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 (<30.0 kg/m2or ≥ 30.0 kg/m2) and randomized in a 1:1 ratio to receive a dose of either Bludigo™ high dose (5.0 mL) or Bludigo™ low dose (2.5 mL). Each randomized subject will serve as his/her own control (i.e., intra-patient controlled) by receiving a dose of normal saline prior to receiving the randomized Bludigo™ dose. All treated subjects will have a follow-up visit 7 to 30 days (± 2 days) after the procedure. A final telephone follow-up call will occur on Day 30 (± 2 days) in subjects who have the follow-up visit before Day 28. Safety assessments will include monitoring of AEs during and post the procedure, clinical laboratory tests, 12-Lead ECG, and vital sign measurements.

Clinical Trial Conditions for indigotindisulfonate sodium

Condition Name

Condition Name for indigotindisulfonate sodium
Intervention	Trials
Ureter Injury	2
Brain Tumors With Ill-defined Margins	1
Ureteral Patency	1
Urinary Retention Postoperative	1

Condition MeSH

Condition MeSH for indigotindisulfonate sodium
Intervention	Trials
Renal Insufficiency	1
Urinary Retention	1
Prolapse	1
Brain Neoplasms	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
Phase 4	3
Phase 3	1
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for indigotindisulfonate sodium
Clinical Trial Phase	Trials
Completed	3
Recruiting	2

Clinical Trial Sponsors for indigotindisulfonate sodium

Sponsor Name

Sponsor Name for indigotindisulfonate sodium
Sponsor	Trials
Prove pharm	2
University of Massachusetts, Worcester	1
Weill Medical College of Cornell University	1

Sponsor Type

Sponsor Type for indigotindisulfonate sodium
Sponsor	Trials
Other	3
Industry	2

Indigotindisulfonate Sodium: Clinical Trials, Market Analysis, and Projections

Last updated: January 1, 2025

Introduction

Indigotindisulfonate sodium, commonly known as indigo carmine, is a diagnostic dye that has recently gained significant attention with its FDA approval for use in the cystoscopic assessment of ureteral integrity. Here, we delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Trial Outcomes

Clinical trials for indigotindisulfonate sodium, marketed as BLUDIGO®, have demonstrated its efficacy in visualizing ureteral orifices during cystoscopy and ureteral catheterization. A randomized intra-patient controlled trial showed that the use of BLUDIGO® significantly improved the ability of physicians to assess ureteral patency. In this trial, 89.8% of physicians reported overall satisfaction with the high dose of indigo carmine, with 73.5% strongly agreeing that their ability to assess ureter patency was improved[4].

Safety Profile

While the drug has shown promising results, it is not without risks. Common adverse reactions reported in clinical trials include constipation, nausea, vomiting, abdominal pain, pyrexia, ALT increase, and dysuria. More severe reactions such as cardiovascular disorders (including cardiac arrest, arrhythmia, and hypertension) and anaphylactic reactions have also been observed[4][5].

Market Analysis

FDA Approval

In July 2022, Provepharm received FDA approval for BLUDIGO™, making it the first and only indigotindisulfonate sodium injection approved by the FDA. This approval marks a significant milestone in the drug's market entry and is expected to boost its adoption in urological and gynecological procedures[5].

Market Demand

The demand for diagnostic dyes in surgical procedures is on the rise due to the increasing number of urological and gynecological surgeries. The approval of BLUDIGO™ fills a critical need for a reliable and effective visualization aid, positioning it well in a growing market.

Competitive Landscape

Indigotindisulfonate sodium faces competition from other diagnostic dyes such as methylene blue and indocyanine green. However, its FDA approval and specific indications for ureteral visualization give it a unique market position. The lack of FDA-approved alternatives for this specific use case further strengthens its market standing[2].

Market Projections

Growth Potential

Given the increasing demand for precise diagnostic tools in surgical procedures, the market for indigotindisulfonate sodium is projected to grow. The drug's efficacy and safety profile, as demonstrated in clinical trials, are expected to drive its adoption in hospitals and surgical centers.

Revenue Projections

While exact revenue projections are not publicly available, the approval and unique positioning of BLUDIGO™ suggest a promising financial outlook. As more healthcare providers become aware of and adopt this drug, revenue is likely to increase, contributing to the growth of Provepharm and the broader diagnostic dye market.

Use in Specific Populations

Pregnancy and Lactation

Available data from case reports and clinical experience indicate that indigotindisulfonate sodium does not pose a significant risk of adverse maternal and fetal effects. However, the data are insufficient to fully evaluate the risk during the first trimester of pregnancy. Animal studies have shown no evidence of fetal harm, but human studies using the intravenous route are lacking[3].

Renal Impairment

The drug is not recommended for patients with an estimated glomerular filtration rate (eGFR) below 30 mL/min. Patients with mild to moderate renal impairment do not require dose adjustments, but careful monitoring is advised[2][4].

Adverse Reactions and Safety Considerations

Cardiovascular Reactions

Severe cardiovascular reactions, including cardiac arrest and arrhythmia, have been reported. Close monitoring of blood pressure and cardiac rhythm is essential during and after administration[4].

Hypersensitivity Reactions

Serious anaphylactic reactions can occur, and emergency equipment and trained personnel should be readily available. The drug can also interfere with light absorption and pulse oximetric methods, which anesthesiologists should be aware of[2][4].

Key Takeaways

• Clinical Efficacy: Indigotindisulfonate sodium has been shown to effectively visualize ureteral orifices, improving the assessment of ureteral patency.
• Market Approval: FDA approval in 2022 has opened up significant market opportunities.
• Safety Profile: While effective, the drug carries risks of cardiovascular and hypersensitivity reactions.
• Market Growth: The market for this drug is projected to grow due to increasing demand for precise diagnostic tools in surgical procedures.
• Use in Specific Populations: Careful consideration is needed for patients with renal impairment and during pregnancy.

FAQs

What is the primary use of indigotindisulfonate sodium?

Indigotindisulfonate sodium is used as a visualization aid in the cystoscopic assessment of the integrity of the ureters in adults following urological and gynecological surgical procedures.

What are the common adverse reactions associated with indigotindisulfonate sodium?

Common adverse reactions include constipation, nausea, vomiting, abdominal pain, pyrexia, ALT increase, and dysuria. Severe reactions can include cardiovascular disorders and anaphylactic reactions.

Is indigotindisulfonate sodium safe for use in patients with renal impairment?

The drug is not recommended for patients with an eGFR below 30 mL/min. Patients with mild to moderate renal impairment do not require dose adjustments but should be monitored carefully.

Can indigotindisulfonate sodium be used during pregnancy?

Available data indicate no significant risk of adverse maternal and fetal effects, but the data are insufficient to fully evaluate the risk during the first trimester. Animal studies show no evidence of fetal harm, but human studies using the intravenous route are lacking.

What is the recommended dosage of indigotindisulfonate sodium?

The recommended dose is 5 mL given intravenously over 1 minute.

Sources

1. ASHP: Drug Shortage Detail: Indigo Carmine Injection.
2. DrugBank: Indigotindisulfonic acid: Uses, Interactions, Mechanism of Action.
3. FDA: BLUDIGO™ (indigotindisulfonate sodium injection, USP) Label.
4. Bludigo: See it in Action | Bludigo® (indigotindisulfonate sodium Injection, USP).
5. Provepharm: Provepharm receives FDA approval for BLUDIGO™ (indigotindisulfonate sodium, USP) Injection.