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piflufolastat

Trade name: PYLARIFY

Small moleculeapprovedImaging agent

Approved

May 26, 2021

Clinical trial activity

58 trials · 32 clinical orgs · 2 marketing orgs

Phase 1
17
Phase 2
29
Phase 3
8
Phase 4
4

Earliest trial started May 1, 2014 (NCT02151760)

Timeline

2010s

  1. Jan 1, 2014

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2016

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2018

    Progenics — Earliest Phase 3 Sponsor(trial)

2020s

  1. May 26, 2021

    Lantheus Medical Imaging — Earliest FDA Approval

  2. May 26, 2021

    Progenics — Marketing Organization

  3. May 26, 2021

    Lantheus Medical Imaging — NDA Secondary Org

  4. May 26, 2021

    Lantheus Medical Imaging — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewMay 26, 2021

Chemistry & pharmacology

Loading structure…

SMILES

O=C(O)CC[C@H](NC(=O)N[C@@H](CCCCNC(=O)c1ccc([18F])nc1)C(=O)O)C(=O)O
Mol. weight
441.4 g/mol
Lipinski Ro5
1 violation(s)
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 dcfpyl
  • 18f dcfpyl
  • 18f-dcfpyl
  • 18f-dcfpyl
  • dcfpyl
  • dcfpyl
  • dcfpyl

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06881823Phase 1/Phase 2 (Phase 2)Jun 29, 2026Novartis
NCT07084909Phase 2/Phase 3 (Phase 3)Oct 31, 2025Lantheus Medical Imaging
NCT06904313Phase 2May 12, 2025—
NCT06756334Early Phase 1 (Phase 1)Dec 19, 2024Anhui Medical University
NCT06361810Phase 1/Phase 2 (Phase 2)Nov 30, 2024Johns Hopkins University, Lantheus Medical Imaging, Merck
NCT06499870Phase 2Sep 6, 2024National Cancer Institute (NCI), Northwestern University
NCT06520449Early Phase 1 (Phase 1)Aug 31, 2024Melbourne Theranostic Innovation Centre
NCT06099093Phase 4Apr 30, 2024Harvard University, Progenics
NCT05919329Phase 4Jan 1, 2024OHSU Knight Cancer Institute, Oregon Health and Science University, Progenics
NCT06074510Phase 4Dec 31, 2023Lantheus Medical Imaging
NCT05849298Phase 2Dec 6, 2023Novartis
NCT06085664Phase 1/Phase 2 (Phase 2)Dec 4, 2023University of Texas at Houston
NCT05820724Phase 2May 1, 2023Department of Veteran Affairs, Lantheus Medical Imaging
NCT05616650Phase 2Dec 29, 2022National Cancer Institute (NCI)
NCT05568537Phase 4Nov 30, 2022Oakland University
NCT05394259N/AOct 28, 2022Lantheus Medical Imaging, University of Texas at Houston
NCT05470699N/AAug 29, 2022City of Hope National Medical Center, National Cancer Institute (NCI)
NCT05155046Phase 2Dec 24, 2021National Cancer Institute (NCI)
NCT05009979Phase 2Dec 7, 2021National Cancer Institute (NCI)
NCT05125016Phase 1/Phase 2 (Phase 2)Nov 19, 2021Regeneron
Showing 20 of 58 trials
Page 1 / 3

Organizations

Research & Development (32)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government14832017
Johns Hopkins UniversityAcademic/Hospital131242014
ProgenicsFor profit10242016
Lantheus Medical ImagingFor profit5242022
University of WisconsinAcademic/Hospital4422017
Department of Veteran AffairsGovernment3322018
Northwestern UniversityAcademic/Hospital3322018
University of Western OntarioAcademic/Hospital3332016
Columbia UniversityAcademic/Hospital2222018
National Institutes of Health (NIH)Government2022018
NovartisFor profit2212023
University of California, Los AngelesAcademic/Hospital2112018
University of Texas at HoustonAcademic/Hospital2222022
Anhui Medical UniversityAcademic/Hospital1112024
Centre for Probe Development and CommercializationAcademic/Hospital1012019
City of Hope National Medical CenterAcademic/Hospital1112022
Cornell UniversityAcademic/Hospital1012016
Department of DefenseGovernment1012019
Harvard UniversityAcademic/Hospital1112024
McGill UniversityAcademic/Hospital1112017
32 organizations
Page 1 / 2

Marketing (3)

OrganizationOrg typeRelationshipDate
Lantheus Medical ImagingFor profitNDA2May 26, 2021
Lantheus Medical ImagingFor profitNDAMay 26, 2021
ProgenicsFor profitMKTGMay 26, 2021