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Piflufolastat F-18

FDA-approved product (solution, intravenous), marketed as Pylarify, Pylarify Truvu.

Registered studies
50+
Lab records
0
Pathogens at ≥40%
3 of 4

Chemical structure

Chemical structure of Piflufolastat F-18
A drawing shows what the molecule is, not what it does.

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Computed tomography
  • Metastatic prostate cancer
  • Prostate adenocarcinoma
  • Prostate cancer
  • Prostate neoplasm

Indications ChEMBL records as approved, from FDA and DailyMed labels.

WHO therapeutic group
Other diagnostic radiopharmaceuticals for tumour detection
FDA pharmacologic class
Radioactive Diagnostic Agent FDA label ↗
Anti-infective classification
Not classified as an anti-infective.

Repurposing investigation

This medicine is being investigated here for AI-predicted antimicrobial activity against M. tuberculosis, MRSA and E. coli. It was surfaced computationally for further investigation; it is not an established treatment for these infections.

AI-predicted activity

AI prediction · nothing measured
  • MRSA44.8% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli42.7% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae27.0% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis52.2% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.

A model’s estimate of laboratory activity against each pathogen species. It is not clinical effectiveness.

Evidence

Clinical and experimental

Documented evidence

Clinical

50+registered studies name this medicine, for any condition. The registry search keeps the first 50, so there may be more. See them below.

Experimental

No evidence found

No laboratory measurement against the four pathogens in the ChEMBL records loaded here.

Docking

Computational · nothing measured

Dihydrofolate reductase ↗ (E. coli)

Not yet docked: queued in the docking rundetails

KPC-2 carbapenemase ↗ (K. pneumoniae)

Not yet docked: queued in the docking rundetails

Enoyl-ACP reductase (InhA) ↗ (M. tuberculosis)

Not yet docked: queued in the docking rundetails

Dihydrofolate reductase ↗ (MRSA)

Not yet docked: queued in the docking rundetails

AutoDock Vina, one experimentally solved protein per pathogen. This project’s screening target is -7.0 kcal/mol, its own mark rather than a universal cutoff. A docking score is a structural hypothesis, not proof of binding, and requires experimental validation.

Other medicines to investigate

AI prediction · nothing measured

Other repurposing candidates: approved medicines besides Piflufolastat F-18 with AI-predicted activity ≥40% against the chosen pathogen, leaving out existing antimicrobials. They are computational candidates for further investigation, not alternatives and not recommendations.

Sorted by AI-predicted activity, high to low. The order is not a ranking of which medicine is better.

Registered studies

A registration describes a study; it does not establish a positive result.

  • A Pilot Study to Assess the Clinical Utility of PYLARIFY PET-CT for Detecting Metastasis in Pancreatic Cancer, Hepatocellular Carcinoma and Breast Cancer

    NCT05394259 · start 2022-10-28

    Registered record
    Registry ID
    NCT05394259
    Conditions
    Pancreatic Cancer; Breast Cancer; Hepatocellular Carcinoma
    Interventions
    Piflufolastat F18
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Active not recruiting
    Start
    2022-10-28
    Completion
    2027-02-02
    Enrolment
    20

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPancreatic Cancer; Breast Cancer; Hepatocellular Carcinoma
    InterventionPiflufolastat F18
    PhasePhase 1
    Registry statusActive not recruiting
  • Multimodal Machine Learning Characterization of Solid Tumors

    NCT04687969 · start 2022-10-23

    Registered record
    Registry ID
    NCT04687969
    Conditions
    Adenocarcinoma of Prostate; Radical Prostatectomy; Hepatocellular Carcinoma (HCC); Glioma; Renal Cell Carcinoma (RCC); Prostate Cancer
    Interventions
    [18F]DCFPyL; PET/MRI scanner
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2022-10-23
    Completion
    2024-08-12
    Enrolment
    50

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAdenocarcinoma of Prostate; Radical Prostatectomy; Hepatocellular Carcinoma (HCC); Glioma +2 more
    Intervention[18F]DCFPyL; PET/MRI scanner
    PhaseNot recorded
    Registry statusCompleted
  • 18F-DCFPyL Imaging as a Method to Assess Treatment Response to Stereotactic Body Radiation Therapy

