Drugs / 18F-Florbetaben
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | Neuraceq | Alzheimer disease | 2023-02-15 | “Neuraceq ® （氟[ 18 F]比他班注射液） 在中国的上市申请已获得受理， 预计于2023年在中国获批， 将成为国内首个上市的可应用于AD诊断的Aβ-PET显像剂” sinotau.com ↗ |
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT07169630 | Oct 2026 → Apr 2029 expected | Alzheimer disease, cognitive impairment with or without cerebellar ataxia | National Institute of Mental Health (NIMH) | Recruiting | No outcome recorded |
| Phase 1 | NCT03706261 | Mar 2019 → Jul 2023 | Alzheimer disease | Adam Brickman | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT04840979 | May 2021 → Dec 2026 expected | Alzheimer disease | Columbia University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03057938 | Jul 2020 → Jan 2022 | subjective cognitive decline | Fundacion Clinic per a la Recerca Biomédica | Withdrawn | No outcome recorded |
| Phase 2 | NCT02831283 | Jun 2016 → Dec 2022 | Alzheimer disease | Patrick Lao | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT05184088 | Jan 2023 → Apr 2026 | AL amyloidosis | Lantheus Holdings, Inc. | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT07624760 | Oct 2026 → May 2028 expected | AL amyloidosis, monoclonal gammopathy of uncertain significance, plasma cell myeloma | University of Zurich | Not yet recruiting | No outcome recorded |
| — | NCT04392960 | Jul 2020 → Jun 2025 | AL amyloidosis | Fondazione IRCCS Policlinico San Matteo di Pavia | Completed | No outcome recorded |
| — | NCT03779815 | Aug 2018 → Feb 2019 | plasma cell myeloma | Ulsan University Hospital | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2025-11-24 | Lantheus Medical Imaging | Results Lantheus to Present Florbetaben F 18 Data at CTAD 2025 lantheus.com ↗
Florbetaben binding to amyloid plaques is unaffected by amyloid-targeting antibodies lecanemab and donanemab |
| 2023-02-15 | Sinotau Pharmaceutical Group | Regulatory Aβ-PET示踪剂Neuraceq®用于Lecanemab III期临床研究，预计2023年在中国获批，助力AD早诊早治 sinotau.com ↗
Neuraceq ® （氟[ 18 F]比他班注射液） 在中国的上市申请已获得受理， 预计于2023年在中国获批， 将成为国内首个上市的可应用于AD诊断的Aβ-PET显像剂 ，满足广大AD患者的需求。 |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-11-24 | Lantheus Medical Imaging | Lantheus to Present Florbetaben F 18 Data at CTAD 2025 lantheus.com ↗ |
| 2023-02-15 | Sinotau Pharmaceutical Group | Aβ-PET示踪剂Neuraceq®用于Lecanemab III期临床研究，预计2023年在中国获批，助力AD早诊早治 sinotau.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | 18F-florbetaben | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07169630 ↗ |
| Modality | Diagnostic / imaging agent | “PET imaging with 18F-florbetaben” NCT02831283 ↗ |
| Route | Intravenous | “single intravenous dose of 300 MBq of FBB” NCT03057938 ↗ |