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Fluciclovine

Trade name: Axumin

Small moleculeapproved

Approved

May 27, 2016

Trans-1-amino-3-[(18)F]fluorocyclobutanecarboxylic acid (also known as Fluciclovine (18F)) was approved under brand name AXUMIN as a radioactive diagnostic agent indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence. Besides, this radioactive compound is used in patients with cervical, ovarian epithelial or endometrial cancers. Fluciclovine F 18 is a synthetic amino acid transported across mammalian cell membranes by amino acid transporters, such as LAT-1 and ASCT2, which are upregulated in prostate cancer cells, but as was shown, this compound has a higher affinity for ASCT2 in comparison with other transporters. — NCATS

Clinical trial activity

63 trials · 45 clinical orgs · 1 marketing orgs

Phase 1
22
Phase 2
32
Phase 3
6
Phase 4
4

Earliest trial started May 13, 2003 (NCT00597246)

Timeline

2000s

  1. Jan 1, 2007

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2009

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 1, 2015

    Blue Earth Diagnostics — Earliest Phase 3 Sponsor(trial)

  2. May 27, 2016

    Blue Earth Diagnostics — Earliest FDA Approval

  3. May 27, 2016

    Blue Earth Diagnostics — NDA Secondary Org

  4. May 27, 2016

    Blue Earth Diagnostics — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewMay 27, 2016

Chemistry & pharmacology

Loading structure…

SMILES

C[C@@]1(F)C[C@@](N)(C1)C(=O)O
Mol. weight
147.15 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • 18f
  • (18f)ah111585
  • 18f-ah111585
  • (18f)facbc
  • (18f)facbc
  • 18f facbc
  • 18f facbc
  • 18f-facbc
  • 18f-facbc
  • (18f)fluciclatide
  • 18f fluciclatide
  • 18f fluciclatide
  • 18f-fluciclatide
  • 18f-fluciclatide
  • 18f-fluciclovine
  • 18f-fluciclovine
  • (18f)ge-148
  • 1-amino-3-fluorocyclobutane-1-carboxylic acid
  • (1r,3r)-1-amino-3(18f)fluorocyclobutane-1-carboxylic acid
  • (1r,3r)-1-amino-3(18f)fluorocyclobutane-1-carboxylic acid
  • (1r,3r)-1-amino-3(18f)fluorocyclobutane-1-carboxylic acid
  • ah111585
  • ah 111585
  • ah-111585
  • anti-(18f)facbc
  • anti-1-amino-3-(18f)fluorocyclobutane-1-carboxylic acid
  • anti-1-amino-3-(18f)fluorocyclobutane-1-carboxylic acid
  • axumin
  • axumin
  • axumin
  • cyclobutanecarboxylic acid, 1-amino-3-(fluoro-18f)-, trans-
  • f(18)1-amino-3-fluorocyclobutane-1-carboxylic acid
  • f(18)-facbc
  • facbc
  • facbc
  • facbc
  • facbc
  • facbc f-18
  • facbc f-18
  • f-facbc
  • fluciclatide
  • fluciclatide
  • fluciclatide
  • fluciclitite
  • fluciclovine
  • fluciclovine
  • fluciclovine
  • fluciclovine
  • fluciclovine (18f)
  • fluciclovine (18f)
  • fluciclovine (18f)
  • fluciclovine (18f)
  • fluciclovine (18f)
  • fluciclovine (18f)
  • fluciclovine f18
  • fluciclovine f 18
  • fluciclovine f 18
  • fluciclovine f 18
  • fluciclovine f 18
  • fluciclovine f-18
  • fluciclovine f-18
  • fluciclovine f-18
  • fluciclovine f-18
  • fluciclovine f-18
  • ge-148
  • ge-148
  • ge-148
  • ge-148
  • ge-148 (18f)
  • ge-148 f-18
  • nmk36
  • nmk 36
  • nmk-36
  • nmk-36
  • nmk-36
  • nmk36 cpd

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06613841Early Phase 1 (Phase 1)Oct 1, 2024University of Pennsylvania
NCT06319027Phase 2Apr 11, 2024ECOG-ACRIN Cancer Research Group, National Cancer Institute (NCI)
NCT06062745Phase 1Feb 29, 2024Blue Earth Diagnostics, Harvard University
NCT06048094Phase 1Feb 29, 2024Baptist Health, Blue Earth Diagnostics
NCT06103838Phase 2Jan 3, 2024National Cancer Institute (NCI)
NCT06064097Phase 2Dec 20, 2023National Cancer Institute (NCI)
NCT05722925Phase 4Oct 4, 2023Blue Earth Diagnostics, OHSU Knight Cancer Institute, Oregon Health and Science University
NCT05553041Early Phase 1 (Phase 1)Jan 31, 2023Blue Earth Diagnostics, Dragon Master Foundation, University of Pennsylvania
NCT05554302Phase 2Dec 31, 2022Baptist Health, Blue Earth Diagnostics, University of Miami
NCT05555550Early Phase 1 (Phase 1)Oct 31, 2022Blue Earth Diagnostics, Dragon Master Foundation, University of Pennsylvania
NCT05479136Phase 3Aug 24, 2022Barrow Neurological Institute, Blue Earth Diagnostics, University of Arizona
NCT05054400Early Phase 1 (Phase 1)Nov 30, 2021University of Texas at Houston
NCT04852523Early Phase 1 (Phase 1)Sep 16, 2021University of Utah
NCT04750473Phase 1Jul 16, 2021Emory University, National Cancer Institute (NCI)
NCT04840069Phase 2Apr 1, 2021Arizona Biomedical Research Commission (ABRC), Barrow Neurological Institute, Blue Earth Diagnostics, University of Arizona
NCT04689048Phase 1Dec 31, 2020Baptist Health, Blue Earth Diagnostics
NCT04410133Phase 3Sep 30, 2020Blue Earth Diagnostics, Precision Medicine
NCT04410367Phase 2/Phase 3 (Phase 3)Jul 31, 2020Blue Earth Diagnostics, Precision Medicine
NCT04158245Phase 2Dec 31, 2019Blue Earth Diagnostics, Tulane University
NCT04114370Early Phase 1 (Phase 1)Dec 1, 2019Blue Earth Diagnostics, University of Pittsburgh
Showing 20 of 63 trials
Page 1 / 4

Organizations

Research & Development (45)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Blue Earth DiagnosticsFor profit24452015
National Cancer Institute (NCI)Government14542007
Emory UniversityAcademic/Hospital131342007
General ElectricFor profit6322007
Harvard UniversityAcademic/Hospital4332015
University of PennsylvaniaAcademic/Hospital4412019
University of Texas at HoustonAcademic/Hospital4422014
University of UtahAcademic/Hospital4432017
Baptist HealthAcademic/Hospital3322020
Barrow Neurological InstituteAcademic/Hospital2022021
Cornell UniversityAcademic/Hospital2212003
Dragon Master FoundationAcademic/Hospital2012022
IND 2 Results LLCFor profit2012015
Nihon Medi PhysicsFor profit2022009
Precision MedicineFor profit2012020
Syne Qua Non LimitedFor profit2012015
University of ArizonaAcademic/Hospital2222021
University of OxfordAcademic/Hospital2122015
University of PittsburghAcademic/Hospital2222018
American College of RadiologyAcademic/Hospital1012016
45 organizations
Page 1 / 3

Marketing (2)

OrganizationOrg typeRelationshipDate
Blue Earth DiagnosticsFor profitNDA2May 27, 2016
Blue Earth DiagnosticsFor profitNDAMay 27, 2016