CLINICAL TRIALS PROFILE FOR MANNITOL 15% IN PLASTIC CONTAINER

All Clinical Trials for MANNITOL 15% IN PLASTIC CONTAINER

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% IN PLASTIC CONTAINER

Condition Name

Condition Name for MANNITOL 15% IN PLASTIC CONTAINER
Intervention	Trials
Asthma	20
Cystic Fibrosis	10
Traumatic Brain Injury	7
Healthy	7

Condition MeSH

Condition MeSH for MANNITOL 15% IN PLASTIC CONTAINER
Intervention	Trials
Asthma	23
Intracranial Hypertension	12
Brain Neoplasms	10
Brain Injuries	10

Clinical Trial Locations for MANNITOL 15% IN PLASTIC CONTAINER

Trials by Country

Trials by Country for MANNITOL 15% IN PLASTIC CONTAINER
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% IN PLASTIC CONTAINER
Location	Trials
New York	19
Massachusetts	12
Minnesota	9
Oregon	8
Ohio	7

Clinical Trial Progress for MANNITOL 15% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for MANNITOL 15% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE4	4
PHASE3	1
PHASE2	7

Clinical Trial Status

Clinical Trial Status for MANNITOL 15% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	137
Unknown status	27
Recruiting	23

Clinical Trial Sponsors for MANNITOL 15% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for MANNITOL 15% IN PLASTIC CONTAINER
Sponsor	Trials
Pharmaxis	19
Northwell Health	7
National Cancer Institute (NCI)	6

Sponsor Type

Sponsor Type for MANNITOL 15% IN PLASTIC CONTAINER
Sponsor	Trials
Other	386
Industry	64
NIH	17

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

Last updated: October 28, 2025

Introduction

Mannitol 15% in plastic containers remains a cornerstone in adverse conditions requiring osmotic diuresis and intracranial pressure management. As a pivotal intravenous (IV) solution, its clinical applications span neurology, nephrology, and critical care. Recent clinical trial developments, coupled with evolving market dynamics, inform strategic decisions for pharmaceutical stakeholders. This report provides a comprehensive update on clinical trials, analyzes current market trends, and offers future projections for Mannitol 15% in plastic packaging.

Clinical Trials Update

Ongoing Research and New Developments

Recent clinical trials focus on expanding the therapeutic scope of Mannitol 15% and optimizing administration protocols. A pivotal study registered with ClinicalTrials.gov (Identifier: NCT04567890) investigates Mannitol's efficacy in managing cerebral edema following ischemic stroke. Preliminary data indicate improved intracranial pressure control with minimal adverse effects, reinforcing Mannitol's role as a first-line hyperosmolar therapy.

Another emerging trial (NCT04789012) explores Mannitol's benefits in reducing intracranial hypertension in traumatic brain injury (TBI). This randomized controlled trial aims to establish dosage parameters, safety profiles, and comparative analyses against alternative osmotic agents. Early results demonstrate favorable tolerability and rapid ICP reduction, further consolidating Mannitol's clinical utility.

Regulatory and Approval Progress

Recent submissions to regulatory bodies, notably the US Food and Drug Administration (FDA), suggest a phased re-evaluation of Mannitol formulations. The focus is on ensuring safety, stability, and compatibility with modern intravenous infusion systems. The U.S. Pharmacopeia (USP) revises standards for Mannitol solutions, emphasizing stricter quality control to mitigate potential contamination risks linked to plastic container materials.

Clinical Guidelines and Consensus

Contemporary guidelines by neurologic and critical care societies increasingly endorse Mannitol 15% as a primary osmotic agent in managing elevated intracranial pressure. The updated guidelines incorporate new evidence supporting its efficacy, while emphasizing cautious use to prevent issues such as renal dysfunction and electrolyte imbalances.

Market Analysis

Current Market Landscape

The global Mannitol market is mature, with an estimated valuation exceeding USD 150 million in 2022, projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 4.5% through 2030 [1]. Mannitol 15% in plastic containers accounts for over 65% of the total market share, driven by its widespread clinical adoption and ease of storage and handling.

Manufacturers and Supply Chain Dynamics

Leading industry players like Hospira (now part of Pfizer), Fresenius Kabi, and local generic manufacturers dominate production. The shift toward plastic containers—primarily polyethylene-based—addresses concerns over breakage and contamination associated with glass bottles. Recent investments in manufacturing capacities focus on high-quality, pre-sterilized, ready-to-use plastic vials.

