CLINICAL TRIALS PROFILE FOR BRILLIANT BLUE G

All Clinical Trials for BRILLIANT BLUE G

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00738413 ↗	Iron Balance Study of Deferasirox, Deferoxamine and the Combination of Both	Unknown status	Weill Medical College of Cornell University	Phase 1/Phase 2	2008-08-01	Subjects with thalassemia major require regular transfusion therapy to sustain life. The iron present in the transfused blood remains in the body where it can cause a variety of organ dysfunctions. Lifelong iron chelation therapy is needed to maintain iron balance but its effectiveness varies greatly. Like that of deferoxamine (Desferal, DFO) the mainstay of chelation therapy for 30 years, the effectiveness of deferasirox (Exjade, ICL670), the newly approved, orally effective iron chelating drug, is not satisfactory in all subjects. Even with good compliance, the iron excretion induced by a given drug exhibits wide subject-to-subject variability. There is often persistent iron overload of extra hepatic tissues such as the heart and pancreas leading to cardiac disease and diabetes. Combining the drugs may be a better approach in those subjects at increased risk. The iron balance studies proposed will permit an assessment of the potential of such a combination to place subjects in net negative iron balance and the relative effectiveness of the combination in relation to that of the individual drugs, an additive effect being expected. With such information, physicians will be able to design individualized chelation regimens that maximize effectiveness while minimizing side effects by adjusting the ratio and/or the dosing schedule of the two drugs.
NCT01718314 ↗	Comparison of Sublingual Misoprostol Versus Lidocaine Spray for Hysteroscopy	Completed	Dr. Sami Ulus Children's Hospital	N/A	2008-03-01	Hysteroscopy is an instrument to visualize the interior walls of uterus (womb) and it enables the doctor to do minor operative procedures. Although it causes little discomfort, sometimes it may be disturbing for the patient. This pain is usually perceived during the passage of the instrument through the cervix (neck of the womb). The investigators would like to minimize this pain by two drugs: Misoprotol and lidocaine
NCT01820520 ↗	Safety and Efficacy of Double Staining With Brilliant Blue G for Macular Surgery	Unknown status	Asociación para Evitar la Ceguera en México	Phase 3	2013-01-01	Study designed to evaluate the safety and efficacy of double staining with brilliant blue G 0.025% as an adjuvant to macular surgery. Patients undergoing surgery for macular hole or epiretinal membrane will be included. Safety will be evaluated by optic coherence tomography, pattern reversal electroretinogram and multifocal electroretinogram.
NCT02052219 ↗	BRILLIANT-SC: A Study of the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy	Withdrawn	Anthera Pharmaceuticals	Phase 3	2014-10-01	The purpose of this study is to compare the effect of blisibimod plus standard of care versus placebo plus standard of care alone on the proportion of subjects achieving improvement in renal disease parameters.
NCT03020459 ↗	Internal Limiting Membrane Peeling-reposition to Treat Idiopathic Macular Holes	Completed	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	N/A	2017-01-01	To compare the morphologic and functional outcomes of internal limiting membrane peeling-reposition versus peeling in idiopathic macular holes
NCT03214406 ↗	Clinical Evaluation of the Efficacy of a Marketed Dentifrice on Plaque and Gingivitis	Completed	Church & Dwight Company, Inc.	N/A	2010-02-08	Parallel, double blind, randomized, Institutional Review Board (IRB) -approved study involving approximately 160 subjects to complete. Subjects were randomly assigned to either the test product (Arm & Hammer Advance White Brilliant Sparkle) or the control (Crest Cavity Protection Regular) based on baseline mean whole-mouth plaque and gingival scores and age.Subjects brushed with their assigned dentifrice two times (2X) daily and were evaluated for gingivitis, bleeding and plaque at Baseline and after 4-, 8-, and 12-weeks of product use. Return to pre-study hygiene regimen for 4 weeks and final evaluation at 16 weeks.

Clinical Trial Conditions for BRILLIANT BLUE G

Condition Name

Condition Name for BRILLIANT BLUE G
Intervention	Trials
Macular Hole	2
NSCLC Stage IV	2
Pemphigus	1
Plaque	1

Condition MeSH

Condition MeSH for BRILLIANT BLUE G
Intervention	Trials
Carcinoma, Non-Small-Cell Lung	2
Retinal Perforations	2
Pemphigus	1
Epiretinal Membrane	1

Clinical Trial Locations for BRILLIANT BLUE G

Trials by Country

Trials by Country for BRILLIANT BLUE G
Location	Trials
China	7
Canada	1
United States	1
Mexico	1
Japan	1

Trials by US State

Trials by US State for BRILLIANT BLUE G
Location	Trials
New York	1

Clinical Trial Progress for BRILLIANT BLUE G

Clinical Trial Phase

Clinical Trial Phase for BRILLIANT BLUE G
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	2
Phase 3	3

Clinical Trial Status

Clinical Trial Status for BRILLIANT BLUE G
Clinical Trial Phase	Trials
Completed	3
RECRUITING	3
Unknown status	2

Clinical Trial Sponsors for BRILLIANT BLUE G

Sponsor Name

Sponsor Name for BRILLIANT BLUE G
Sponsor	Trials
Fudan University	2
Ono Pharmaceutical Co. Ltd	1
Weill Medical College of Cornell University	1

Sponsor Type

Sponsor Type for BRILLIANT BLUE G
Sponsor	Trials
Other	6
Industry	4

BRILLIANT BLUE G Market Analysis and Financial Projection

Last updated: April 28, 2026

Brilliant Blue G: Clinical-trials update, market analysis, and pricing-and-usage projection

What is Brilliant Blue G and where is it in development?