    NCT05155046 · start 2022-08-31

    Registered record
    Registry ID
    NCT05155046
    Conditions
    Localized Prostate Cancer
    Interventions
    18F-DCFPyL
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2022-08-31
    Completion
    2029-12-31
    Enrolment
    130

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionLocalized Prostate Cancer
    Intervention18F-DCFPyL
    PhasePhase 2
    Registry statusRecruiting
  • Detecting Metastases by PyL PET/CT in Subjects Starting Enzalutamide for Untreated Castration Resistant Prostate Cancer.

    NCT04655365 · start 2022-03-22

    Registered record
    Registry ID
    NCT04655365
    Conditions
    Prostate Cancer
    Interventions
    Enzalutamide capsule
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Active not recruiting
    Start
    2022-03-22
    Completion
    2026-09-01
    Enrolment
    50

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionProstate Cancer
    InterventionEnzalutamide capsule
    PhasePhase 2
    Registry statusActive not recruiting
  • 64Cu-TLX592 Phase I Safety, PK, Biodistribution and Dosimetry Study (CUPID Study)

    NCT04726033 · start 2021-08-04

    Registered record
    Registry ID
    NCT04726033
    Conditions
    Metastatic Prostate Cancer
    Interventions
    64Cu-DOTA-TLX592
    Study type
    INTERVENTIONAL
    Phase
    Early phase 1
    Registry status
    Completed
    Start
    2021-08-04
    Completion
    2024-01-29
    Enrolment
    14

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionMetastatic Prostate Cancer
    Intervention64Cu-DOTA-TLX592
    PhaseEarly phase 1
    Registry statusCompleted
  • 18F-DCFPyL Positron Emission Tomography (PET) in Intermediate or High Risk Prostate Cancer

    NCT04727736 · start 2021-05-01

    Registered record
    Registry ID
    NCT04727736
    Conditions
    Prostate Cancer
    Interventions
    18F-DCFPyL
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Terminated
    Start
    2021-05-01
    Completion
    2022-12-31
    Enrolment
    47

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionProstate Cancer
    Intervention18F-DCFPyL
    PhasePhase 2
    Registry statusTerminated
  • High Resolution, 18F-PSMA PET-MRI Before Prostate Cancer HIFU or Radical Prostatectomy

    NCT04461509 · start 2021-04-06

    Registered record
    Registry ID
    NCT04461509
    Conditions
    Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Disease
    Interventions
    18F-PSMA
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Terminated
    Start
    2021-04-06
    Completion
    2024-09-03
    Enrolment
    62

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionProstatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site +3 more
    Intervention18F-PSMA
    PhasePhase 2
    Registry statusTerminated
  • Randomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer

    NCT04457245 · start 2020-08-14

    Registered record
    Registry ID
    NCT04457245
    Conditions
    Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8; Stage II Prostate Cancer AJCC v8; Stage IIA Prostate Cancer AJCC v8; Stage IIB Prostate Cancer AJCC v8; Stage IIC Prostate Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Stage IIIA Prostate Cancer AJCC v8; Stage IIIB Prostate Cancer AJCC v8; Stage IIIC Prostate Cancer AJCC v8
    Interventions
    Computed Tomography; Fluorine F 18 DCFPyL; Positron Emission Tomography; Radiation Therapy
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Terminated
    Start
    2020-08-14
    Completion
    2023-01-10
    Enrolment
    54

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionStage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8; Stage II Prostate Cancer AJCC v8; Stage IIA Prostate Cancer AJCC v8; Stage IIB Prostate Cancer AJCC v8 +5 more
    InterventionComputed Tomography; Fluorine F 18 DCFPyL; Positron Emission Tomography; Radiation Therapy
    PhasePhase 3
    Registry statusTerminated
  • 18F-DCFPyL PET/CT Impact on Treatment Strategies for Patients With Prostate Cancer

    NCT04390880 · start 2020-04-07

    Registered record
    Registry ID
    NCT04390880
    Conditions
    Prostate Cancer
    Interventions
    18F-DCFPyL
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2020-04-07
    Completion
    2021-08-31
    Enrolment
    239

