Drugs / Florbetaben
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 | 2022-07-08 | “2022 年7月8日，先通医药的氟[18F]比他班注射液（ Neuraceq TM ） 上市申请获得受理。” sinotau.com ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03119558 | May 2016 → Aug 2018 | amyloidosis | Stanford University | Completed | No outcome recorded |
| Phase 11 trial · 1 met primary | ||||||
| Phase 1 | NCT01138111 | Jun 2008 → Dec 2011 | Alzheimer disease, senile plaque formation | Lantheus Biosciences Ltd. | Completed | Met primary |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03744312 | Sep 2018 → Jul 2022 | Alzheimer disease | Columbia University | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT04576793 | Nov 2020 → May 2027 expected | Alzheimer disease | Columbia University | Recruiting | No outcome recorded |
| Phase 2 | NCT00928304 | Jun 2009 → Jan 2011 | Down syndrome, senile plaque formation | Lantheus Biosciences Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT00750282 | Aug 2008 → Nov 2010 | Alzheimer disease, senile plaque formation | Lantheus Biosciences Ltd. | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT01020838 | Nov 2009 → Sep 2011 | Alzheimer disease | Lantheus Biosciences Ltd. | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT05527288 | Jan → Sep 2021 | Alzheimer disease, mental disorder | Sinotau Pharmaceutical Group | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| 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 |
| 2023-09-15 | Sinotau Pharmaceutical Group | Regulatory 国内首个！先通医药Aβ-PET显像剂氟[18F]贝他苯注射液正式获批 sinotau.com ↗
9月15日，先通医药产品欧韦宁 ® 氟[ 18 F]贝他苯注射液获得国家药品监督管理局（NMPA）正式批准。 |
| 2023-05-11 | Sinotau Pharmaceutical Group | Regulatory 阿尔茨海默病诊疗迈入新时代：先通医药与多家AD药品跨国制药企业达成合作意向，助力国内精准诊疗一体化联动发展 sinotau.com ↗
先通医药XTR-005注射液的上市申请已获得NMPA受理，预计于2023年下半年获批。 |
| 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。 |
| 2022-07-11 | Sinotau Pharmaceutical Group | Regulatory 首个β-淀粉样蛋白PET扫描示踪剂的中国上市申请获受理 sinotau.com ↗
2022 年7月8日，先通医药的氟[18F]比他班注射液（ Neuraceq TM ） 上市申请获得受理。 |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-11-24 | Lantheus Medical Imaging | Lantheus to Present Florbetaben F 18 Data at CTAD 2025 lantheus.com ↗ |
| 2023-09-15 | Sinotau Pharmaceutical Group | 国内首个！先通医药Aβ-PET显像剂氟[18F]贝他苯注射液正式获批 sinotau.com ↗ |
| 2023-05-11 | Sinotau Pharmaceutical Group | 阿尔茨海默病诊疗迈入新时代：先通医药与多家AD药品跨国制药企业达成合作意向，助力国内精准诊疗一体化联动发展 sinotau.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 ↗ |
| 2022-07-11 | Sinotau Pharmaceutical Group | 首个β-淀粉样蛋白PET扫描示踪剂的中国上市申请获受理 sinotau.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Florbetaben | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00750282 ↗ |
| Known as | 18F-Florbetaben | “Administration of 8.0 mCi 18F-Florbetaben (Neuraceq®) IV followed by simultaneous acquisition PET emission and cardiac MRI sequence scan 45-60 minutes post-injection.” NCT03119558 ↗ |
| Known as | BAY-949172 | “Florbetaben, a 18F-labeled stilbene derivative (Neuraceq®, formerly known as BAY-949172), is a diagnostic radiopharmaceutical developed to visualize β-amyloid plaques in the brain.” PMID 30043115 ↗ Jul 20184“Florbetaben (BAY94-9172)” NCT01020838 ↗ “Florbetaben (BAY94-9172)” NCT00928304 ↗ “Florbetaben (BAY94-9172)” NCT01138111 ↗ “Florbetaben (BAY94-9172)” NCT00750282 ↗ |
| Known as | Neuraceq | “Administration of 8.0 mCi 18F-Florbetaben (Neuraceq®) IV followed by simultaneous acquisition PET emission and cardiac MRI sequence scan 45-60 minutes post-injection.” NCT03119558 ↗ |
| Modality | Diagnostic / imaging agent | “Florbetaben (¹⁸F) is a promising ¹⁸F-labelled amyloid-β-targeted PET tracer in clinical development.” PMID 21481640 ↗ Apr 2011 |
| Route | Intravenous | “single IV injection” NCT00928304 ↗ |