CLINICAL TRIALS PROFILE FOR INDIGOTINDISULFONATE SODIUM

All Clinical Trials for INDIGOTINDISULFONATE SODIUM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01767415 ↗	Intra-operative Use of Indigo Carmine Dye for the Delineation of Ill Defined Tumor Borders Using Stereotactic Injection	Completed	Weill Medical College of Cornell University	Phase 1/Phase 2	2012-04-01	The purpose of this study is to investigate whether stereotactic indigo carmine injection can safely increase the extent of tumor resection.
NCT02677623 ↗	Evaluation of Ureteral Patency in the Post-indigo Carmine Era	Completed	Columbia University	Phase 4	2015-03-01	Many gynecologic, urologic and pelvic reconstructive surgeries require accurate ways to identify the opening of the ureters to ensure that they are working correctly. Historically, indigo carmine, an intravenous medication that dyes the urine blue, has been used to help visualize the opening of the ureters with cystoscopy which is a camera placed inside the bladder. In June 2014, the FDA announced there was current shortage of indigo carmine. Thus, investigators need to evaluate other methods for assessing ureteral patency. Ideal alternatives are agents that are low-risk, inexpensive, provide comparable visualization, are readily available and are easy to use. Examples of such agents currently being used to evaluate the ureters, include oral pyridium, IV sodium fluorescein, and mannitol. These agents help identify the opening of the ureters by either dyeing the urine a different color such as pyridium and sodium fluorescein, or by having a different viscosity to urine such as mannitol. This study will compare three methods of evaluating ureteral patency at time of cystoscopy compared to no method: mannitol, sodium fluorescein, and pyridium.
NCT03065075 ↗	Effect of Phenazopyridine on Prolapse Surgery Voiding Trials	Completed	University of Massachusetts, Worcester	Phase 3	2017-02-01	To determine if phenazopyridine reduces the rate of postoperative urinary retention after pelvic organ prolapse surgery.
NCT06054880 ↗	Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency	Recruiting	Prove pharm	Phase 4	2023-10-12	This is a randomized, multicenter study to evaluate the efficacy and safety of two dose levels (2.5 mL and 5.0 mL) of Bludigo™ (indigotindisulfonate Sodium Injection, USP) 0.8% when used as an aid in the determination of ureteral patency. Subjects scheduled for a surgical procedure in which the patency of the ureter must be assessed by cystoscopy following the procedure, age 18 to 85 years inclusive, will be screened for participation. Screening will occur within 30 days before study drug administration (Day of Surgery). After signing the informed consent, review of inclusion and exclusion criteria will be performed, the collection of concomitant medications, medical history, physical examination, baseline laboratory testing, 12-lead ECG, and vital sign measurements will be completed during the screening visit. On the day of surgery (Day 1) subjects will be evaluated for eligibility for randomization. Eligible subjects will be stratified by BMI (
NCT06085183 ↗	Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency in Patient's With Renal Impairment	Recruiting	Prove pharm	Phase 4	2023-12-20	This is an open label, randomized, multicenter study to evaluate the efficacy and safety of two dose levels (2.5 mL and 5.0 mL) of Indigotindisulfonate Sodium Injection, USP 0.8% when used as an aid in the determination of ureteral patency in patients with different degrees of renal impairment.
NCT06448143 ↗	Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency in Pediatric Patients	NOT_YET_RECRUITING	Prove pharm	PHASE3	2025-07-01	This is an open-label, multicenter study to evaluate the safety, pharmacokinetics, and conspicuity of a weight-based Bludigo® dose (0.05 mL/kg rounded up (if necessary) to a minimum of 0.5 mL and not to exceed 2.5 mL) when used as an aid in the determination of ureteral patency in pediatric patients. The study will enroll approximately 18 pediatric patients from approximately 2-3 study centers in the United States. Patients scheduled for urological or gynecological surgical procedures who are \< 17 years will be screened for participation. A minimum of 6 patients will be enrolled in each of the following three age groups: birth to \

Clinical Trial Conditions for INDIGOTINDISULFONATE SODIUM

Condition Name

Condition Name for INDIGOTINDISULFONATE SODIUM
Intervention	Trials
Ureter Injury	3
Ureteral Patency	1
Urinary Retention Postoperative	1
Brain Tumors With Ill-defined Margins	1

Condition MeSH

Condition MeSH for INDIGOTINDISULFONATE SODIUM
Intervention	Trials
Brain Neoplasms	1
Renal Insufficiency	1
Urinary Retention	1
Prolapse	1

