CLINICAL TRIALS PROFILE FOR SODIUM ROSE BENGAL I 131

All Clinical Trials for SODIUM ROSE BENGAL I 131

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04686461 ↗	Effect of Thymoquinone Extracted From Nigella Sativa in the Treatment of Arsenical Keratosis	Recruiting	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh	N/A	2019-10-20	Prepare an ointment from Nigella sativa seeds extract and apply it over palmer arsenical keratosis patient for 12 weeks. After than the effect of the ointment will be observed by measuring the keratotic nodular size before and after the intervention.
NCT00797030 ↗	Topical Cyclosporine for the Treatment of Dry Eye in Patients Infected With the Human Immunodeficiency Virus	Unknown status	Universidade Federal do Rio de Janeiro	Phase 4	2006-10-01	This study evaluates the use of topical cyclosporine 0.05% and sodium carboxymethylcellulose 0.5% for the treatment of dry eye disease in patients infected with the human immunodeficiency virus. Twenty HIV-positive-patients were selected from the Department of Infectious Diseases of the Federal University of Rio de Janeiro Hospital. Dry eye diagnosis was based on a dry eye questionnaire (Ocular Surface Disease Index - OSDI®), Schirmer I Test, break up time and 1% rose bengal staining of the ocular surface. The patients were divided into two groups with ten patients. Group I received sodium carboxymethylcellulose 0.5% drops and group II received sodium carboxymethylcellulose 0,5% drops and topical cyclosporine 0.05% for six months.
NCT01240382 ↗	Phase III Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye	Completed	Santen Pharmaceutical Co., Ltd.	Phase 3	1969-12-31	To investigate that the efficacy of 3% DE-089 ophthalmic solution (one drop at a time, 6 times daily, 4 weeks topical administration), in comparison to 0.1% sodium hyaluronate ophthalmic solution (0.1% HA) (one drop at a time, 6 times daily, 4 weeks topical administration), is at least non-inferior in the change in fluorescein staining score, and is superior in the change in Rose bengal score, in a multicenter, double-masked, parallel-group comparison study. Safety profile will likewise be compared.

Clinical Trial Conditions for SODIUM ROSE BENGAL I 131

Condition Name

Condition Name for SODIUM ROSE BENGAL I 131
Intervention	Trials
Dry Eye	1
Dry Eye Syndromes	1
HIV Seropositivity	1

Condition MeSH

Condition MeSH for SODIUM ROSE BENGAL I 131
Intervention	Trials
Keratoconjunctivitis Sicca	2
Dry Eye Syndromes	2
Acquired Immunodeficiency Syndrome	1

Clinical Trial Locations for SODIUM ROSE BENGAL I 131

Trials by Country

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Trials by Country for SODIUM ROSE BENGAL I 131
Location	Trials
Brazil	1
Bangladesh	1
Japan	1

Clinical Trial Progress for SODIUM ROSE BENGAL I 131

Clinical Trial Phase

Clinical Trial Phase for SODIUM ROSE BENGAL I 131
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
N/A	1

Clinical Trial Status

Clinical Trial Status for SODIUM ROSE BENGAL I 131
Clinical Trial Phase	Trials
Unknown status	1
Completed	1
Recruiting	1

Clinical Trial Sponsors for SODIUM ROSE BENGAL I 131

Sponsor Name

Sponsor Name for SODIUM ROSE BENGAL I 131
Sponsor	Trials
Universidade Federal do Rio de Janeiro	1
Santen Pharmaceutical Co., Ltd.	1
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh	1

Sponsor Type

Sponsor Type for SODIUM ROSE BENGAL I 131
Sponsor	Trials
Other	2
Industry	1

Sodium Rose Bengal I-131: Clinical Trials, Market Analysis, and Projections

Introduction

Sodium Rose Bengal I-131, also known as Robengatope, has a rich history in medical diagnostics and therapeutic applications. This article will delve into the current status of clinical trials, market analysis, and future projections for this drug.

Historical Use and Approval

Sodium Rose Bengal I-131 was first approved by the U.S. Food and Drug Administration (FDA) on November 23, 1971, for use as a diagnostic aid in determining liver function[5].

Current Clinical Trial Status

As of the latest updates, the global R&D status of Sodium Rose Bengal I-131 is listed as withdrawn. This indicates that active clinical trials and development phases for this specific formulation have been halted[5].

