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sodium fluoride (18F)

Small moleculeapprovedImaging agent

Approved

Feb 24, 1972

FLUORIDE ION F-18 (as sodium fluoride F-18) is a radioactive diagnostic agent for positron emission tomography (PET) indicated for imaging of bone to define areas of altered osteogenic activity. FLUORIDE ION F-18 normally accumulates in the skeleton in an even fashion, with greater deposition in the axial skeleton (e.g. vertebrae and pelvis) than in the appendicular skeleton and greater deposition in the bones around joints than in the shafts of long bones. Increased FLUORIDE ION F-18 deposition in the bone can occur in areas of increased osteogenic activity during growth, infection, malignancy (primary or metastatic) following trauma, or inflammation of the bone. — NCATS

Clinical trial activity

291 trials · 182 clinical orgs · 30 marketing orgs

Phase 1
31
Phase 2
101
Phase 3
66
Phase 4
37

Earliest trial started Nov 1, 1998 (NCT00018447)

Timeline

1970s

  1. Feb 24, 1972

    General Electric — Earliest FDA Approval

  2. Feb 24, 1972

    General Electric — NDA Secondary Org

  3. Feb 24, 1972

    General Electric — NDA Organization

1990s

  1. Jul 11, 1997

    Colgate Palmolive — NDA Secondary Org

  2. Jan 1, 1998

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2000

    Colgate Palmolive — Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2006

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 26, 2011

    National Institutes of Health (NIH) — NDA Secondary Org

  2. Dec 26, 2012

    Houston Cyclotron — Marketing Organization

  3. Jun 28, 2013

    University of Pennsylvania — Marketing Organization

  4. Dec 23, 2013

    University of Texas at Houston — Marketing Organization

  5. Mar 13, 2014

    University of California, San Francisco — Marketing Organization

  6. Sep 22, 2014

    Shertech Labs Llc — Marketing Organization

  7. Oct 21, 2014

    Zevacor — Marketing Organization

  8. Oct 21, 2014

    Decatur Memorial Hospital — Marketing Organization

  9. Oct 29, 2014

    Essential Isotopes, LLC — Marketing Organization

  10. Nov 19, 2014

    Feinstein Institute for Medical Research — Marketing Organization

  11. Nov 28, 2014

    NCM USA — Marketing Organization

  12. Jan 9, 2015

    Biomedical Research Foundation — Marketing Organization

  13. Feb 27, 2015

    Precision Nuclear — Marketing Organization

  14. Apr 20, 2015

    University of Utah — Marketing Organization

  15. Apr 22, 2015

    Spectron Mrc Llc — Marketing Organization

  16. Apr 22, 2015

    Nukemed — Marketing Organization

  17. Jul 21, 2015

    Stanford University — Marketing Organization

  18. Jul 29, 2015

    Hot Shots Nuclear Medicine — Marketing Organization

  19. Jul 30, 2015

    Cardinal Health — Marketing Organization

  20. Aug 18, 2015

    Sofie — Marketing Organization

  21. Sep 28, 2015

    Siemens — Marketing Organization

  22. Oct 19, 2015

    3d Imaging Drug Design & Development — Marketing Organization

  23. Oct 23, 2015

    Jubilant DraxImage Inc. — Marketing Organization

  24. Oct 23, 2015

    Jubilant Innovation Ltd. — Marketing Organization

  25. Nov 17, 2015

    Midwest Medical Isotopes — Marketing Organization

  26. Nov 17, 2015

    University of Iowa — Marketing Organization

  27. May 19, 2016

    Columbia University — Marketing Organization

2020s

  1. Dec 6, 2022

    BAMF Health — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

  • BoneBINDING AGENT

    Bone binding agent

Combination products

Approval history

  • approvedFeb 24, 1972

Chemistry & pharmacology

Loading structure…

SMILES

[F-].[Na+]
Mol. weight
41.99 g/mol
Lipinski Ro5
Pass
Rule of 3
Yes
Chirality
Achiral Molecule
Inorganic
Yes
Polymer
No
Delivery
Parenteral, Topical
Availability
Prescription Only
Imaging
18-fluorine

Oral

No

Parenteral

Yes

Topical

Yes

Sources

Also known as

  • 18f
  • 18f-fluoride
  • 18f naf
  • 18f naf
  • 18f-naf
  • 18f-naf
  • 18f-sodium fluoride
  • 18-naf
  • calcium fluoride
  • calcium fluoride
  • dentiplus
  • durafluor
  • duraphat
  • duraphat
  • duraphat
  • en-de-kay
  • fluor-a-day
  • fluoride
  • fluoride
  • fluoride ion f-18
  • fluorigard
  • fluorigard
  • fluorigard daily
  • fluorigard weekly
  • fluorine-18
  • fluorine-18
  • fluorine f-18
  • fluorine f-18
  • fluorinse
  • fluorinse
  • fluor ret
  • minute-gel
  • minute-gel
  • nafril ret
  • neutra care
  • neutra care
  • ossin
  • ossin
  • osteofluor
  • osteofluor
  • pediaflor
  • pediaflor
  • point-two
  • point-two
  • sodium fluoride
  • sodium fluoride
  • sodium fluoride
  • sodium fluoride
  • sodium fluoride
  • sodium fluoride
  • sodium fluoride
  • sodium fluoride
  • sodium fluoride
  • sodium fluoride (18f)
  • sodium fluoride (18f)
  • sodium fluoride (18f)
  • sodium fluoride-18f
  • sodium fluoride (f18)
  • sodium fluoride (f18)
  • sodium fluoride f 18
  • sodium fluoride f 18
  • sodium fluoride f-18
  • sodium fluoride f-18
  • sodium fluoride f-18
  • sodium fluoride f-18
  • sodium fluoride f 18 injection
  • sodium fluoride topical preparation
  • sodium monofluoride
  • thera-flur
  • zymafluor
  • zymafluor

