Last Updated: June 25, 2026

CLINICAL TRIALS PROFILE FOR MANNITOL 5%


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All Clinical Trials for MANNITOL 5%

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 5%

Condition Name

Condition Name for MANNITOL 5%
Intervention Trials
Asthma 20
Cystic Fibrosis 10
Healthy 7
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Condition MeSH

Condition MeSH for MANNITOL 5%
Intervention Trials
Asthma 23
Intracranial Hypertension 12
Brain Neoplasms 10
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Clinical Trial Locations for MANNITOL 5%

Trials by Country

Trials by Country for MANNITOL 5%
Location Trials
United States 137
Canada 39
United Kingdom 35
Australia 34
Italy 21
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Trials by US State

Trials by US State for MANNITOL 5%
Location Trials
New York 19
Massachusetts 12
Minnesota 9
Oregon 8
Ohio 7
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Clinical Trial Progress for MANNITOL 5%

Clinical Trial Phase

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

Clinical Trial Status for MANNITOL 5%
Clinical Trial Phase Trials
Completed 137
Unknown status 27
RECRUITING 23
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Clinical Trial Sponsors for MANNITOL 5%

Sponsor Name

Sponsor Name for MANNITOL 5%
Sponsor Trials
Pharmaxis 19
Northwell Health 7
National Cancer Institute (NCI) 6
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Sponsor Type

Sponsor Type for MANNITOL 5%
Sponsor Trials
Other 387
Industry 64
NIH 17
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Last updated: May 2, 2026

What does “MANNITOL 5%” look like in clinical development, and what does the market projection imply?

What is Mannitol 5% in-market and how is it positioned clinically?

“Mannitol 5%” is an aqueous mannitol solution at 5% w/v, typically supplied as an IV osmotic agent used for indications that rely on osmotic shifting (e.g., raised intracranial pressure), fluid management in select clinical settings, and specific perioperative or procedural uses. In practice, “mannitol 5%” is marketed as a generic injectable strength within broader mannitol product portfolios, and clinical use patterns depend on local labeling and hospital protocols rather than new drug approvals.

For a clinical-trials update and market projection focused on “MANNITOL 5%” as a strength, the governing reality is that mannitol is an older, off-patent excipient-grade active with a mature global supply chain. That typically produces:

  • Limited late-stage, strength-specific innovation (most clinical evidence and trials concern the active, dosing schedules, or alternative formulations).
  • Commercial differentiation via manufacturing, container system, and regulatory labeling, not via first-in-class efficacy.

What clinical trials are actively relevant for “mannitol 5%” right now?

No complete, strength-specific clinical-trials dataset can be produced from the information provided in the request. A valid trials update requires an auditable list of studies (e.g., registry entries with exact strength/formulation matches), trial phases, dates, recruitment status, endpoints, and locations. Without that, a “clinical trials update” would be non-actionable.

How big is the mannitol injection market, and where does 5% fit?

“Mannitol injection” is sold as multiple strengths and container presentations (commonly 5% and 10% are discussed in many markets). The economic question for “MANNITOL 5%” is not the entire mannitol injection category, but the subset of sales tied to 5%. Published market research typically aggregates mannitol injection across strengths, and strength-specific shares often do not appear in public sources.

Given the constraints of the request, a strength-specific market size and projection cannot be calculated with proof-based rigor (no cited market model, no disclosed segment share, no independent revenue attribution to the 5% strength).

What is the practical investment/R&D implication of the “5% strength” angle?

For mannitol, the bottleneck is rarely “clinical evidence for 5%.” Instead, the gating items are:

  • Regulatory labeling for the exact strength and route (IV) in each geography.
  • Manufacturing compliance and supply reliability for injectable products.
  • Tender-driven price competition, where competing generics set the economic ceiling.
  • Container compatibility and stability evidence that supports shelf-life and handling.

What market projection can be stated with provable boundaries?

A defensible projection requires at minimum:

  • a base-year market size for mannitol injection,
  • a 5% strength share (or an explicit 5% segment definition in the underlying model),
  • growth drivers (incidence trends for labeled indications, hospital formulary conversion, tender cadence),
  • headwinds (price erosion, supplier consolidation, raw material cost changes).

No such inputs are provided and none are recoverable from the request alone without external source identification.


Key Takeaways

  • “MANNITOL 5%” is a mature IV strength of a long-established osmotic agent where clinical differentiation is usually limited.
  • A strength-specific “clinical trials update” and a strength-specific market projection require auditable, source-backed registry and market-segmentation inputs that are not present in the request.
  • The most actionable commercial variables for mannitol products are typically regulatory labeling, manufacturing reliability, and tender pricing, not novel clinical endpoints for the 5% strength.

FAQs

1) Is mannitol 5% considered a new-drug category?
No. Mannitol is a well-established active with mature clinical use; product differentiation is generally formulation and regulatory/CMC, not new mechanisms.

2) Do clinical trials usually target mannitol 5% specifically?
Usually not as the primary focus. Trials more often address mannitol dosing regimens, concentrations broadly, or clinical contexts for the active.

3) Can the market projection be done without strength-level segmentation?
Not with credibility for “MANNITOL 5%.” Most public market research aggregates across strengths unless a model explicitly segments 5%.

4) What drives sales for mannitol injection in practice?
Hospital protocols and tenders, plus availability and label fit for the local regulatory indications.

5) Where do competitive advantages typically exist for mannitol products?
Regulatory approvals, manufacturing quality and supply stability, packaging/container performance, and pricing execution in tender markets.


References (APA)

No cited sources were provided in the request, and no external sources can be generated reliably without access to the underlying clinical trial registry and market research documents.

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