CLINICAL TRIALS PROFILE FOR TRYPAN BLUE

All Clinical Trials for TRYPAN BLUE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00947453 ↗	Sputum Matrix Metalloproteinases (MMP) mRNA and Montelukast	Completed	Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)	Phase 2	2009-07-01	Matrix metalloproteinases (MMPs) are a group of 24 zinc containing enzymes in man. These enzymes were originally described as cleaving extracellular matrix (ECM) substrates with a predominant role in ECM homeostasis, but it is now clear that they have much wider functionality. An imbalance between MMP activity and that of their inhibitors (tissue inhibitors of metalloproteinases, TIMPs) is considered to play a critical role in the synthesis or degradation of the extracellular matrix of the airway architecture which results in fixed airflow obstruction in both asthma and chronic obstructive pulmonary disease (COPD). Using quantitative real time polymerase chain reaction (RT-PCR) the investigators have identified a difference between the level of steady state mRNA for MMP-9, MMP-14 and MMP-2 in 2 patients with asthma compared to 4 healthy controls using our method. However the investigators require further refinement of the process in order to optimise RNA quality and to evaluate the effect of montelukast across the entire family of MMPs and their inhibitors (TIMPs).
NCT00947453 ↗	Sputum Matrix Metalloproteinases (MMP) mRNA and Montelukast	Completed	University of East Anglia	Phase 2	2009-07-01	Matrix metalloproteinases (MMPs) are a group of 24 zinc containing enzymes in man. These enzymes were originally described as cleaving extracellular matrix (ECM) substrates with a predominant role in ECM homeostasis, but it is now clear that they have much wider functionality. An imbalance between MMP activity and that of their inhibitors (tissue inhibitors of metalloproteinases, TIMPs) is considered to play a critical role in the synthesis or degradation of the extracellular matrix of the airway architecture which results in fixed airflow obstruction in both asthma and chronic obstructive pulmonary disease (COPD). Using quantitative real time polymerase chain reaction (RT-PCR) the investigators have identified a difference between the level of steady state mRNA for MMP-9, MMP-14 and MMP-2 in 2 patients with asthma compared to 4 healthy controls using our method. However the investigators require further refinement of the process in order to optimise RNA quality and to evaluate the effect of montelukast across the entire family of MMPs and their inhibitors (TIMPs).
NCT01903473 ↗	Donor Regulatory T Cells Infusion in Patients With Chronic Graft-versus-host Disease (GVHD)	Recruiting	University Hospital of Liege	Phase 2	2013-07-01	The immune system has offensive and defensive capacities. In bone marrow transplantation, offensive cells in the donor grafts may attack host's organs, leading to a complication known as Graft versus Host Disease (GVDH). At present, patients receive steroid treatment to combat this tricky situation. Nevertheless, some patients do not respond to this therapy. Recently, it has been shown that immune system cells having defensive capacities can help in preventing the occurrence of a GVDH. This study aims to evaluate if these protective cells together with a non-standard immunosuppressor can improve the clinical condition and suppress the activity of the offensive cells in the graft.
NCT01903473 ↗	Donor Regulatory T Cells Infusion in Patients With Chronic Graft-versus-host Disease (GVHD)	Recruiting	University of Liege	Phase 2	2013-07-01	The immune system has offensive and defensive capacities. In bone marrow transplantation, offensive cells in the donor grafts may attack host's organs, leading to a complication known as Graft versus Host Disease (GVDH). At present, patients receive steroid treatment to combat this tricky situation. Nevertheless, some patients do not respond to this therapy. Recently, it has been shown that immune system cells having defensive capacities can help in preventing the occurrence of a GVDH. This study aims to evaluate if these protective cells together with a non-standard immunosuppressor can improve the clinical condition and suppress the activity of the offensive cells in the graft.

Clinical Trial Conditions for TRYPAN BLUE

Condition Name

Condition Name for TRYPAN BLUE
Intervention	Trials
Acute Graft-Versus-Host Disease	1
Asthma	1
Chronic Graft-Versus-Host Disease	1
Disc Degeneration	1

Condition MeSH

Condition MeSH for TRYPAN BLUE
Intervention	Trials
Graft vs Host Disease	1
Stomach Neoplasms	1
Asthma	1
Pleural Effusion, Malignant	1

Clinical Trial Locations for TRYPAN BLUE

Trials by Country

Trials by Country for TRYPAN BLUE
Location	Trials
United States	2
Belgium	2
Singapore	1
United Kingdom	1
China	1

Trials by US State

Trials by US State for TRYPAN BLUE
Location	Trials
Florida	1
Ohio	1

Clinical Trial Progress for TRYPAN BLUE

Clinical Trial Phase

Clinical Trial Phase for TRYPAN BLUE
Clinical Trial Phase	Trials
PHASE2	1
Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for TRYPAN BLUE
Clinical Trial Phase	Trials
Not yet recruiting	2
Recruiting	2
Completed	1

Clinical Trial Sponsors for TRYPAN BLUE

Sponsor Name

Sponsor Name for TRYPAN BLUE
Sponsor	Trials
Sheng Hu	1
National University of Singapore	1
Vanderbilt University Medical Center	1

Sponsor Type

Sponsor Type for TRYPAN BLUE
Sponsor	Trials
Other	11
Industry	1

Trypan Blue (Patent and Clinical/Market Intelligence Report)

Last updated: May 4, 2026

What is trypan blue in development and how is it used?

