Drugs / BR55
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT01253213 | Jul 2010 → Dec 2012 | prostate cancer | Bracco Diagnostics, Inc | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02142608 | Aug 2014 → Jul 2015 | prostate cancer | Bracco Diagnostics, Inc | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT04248153 | Oct 2019 → Feb 2020 | ovarian cancer | Bracco Diagnostics, Inc | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03493464 | Dec 2018 → Apr 2021 | ovarian cancer | Bracco Diagnostics, Inc | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03486327 | Jul 2018 → Nov 2020 | pancreatic ductal adenocarcinoma | Bracco Diagnostics, Inc | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2025-02-06 | Bracco Diagnostics, Inc | Regulatory Bracco Imaging Receives FDA Fast Track Designation for BR55 bracco.com ↗
Bracco Imaging, a global leader in diagnostic imaging, announced today that the U.S. FDA has granted Fast Track designation for the development of BR55 (perfluorobutane/nitrogen lipopeptide-coated microbubbles) injection for detecting areas of active bowel inflammation in patients with Crohn's disease. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2025-02-06 | Bracco Diagnostics, Inc | Bracco Imaging Receives FDA Fast Track Designation for BR55 bracco.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BR55 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03493464 ↗ |
| Modality | Diagnostic / imaging agent | “Targeted Ultrasound Contrast Agent” NCT01253213 ↗ |
| Route | Intravenous | “All patients received BR55 as a single intravenous injection” NCT02142608 ↗ |