Drug intelligence / Profile preview

indigotindisulfonate sodium

Development stage
Approved
Lead developer
Provepharma
Modality
Small Molecules
Administration
Intravenous, Intramuscular, Oral, Endoscopic Instillation
01

Overview

Indigotindisulfonate sodium, commonly known as Indigo Carmine, is a small molecule diagnostic dye used as a visualization aid in various medical and surgical procedures. It is a dark blue dye that, when administered intravenously, is rapidly filtered by the kidneys and excreted into the urine, retaining its intense blue color. This property allows for the cystoscopic assessment of ureteral integrity and patency following urological and gynecological surgeries. In July 2022, the FDA approved Bludigo (developed by Provepharm) as the first standardized injectable form for this indication. Beyond urology, the dye is extensively used in gastroenterology for diagnostic chromoendoscopy, where it is applied topically to the mucosal surface to enhance the detection of lesions, polyps, and dysplasia by pooling in surface irregularities. It is also utilized in brain tumor margin delineation and rectal cancer lymph node staging, and serves as a widely used food colorant (FD&C Blue #2 in the US and E132 in the EU).

Brand names
Bludigo
Other names
Indigo CarmineFD&C Blue #2E132E-132E 132Indigotindisulfonate
02

Targets

DNA

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