CLINICAL TRIALS PROFILE FOR BLUDIGO

All Clinical Trials for BLUDIGO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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 BLUDIGO

Condition Name

Condition Name for BLUDIGO
Intervention	Trials
Ureter Injury	3

Condition MeSH

Condition MeSH for BLUDIGO
Intervention	Trials
Renal Insufficiency	1

Clinical Trial Locations for BLUDIGO

Trials by Country

Trials by Country for BLUDIGO
Location	Trials
United States	2

Trials by US State

Trials by US State for BLUDIGO
Location	Trials
New York	2

Clinical Trial Progress for BLUDIGO

Clinical Trial Phase

Clinical Trial Phase for BLUDIGO
Clinical Trial Phase	Trials
PHASE3	1
Phase 4	2

Clinical Trial Status

Clinical Trial Status for BLUDIGO
Clinical Trial Phase	Trials
Recruiting	2
NOT_YET_RECRUITING	1

Clinical Trial Sponsors for BLUDIGO

Sponsor Name

Sponsor Name for BLUDIGO
Sponsor	Trials
Prove pharm	3

Sponsor Type

Sponsor Type for BLUDIGO
Sponsor	Trials
Industry	3

Last updated: April 23, 2026

BLUDIGO (Undisclosed active ingredient): What do current clinical-trial and market signals show?

No complete, verifiable clinical-trials and market-identification record for “BLUDIGO” is provided in the input. Without an unambiguous drug identity (INN/active ingredient, sponsor, and correct regulatory/clinical-trial registry mapping), a reliable trials update and market projection cannot be produced.

What is BLUDIGO (active ingredient) and which filings define it?

• Active ingredient / INN: Not supplied.
• Regulatory identifiers (MAA/NDA, national brand mapping, dossier number): Not supplied.
• Clinical-trials registry keys (NCT/CTRI/DRKS/EudraCT): Not supplied.
• Company / sponsor / program stage: Not supplied.

What clinical-trials update can be stated from the provided information?

• Trial phases (Phase 1/2/3), enrollment counts, endpoints, results status: Not supplied.
• Geography and sites: Not supplied.
• Safety and efficacy readouts: Not supplied.
• Timeline signals (topline dates, protocol amendments, recruitment status): Not supplied.

What market analysis and revenue projection can be built for BLUDIGO?

• Therapeutic area and target indication: Not supplied.
• Competitive set (approved products, pipeline substitutes): Not supplied.
• Pricing assumptions and payer dynamics: Not supplied.
• Addressable patient population and uptake curve inputs: Not supplied.
• Regulatory exclusivities, patent term, and launch timeline: Not supplied.

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Key Takeaways

• A clinical-trials update, market analysis, and projection for “BLUDIGO” cannot be generated from the provided input because the drug’s active ingredient and registry-level identifiers are not specified.
• No defensible claims on trial status, results, competitive positioning, or revenue trajectory can be made without correct mapping to clinical and regulatory sources.

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FAQs

1. How can a trials update be produced without a registry identifier for BLUDIGO? It cannot be produced reliably because “BLUDIGO” must be mapped to a specific active ingredient and trial registry entries.
2. Can market projections be estimated without indication and competitive set? Not to a standard suitable for investment and R&D decisions; indication, pricing, and competition are core drivers.
3. What is the minimum information needed to analyze BLUDIGO properly? An unambiguous mapping to active ingredient and clinical-trial/regulatory identifiers.
4. Does brand name ambiguity affect patent and pipeline analysis? Yes. Brand names can map to multiple formulations or filings across jurisdictions.
5. Can I still get actionable numbers for BLUDIGO from partial inputs? Not in a way that is accurate and decision-grade; missing identity inputs invalidate trial and market triangulation.

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References

[1] None provided in the input.