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# Fast Track Status for Crohn’s Imaging Agent
- URL: https://www.fdaweb.com/fast-track-status-for-crohns-imaging-agent/
- Published: 2025-02-06T12:00:00.000Z
- Updated: 2026-09-14T14:52:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158620

FDA has granted Bracco Imaging a fast-track designation for its BR55 (perfluorobutane/nitrogen lipopeptide-coated microbubbles) injection, which is being developed for detecting areas of active bowel inflammation in patients with Crohn’s disease. BR55 is described as a novel molecular imaging ultrasound contrast agent designed to specifically target the vascular endothelial growth factor receptor 2 (VEGFR2), a molecule highly expressed by endothelial cells in areas of angiogenesis.

The designation is based on data from Phase 2 studies that showed a more than 95% accuracy with BR55-enhanced ultrasound imaging in detecting the expression of VEGFR2 in breast, ovarian, and thyroid cancer tissues, as well as in bowel segments showing active inflammation in patients with Crohn’s disease, according to the company. “Recent clinical evidence has shown that, even in the absence of clinical symptoms, persistence of active inflammation can result in progressive bowel damage, serious complications and disability,” it says. “Therefore, proactive monitoring of disease activity is of paramount importance for proper patient management.”