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Bludigo (INDIGOTINDISULFONATE)
Bludigo (generic name: INDIGOTINDISULFONATE) is a Small molecule drug developed by Provepharm Sas. It is currently FDA-approved (first approved 2022) for visualization aid in the cystoscopic assessment of the integrity of the ureters in adults following urological and gynecological open, robotic, or endoscopic surgical procedures.
Bludigo works by emitting a blue fluorescence when exposed to ultraviolet light, allowing for visualization of the ureters.
At a glance
| Generic name | INDIGOTINDISULFONATE |
|---|---|
| Sponsor | Provepharm Sas |
| Modality | Small molecule |
| Therapeutic area | Nephrology |
| Phase | FDA-approved |
| First approval | 2022 |
Mechanism of action
Indigotindisulfonate is a dye excreted by the kidney through tubular secretion and enhances visualization of the ureteral orifices by its deep blue color.
Approved indications
- visualization aid in the cystoscopic assessment of the integrity of the ureters in adults following urological and gynecological open, robotic, or endoscopic surgical procedures
Common side effects
- Constipation
- Nausea
- Vomiting
- Abdominal Pain
- Pyrexia
- ALT increase
- Dysuria
Key clinical trials
- 3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution as an Aid for Ureteral Patency (PHASE3)
- Indigotindisulfonate Sodium as an Aid in Determination of Ureteral Patency in Patient's With Renal Impairment (PHASE4)
- Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency (PHASE4)
- Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency in Pediatric Patients (PHASE3)
- Intra-operative Use of Indigo Carmine Dye for the Delineation of Ill Defined Tumor Borders Using Stereotactic Injection (PHASE1,PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Bludigo CI brief — competitive landscape report
- Bludigo updates RSS · CI watch RSS
- Provepharm Sas portfolio CI
Frequently asked questions about Bludigo
What is Bludigo?
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Related
- Manufacturer: Provepharm Sas — full pipeline
- Therapeutic area: All drugs in Nephrology
- Indication: Drugs for visualization aid in the cystoscopic assessment of the integrity of the ureters in adults following urological and gynecological open, robotic, or endoscopic surgical procedures
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing