Drugs / 18F-Florbetaben

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) NEURACEQ 2025-06-23 fda.gov
Approved US (FDA) NEURACEQ 2014-03-19 fda.gov
Approved EU (EMA) Neuraceq 2014-02-20 europa.eu

Trials 13 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT07169630 Jul 2026 → Apr 2029 expected Alzheimer disease, cognitive impairment with or without cerebellar ataxia National Institute of Mental Health (NIMH) Recruiting No outcome recorded
Phase 1 NCT06790394 Oct 2025 → Sep 2026 expected amyloidosis Lantheus Holdings, Inc. Recruiting No outcome recorded
Phase 1 NCT03706261 Mar 2019 → Jul 2023 Alzheimer disease Adam Brickman Completed No outcome recorded
Phase 23 trials
Phase 2 NCT04840979 May 2021 → Dec 2026 expected Alzheimer disease Columbia University Active not recruiting No outcome recorded
Phase 2 NCT03057938 Jul 2020 → Jan 2022 subjective cognitive decline Fundacion Clinic per a la Recerca Biomédica Withdrawn No outcome recorded
Phase 2 NCT02831283 Jun 2016 → Dec 2022 Alzheimer disease Patrick Lao Completed No outcome recorded
Phase 31 trial
Phase 3 NCT05184088 Jan 2023 → Apr 2026 AL amyloidosis Lantheus Holdings, Inc. Completed No outcome recorded
Phase 41 trial
Phase 4 NCT02681172 Oct 2015 → Sep 2016 Alzheimer disease Piramal Imaging Limited Completed No outcome recorded
Phase not applicable5 trials
NCT07624760 Oct 2026 → May 2028 expected AL amyloidosis, monoclonal gammopathy of uncertain significance, plasma cell myeloma University of Zurich Not yet recruiting No outcome recorded
NCT04392960 Jul 2020 → Jun 2025 AL amyloidosis Fondazione IRCCS Policlinico San Matteo di Pavia Completed No outcome recorded
NCT03616496 Jun 2019 → Jan 2025 amyloidosis Central Hospital, Nancy, France Completed No outcome recorded
NCT03779815 Aug 2018 → Feb 2019 plasma cell myeloma Ulsan University Hospital Completed No outcome recorded
NCT01222351 Dec 2010 → Oct 2014 Alzheimer disease 2 New York State Psychiatric Institute Completed No outcome recorded

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 13 sources stand behind the page.

FieldValueCited text
Known as 18F-florbetaben ClinicalTrials.gov intervention name — accepted as the source's own label NCT04840979
8

NCT03706261

NCT04392960

NCT02831283

NCT07169630

NCT03057938

NCT07624760

NCT03779815

NCT05184088

Known as BAY 94-9172 ClinicalTrials.gov intervention name — accepted as the source's own label NCT01222351
Known as Florbetaben 18F ClinicalTrials.gov intervention name — accepted as the source's own label NCT02681172
Known as Florbetaben F18 ClinicalTrials.gov intervention name — accepted as the source's own label NCT06790394
Known as Neuraceq Neuraceq (florbetaben 18F) PET scan” NCT02681172
1

NCT03616496

Modality Diagnostic / imaging agent “FBB Positron Emission Tomography (PET) scan” NCT02681172
Route Intravenous “Florbetaben 18F is given as an i.v. injection” NCT02681172