Drugs / florbetapir F 18
florbetapir F 18
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | AMYVID | — | 2025-06-23 | fda.gov ↗ |
| Approved | EU (EMA) | Amyvid | — | 2013-01-14 | europa.eu ↗ |
| Approved | US (FDA) | AMYVID | — | 2012-04-06 | fda.gov ↗ |
| Rejected (CRL) | US (FDA) | Amyvid | — | 2011-03-18 | “complete response letter from the U.S. Food and Drug Administration (FDA) for their New Drug Application (NDA) for Amyvid™ (florbetapir F 18 injection)” lilly.com ↗ |
Trials 22
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT01565291 | Jun 2007 → Jan 2008 | Alzheimer disease | Avid Radiopharmaceuticals | Completed | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT05164536 | Aug 2021 → Nov 2022 | Alzheimer disease | Invicro | Completed | No outcome recorded |
| Phase 1 | NCT01660815 | Aug 2012 → Jan 2013 | Alzheimer disease | Avid Radiopharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01565343 | Apr 2008 → Apr 2009 | Alzheimer disease | Avid Radiopharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01565330 | Mar → Aug 2008 | Alzheimer disease | Avid Radiopharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01564706 | Oct 2007 → Jan 2008 | Alzheimer disease | Avid Radiopharmaceuticals | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01503944 | Mar 2010 → Jul 2011 | Alzheimer disease, Lewy body dementia, Parkinson disease | Avid Radiopharmaceuticals | Completed | No outcome recorded |
| Phase 29 trials · 1 met primary | ||||||
| Phase 2 | NCT05820191 | Jul 2024 → Jul 2026 overdue | glioblastoma | Universidad Central del Caribe | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04572477 | Jun 2017 → Nov 2023 | vascular dementia | Chang Gung Memorial Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT02079766 | Jun 2014 → Oct 2015 | dementia pugilistica | Avid Radiopharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01518374 | Dec 2009 → May 2017 | Alzheimer disease, cognitive impairment with or without cerebellar ataxia | Avid Radiopharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01890343 | Sep 2009 → Dec 2012 | Alzheimer disease, frontotemporal dementia | Avid Radiopharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00855868 | Mar 2009 → Jan 2011 | Alzheimer disease | Avid Radiopharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00857506 | Jan 2009 → Dec 2011 | Alzheimer disease, cognitive impairment with or without cerebellar ataxia | Avid Radiopharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00857532 | Jan 2009 → Nov 2011 | Parkinson disease | Avid Radiopharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00702143 | Jun → Dec 2008 | Alzheimer disease, cognitive impairment with or without cerebellar ataxia | Avid Radiopharmaceuticals | Completed | Met primary |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT01662882 | Oct 2012 → Feb 2013 | Alzheimer disease, cognitive impairment with or without cerebellar ataxia | Avid Radiopharmaceuticals | Completed | Met primary |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT01400425 | Jul 2011 → Jul 2012 | subjective cognitive decline | Avid Radiopharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00857415 | Dec 2008 → Mar 2010 | Alzheimer disease | Avid Radiopharmaceuticals | Completed | Met primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT02051790 | Mar → Aug 2014 | Alzheimer disease | Avid Radiopharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT01703702 | Oct 2012 → Apr 2015 | Alzheimer disease | Avid Radiopharmaceuticals | Completed | Mixed |
| Phase not applicable1 trial | ||||||
| — | NCT01565356 | Mar → May 2010 | Alzheimer disease | Avid Radiopharmaceuticals | Completed | No outcome recorded |
| Comparator or background therapy7 trials | ||||||
| Phase 0 | NCT04474405 Background | Aug → Dec 2013 | Alzheimer disease | Avid Radiopharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT03019536 Background | Jan 2017 → Jun 2019 | Alzheimer disease | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT02051764 Background | May 2014 → Dec 2016 | Alzheimer disease | Avid Radiopharmaceuticals | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01565382 Background | Feb 2011 | Alzheimer disease | Avid Radiopharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT02107599 Background | Mar → May 2014 | Alzheimer disease | Avid Radiopharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT01946243 Background | Aug 2013 → Apr 2014 | Alzheimer disease | Avid Radiopharmaceuticals | Completed | No outcome recorded |
