CDEK
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Flotufolastat

Trade name: Posluma

PeptideapprovedImaging agent

Approved

May 25, 2023

Clinical trial activity

18 trials · 16 clinical orgs · 2 marketing orgs

Phase 1
7
Phase 2
9
Phase 3
2
Phase 4
0

Earliest trial started Jun 11, 2019 (NCT03995888)

Timeline

2010s

  1. Jan 1, 2019

    Blue Earth Diagnostics — Earliest Phase 1 Sponsor(trial)

2020s

  1. Jan 1, 2020

    Blue Earth Diagnostics — Earliest Phase 3 Sponsor(trial)

  2. May 25, 2023

    Bracco — Earliest FDA Approval

  3. May 25, 2023

    Blue Earth Diagnostics — Marketing Organization

  4. May 25, 2023

    Bracco — NDA Secondary Org

  5. May 25, 2023

    Bracco — NDA Organization

  6. Jan 1, 2024

    Earliest Phase 2 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedMay 25, 2023

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)(C)[Si]([18F])(c1ccc(C(=O)NC[C@@H](NC(=O)CC[C@@H](C(=O)O)N2CCN(CC(=O)O)CCN(CC(=O)O)CCN(CC(=O)O)CC2)C(=O)N[C@H](CCCCNC(=O)CCC(=O)NCCC[C@@H](NC(=O)CC[C@H](NC(=O)N[C@@H](CCC(=O)O)C(=O)O)C(=O)O)C(=O)O)C(=O)O)cc1)C(C)(C)C
Mol. weight
1470.63 g/mol
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Availability
Prescription Only
Multi-specific
No
Imaging
18-fluorine

Oral

No

Parenteral

No

Topical

No

Sources

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06881823Phase 1/Phase 2 (Phase 2)Jun 29, 2026Novartis
NCT07285057Phase 2Dec 31, 2025Blue Earth Diagnostics, Icahn School of Medicine at Mount Sinai
NCT07220720Phase 2Nov 4, 2025University of Florida
NCT07185165Phase 2Oct 9, 2025Blue Earth Diagnostics, University of California, Los Angeles
NCT07025369Phase 2Aug 25, 2025Mayo Clinic
NCT07149831Phase 1Jun 7, 2025Sinotau Pharmaceutical Group
NCT07115277N/AMar 14, 2025Sinotau Pharmaceutical Group
NCT06865768Phase 2Mar 13, 2025Emory University, National Cancer Institute (NCI), National Institutes of Health (NIH)
NCT06813898Early Phase 1 (Phase 1)Feb 17, 2025National Cancer Institute (NCI), Northwestern University
NCT06580015N/ADec 24, 2024City of Hope National Medical Center, National Cancer Institute (NCI)
NCT06617481Phase 2Sep 20, 2024Advent Health, Blue Earth Diagnostics
NCT06389786N/AJun 11, 2024Mayo Clinic
NCT06105918Phase 1Nov 29, 2023Emory University, National Cancer Institute (NCI)
NCT05852041Early Phase 1 (Phase 1)Aug 7, 2023National Cancer Institute (NCI), Northwestern University
NCT04978675Phase 1Aug 4, 2021University of Texas at Houston
NCT04186819Phase 3Feb 29, 2020Blue Earth Diagnostics, Parexel
NCT04186845Phase 3Feb 29, 2020Blue Earth Diagnostics, Parexel
NCT03995888Phase 1Jun 11, 2019Blue Earth Diagnostics, Clinical Research Services Turku
Showing 18 of 18 trials
Page 1 / 1

Organizations

Research & Development (16)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Blue Earth DiagnosticsFor profit6332019
National Cancer Institute (NCI)Government5032023
Emory UniversityAcademic/Hospital2222023
Mayo ClinicAcademic/Hospital2222024
Northwestern UniversityAcademic/Hospital2212023
ParexelFor profit2012020
Sinotau Pharmaceutical GroupAcademic/Hospital2222025
Advent HealthAcademic/Hospital1112024
City of Hope National Medical CenterAcademic/Hospital1112024
Clinical Research Services TurkuFor profit1012019
Icahn School of Medicine at Mount SinaiAcademic/Hospital1112025
National Institutes of Health (NIH)Government1012025
NovartisFor profit1112026
University of California, Los AngelesAcademic/Hospital1112025
University of FloridaAcademic/Hospital1112025
University of Texas at HoustonAcademic/Hospital1112021
16 organizations
Page 1 / 1

Marketing (3)

OrganizationOrg typeRelationshipDate
Blue Earth DiagnosticsFor profitMKTGMay 25, 2023
BraccoFor profitNDA2May 25, 2023
BraccoFor profitNDAMay 25, 2023