Brilliant Blue G (also named Brilliant Blue FCF in some contexts) is a synthetic triphenylmethane dye used as a colorant in foods, beverages, pharmaceuticals, and cosmetics. Patent and R&D activity for dyes often sits in a different track than small-molecule therapeutics: commercial value is tied to regulatory status, manufacturing yield, impurity profile, and end-use specifications rather than late-stage clinical programs.

A current, drug-like clinical-trials program (e.g., Phase 1-3 safety and efficacy) must be supported by trial registries, publications, or regulator documents. No such trial record set is provided in the prompt, and no source-backed clinical-trials particulars can be produced without primary evidence.

Clinical-trials update (evidence-based): none provided in the available input, so no registry-grade update can be stated.

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What does the market for Brilliant Blue G look like?

Brilliant Blue G competes in the synthetic colorant market, not the oncology or cardiometabolic “drug” market. Demand is driven by food and beverage coloring, confectionery, dairy products, and pharmaceutical excipient use (coatings and dyes). The commercial “market” is therefore shaped by:

• Regulatory approvals and permitted use levels in major jurisdictions
• Batch-to-batch quality (titanium residues, heavy metals, specific impurities, particle characteristics)
• Stability requirements (heat, light, pH, solubility)
• Cost vs. alternatives (other FD&C lakes and dyes)

Commercial market size, forecasts, and specific shipment volumes require sources (industry reports, customs trade data, or regulator use-level analytics). No such inputs are present in the prompt, so market-sizing numbers cannot be presented.

Market analysis (evidence-based): no source-backed market size, CAGR, or segment shares can be stated.

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What pricing and “usage projection” can be modeled for Brilliant Blue G?

For colorants, “projection” is typically a demand model using consumption drivers:

• Food and beverage production growth
• Formulation shifts toward water-soluble, stable dyes
• Compliance-driven reformulation that changes dye usage levels
• Substitution risk from alternative colors or regulatory restrictions

A pricing model also needs inputs that are not present: benchmark spot prices, contracts, or import/export averages by grade and region.

Pricing-and-usage projection (evidence-based): not computable from the provided input without introducing non-cited numbers.

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What are the key regulatory and development constraints that govern commercial use?

Colorant development is governed more by compliance than by clinical endpoints. For Brilliant Blue G, relevant constraints usually include:

• Positive listings in food categories and maximum permitted concentrations
• Lakes vs. soluble dye availability for specific application requirements
• Impurity specifications and test methods aligned to compendial or national standards
• Occupational and consumer safety requirements for manufacturing and finished goods

Regulatory constraints (evidence-based): no jurisdictional approval status or numeric limits are provided in the prompt, so no hard listing data can be quoted.

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Where does intellectual property typically sit for Brilliant Blue G?

For dyes, IP generally clusters around:

• Manufacturing processes (yield improvement, purification, impurity reduction)
• Intermediate production routes
• Crystallization, milling, and formulation specs
• Lakes or blends for specific application performance

A credible patent landscape requires patent database searches and citation mapping, none of which are included in the prompt.

IP landscape (evidence-based): cannot be summarized with hard numbers (filings, assignees, families, claim scope) without source records.

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Actionable view for R&D or investment

With no source-backed clinical trial registry entries, market sizing, regulatory numeric limits, pricing benchmarks, or patent records supplied, a defensible “update” cannot be produced.

What can be concluded strictly from the prompt’s content is limited to one fact: Brilliant Blue G is a colorant, and its commercial trajectory depends on regulatory permission, manufacturing compliance, and formulation demand rather than clinical efficacy endpoints. However, without cited, registry-grade, regulator-grade, or industry-grade figures, any attempt to give “clinical progress,” “market size,” “forecast,” or “pricing” numbers would not meet an evidence standard.

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Key Takeaways

• Brilliant Blue G is a synthetic dye used for coloration; its business case typically hinges on regulatory acceptance, specs, and manufacturing performance rather than Phase 1-3 efficacy trials.
• A clinical-trials update requires registry or publication evidence; none is present in the provided input, so no trial status can be stated.
• Market analysis and forecasts require external sizing and pricing data; none is present in the provided input, so no numeric projections can be produced.
• Investment and R&D diligence for this type of asset should prioritize regulatory listings, impurity/control specs, and process IP, but patent and regulatory facts must be sourced.

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FAQs

1. Is Brilliant Blue G developed as a therapeutic drug in Phase 1-3?
   Not based on the provided input; no clinical trial evidence is included.

2. What drives demand for Brilliant Blue G?
   End-use demand in food, beverages, and pharma applications for coloring performance and compliance.

3. How is growth usually measured in the colorant market?
   By application consumption, regulatory-permitted use, and formulation adoption, typically supported by industry and trade data.

4. What are the most important technical risk areas?
   Impurity profile, batch consistency, stability (pH, heat, light), and solubility or lake formation performance.

5. What kind of patents matter most for dyes like Brilliant Blue G?
   Process and purification IP, intermediates, and application-performance formulations or lakes.

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References

No sources were provided in the prompt, and no citations can be generated without external material.