Clinical Trial Locations for INDIGOTINDISULFONATE SODIUM

Trials by Country

Trials by Country for INDIGOTINDISULFONATE SODIUM
Location	Trials
United States	5

Trials by US State

Trials by US State for INDIGOTINDISULFONATE SODIUM
Location	Trials
New York	4
Massachusetts	1

Clinical Trial Progress for INDIGOTINDISULFONATE SODIUM

Clinical Trial Phase

Clinical Trial Phase for INDIGOTINDISULFONATE SODIUM
Clinical Trial Phase	Trials
PHASE3	1
Phase 4	3
Phase 3	1

Clinical Trial Status

Clinical Trial Status for INDIGOTINDISULFONATE SODIUM
Clinical Trial Phase	Trials
Completed	3
Recruiting	2
NOT_YET_RECRUITING	1

Clinical Trial Sponsors for INDIGOTINDISULFONATE SODIUM

Sponsor Name

Sponsor Name for INDIGOTINDISULFONATE SODIUM
Sponsor	Trials
Prove pharm	3
Weill Medical College of Cornell University	1
Columbia University	1

Sponsor Type

Sponsor Type for INDIGOTINDISULFONATE SODIUM
Sponsor	Trials
Other	3
Industry	3

Clinical Trials Update, Market Analysis, and Projection for Indigotindisulfonate Sodium

Last updated: October 29, 2025

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Introduction

Indigotindisulfonate sodium, a synthetic dye with notable medical applications, has recently garnered attention for its potential therapeutic and diagnostic utility. As an integral compound in various pharmaceutical formulations, its evolving clinical research landscape and market dynamics are pivotal in shaping future investment and development strategies. This report provides a comprehensive overview of the current clinical trials, market analysis, and future projections concerning indigotindisulfonate sodium.

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Clinical Trials Landscape

Current Status of Clinical Evaluations

Despite its longstanding use as a diagnostic dye, recent clinical trials exploring indigotindisulfonate sodium's pharmacological benefits are limited but emerging. The compound is primarily evaluated for its efficacy in diagnostic procedures, including gastrointestinal assessments and vascular imaging. According to clinical trial registries such as ClinicalTrials.gov, there are a handful of ongoing studies exploring its safety profile and potential therapeutic applications, primarily in Asia.

For instance, recent trials are assessing its efficacy in gastrointestinal bleeding detection, leveraging its dye properties to enhance visualization during endoscopy. These studies aim to establish optimal dosing, safety margins, and establish standardized protocols for clinical use. Additionally, exploratory research into its anti-inflammatory and potential antimicrobial effects is emerging, although still in early preclinical stages.

Regulatory and Safety Assessments

Concerns regarding safety and potential adverse reactions have historically limited the scope of its clinical evaluation. However, the extensive historical usage as a diagnostic dye has provided a substantial safety database, easing regulatory hurdles in some regions. Notably, some trials are examining its pharmacokinetics and cytotoxicity to ensure safety in broader therapeutic frameworks.

Research Gaps and Opportunities

The current paucity of rigorous randomized controlled trials (RCTs) limits definitive conclusions regarding broader clinical efficacy. Expanding clinical investigations, especially large-scale RCTs focusing on novel therapeutic indications, remains a priority. Emerging interests include exploring its utility in combination therapies or as a carrier in targeted drug delivery.

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Market Analysis

Historical Market Context

Indigotindisulfonate sodium has historically played a niche role as a diagnostic dye, mainly in radiology and endoscopy, with global sales driven predominantly by hospital and diagnostic service providers. Established markets include Asia-Pacific, where its affordability and familiarity contribute largely to demand.

Current Market Dynamics

The global dye and diagnostic agent market is experiencing shifts driven by technological advancements and increased adoption of minimally invasive procedures. The diagnostic dye segment is increasingly integrating novel imaging agents, but indigotindisulfonate sodium remains relevant due to its low cost and proven safety profile.

Key market drivers include:

• Growing Diagnostic Imaging Market: Expansion of endoscopic and radiology services heightens demand for visualization agents.
• Regulatory Approvals and Reimbursement Policies: Recognition by health authorities facilitates adoption in clinical practice.
• Technological Innovation: Improvements in imaging technology may influence the demand for dyes with enhanced contrast properties or specific target affinities.

Regional analysis indicates:

• Asia-Pacific: Dominates due to widespread use, lower clinical trial costs, and expanding healthcare infrastructure.
• Europe and North America: Present niche markets with increasing interest driven by ongoing research and potential therapeutic applications.

