fluoroestradiol

Trade name: Cerianna

Small moleculeapprovedImaging agent

Approved

May 20, 2020

Fluoroestradiol F-18, also known as [18F]16α-fluoroestradiol and sold under the brand name Cerianna, is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) imaging. It is an analog of estrogen and is used to detect estrogen receptor-positive breast cancer lesions. — Wikipedia

Clinical trial activity

30 trials · 25 clinical orgs · 2 marketing orgs

Phase 1
5
Phase 2
15
Phase 3
2
Phase 4
1

Earliest trial started Sep 1, 2008 (NCT00602043)

Timeline

2000s

  1. Jan 1, 2008

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2013

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2013

    Earliest Phase 3 Sponsor(trial)

2020s

  1. May 20, 2020

    Zionexa — Earliest FDA Approval

  2. May 20, 2020

    Zionexa — Marketing Organization

  3. May 20, 2020

    Zionexa — NDA Secondary Org

  4. May 20, 2020

    General Electric — Marketing Organization

  5. May 20, 2020

    Zionexa — NDA Organization

Indications

Mechanism of action

Approval history

  • approvedMay 20, 2020

Chemistry & pharmacology

Loading structure…

SMILES

C[C@]12CC[C@@H]3c4ccc(O)cc4CC[C@H]3[C@@H]1C[C@@H](F)[C@@H]2O
Mol. weight
290.38 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Imaging
18-fluorine

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • 18f 16 alpha-fluoroestradiol
  • 18f fes
  • 18f fes
  • 18f fluoroestradiol
  • 6alpha-[18f]fluoro-17beta-estradiol
  • 6α-[18f]fluoro-17β-estradiol
  • f-18 16 alpha-fluoroestradiol
  • f-18 fes
  • fluorestradiol
  • fluoroestradiol
  • fluoroestradiol
  • fluoroestradiol f-18

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07112053Phase 2Nov 24, 2025University of Washington
NCT06260033Phase 2Jul 23, 2024City of Hope National Medical Center, National Cancer Institute (NCI)
NCT05916196Phase 2Sep 1, 2023University of Pennsylvania
NCT05486182Phase 4Feb 8, 2022General Electric, Keosys, Simbec-Orion, Zionexa
NCT04692103Phase 2Jul 10, 2021University of Washington
NCT04727632Early Phase 1 (Phase 1)Apr 28, 2021University of Utah
NCT04347135Phase 1/Phase 2 (Phase 2)Jun 30, 2020Mayo Clinic
NCT04252859Early Phase 1 (Phase 1)Jun 30, 2020University of Utah
NCT04382911Phase 2Jun 1, 2020University of North Carolina at Chapel Hill
NCT03873428N/AMay 31, 2019Centre Georges Francois Leclerc
NCT03619044N/ASep 30, 2018University of Toulouse
NCT03544762Phase 3Sep 8, 2017National Taiwan University
NCT03065712Phase 2Feb 22, 2017The University of Texas, Dallas
NCT02806050Phase 2Sep 1, 2016University of Groningen
NCT02899533Phase 1Jul 1, 2016University of Pennsylvania
NCT02398773Phase 2Feb 2, 2016ECOG-ACRIN Cancer Research Group, National Cancer Institute (NCI)
NCT03507088N/ASep 1, 2015Fudan University
NCT02559544N/AMay 1, 2015University of Pennsylvania
NCT02374931N/AApr 1, 2015National Cancer Institute (NCI), Vanderbilt University
NCT01988324Phase 2Aug 31, 2014University of Groningen
Showing 20 of 30 trials
Page 1 / 2

Organizations

Research & Development (25)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government7222008
University of WashingtonAcademic/Hospital5522010
University of PennsylvaniaAcademic/Hospital4332008
University of GroningenAcademic/Hospital3312011
University of UtahAcademic/Hospital2212020
Centre Georges Francois LeclercAcademic/Hospital1112019
City of Hope National Medical CenterAcademic/Hospital1112024
Cornell UniversityAcademic/Hospital1112013
ECOG-ACRIN Cancer Research GroupAcademic/Hospital1012016
Fudan UniversityAcademic/Hospital1112015
General ElectricFor profit1012022
KeosysFor profit1012022
Mayo ClinicAcademic/Hospital1112020
National Taiwan UniversityAcademic/Hospital1112017
Simbec-OrionFor profit1012022
The University of Texas, DallasAcademic/Hospital1112017
University of Alabama, BirminghamAcademic/Hospital1012008
University of AngersAcademic/Hospital1112012
University of North Carolina at Chapel HillAcademic/Hospital1112020
University of ParisAcademic/Hospital1112012
25 organizations
Page 1 / 2

Marketing (5)

OrganizationOrg typeRelationshipDate
General ElectricFor profitMKTGMay 20, 2020
ZionexaFor profitMKTGMay 20, 2020
ZionexaFor profitSYNMay 20, 2020
ZionexaFor profitNDA2May 20, 2020
ZionexaFor profitNDAMay 20, 2020