Drugs / BAY 94-9172
BAY 94-9172
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | NEURACEQ | — | 2025-06-23 | fda.gov ↗ |
| Approved | US (FDA) | NEURACEQ | — | 2014-03-19 | fda.gov ↗ |
| Approved | EU (EMA) | Neuraceq | — | 2014-02-20 | europa.eu ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06790394 | Oct 2025 → Sep 2026 overdue | amyloidosis | Lantheus Holdings, Inc. | Recruiting | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT02681172 | Oct 2015 → Sep 2016 | Alzheimer disease | Piramal Imaging Limited | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT03616496 | Jun 2019 → Jan 2025 | amyloidosis | Central Hospital, Nancy, France | Completed | No outcome recorded |
| — | NCT01222351 | Dec 2010 → Oct 2014 | Alzheimer disease 2 | New York State Psychiatric Institute | Completed | No outcome recorded |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BAY 94-9172 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01222351 ↗ |
| Known as | Florbetaben 18F | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02681172 ↗ |
| Known as | Florbetaben F18 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06790394 ↗ |
| Known as | Neuraceq | “Neuraceq (florbetaben 18F) PET scan” NCT02681172 ↗ |
| Modality | Diagnostic / imaging agent | “FBB Positron Emission Tomography (PET) scan” NCT02681172 ↗ |
| Route | Intravenous | “Florbetaben 18F is given as an i.v. injection” NCT02681172 ↗ |