Back to discover
Drug

florbetapir F-18

Established medicine
ResearchOngoing clinical research
Also known as florbetapir-fluorine-18, Florbetapir (18-F), Florbetapir (18F), Florbetapir F 18+1 more

florbetapir-fluorine-18, Florbetapir (18-F), Florbetapir (18F), Florbetapir F 18, Florbetapir F18.

RxNorm1427224ChEMBLCHEMBL1774461ATCV09AX05UNII6W15Z5R0RU
1
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Effects of Brain Beta Amyloid on Postoperative Cognition and 18F-AV-45-A14: Clinical Evaluation of Florbetapir F 18 (18F-AV-45)

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

Autopsy Follow-up of Subjects Previously Imaged With Florbetapir F 18 (18F-AV-45) PET in Trial 18F-AV-45-A07

Clinical trial2025-03-21Results posted · ClinicalTrials.gov

Multiple-Dose, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY3303560 in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild to Moderate Alzheimer's Disease

Clinical trial2023-10-10Results posted · ClinicalTrials.gov

Evaluation of Physician Training for Interpretation of Florbetapir-PET Scans: Evaluation of Inter-reader Reliability Using Images From Subjects With a Clinical Presentation of AD or MCI

Clinical trial2022-08-16Results posted · ClinicalTrials.gov

Phase 1 Evaluation of [18F]MK-6240 PET as an Imaging Marker for Tau Protein in the Brain of Patients With Alzheimer's Disease Compared to Healthy Volunteers

Clinical trial2021-06-09Completed · ClinicalTrials.gov

An Exploratory Evaluation of the Tau Protein Binding Properties, Whole-Body Biodistribution and Safety of 18F-AV-1451 Injection in Healthy Volunteers and Cognitively Impaired Subjects

Clinical trial2020-09-25Results posted · ClinicalTrials.gov

An Open Label, Multicenter Study, Evaluating the Safety and Imaging Characteristics of 18F-AV-1451 in Cognitively Healthy Volunteers, Subjects With Mild Cognitive Impairment, and Subjects With Alzheimer's Disease

Clinical trial2020-09-22Results posted · ClinicalTrials.gov

18F-AV-1451 and Florbetapir F 18 PET Imaging in Subjects With Repetitive Brain Trauma at High Risk for Chronic Traumatic Encephalopathy

Clinical trial2020-09-07Results posted · ClinicalTrials.gov

Longitudinal Study of Brain Amyloid imaGing in MEMENTO

Clinical trial2019-10-09Completed · ClinicalTrials.gov

Clinical Evaluation of Florbetapir F 18 (18F-AV-45)

Clinical trial2018-07-18Results posted · ClinicalTrials.gov

Phase 0 Evaluation of [18F]MNI-958 as a Potential PET Radioligand for Imaging Tau Protein in the Brain of Patients With Probable Alzheimer's Disease or Progressive Supranuclear Palsy Compared With Healthy Volunteers

Clinical trial2018-05-11Completed · ClinicalTrials.gov

Marketing authorisation: Amyvid (EMA)

Regulatory2013-01-14EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
florbetapir F-18
Aliases & brands
florbetapir-fluorine-18Florbetapir (18-F)Florbetapir (18F)Florbetapir F 18Florbetapir F18
RxNorm CUI
1427224
ChEMBL ID
CHEMBL1774461
ATC codes
V09AX05
UNII
6W15Z5R0RU
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2013-01-14
Latest approval
2013-01-14
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2013-01-14Original application approval
Marketing authorisation: Amyvid (EMA)
Indication: This medicinal product is for diagnostic use only. Amyvid is a radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of ?-amyloid neuritic plaque density in… Show full indication

This medicinal product is for diagnostic use only. Amyvid is a radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of ?-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment. Amyvid should be used in conjunction with a clinical evaluation. A negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of AD.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

35 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
35
registered trials across all phases
LATEST COMPLETION 2021
1
Active studies
16
Late-stage (III+)
31
Completed
3
Discontinued
PHASE DISTRIBUTIONn = 35
Early Phase 15Phase 16Phase 28Phase 2 / 32Phase 35Phase 45Phase N / A4

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Effects of Brain Beta Amyloid on Postoperative Cognition and 18F-AV-45-A14: Clinical Evaluation of Florbetapir F 18 (18F-AV-45)

Active, not recruitingPH IVUniversity of California, San Franciscon=662026

A Randomized, Multicenter, Multicountry Study to Evaluate the Effectiveness of Florbetapir (18F) PET Imaging in Changing Patient Management and to Evaluate the Relationship Between Florbetapir (18F) PET Scan Status and Cognitive Decline

CompletedPH IVAvid Radiopharmaceuticalsn=6412015

Evaluation of Reader Training Processes by Comparing Clinical Interpretations to Centralized Expert Reads

CompletedPH IVAvid Radiopharmaceuticalsn=2412014

A Study to Evaluate the Improvement in Reader Accuracy When Using a Read Method That Incorporates Commercially Available Quantitative Analysis Software as an Adjunct to the Clinical Visual Interpretation of Amyvid Brain Scans

CompletedPH IVAvid Radiopharmaceuticalsn=962014

The Feasibility and Reliability of Utilizing Commercially Available Quantitative Analysis Software as an Adjunct to the Clinical Qualitative Interpretation of Amyvid Brain Scans

CompletedPH IVAvid Radiopharmaceuticalsn=962014

Recent completions

Trials that read out recently, adding to the completed evidence base.

Phase 1 Evaluation of [18F]MK-6240 PET as an Imaging Marker for Tau Protein in the Brain of Patients With Alzheimer's Disease Compared to Healthy Volunteers

CompletedPH IInvicron=102021

Longitudinal Study of Brain Amyloid imaGing in MEMENTO

CompletedPH IIIUniversity Hospital, Bordeauxn=4482019

Multiple-Dose, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY3303560 in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild to Moderate Alzheimer's Disease

CompletedPH IEli Lilly and Companyn=222019

Phase 0 Evaluation of [18F]MNI-958 as a Potential PET Radioligand for Imaging Tau Protein in the Brain of Patients With Probable Alzheimer's Disease or Progressive Supranuclear Palsy Compared With Healthy Volunteers

CompletedPH IMolecular NeuroImagingn=122018

An Open Label, Multicenter Study, Evaluating the Safety and Imaging Characteristics of 18F-AV-1451 in Cognitively Healthy Volunteers, Subjects With Mild Cognitive Impairment, and Subjects With Alzheimer's Disease

CompletedPH II/IIIAvid Radiopharmaceuticalsn=3832017

Clinical Evaluation of Florbetapir F 18 (18F-AV-45)

CompletedPH IIAvid Radiopharmaceuticalsn=1,7682017
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.