florbetaben F-18

Trade name: neuraceq

Small moleculeapprovedImaging agent

Approved

Mar 19, 2014

Florbetaben F18 is a18F-labeled stilbene derivative used as a tracer for PET imaging of beta-amyloid deposits in the human brain. The F 18 isotope produces a positron signal that is detected by a PET scanner. 3H-florbetaben in vitro binding experiments reveal two binding sites (Kd of 16 nM and 135 nM) in frontal cortex homogenates from patients with AD. Binding of florbetaben F18 to beta-amyloid plaques in post-mortem brain sections from patients with AD using autoradiography correlates with both immunohistochemical and Bielschowsky silver stains. Florbetaben F 18 does not bind to tau or alpha-synuclein in tissue from patients with AD. Neither Neuraceq nor non-radioactive florbetaben F 19 bind to AT8 positive tau deposits in brain tissue from patients with frontotemporal dementia (FTD), using autoradiography and immunohistochemistry, respectively. — NCATS

Clinical trial activity

24 trials · 17 clinical orgs · 1 marketing orgs

Phase 1
8
Phase 2
8
Phase 3
4
Phase 4
1

Earliest trial started Jun 1, 2008 (NCT01138111)

Timeline

2000s

  1. Jan 1, 2008

    Piramal — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2008

    Piramal — Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2009

    Piramal — Earliest Phase 3 Sponsor(trial)

2010s

  1. Mar 19, 2014

    Piramal — Earliest FDA Approval

  2. Mar 19, 2014

    Piramal — NDA Secondary Org

  3. Mar 19, 2014

    Piramal — NDA Organization

Indications

Mechanism of action

Approval history

  • approvedMar 19, 2014

Chemistry & pharmacology

Loading structure…

SMILES

CNc1ccc(/C=C/c2ccc(OCCOCCOCCF)cc2)cc1
Mol. weight
359.44 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Imaging
18-fluorine

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • 18f-bay94-9172
  • [18f]florbetaben
  • [18f]florbetaben
  • 18f-florbetaben
  • 18f-florbetaben
  • 18f-florbetaben
  • 4-(n-methylamino)-4'-(2-(2-(2-fluoroethoxy)ethoxy)ethoxy)stilbene
  • bay 94-9172
  • bay-949172
  • bay-949172
  • bay94 9172
  • bay94-9172
  • florbetaben
  • florbetaben
  • florbetaben
  • florbetaben
  • florbetaben (18f)
  • florbetaben (18f)
  • florbetaben (18f)
  • florbetaben (18f)
  • florbetaben (18f)
  • florbetaben f18
  • florbetaben f18
  • florbetaben f18
  • florbetaben f18
  • florbetaben f-18
  • florbetaben f-18
  • florbetaben f-18
  • florbetaben f-18
  • florbetaben f-18
  • florbetaben f18 injection
  • neuraceq
  • neuraceq
  • neuraceq
  • neuraceq
  • unii-tla7312toi
  • unii-tla7312toi

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07169630Phase 1Dec 2, 2025National Institute of Mental Health (NIMH)
NCT05184088Phase 3Jan 31, 2023pharmtrace klinische Entwicklung GmbH, Piramal
NCT05504200N/AMar 16, 2022Royal National Orthopaedic Hospital NHS Trust
NCT05361382Phase 1Nov 23, 2021National Institute on Aging (NIA), University of Pittsburgh
NCT05527288N/AJan 28, 2021Sinotau Pharmaceutical Group
NCT04576793Phase 2Nov 1, 2020Columbia University, National Institute on Aging (NIA)
NCT04392960N/AJun 30, 2020University of Pavia
NCT04105634Early Phase 1 (Phase 1)Oct 1, 2019University of Pennsylvania
NCT03616496Phase 2/Phase 3 (Phase 3)Jun 4, 2019University of Lorraine
NCT03706261Phase 1Mar 22, 2019Columbia University, National Institute on Aging (NIA)
NCT03744312Phase 1/Phase 2 (Phase 2)Sep 10, 2018Columbia University
NCT03779815N/AAug 20, 2018University of Ulsan
NCT03057938Phase 2Mar 15, 2017University of Barcelona
NCT02664571N/AMar 1, 2017Centre Hospitalier Universitaire de Nīmes
NCT02831283Phase 2Jun 1, 2016Columbia University, National Institute on Aging (NIA)
NCT03119558Early Phase 1 (Phase 1)May 26, 2016Stanford University
NCT02669225Early Phase 1 (Phase 1)Jan 20, 2016National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NCT02681172Phase 4Oct 1, 2015Piramal
NCT02362880Phase 2/Phase 3 (Phase 3)Feb 1, 2015University of Barcelona
NCT01222351N/ADec 1, 2010Bayer, Columbia University, National Institute on Aging (NIA)
Showing 20 of 24 trials
Page 1 / 2

Organizations

Research & Development (17)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
PiramalFor profit6642008
Columbia UniversityAcademic/Hospital5532010
National Institute on Aging (NIA)Government5032010
BayerFor profit4032008
University of BarcelonaAcademic/Hospital2222015
Centre Hospitalier Universitaire de NīmesAcademic/Hospital1112017
National Institute of Mental Health (NIMH)Government1112025
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Government1112016
pharmtrace klinische Entwicklung GmbHAcademic/Hospital1012023
Royal National Orthopaedic Hospital NHS TrustAcademic/Hospital1112022
Sinotau Pharmaceutical GroupAcademic/Hospital1112021
Stanford UniversityAcademic/Hospital1112016
University of LorraineAcademic/Hospital1112019
University of PaviaAcademic/Hospital1112020
University of PennsylvaniaAcademic/Hospital1112019
University of PittsburghAcademic/Hospital1112021
University of UlsanAcademic/Hospital1112018
17 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
PiramalFor profitNDA2Mar 19, 2014
PiramalFor profitNDAMar 19, 2014