Last reviewed · How we verify
Bludigo (Indigo carmine)
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