Back to discover
Drug

Florbetaben f-18

Established medicine
ResearchActive indication expansion
Also known as 4-((1E)-2-(4-(2-(2-(2-((SUP 18(F))FLUOROETHOXY)ETHOXY)ETHOXY)PHENYL)ETH-1-EN-1-YL)-N-METHYLANILINE, FLORBETABEN(18F), Florbetaben (18-F), Florbetaben (18F)+1 more

4-((1E)-2-(4-(2-(2-(2-((SUP 18(F))FLUOROETHOXY)ETHOXY)ETHOXY)PHENYL)ETH-1-EN-1-YL)-N-METHYLANILINE, FLORBETABEN(18F), Florbetaben (18-F), Florbetaben (18F), florbetaben F18.

RxNorm1492940ChEMBLCHEMBL566752ATCV09AX06UNIITLA7312TOI
1
Active clinical trials
21
Regulatory events
Latest activity
beta

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

A Test-retest Study to Evaluate the Reproducibility of [18F]Florbetaben PET Imaging in Patients With Cardiac Amyloidosis and Control Patients

Clinical trial2026-09-01Primary completion · ClinicalTrials.gov

Label change: FLORBETABEN F 18 (NDA204677)

Regulatory2026-07-22FDA

Indication expansion: FLORBETABEN F 18 (NDA204677)

Regulatory2025-06-23FDA

Label change: FLORBETABEN F 18 (NDA204677)

Regulatory2025-06-23FDA

Label change: FLORBETABEN F 18 (NDA204677)

Regulatory2023-10-31FDA

Supplemental approval: FLORBETABEN F 18 (NDA204677)

Regulatory2022-06-08FDA

Label change: FLORBETABEN F 18 (NDA204677)

Regulatory2020-01-10FDA

Supplemental approval: FLORBETABEN F 18 (NDA204677)

Regulatory2018-07-10FDA

Label change: FLORBETABEN F 18 (NDA204677)

Regulatory2017-06-16FDA

Label change: FLORBETABEN F 18 (NDA204677)

Regulatory2016-10-03FDA

Label change: FLORBETABEN F 18 (NDA204677)

Regulatory2016-08-25FDA

Supplemental approval: FLORBETABEN F 18 (NDA204677)

Regulatory2016-03-08FDA

Profile

Identifiers & mechanism

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

Canonical name
Florbetaben f-18
Aliases & brands
4-((1E)-2-(4-(2-(2-(2-((SUP 18(F))FLUOROETHOXY)ETHOXY)ETHOXY)PHENYL)ETH-1-EN-1-YL)-N-METHYLANILINEFLORBETABEN(18F)Florbetaben (18-F)Florbetaben (18F)florbetaben F18
RxNorm CUI
1492940
ChEMBL ID
CHEMBL566752
ATC codes
V09AX06
UNII
TLA7312TOI
Regulatory jurisdictions
fdaema

Regulatory timeline

21 events

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.

Approval / market entry confirmed across FDA and EMA (2014-02-20 → 2016-01-25)
Earliest approval
2014-02-20
Latest approval
2025-06-23
Authorities
FDA · EMA
Total events
21
fdaU.S. Food and Drug Administration· 20 events
2026-07-22Label change
Label change: FLORBETABEN F 18 (NDA204677)
Evidence ↗
2025-06-23Label change
Label change: FLORBETABEN F 18 (NDA204677)
Evidence ↗
2025-06-23Indication expansion
Indication expansion: FLORBETABEN F 18 (NDA204677)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2014-02-20ApprovalMulti-authority
Approval: Neuraceq (EMA)
Indication: This medicinal product is for diagnostic use only. Neuraceq is a radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of ? amyloid neuritic plaque density… Show full indication

This medicinal product is for diagnostic use only. Neuraceq 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. Neuraceq 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 ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

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

Clinical trials

1 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
1
registered trials across all phases
1
Active studies
1
Recruiting
PHASE DISTRIBUTIONn = 1
Phase 11
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.