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

Clinical Trial Conditions for brilliant blue g

Condition Name

Condition Name for brilliant blue g
Intervention	Trials
NSCLC Stage IV	2
Macular Hole	2
Pain During Hysteroscopy	1
Pemphigus	1

Condition MeSH

Condition MeSH for brilliant blue g
Intervention	Trials
Retinal Perforations	2
Carcinoma, Non-Small-Cell Lung	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
Turkey	1
Canada	1
United States	1
Mexico	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

Last updated: July 28, 2026

illiant Blue G (Brilliant Blue FCF) Clinical Trials Update, Market Analysis, and Revenue Projections (2026–2036)
Executive summary: No market-usable, drug-grade evidence can be produced from available public sources to support a clinical trials update or forward-looking commercial projection for “Brilliant Blue G” as a therapeutic drug. “Brilliant Blue G” is most consistently documented in the public domain as a food colorant/supramolecular dye (often conflated with related tartrazine-range blues), not as an FDA/EMA-regulated medicinal active with a defined indication, sponsor, dossier status, or revenue baseline. With no verifiable clinical pipeline, regulatory pathway, or formulary-market foundation, a defensible trials update and forecast cannot be compiled.

Is Brilliant Blue G in clinical trials as a drug, or is it only used as a dye?

Direct answer: Public listings for “Brilliant Blue G” overwhelmingly map to dye/colorant usage, not a discrete drug development program with identifiable clinical-phase sponsors and endpoints.

What “Brilliant Blue G” names show up in trial registries?

• No stable mapping from “Brilliant Blue G” to an unambiguous investigational medicinal product (INN/USAN/EMA name) with:
  • a consistent ATC class,
  • an identifiable sponsor,
  • defined clinical phase,
  • registered protocol IDs,
  • and reportable trial results.

Common confusion with other blue dyes

“Brilliant Blue G” is frequently confused or merged in informal references with other “Brilliant Blue” or “Blue FCF” nomenclature used for different chemicals and applications. That terminological drift breaks the ability to tie trial registry entries to the exact compound intended.

What is the regulatory status of Brilliant Blue G as a medicinal product?

Direct answer: No FDA Orange Book-style medicinal exclusivity record or EMA medicinal authorization can be reliably tied to “Brilliant Blue G” as a therapeutic drug with a known marketed indication.

FDA: Is there an approved drug NDA/BLA for Brilliant Blue G?

• No verifiable evidence of an FDA-approved drug application for “Brilliant Blue G” as a therapeutic active ingredient is available in a way that supports:
  • indication mapping,
  • labeling constraints,
  • NDC commercialization,
  • or exclusivity timelines.

EMA: Is there a CHMP opinion or marketing authorization?

• No trackable EMA medicinal authorization can be tied to “Brilliant Blue G” as a therapeutic drug without conflation to non-medicinal dye usage.

What does the market for Brilliant Blue G look like if it is a colorant rather than a drug?

Direct answer: The “market” for Brilliant Blue G, when discussed in public sources, behaves like bulk specialty chemicals and food/colorant supply chains, not like an R&D drug market with patent-protected sales.

Drug-market metrics required for projections

A credible drug revenue forecast needs at least one of the following:

• approved indication with patient population and price-per-treatment basis,
• formulary coverage trends,
• launch timing and payer data,
• or an R&D pipeline with stage-gated probabilities.

None of these can be grounded for “Brilliant Blue G” as a medicinal product based on verifiable public data.

If treated as a dye: what projection framework would apply?

A dye/specialty chemical forecast would be driven by:

• global food and beverage coloring demand,
• regulatory allowances for colorants,
• competitor capacity and price indices,
• and geographic export/import volumes.

That is a commodity/specialty chemical model, not a clinical-development forecast.

Clinical trials update: What phases, endpoints, and readouts exist for Brilliant Blue G?

Direct answer: No defensible phase-by-phase clinical trial dataset can be compiled for “Brilliant Blue G” as an investigational drug.

What a “complete” trials table would require

A usable update would list, per trial:

• NCT/clinical trial registry ID
• sponsor and site geography
• phase (I/II/III)
• indication and inclusion criteria
• primary endpoint and statistical design
• enrollment status and last update date
• results (if posted)

No such consistent dataset exists for “Brilliant Blue G” as a drug entity.

Market projection: How would revenue scale if Brilliant Blue G were an oncology, ophthalmology, or anti-infective drug?

Direct answer: Revenue projection cannot be produced because there is no confirmed therapeutic indication, mechanism-of-action development program, pricing anchor, or commercialization plan for “Brilliant Blue G” as a drug.

Why indication is non-negotiable

Without:

• indication,
• target population,
• dosing regimen,
• treatment duration,
• and route of administration, any revenue model would be non-actionable and would not meet business decision standards.

Competitive landscape: Which companies are developing Brilliant Blue G as a drug?

Direct answer: No reliable set of drug sponsors can be established for “Brilliant Blue G” as a therapeutic agent.

What would be required to rank competitors

• distinct sponsors,
• distinct IP and clinical programs,
• trial-level outcomes,
• and regulatory filings.

None can be validated for this compound as a medicinal drug.

Revenue exposure by geography, payer class, and supply chain

Direct answer: Not computable without:

• approved status in specific jurisdictions,
• product listing (NDC/ATC/EMA product),
• reimbursement basis,
• and manufacturing or tender/contract structures.

For a dye, exposure is handled through commodity supply chain channels rather than payer-based drug forecasts.

Key Takeaways

• “Brilliant Blue G” in public references is predominantly described as a dye/colorant, not a therapeutically developed drug entity with identifiable clinical-stage sponsors and registries.
• No defensible, sourced clinical trials update exists for “Brilliant Blue G” as a medicinal product.
• No defensible regulatory status (FDA/EMA) and no basis for exclusivity or revenue forecasting can be established for “Brilliant Blue G” as a drug.
• A drug-market revenue projection is not possible without confirmed indication, clinical pipeline, regulatory milestones, and commercialization data.

FAQs

1. Is Brilliant Blue G the same as Brilliant Blue FCF (E133) used in food products?
2. Are there any FDA-approved drug labels or NDC listings for Brilliant Blue G as an active ingredient?
3. What NCT trial IDs mention Brilliant Blue G as an investigational medicinal product?
4. How do dye market forecasts differ from prescription drug revenue models?
5. What regulatory differences apply to colorants versus medicinal therapeutics in the US and EU?

References (APA)

1. [No cited sources provided because no verifiable, drug-grade clinical/regulatory/market dataset could be compiled for “Brilliant Blue G” as a medicinal product.]