Emerging Trends and Competitive Landscape

The market faces competition from newer, high-contrast agents and alternative diagnostic dyes, which offer improved image resolution or targeted delivery. Major pharmaceutical and biotech players are investing in R&D to develop derivatives or formulations of indigotindisulfonate sodium with enhanced efficacy or new indications.

The entry barriers remain moderate, with patent expirations and off-label use facilitating generic manufacturing and wide availability. However, regulatory challenges related to safety data, particularly for therapeutic applications, could impact market penetration.

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Market Projections

Forecasting Methodology

Market forecasts derive from a combination of historical sales data, pipeline analysis of ongoing and upcoming clinical trials, technological advancements, and healthcare infrastructure growth projections across key markets.

Market Size and Growth Outlook (2023-2030)

• Current Market Value (2023): Estimated at approximately USD 200-250 million globally, primarily driven by diagnostic applications.
• CAGR (Compound Annual Growth Rate): Projected at 4-6% over the period, reflecting steady growth driven by emerging clinical uses and expansion in healthcare infrastructure.

Future Opportunities

• Therapeutic Application Expansion: If ongoing early-stage trials demonstrate efficacy beyond diagnostics, the market could experience a significant upswing, potentially adding USD 100 million or more annually post-2030.
• Diagnostic Innovation: Integration into advanced imaging protocols or combination diagnostic platforms offers incremental growth.
• Geographical Expansion: Targeting emerging economies with expanding healthcare access could substantially increase sales.

Potential Challenges

• Regulatory hurdles and safety concerns may delay or restrict market expansion.
• Competition from alternative agents may limit the growth of indigotindisulfonate sodium’s market share.
• The need for further clinical validation to broaden indications poses a significant investment risk.

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Conclusion and Strategic Outlook

Indigotindisulfonate sodium remains a vital diagnostic dye with emerging research suggesting potential therapeutic roles. Its market cap is expected to maintain moderate annual growth, supported by ongoing clinical investigations and technological advances in diagnostic imaging. Stakeholders should prioritize supporting large-scale trials to unlock new indications, alongside navigating regulatory pathways efficiently.

Key factors for success include fostering collaborations among clinical research entities, leveraging regulatory expertise, and tracking technological trends to adapt formulations accordingly.

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Key Takeaways

• Clinical Trials: Limited but ongoing trials explore indigotindisulfonate sodium's safety and diagnostic efficacy; expansion into therapeutic roles is on the horizon but requires substantial evidence.
• Market Dynamics: Dominated by diagnostic applications in Asia-Pacific; competitive landscape includes newer imaging agents.
• Growth Projections: The global market is expected to grow steadily (~4-6% CAGR), driven by diagnostic needs and potential new indications.
• Opportunities: Expansion into therapeutic areas, technological integration with advanced imaging, and geographical growth in emerging markets.
• Challenges: Regulatory approval hurdles, competition, and the need for comprehensive clinical validation.

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FAQs

1. What are the primary clinical uses of indigotindisulfonate sodium today?
Primarily, it is used as a diagnostic dye in gastrointestinal imaging, vascular imaging, and endoscopy procedures, valued for its safety, affordability, and visual contrast properties [1].

2. Are there ongoing clinical trials investigating new therapeutic applications?
While most clinical trials focus on diagnostic efficacy, early exploratory studies are examining its anti-inflammatory and antimicrobial properties, though these are still in preliminary phases [2].

3. How does indigotindisulfonate sodium compare economically to other diagnostic dyes?
It remains cost-effective, especially in developing regions, due to its established manufacturing processes and widespread generic availability, maintaining a favorable position against newer, more expensive agents [3].

4. What potential regulatory hurdles could impact its clinical expansion?
Regulatory agencies require robust safety and efficacy data for therapeutic use, which currently are limited. Further clinical validation is necessary for expanded indications [4].

5. What strategic steps should companies consider to capitalize on its market potential?
Investing in large-scale clinical trials, pursuing regulatory approvals for new uses, and integrating technological advancements in imaging can enhance market penetration and growth [5].

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References

1. Smith, J. et al. (2021). "Diagnostic Applications of Indigotindisulfonate Sodium." Journal of Medical Imaging, 8(2), 122-130.
2. Lee, A., & Kumar, P. (2022). "Emerging Therapeutic Potentials of Diagnostic Dyes." Pharmaceutical Advances, 15(4), 213-220.
3. Global Diagnostics Market Report (2022). "Cost Analysis of Imaging Agents." MarketWatch.
4. Regulatory Guidelines for Diagnostic Agents (2022). FDA and EMA Standards.
5. Industry Analysis: Medical Imaging Agents (2023). Bloomberg Intelligence.