Trypan blue is a dye used in medicine for cell viability testing and in procedures where it helps visualize tissue. In oncology and diagnostics, it is used as a staining agent rather than as a systemic therapeutic. Public clinical development for systemic “drug-like” efficacy endpoints is limited compared with conventional small molecules and biologics.

This report focuses on clinical-trial activity and market implications for trypan blue as a marketed dye/staining product.

What clinical trials are active, completed, or recruiting?

No complete, citable set of up-to-date trial records (registrations, status, sites, endpoints, enrollment counts, dates) can be produced from the information available in this session. Producing an authoritative “clinical trials update” requires specific trial identifiers (e.g., NCT numbers), registry status, and dated milestones. Without those records, any listing would be incomplete.

What does the market look like for trypan blue?

Market positioning

Trypan blue competes in the “cell viability stains and tissue staining” area rather than in a defined pharmaceutical therapeutic category. Its market demand is driven by:

• Cell culture workflows in research labs and translational programs
• QC and viability testing in bioprocessing and assay development
• Specific staining applications in procedure workflows, where regulatory approval and labeling determine substitution risk

Commercial drivers

• Stability and low cost relative to proprietary viability assays
• Compatibility with standard workflows (microscopy-based viability counting)
• Lab procurement cycles (replacement of inventory and consumables rather than episodic drug demand)
• Regulatory requirements for use-cases where dye labeling and intended use affect purchasing decisions

Pricing and reimbursement

For staining reagents, reimbursement typically does not mirror therapeutic drug reimbursement models. Demand is often captured by:

• Distributor and direct lab supply channels
• Procedure supply contracts in specialty settings (when indicated)
• Research-use-only vs clinical-use labeling (where applicable)

How should investors and R&D teams project demand for trypan blue?

Base-case projection approach

A defensible projection for trypan blue is built on consumable and workflow metrics, not on dose, penetration, and treatment duration:

• Installed base of cell culture and bioprocess platforms
• Frequency of viability testing (assays per platform per period)
• Substitution risk from alternative viability stains and automated assays
• Regulatory and labeling constraints affecting clinical procedure use

Key projection sensitivities

• Shift toward automated viability workflows and reagent kits that reduce manual counting
• Changes in cell therapy and biologics manufacturing scale (more upstream testing can increase stain usage)
• Procurement pressure and generic substitution (often favorable for low-cost reagents like trypan blue)
• Regulatory labeling changes for specific clinical staining uses (can raise or suppress demand)

What is the patent landscape outlook for trypan blue?

Trypan blue is an established chemical dye with a long history of use. Patent value typically concentrates in:

• Formulations and packaging
• Specific labeled uses and manufacturing processes
• Concentrations, solvent systems, and compatibility claims for particular assay methods

A complete patent mapping requires a patent database run with time-bounded extraction of:

• Assignee ownership
• Claim scope around composition, method of use, and manufacturing
• Expiration schedules and family status

No citable patent set is available from the information in this session, so a hard-edged patent landscape cannot be produced here.

What is the near-term development and regulatory path likely to be?

For trypan blue as a staining reagent, the near-term pathway typically depends on:

• Label expansion or new intended-use approvals for particular clinical workflows
• Method-of-use optimization claims in assay or procedure contexts
• Manufacturing and quality system updates to maintain compliance

Systemic drug-grade clinical programs are less typical for trypan blue given its role as a dye.

Market forecast for trypan blue: what can be stated with proof?

No numbers can be asserted without cited sources for:

• Market size by geography and segment
• Unit volumes, pricing, or shipment data
• Clinical and regulatory events tied to sales

Producing an evidence-based forecast requires market data and trial endpoints tied to measurable commercial outcomes. No citable market dataset is available in this session.

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Key Takeaways

• Trypan blue functions primarily as a staining and cell-viability dye, so the commercial model tracks lab and procedure workflows rather than classic chronic therapeutic demand.
• A precise “clinical trials update” and dated status requires registry extracts (e.g., NCT IDs, enrollment, endpoints, recruitment status) that are not available in this session.
• Market projections should be consumption- and workflow-driven, with substitution risk from automated assays and assay kits.
• A rigorous patent landscape requires database-backed extraction of families, assignees, claim scope, and expiration schedules; it cannot be completed here without citable records.

FAQs

1) Is trypan blue being developed as a systemic therapeutic?

Not in a way that can be substantiated with citable clinical trial records from this session; trypan blue is primarily used as a dye in staining and viability testing workflows.

2) What drives trypan blue demand?

Cell viability testing frequency in research and bioprocessing, plus any procedure-specific labeled clinical staining uses.

3) What are the main competitive threats?

Alternative viability dyes, proprietary assay kits, and automated workflows that reduce manual viability counting.

4) What will determine whether trypan blue expands clinically?

Intended-use labeling and regulatory acceptance for specific staining or diagnostic workflow claims.

5) What data is most important for forecasting sales?

Installed base and assay frequency (consumption metrics), substitution rates, and any labeled-use regulatory changes.

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References

[1] No external sources were provided or retrievable in this session.