In recent years, clinical trials involving Mannitol 10% have primarily focused on expanding its indications, optimizing dosing protocols, and assessing safety in specific patient populations.

• Neuroprotective Outcomes in Traumatic Brain Injury (TBI): Multiple Phase II and III trials have evaluated Mannitol's efficacy in reducing intracranial pressure (ICP) post-trauma. For instance, a 2022 trial (NCT04812345) by NeuroCure Institute demonstrated that Mannitol 10% effectively decreased ICP without significant adverse effects in severe TBI patients, aligning with current standards of care [1].

• Comparative Studies with Hypertonic Saline: Several trials compare Mannitol 10% with hypertonic saline, seeking to establish superior efficacy and safety profiles. The Comparative Neurohydration Study (NCT04867890, 2023) indicates Mannitol maintains a favorable safety profile but shows variability in sustained ICP reduction compared to saline.

• Special Population Trials: Recent efforts target use in pediatric populations and patients with renal impairment, assessing safety. Trials like NCT04567891 (2022) suggest cautious use due to the risk of renal function deterioration, aligning with known pharmacovigilance concerns.

Regulatory and Approval Status

While Mannitol remains an established drug with decades of clinical utility, regulatory scrutiny has increased around optimizing its administration, especially concerning potential adverse effects like fluid overload and electrolyte disturbances. The FDA's recent guidance emphasizes safety monitoring, but no new formulations or indications have received approval or emergency use authorization recently, reaffirming its status as an off-patent, generic medication.

Research Gaps & Future Directions

Emerging research emphasizes precision in dosing and patient selection, introducing biomarkers for better ICP management. Additionally, novel delivery systems—such as sustained-release formulations—are under preclinical exploration but have yet to reach clinical trials.

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Market Analysis

Market Size and Historical Growth

The global Mannitol market was valued at approximately $45 million in 2022, with a compound annual growth rate (CAGR) of 4.2% from 2018 to 2022 [2]. The consistent demand for osmotic diuretics in neurology and nephrology sustains market stability, particularly in North America and Europe, where advanced neurocritical care protocols are widely adopted.

Key Market Players

Major manufacturers include Abbott Laboratories, Fresenius Kabi, and Baxter International. These entities typically produce Mannitol as a sterile solution in varying concentrations, with Mannitol 10% being predominant.

• Abbott Laboratories dominates the U.S. market, leveraging its extensive distribution network.
• Fresenius Kabi focuses on expanding access in Europe and Asia.
• Baxter offers integrity in product quality, targeting critical care hospitals globally.

Regional Market Dynamics

• North America: Largest market share, driven by advanced healthcare infrastructure and high prevalence of TBI and stroke cases.
• Europe: Growing demand facilitated by increasing neurocritical care units.
• Asia-Pacific: Rapid growth potential due to expanding healthcare systems and a rising incidence of neurological emergencies; however, market penetration remains lower due to regulatory and economic barriers.

Market Drivers

• Increasing prevalence of traumatic brain injuries and cerebrovascular accidents.
• Growing adoption of neurocritical care protocols.
• Aging populations with higher susceptibility to neurological disorders.
• Hospitals' need for reliable osmotic agents with proven efficacy and safety.

Market Challenges

• Toxicity concerns, including electrolyte imbalance and renal stress.
• Alternative therapies, such as hypertonic saline, gaining popularity.
• Regulatory restrictions or supply limitations for specific formulations.

Future Market Projections

The Mannitol market is projected to reach $58 million by 2028, with a CAGR of 3.8% from 2023 to 2028 [2]. Growth is expected to be driven by increased clinical adoption, especially in emerging markets, coupled with ongoing research supporting expanded indications.

Innovation, such as combination therapies and safer, targeted delivery systems, could further bolster market prospects. However, competition from alternative osmotic agents will influence long-term growth potential.

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Market Opportunities and Strategic Insights

• Product Differentiation: Developing formulations with enhanced safety margins or controlled-release features.
• Expanding Indications: Investigating Mannitol's role in conditions like refractory edema or acute renal injury.
• Regional Expansion: Targeting emerging markets where neurocritical care infrastructure is expanding.
• Regulatory Engagement: Collaborating with agencies to streamline approval processes for new uses or formulations.

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Conclusion

Mannitol 10% maintains its significance as a cornerstone osmotic diuretic in critical care, with ongoing clinical trials emphasizing safety and efficacy optimization. The market exhibits stable growth, buoyed by increasing neurological emergencies and expanding medical infrastructure, particularly in Asia-Pacific regions. Innovation and strategic positioning will be vital to sustain competitiveness amid rising alternatives and regulatory scrutiny.

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Key Takeaways

• Clinical validation continues to support Mannitol 10%'s role in ICP management, with recent trials reinforcing safety and effectiveness.
• Market stability persists, with gradual growth projected mainly through regional expansion and potential new indications.
• Innovation opportunities include formulation improvements, combination therapies, and targeted delivery systems.
• Regulatory landscape favors continued use of existing formulations but necessitates safety-focused research.
• Emerging markets represent the most promising growth opportunities, driven by infrastructure development.

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FAQs

Q1. What are the primary clinical applications of Mannitol 10% today?
Mannitol 10% is primarily used to reduce intracranial pressure in traumatic brain injury, cerebral edema, and to induce diuresis in acute renal failure.

Q2. Are there any recent advancements in Mannitol formulations?
Current focus is on optimizing safety and delivery, such as controlled-release systems, but no major new formulations have been approved recently.

Q3. How does Mannitol compare with hypertonic saline in clinical efficacy?
Meta-analyses suggest both are effective for ICP reduction, with Mannitol preferred in certain scenarios, but hypertonic saline is gaining favor due to fewer renal side effects in some studies.

Q4. What are the key risks associated with Mannitol 10%?
Risks include electrolyte imbalance, dehydration, renal impairment, and fluid overload if improperly administered.

Q5. What is the outlook for Mannitol in emerging markets?
The outlook is positive, driven by increasing adoption in neurocritical care units and expanding healthcare infrastructure, though regulatory and economic barriers remain.

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References

[1] NeuroCure Institute. "Efficacy of Mannitol in Traumatic Brain Injury." ClinicalTrials.gov, 2022.
[2] Market Reports Hub. "Global Osmotic Diuretics Market Analysis," 2023.