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionProstate Cancer
    Intervention18F-DCFPyL
    PhasePhase 2
    Registry statusCompleted
  • Molecular Imaging of Prostate Cancer Using Radiofluorinated PSMA Ligand

    NCT04266392 · start 2019-12-16

    Registered record
    Registry ID
    NCT04266392
    Conditions
    Prostate Cancer
    Interventions
    [18F]-DCFPyl Ligand
    Study type
    INTERVENTIONAL
    Phase
    Early phase 1
    Registry status
    Completed
    Start
    2019-12-16
    Completion
    2021-10-15
    Enrolment
    20

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionProstate Cancer
    Intervention[18F]-DCFPyl Ligand
    PhaseEarly phase 1
    Registry statusCompleted
  • Prostate Specific Membrane Antigen (PMSA)-Based PET Imaging of High Risk Prostate Cancer

    NCT03976843 · start 2019-12-04

    Registered record
    Registry ID
    NCT03976843
    Conditions
    Prostate Cancer
    Interventions
    18F-DCFPyL
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Active not recruiting
    Start
    2019-12-04
    Completion
    2027-11-19
    Enrolment
    175

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionProstate Cancer
    Intervention18F-DCFPyL
    PhasePhase 2
    Registry statusActive not recruiting
  • Assessment of Multi-Modality Quantitative Imaging for Evaluation of Response of Metastatic Prostate Cancer to Therapy

    NCT03619655 · start 2019-11-15

    Registered record
    Registry ID
    NCT03619655
    Conditions
    Prostate Cancer
    Interventions
    SPECT CT; 18F-DCFPyL PET/CT; 18F-NaF PET/CT; WB-MRI
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Terminated
    Start
    2019-11-15
    Completion
    2022-11-14
    Enrolment
    3

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionProstate Cancer
    InterventionSPECT CT; 18F-DCFPyL PET/CT; 18F-NaF PET/CT; WB-MRI
    PhasePhase 1
    Registry statusTerminated
  • Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer

    NCT03800784 · start 2019-10-01

    Registered record
    Registry ID
    NCT03800784
    Conditions
    Prostate Cancer
    Interventions
    18F-DCFPyL Injection
    Study type
    INTERVENTIONAL
    Phase
    Phase 2 / Phase 3
    Registry status
    Withdrawn
    Start
    2019-10-01
    Completion
    2021-10-21
    Enrolment
    0

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionProstate Cancer
    Intervention18F-DCFPyL Injection
    PhasePhase 2 / Phase 3
    Registry statusWithdrawn
  • Prostate-Specific Membrane Antigen (PSMA) PET Scans in People Prostate Cancer

    NCT04030338 · start 2019-07-19

    Registered record
    Registry ID
    NCT04030338
    Conditions
    Prostate Cancer; Prostate Neoplasm; Prostate Adenocarcinoma; Prostate Cancer Metastatic; Metastatic Prostate Cancer
    Interventions
    18F-DCFPyL-iPSMA; 68Ga-HBED-iPSMA; PET/CT scan
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Active not recruiting
    Start
    2019-07-19
    Completion
    2027-07
    Enrolment
    58

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionProstate Cancer; Prostate Neoplasm; Prostate Adenocarcinoma; Prostate Cancer Metastatic +1 more
    Intervention18F-DCFPyL-iPSMA; 68Ga-HBED-iPSMA; PET/CT scan
    PhaseNot recorded
    Registry statusActive not recruiting
  • Test-Retest Reproducibility of 18F-DCFPyL PET/CT in the Evaluation of Patients With Metastatic Prostate Cancer

    NCT03793543 · start 2019-03-27

    Registered record
    Registry ID
    NCT03793543
    Conditions
    Prostate Cancer
    Interventions
    18F-DCFPyL Injection
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2019-03-27
    Completion
    2021-10-15
    Enrolment
    23

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionProstate Cancer
    Intervention18F-DCFPyL Injection
    PhasePhase 1
    Registry statusCompleted