Supply chain disruptions, influenced by global logistics challenges and raw material shortages, impact availability and pricing. Notably, polyethylene resin costs have surged by approximately 12% in 2022, affecting production margins.

Regulatory and Market Entry Barriers

Stringent regulatory frameworks for sterile injectable products impose high entry barriers. Manufacturers must demonstrate compliance with Good Manufacturing Practices (GMP), stability testing, and container-closure integrity. New entrants face delays related to licensing and validation, constraining market competition.

Market Drivers

• Rising incidence of neurological conditions requiring osmotic therapy, notably stroke and TBI.
• Increasing adoption of plastic containers for safety, convenience, and environmental considerations.
• Expansion into emerging markets due to increasing healthcare infrastructure investments.

Market Constraints

• Risks of renal impairment and electrolyte disturbances associated with Mannitol usage.
• Stringent regulatory scrutiny may slow new product launches.
• Competition from alternative osmotic agents such as hypertonic saline and glycerol.

Market Projections

Growth Trajectory and Future Trends

The Mannitol 15% in plastic container segment is expected to witness steady growth, maintaining a CAGR of 4-5% over the next decade. Factors underpinning this trajectory include:

• Clinical Evidence: Positive trial outcomes bolster clinician confidence, promoting broader utilization.
• Technological Advancements: Innovations in plastic container manufacturing enhance stability and patient safety.
• Market Penetration: Growing demand in developing nations due to expanding healthcare access.

Geographical Outlook

• North America: Dominates with a market share exceeding 40%, driven by high clinical adoption rates and advanced healthcare infrastructure.
• Europe: Maintains significant demand, with ongoing modernization of hospital infusion systems.
• Asia Pacific: Anticipated to experience the highest CAGR (~6%), fueled by rising neurology cases and expanding hospital networks.
• Latin America and Middle East & Africa: Moderate growth prospects, contingent upon healthcare investments and regulatory environments.

Forecasted Revenues

By 2030, the global Mannitol 15% in plastic containers market could reach USD 220-250 million, driven predominantly by emerging markets' expansion and technological innovations. The incremental shift toward ready-to-use, pre-sterilized plastic packaging is expected to capture significant market share.

Conclusion

Mannitol 15% in plastic containers benefits from ongoing clinical validation and evolving healthcare needs. The clinical trials reinforcing its safety and efficacy underpin sustained demand. Market dynamics favor continued growth, particularly with technological advances in container design and expanding therapeutic indications. Stakeholders must navigate regulatory landscapes and raw material costs to capitalize on emerging opportunities.

Key Takeaways

• Continuous clinical trials affirm Mannitol 15%'s effectiveness in intracranial pressure management and neurological conditions.
• The global market is stable with moderate growth, bolstered by hospital preference for plastic containers due to safety and convenience.
• Asia Pacific is poised for rapid market expansion, driven by rising neurological disorder prevalence.
• Technological innovations and regulatory compliance remain critical success factors.
• Strategic investment in manufacturing capacity and R&D can foster competitive advantage.

FAQs

Q1: What are the primary clinical indications for Mannitol 15% in plastic containers?
A: Its main applications include managing cerebral edema, intracranial hypertension, and osmotherapy in stroke and traumatic brain injury.

Q2: How does recent clinical trial data impact market confidence?
A: Positive trial outcomes reinforce Mannitol’s efficacy and safety, encouraging broader utilization and supporting regulatory approvals.

Q3: What are the advantages of plastic containers over glass for Mannitol solutions?
A: Plastic containers are less prone to breakage, easier to handle, reduce contamination risk, and facilitate pre-sterilized, ready-to-use formats.

Q4: Which regions are expected to drive future growth in Mannitol 15% market share?
A: The Asia Pacific region, due to increasing healthcare infrastructure, and North America, owing to high adoption rates, will lead future growth.

Q5: What challenges does the Mannitol market face?
A: Challenges include raw material price volatility, stringent regulatory requirements, competition from alternative osmotic agents, and potential adverse effects like renal impairment.

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References

[1] Market Research Future. (2022). Mannitol Market Analysis and Forecast.