Drugs / Flortaucipir F18
Flortaucipir F18
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | TAUVID | — | 2020-05-28 | fda.gov ↗ |
Trials 25
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04474405 | Aug → Dec 2013 | Alzheimer disease | Avid Radiopharmaceuticals | Completed | No outcome recorded |
| Phase 112 trials · 1 met primary | ||||||
| Phase 1 | NCT07580703 | Apr → Dec 2026 expected | Alzheimer disease | Eli Radiopharma | Recruiting | No outcome recorded |
| Phase 1 | NCT04263337 | Mar 2020 → Aug 2028 expected | brain injury | University of North Carolina, Chapel Hill | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03040713 | Apr 2017 → Oct 2018 | frontotemporal dementia | Avid Radiopharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT03052972 | Mar 2017 → Aug 2018 | cognitive disorder | Avid Radiopharmaceuticals | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02350634 | Nov 2016 → Jun 2017 | Alzheimer disease | Avid Radiopharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02850146 | Aug 2016 → Sep 2023 | cognitive disorder | University of Southern California | Completed | No outcome recorded |
| Phase 1 | NCT03283449 | Feb 2016 → Feb 2025 | primary progressive aphasia | University of Chicago | Completed | No outcome recorded |
| Phase 1 | NCT02512029 | Oct 2015 → Apr 2017 | traumatic brain injury | Avid Radiopharmaceuticals | Withdrawn | No outcome recorded |
| Phase 1 | NCT02278354 | Feb 2015 → Feb 2017 | Alzheimer disease | Avid Radiopharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02336360 | Jan → Jun 2015 | Alzheimer disease | Avid Radiopharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT04468347 | Oct 2014 → Feb 2018 | Alzheimer disease, cognitive impairment with or without cerebellar ataxia | Avid Radiopharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01992380 | Nov 2013 → May 2014 | Alzheimer disease | Avid Radiopharmaceuticals | Completed | Met primary |
| Phase 29 trials | ||||||
| Phase 2 | NCT06723015 | Nov 2025 → Aug 2028 expected | Alzheimer disease, cognitive impairment with or without cerebellar ataxia | Mayo Clinic | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT04080544 | Jan 2019 → Jun 2022 | Alzheimer disease | Neil M Rofsky, MD, MHA | Completed | No outcome recorded |
| Phase 2 | NCT03467477 | Mar → Nov 2018 | Alzheimer disease | Avid Radiopharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03322462 | Nov 2017 → Aug 2018 | Alzheimer disease | Avid Radiopharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02707978 | Sep 2017 → Sep 2020 | Alzheimer disease | Tammie L. S. Benzinger, MD, PhD | Withdrawn | No outcome recorded |
| Phase 2 | NCT02676843 | Apr 2016 → Nov 2018 | frontotemporal dementia, tauopathy | Columbia University | Completed | No outcome recorded |
| Phase 2 | NCT02278367 | Dec 2014 → Jun 2019 | Alzheimer disease, depressive disorder, traumatic brain injury | Avid Radiopharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02079766 | Jun 2014 → Oct 2015 | dementia pugilistica | Avid Radiopharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02051764 | May 2014 → Dec 2016 | Alzheimer disease | Avid Radiopharmaceuticals | Terminated | No outcome recorded Stop: Enrollment |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT03901105 | Mar → Apr 2019 | Alzheimer disease | Avid Radiopharmaceuticals | Completed | Met primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT03821857 | Jun 2019 → May 2030 expected | Alzheimer disease | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 4 | NCT03582488 | Jun 2018 → Sep 2027 expected | Lewy body dementia | Kejal Kantarci | Enrolling by invitation | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT03019536 Background | Jan 2017 → Jun 2019 | Alzheimer disease | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT04417998 Comparator | Jun 2020 → Dec 2023 | — | Mayo Clinic | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-05-15 | IGC Pharma, LLC | Results IGC Pharma to Present Tau-PET Biomarker Research at 2026 Global Tau Conference igcpharma.com ↗
The findings suggest that among amyloid-positive participants with elevated tau burden, more focal tau spreading patterns were associated with worse cognitive and clinical outcomes and faster tau accumulation over time, particularly in APOE4 carriers. |
| 2020-05-28 | Eli Lilly and Company | Regulatory Lilly Receives U.S. FDA Approval of TAUVID™ (flortaucipir F 18 injection) for Use in Patients Being Evaluated for Alzheimer's Disease lilly.com ↗
TAUVID is the first and only approved diagnostic agent to image tau NFTs in the brain. |
| 2018-09-05 | Eli Lilly and Company | Results Lilly Announces Positive Phase 3 Results in Study of Flortaucipir PET Imaging Agent lilly.com ↗
Eli Lilly and Company (NYSE: LLY) and Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Lilly, today announced that a Phase 3 study of flortaucipir F 18, a Positron Emission Tomography (PET) imaging agent, met its two primary endpoints, defined as predicting brain tau pathology and predicting Alzheimer's disease diagnosis. |
| 2016-07-27 | Eli Lilly and Company | Results New Studies Suggest Relationship between Tau Pathology and Progression of Alzheimer's Disease lilly.com ↗
The first analysis, "Evolution of [18F] AV-1451 PET Tau Signal: Interim Analysis of an 18 Month Phase 2 Study," suggested the presence of tau tangles increased significantly over an 18-month period, consistent with ongoing cognitive decline in beta-amyloid positive patients. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-05-15 | IGC Pharma, LLC | IGC Pharma to Present Tau-PET Biomarker Research at 2026 Global Tau Conference igcpharma.com ↗ |
| 2020-05-28 | Eli Lilly and Company | Lilly Receives U.S. FDA Approval of TAUVID™ (flortaucipir F 18 injection) for Use in Patients Being Evaluated for Alzheimer's Disease lilly.com ↗ |
| 2018-09-05 | Eli Lilly and Company | Lilly Announces Positive Phase 3 Results in Study of Flortaucipir PET Imaging Agent lilly.com ↗ |
| 2016-07-27 | Eli Lilly and Company | New Studies Suggest Relationship between Tau Pathology and Progression of Alzheimer's Disease lilly.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 29 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Flortaucipir F18 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04468347 ↗ |
| Known as | 18F-AV-1451 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02512029 ↗ |
| Known as | 18F-flortaucipir | “OBJECTIVE: 18F-flortaucipir (Tauvid™) is an 18F-labeled diagnostic positron emission tomography (PET) radiopharmaceutical, which was developed to detect tau pathology in the brain” PMID 42467182 ↗ Jul 2026 |
| Known as | F 18 T807 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02707978 ↗ |
| Known as | flortaucipir | “OBJECTIVE: 18F-flortaucipir (Tauvid™) is an 18F-labeled diagnostic positron emission tomography (PET) radiopharmaceutical, which was developed to detect tau pathology in the brain” PMID 42467182 ↗ Jul 2026 |
| Modality | Diagnostic / imaging agent | “Test-Retest Reproducibility for the Tau PET Imaging Agent Flortaucipir F 18.” PMID 29284675 ↗ Dec 2017 |
| Route | Intravenous | “IV injection” NCT01992380 ↗ |