| — | NCT02029547 Background | Oct 2014 → May 2015 | Alzheimer disease | Avid Radiopharmaceuticals | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2025-06-25 | Eli Lilly and Company | Regulatory FDA approves updated label for Lilly’s Amyvid (florbetapir F 18 injection) to support diagnosis of Alzheimer’s disease in patients lilly.com ↗
INDIANAPOLIS, JUNE 25, 2025 – Eli Lilly and Company (NYSE: LLY) announced that the U.S. FDA has approved a label update for Amyvid (florbetapir F 18 injection) for intravenous use. |
| 2015-07-22 | Eli Lilly and Company | Results New Study Shows Florbetapir F 18 Injection Scans Led to Change in Diagnosis and Management of Patients Being Evaluated for Cognitive Decline lilly.com ↗ |
| 2014-07-16 | Eli Lilly and Company | Results New Study Shows Beta-Amyloid Imaging is Associated with Altered Diagnosis and Management of Alzheimer's Disease lilly.com ↗
Diagnosis changed after PET scan for 58 percent of AUC cases versus 45 percent of non-AUC cases (p=0.10). |
| 2013-09-27 | Eli Lilly and Company | Regulatory Lilly Disappointed in Medicare Decision to Deny Appropriate Patient Access to Beta-Amyloid Imaging Agents, Including Amyvid™ (Florbetapir F 18 Injection), Despite Support From Experts, Patients and the Alzheimer's Disease Community lilly.com ↗
Eli Lilly and Company (NYSE: LLY) is disappointed that the Centers for Medicare & Medicaid Services (CMS) has denied patient access to beta-amyloid imaging agents, such as Amyvid™ (Florbetapir F 18 Injection). |
| 2013-07-03 | Eli Lilly and Company | Regulatory Lilly Disappointed in Draft Medicare Coverage Decision for Beta-Amyloid Imaging Agents lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced that the Centers for Medicare & Medicaid Services (CMS) has issued a draft decision proposing Coverage with Evidence Development for the use of beta-amyloid positron emission tomography (PET) imaging agents. |
| 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 ↗ |
| 2012-10-19 | Eli Lilly and Company | Regulatory Amyvid™ (Florbetapir F 18 Injection) Recommended for Approval in Europe as a Diagnostic Tool for PET Imaging of Beta-Amyloid Plaque Density lilly.com ↗
The positive opinion is now referred for final action to the European Commission, which has the authority to approve medicines for the European Union (EU). |
| 2012-04-09 | Eli Lilly and Company | Regulatory FDA Approves Amyvid™ (Florbetapir F 18 Injection) for Use in Patients Being Evaluated for Alzheimer's Disease and Other Causes of Cognitive Decline lilly.com ↗
today announced the U.S. Food and Drug Administration (FDA) approval of Amyvid™, a radioactive diagnostic agent indicated for brain imaging of beta-amyloid plaques in patients with cognitive impairment who are being evaluated for Alzheimer's Disease and other causes of cognitive decline. |
| 2011-03-18 | Eli Lilly and Company | Regulatory Lilly and Avid Receive Complete Response Letter from FDA for Amyvid™ (florbetapir F 18 injection) lilly.com ↗
Eli Lilly and Company (NYSE: LLY) and its wholly owned subsidiary, Avid Radiopharmaceuticals, Inc., have received a complete response letter from the U.S. Food and Drug Administration (FDA) for their New Drug Application (NDA) for Amyvid™ (florbetapir F 18 injection), a Positron Emission Tomography (PET) imaging agent under investigation for the detection of beta-amyloid plaque in the brains of living patients. |
| 2011-01-20 | Eli Lilly and Company | Regulatory Statement from Lilly and Avid on FDA Advisory Committee Recommendation for Amyvid™ (Florbetapir) NDA lilly.com ↗
The Committee supported that efficacy was established and there were no significant safety concerns raised. |
| 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 14 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 29 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | florbetapir F 18 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02051790 ↗ |
| Known as | 18F-AV-45 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01503944 ↗ |
| Known as | Amyvid | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05820191 ↗ |
| Known as | Florbetapir (18F) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02107599 ↗ |
| Modality | Diagnostic / imaging agent | “positron emission tomography (PET) imaging” NCT00702143 ↗ |
| Route | Intravenous | “IV injection, 370MBq (10mCi), single dose” NCT00702143 ↗ |