Mechanism of Action and Therapeutic Areas

Rose Bengal, the active component, has been studied for its diverse therapeutic applications. It is known for its ability to generate reactive oxygen species, which makes it effective in photodynamic therapy and as an antibacterial agent. In the context of Sodium Rose Bengal I-131, it was primarily used for hepatobiliary imaging due to its ability to be taken up by the liver and excreted into the bile[5].

Diagnostic Applications

Historically, Sodium Rose Bengal I-131 was used to evaluate liver function and visualize the hepatobiliary system. It was particularly useful in assessing jaundiced patients by providing clear images of liver uptake and excretion patterns[5].

Challenges and Limitations

Commercial-grade Rose Bengal, which includes Sodium Rose Bengal I-131, has faced significant regulatory challenges. The purity of commercial-grade Rose Bengal varies, often containing impurities, which poses difficulties in validating it for modern diagnostic and therapeutic use. This led to its removal from the United States Pharmacopeia (USP) in 2019[1].

Alternative and Emerging Applications

Despite the withdrawal of Sodium Rose Bengal I-131 from active development, Rose Bengal itself continues to be explored for other medical applications. For instance, pharmaceutical-grade Rose Bengal (HP-RB) is being studied for its antibacterial properties, particularly against multidrug-resistant bacteria and in the treatment of skin and soft tissue infections[1].

Photodynamic Antimicrobial Therapy

A notable example is the work by Provectus Biopharmaceuticals and their newly launched entity, VisiRose, which is focused on commercializing Rose Bengal Photodynamic Antimicrobial Therapy (RB PDAT) for treating infectious keratitis and other serious eye infections. This application leverages the photosensitizing properties of Rose Bengal to target microbial infections[4].

Market Analysis

The market for diagnostic and therapeutic agents using Rose Bengal derivatives is evolving. While Sodium Rose Bengal I-131 itself is no longer in active development, the broader interest in Rose Bengal's medical applications suggests a potential market niche.

Competitive Landscape

The competitive landscape includes other diagnostic agents and therapeutic modalities for liver function assessment and antimicrobial treatments. However, the unique properties of Rose Bengal, particularly its ability to generate reactive oxygen species, position it as a valuable candidate for specific therapeutic applications.

Market Projections

Given the current trends and the launch of new entities like VisiRose, there is a potential for growth in the market for Rose Bengal-based treatments. The focus on antimicrobial therapies and ophthalmic applications could drive innovation and investment in this area.

Key Takeaways

• Withdrawal of Sodium Rose Bengal I-131: The drug is no longer in active clinical trials or development.
• Emerging Applications: Pharmaceutical-grade Rose Bengal is being explored for antibacterial and photodynamic therapies.
• Market Potential: The unique properties of Rose Bengal suggest a potential market niche, particularly in ophthalmic and antimicrobial treatments.
• Regulatory Challenges: Purity and regulatory issues have hindered the use of commercial-grade Rose Bengal in modern medical settings.

FAQs

What is the current status of Sodium Rose Bengal I-131 in clinical trials?

The global R&D status of Sodium Rose Bengal I-131 is listed as withdrawn, indicating that active clinical trials and development have been halted[5].

What are the primary therapeutic areas for Rose Bengal?

Rose Bengal is being studied for its antibacterial properties, particularly against multidrug-resistant bacteria, and for photodynamic antimicrobial therapy in ophthalmology[1][4].

Why was Sodium Rose Bengal I-131 removed from the USP?

It was removed due to the variability in purity and the presence of impurities in commercial-grade Rose Bengal, posing significant regulatory challenges[1].

What is the role of VisiRose in the development of Rose Bengal-based treatments?

VisiRose is a clinical-stage biotechnology company focused on commercializing Rose Bengal Photodynamic Antimicrobial Therapy (RB PDAT) for treating infectious keratitis and other serious eye infections[4].

What are the potential market projections for Rose Bengal-based treatments?

The market is expected to grow due to the focus on antimicrobial therapies and ophthalmic applications, driven by the unique properties of Rose Bengal.

Sources

1. Antibacterial Activity of Pharmaceutical-Grade Rose Bengal: MDPI, Molecules, 2022.
2. AHRQ Healthcare Horizon Scanning System – Status Update: AHRQ, 2014.
3. Thermo Scientific Chemicals Rose Bengal: Fisher Scientific.
4. Provectus Biopharmaceuticals Launches VisiRose: BioSpace, 2024.
5. Rose bengal sodium I-131: Synapse, Patsnap.