Drugs / florbetapir
florbetapir
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | Alzheimer disease | — | “A marketing application for florbetapir has recently been submitted to the U.S. Food and Drug Administration (FDA).” lilly.com ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02120664 | Apr 2014 → Sep 2015 | Alzheimer disease | Avid Radiopharmaceuticals | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT04588649 | Jan → Mar 2016 | cerebrovascular disorder, dementia | Chang Gung Memorial Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02039024 | Mar 2012 → Dec 2015 | Parkinson disease | Chang Gung Memorial Hospital | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02016560 | Dec 2013 → Jul 2017 | Alzheimer disease | Avid Radiopharmaceuticals | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT02813434 | Sep 2014 → Jan 2025 | dementia | Centre Hospitalier Universitaire, Amiens | Completed | No outcome recorded |
| Phase 3 | NCT02164643 | Jun 2014 → Oct 2019 | Alzheimer disease | University Hospital, Bordeaux | Completed | No outcome recorded |
| Phase 3 | NCT01447719 | Mar 2010 → Mar 2011 | Alzheimer disease | Avid Radiopharmaceuticals | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| — | NCT01565369 Background | Jan 2011 | Alzheimer disease | Avid Radiopharmaceuticals | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2013-01-15 | Eli Lilly and Company | Regulatory Amyvid™ (Florbetapir F 18 Injection) Approved in European Union for Use in Patients With Cognitive Impairment Being Evaluated for Alzheimer's Disease and Other Causes of Cognitive Impairment lilly.com ↗ |
| 2010-12-20 | Eli Lilly and Company | Regulatory Lilly Announces Completion of Avid Acquisition and FDA Priority Review for florbetapir lilly.com ↗
Lilly and Avid are also pleased to announce that the U.S. Food and Drug Administration (FDA) has assigned priority review designation to the marketing application for florbetapir, Avid's lead program in development. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2013-01-15 | Eli Lilly and Company | Amyvid™ (Florbetapir F 18 Injection) Approved in European Union for Use in Patients With Cognitive Impairment Being Evaluated for Alzheimer's Disease and Other Causes of Cognitive Impairment lilly.com ↗ |
| 2010-12-20 | Eli Lilly and Company | Lilly Announces Completion of Avid Acquisition and FDA Priority Review for florbetapir lilly.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | florbetapir | “During this study, subjects will receive a single i.v. administration of approximately 370MBq (10 mCi) florbetapir F-18 immediately prior to imaging.” NCT02039024 ↗ |
| Known as | (E)-4-(2-(6-(2-(2-(2-\[18F\]fluoroethoxy) ethoxy) ethoxy)pyridin-3-yl)vinyl)-N-methylbenzenamine | “Name: \[18F\]AV-45, (E)-4-(2-(6-(2-(2-(2-\[18F\]fluoroethoxy) ethoxy) ethoxy)pyridin-3-yl)vinyl)-N-methylbenzenamine Dosage form: intravenous injection” NCT04588649 ↗ |
| Known as | 18F-AV-45 | “This study is aimed at examining the interest of amyloid radiotracer Florbetapir (18F-AV-45) for the etiological diagnosis of poststroke cognitive impairment and dementia.” NCT02813434 ↗1“\[18F\]AV-45 PET Imaging” NCT04588649 ↗ |
| Known as | AV-45 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04588649 ↗ |
| Known as | florbetapir F-18 | “During this study, subjects will receive a single i.v. administration of approximately 370MBq (10 mCi) florbetapir F-18 immediately prior to imaging.” NCT02039024 ↗ |
| Modality | Diagnostic / imaging agent | “The sensitivity and specificity of florbetapir PET imaging for detection of moderate to frequent plaques were” PMID 22749065 ↗ Jun 2012 |
| Route | Intravenous | “IV injection” NCT01565369 ↗ |