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07225478Phase 3Oct 31, 2025Colgate Palmolive
NCT07273539N/AOct 27, 2025Healeon Medical Inc, University of Birmingham
NCT07134231Phase 3Oct 9, 2025Colgate Palmolive, Federal University of Alagoas
NCT06932926Phase 2Sep 30, 2025Cairo University
NCT07181967N/ASep 15, 2025Assiut University
NCT07065305Early Phase 1 (Phase 1)Sep 15, 2025Al Azhar University, Misr University for Science and Technology
NCT07284563Phase 2Sep 1, 2025—
NCT07141576N/ASep 1, 2025Cairo University
NCT06961604Early Phase 1 (Phase 1)Jun 1, 2025Atlantic Health System
NCT06902532N/AMay 1, 2025Cairo University
NCT07113847Phase 2/Phase 3 (Phase 3)Apr 1, 2025British University In Egypt
NCT06892834Phase 2Mar 25, 2025All Sum Research Center Ltd., Procter and Gamble
NCT07063433N/AFeb 1, 2025British University In Egypt
NCT06797882Phase 2Jan 31, 2025National University of Malaysia
NCT06732518Phase 3Jan 30, 2025Colgate Palmolive, Federal University of Alagoas
NCT06821724N/ADec 1, 2024National Research Center, Egypt
NCT06829277N/ANov 1, 2024MTI University
NCT07229105N/AAug 12, 2024Bezmialem University
NCT06837779N/AJul 1, 2024Al Azhar University
NCT06430060Phase 3Jun 30, 2024Colgate Palmolive
Showing 20 of 291 trials
Page 1 / 15

Organizations

Research & Development (182)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Colgate PalmoliveFor profit484252000
GlaxoSmithKlineFor profit333252007
Cairo UniversityAcademic/Hospital262652017
National Cancer Institute (NCI)Government10632009
Procter and GambleFor profit9952012
The University of Hong KongAcademic/Hospital8832006
Alexandria UniversityAcademic/Hospital5542018
Al Azhar UniversityAcademic/Hospital4432019
Federal University of ParaibaAcademic/Hospital4232006
Johnson and JohnsonFor profit4412009
King Abdul-Aziz UniversityAcademic/Hospital4422009
University of California, San FranciscoAcademic/Hospital4432003
University of Texas, San AntonioAcademic/Hospital4232012
University of WashingtonAcademic/Hospital4232003
Healeon Medical IncFor profit3312022
Indiana UniversityAcademic/Hospital3222012
Mansoura UniversityAcademic/Hospital3322020
National Institute of Dental and Craniofacial Research (NIDCR)Government3022001
Rowpar Pharmaceuticals, Inc.For profit3322016
Stanford UniversityAcademic/Hospital3332006
182 organizations
Page 1 / 10

Marketing (31)

OrganizationOrg typeRelationshipDate
3d Imaging Drug Design & DevelopmentFor profitMKTGOct 19, 2015
BAMF HealthFor profitMKTGDec 6, 2022
Biomedical Research FoundationAcademic/HospitalMKTGJan 9, 2015
Cardinal HealthAcademic/HospitalMKTGJul 30, 2015
Colgate PalmoliveFor profitNDA2Jul 11, 1997
Columbia UniversityAcademic/HospitalMKTGMay 19, 2016
Decatur Memorial HospitalAcademic/HospitalMKTGOct 21, 2014
Essential Isotopes, LLCFor profitMKTGOct 29, 2014
Feinstein Institute for Medical ResearchAcademic/HospitalMKTGNov 19, 2014
General ElectricFor profitNDA2Feb 24, 1972
General ElectricFor profitNDAFeb 24, 1972
Hot Shots Nuclear MedicineFor profitMKTGJul 29, 2015
Houston CyclotronFor profitMKTGDec 26, 2012
Jubilant DraxImage Inc.For profitMKTGOct 23, 2015
Jubilant Innovation Ltd.For profitMKTGOct 23, 2015
Midwest Medical IsotopesFor profitMKTGNov 17, 2015
NCM USAFor profitMKTGNov 28, 2014
National Institutes of Health (NIH)GovernmentNDA2Jan 26, 2011
NukemedFor profitMKTGApr 22, 2015
Precision NuclearFor profitMKTGFeb 27, 2015
Shertech Labs LlcFor profitMKTGSep 22, 2014
SiemensFor profitMKTGSep 28, 2015
SofieFor profitMKTGAug 18, 2015
Spectron Mrc LlcFor profitMKTGApr 22, 2015
Stanford UniversityAcademic/HospitalMKTGJul 21, 2015
University of California, San FranciscoAcademic/HospitalMKTGMar 13, 2014
University of IowaAcademic/HospitalMKTGNov 17, 2015
University of PennsylvaniaAcademic/HospitalMKTGJun 28, 2013
University of Texas at HoustonAcademic/HospitalMKTGDec 23, 2013
University of UtahAcademic/HospitalMKTGApr 20, 2015
ZevacorFor profitMKTGOct 21, 2014