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Bludigo (Indigo carmine)
Bludigo (generic name: Indigo carmine) is a indigo carmine Small molecule drug developed by Provepharm Sas. It is currently FDA-approved (first approved 2022) for Visualization of the ureteral orifices. Also known as: Indigotindisulfonate sodium, FD&C Blue 2.
Bludigo works by being absorbed by the body and then excreted in the urine, where it stains the ureteral orifices, making them visible during medical procedures.
At a glance
| Generic name | Indigo carmine |
|---|---|
| Also known as | Indigotindisulfonate sodium, FD&C Blue 2 |
| Sponsor | Provepharm Sas |
| Drug class | indigo carmine |
| Modality | Small molecule |
| Therapeutic area | Nephrology |
| Phase | FDA-approved |
| First approval | 2022 |
Mechanism of action
Indigotindisulfonate is dye excreted by the kidney through tubular secretion and enhances visualization of the ureteral orifices by its deep blue color.
Approved indications
- Visualization of the ureteral orifices
Common side effects
- Constipation
- Nausea
- Vomiting
- Abdominal Pain
- Pyrexia
- ALT increase
- Dysuria
Serious adverse events
- Cardiac arrest
- Arrhythmia
- Asystole
- Atrioventricular block second degree
- Anaphylactic reactions
- Bronchospasm
- Hypotension
- Dyspnea
- Urticaria
- Erythema
Key clinical trials
- 3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution as an Aid for Ureteral Patency (PHASE3)
- Virtual Versus Dye-based Chromoendoscopy in Inflammatory Bowel Disease Surveillance Colonoscopy (NA)
- A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II)
- Clinical Trial to Evaluate the Efficacy and Safety of SUBMO® as a Submucosal Injection Agent in Endoscopic Resection of Superficial Gastrointestinal Lesions. (NA)
- BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis (NA)
- Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
- Post Market Surveillance to Evaluate the Efficacy and Safety of the INDIGO Aspiration System in Japan
- A Phase 3 Study of Obexelimab in Patients With IgG4-Related Disease (PHASE3)
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
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Related
- Drug class: All indigo carmine drugs
- Manufacturer: Provepharm Sas — full pipeline
- Therapeutic area: All drugs in Nephrology
- Indication: Drugs for Visualization of the ureteral orifices
- Also known as: Indigotindisulfonate sodium, FD&C Blue 2
- Compare: Bludigo vs similar drugs
- Pricing: Bludigo cost, discount & access