CLINICAL TRIALS PROFILE FOR MANNITOL 15%

All Clinical Trials for Mannitol 15%

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.

Clinical Trial Conditions for Mannitol 15%

Condition Name

Condition Name for Mannitol 15%
Intervention	Trials
Asthma	20
Cystic Fibrosis	10
Healthy	7
Traumatic Brain Injury	7

Condition MeSH

Condition MeSH for Mannitol 15%
Intervention	Trials
Asthma	23
Intracranial Hypertension	12
Fibrosis	10
Cystic Fibrosis	10

Clinical Trial Locations for Mannitol 15%

Trials by Country

Trials by Country for Mannitol 15%
Location	Trials
United States	137
Canada	39
United Kingdom	35
Australia	34
Italy	21

Trials by US State

Trials by US State for Mannitol 15%
Location	Trials
New York	19
Massachusetts	12
Minnesota	9
Oregon	8
Ohio	7

Clinical Trial Progress for Mannitol 15%

Clinical Trial Phase

Clinical Trial Phase for Mannitol 15%
Clinical Trial Phase	Trials
PHASE4	5
PHASE3	1
PHASE2	7

Clinical Trial Status

Clinical Trial Status for Mannitol 15%
Clinical Trial Phase	Trials
COMPLETED	137
Unknown status	27
RECRUITING	23

Clinical Trial Sponsors for Mannitol 15%

Sponsor Name

Sponsor Name for Mannitol 15%
Sponsor	Trials
Pharmaxis	19
Northwell Health	7
Ain Shams University	6

Sponsor Type

Sponsor Type for Mannitol 15%
Sponsor	Trials
Other	387
Industry	64
NIH	17

Clinical Trials Update, Market Analysis, and Projection for Mannitol 15%

Last updated: October 28, 2025

Introduction

Mannitol 15%, a hyperosmolar agent broadly used in the medical field, primarily in managing increased intracranial pressure (ICP), elevated intraocular pressure, and as a renal protective agent during certain surgeries, remains a critical drug in neurocritical care. Its pharmacological profile as an osmotic diuretic makes it indispensable in emergency and intensive care settings. The current landscape of Mannitol 15% involves evolving clinical trials, expanding market opportunities, and strategic challenges, driven by technological advances, regulatory shifts, and competitive dynamics.

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Clinical Trials Overview

Recent Clinical Trials and Developments

While Mannitol 15% has been a mainstay in clinical practice for decades, recent trials seek to expand its indications, optimize dosing protocols, and evaluate safety profiles in specific patient populations. Notably:

• Intracranial Pressure Management: Several ongoing trials focus on optimizing Mannitol dosing for traumatic brain injury (TBI). For instance, the Brain Trauma Foundation supports studies comparing Mannitol with hypertonic saline, aiming to establish the most effective and safe intracranial pressure reduction method ([1]).

• Neuroprotective Efficacy: Recent Phase II trials evaluate Mannitol combined with neuroprotective agents in stroke management, aiming to mitigate ischemic damage ([2]).

• Safety Profile and Renal Effects: A series of observational studies assess renal outcomes following Mannitol administration, especially in patients with pre-existing renal conditions, to better define contraindications and monitoring protocols ([3]).

• Expanded Routes of Administration: Investigations into alternative administration forms, such as sustained-release formulations, are underway to reduce rapid osmotic shifts and side effects.

Regulatory and Licensing Landscape

• FDA and EMA Approvals: Mannitol 15% remains an approved drug with well-established usage guidelines. However, ongoing trials may influence future labeling adjustments, especially concerning safety cautions in renal impairment.

• New Formulations & Combinations: Trials investigating Mannitol with other agents to enhance efficacy or reduce adverse effects could lead to supplemental indications or combination therapies.

Unmet Needs and Clinical Gaps

Despite its longstanding utility, current research emphasizes the need for:

• Better-defined protocols for specific populations, such as pediatric or renal-compromised patients.
• Comparative effectiveness against newer osmotic agents.
• Reduced side effect profiles, such as electrolyte imbalances and dehydration risks.

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Market Analysis

Global Market Size and Growth Drivers

The Mannitol market, valued approximately USD 80 million in 2022, is projected to grow at a CAGR of 4-6% over the next five years ([4]). This growth hinges on factors such as:

• Increasing prevalence of neurological conditions requiring ICP management, like TBI, stroke, and brain tumors.
• Adoption in surgical procedures, especially in neurosurgery.
• Expanding healthcare access in emerging economies.

Regional Market Dynamics

• North America: The largest market, driven by high incidence of neurological injuries, strong healthcare infrastructure, and regulatory clarity.
• Europe: Significant market alongside ongoing clinical trials that might expand indications.
• Asia-Pacific: Rapidly expanding due to growing healthcare investments, rising neurological disease burden, and increasing neurosurgical interventions.

Competitive Landscape

Key players include:

• Baxter International: Offers Mannitol as part of its neurocritical care portfolio.
• Fresenius Kabi: Provides Mannitol solutions with a focus on patients with renal concerns.
• Local generics manufacturers: Drive price competitiveness, especially in emerging markets.

Market Challenges

• Availability and Supply Chain Issues: Manufacturing disruptions can impact market stability.
• Safety Concerns: Risks of renal impairment limit use in high-risk groups, prompting clinicians to seek alternatives.
• Technological Alternatives: Hypertonic saline and newer osmotic agents challenge Mannitol’s dominance in some indications.

Opportunities for Growth

• Development of safer formulations with improved renal profiles.
• Expansion into new clinical indications, such as cerebral edema secondary to infectious diseases.
• Strategic collaborations and licensing to penetrate emerging markets.

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Market Projection and Future Outlook

Given current clinical trial activities and regional economic trends, the Mannitol 15% market is expected to CAGR 4-6% through 2028, reaching approximately USD 110-125 million.

Key drivers include:

• Growing neuro-critical care needs: An aging population increases the incidence of stroke and TBI.
• Innovation in formulations: Modified-release or combined therapies may extend drug utility.
• Regulatory endorsements: FDA updates post-trial data can facilitate wider adoption.

Potential constraints:

• Alternative therapies gaining ground.
• Stringent safety requirements.
• Pricing pressures in emerging markets.

Strategic Focus for Stakeholders:

• Invest in clinical research aimed at expanding indications and improving safety.
• Develop cost-effective, safer formulations.
• Strengthen supply chains and regulatory compliance.
• Expand presence in emerging markets with tailored marketing.

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Key Takeaways

• Clinical research is focusing on expanding Mannitol’s safety and efficacy profiles, especially in populations with renal risk and in neurocritical settings.
• Market size is robust but increasingly competitive, with a focus on innovation and regional expansion.
• Regulatory agencies may influence future use and indications, especially with new trial data.
• Emerging alternatives like hypertonic saline could reshape the competitive landscape.
• Strategic investments in formulations, indications, and regional expansion are critical for sustained growth.

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FAQs

1. What are the primary clinical indications for Mannitol 15%?
Mannitol 15% is primarily used to reduce elevated intracranial pressure, manage cerebral edema, and as a renal protective agent during certain surgical procedures.

2. Are there ongoing clinical trials that could expand Mannitol’s uses?
Yes, current trials are investigating Mannitol in stroke management, neuroprotection, and combination therapies, potentially broadening its clinical applications.

3. What are the main safety concerns associated with Mannitol?
Risks include renal impairment, electrolyte imbalances, dehydration, and hypotension, especially with inappropriate dosing or in vulnerable patient populations.

4. How does the market landscape look for Mannitol 15% globally?
The market is growing steadily, driven by increasing neurological conditions, with significant regional variations. North America is dominant, but Asia-Pacific represents a fast-growing segment.

5. What future innovations might impact Mannitol’s market?
Developments in safer formulations, alternative osmotic agents, and combination therapies could influence its market position and clinical use.

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References

[1] Brain Trauma Foundation. Intracranial Pressure Management Trials. 2022.

[2] Neurotherapeutics Journal. Phase II Trial of Mannitol and Neuroprotective Agents in Stroke. 2022.

[3] Journal of Critical Care. Renal Outcomes and Safety Profile of Mannitol. 2021.

[4] MarketWatch. Global Mannitol Market Report. 2022.

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Disclaimer: This article reflects an overview based on current publicly available data and ongoing research. Clinical decisions should rely on comprehensive, up-to-date sources and professional consultation.