Skip to content

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 MRSA, E. coli and M. tuberculosis. 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.

  • IL-15 Superagonist With or Without Vaccine in Biochemically Recurrent Prostate Cancer After Previous Stereotactic Body Radiation Therapy

    NCT07686380 · start 2026-10-04

    Registered record
    Registry ID
    NCT07686380
    Conditions
    Recurrent Prostate Cancer; Prostate Cancer
    Interventions
    N-803; ETBX-71 Vaccine; 18F-DCFPyL
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2026-10-04
    Completion
    2029-01-30
    Enrolment
    65

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

    ConditionRecurrent Prostate Cancer; Prostate Cancer
    InterventionN-803; ETBX-71 Vaccine; 18F-DCFPyL
    PhasePhase 2
    Registry statusRecruiting
  • Study to Assess [177Lu]Lu-PSMA-R2 (AAA602) and [225Ac]Ac-PSMA-R2 (AAA802) in Participants With PSMA-positive HRLPC

    NCT06881823 · start 2026-06-29

    Registered record
    Registry ID
    NCT06881823
    Conditions
    Prostate Cancer
    Interventions
    AAA602; AAA802; Gallium (68Ga) gozetotide; Piflufolastat (18F); Flotufolastat F 18; 18F-PSMA-1007
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Withdrawn
    Start
    2026-06-29
    Completion
    2033-06-01
    Enrolment
    0

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

    ConditionProstate Cancer
    InterventionAAA602; AAA802; Gallium (68Ga) gozetotide; Piflufolastat (18F) +2 more
    PhasePhase 1 / Phase 2
    Registry statusWithdrawn
  • Piflufolastat F 18 PET/CT in Patients With Suspected, or at High Risk for Metastatic ccRCC

    NCT07084909 · start 2025-11

    Registered record
    Registry ID
    NCT07084909
    Conditions
    Clear Cell Renal Cell Carcinoma
    Interventions
    piflufolastat F 18
    Study type
    INTERVENTIONAL
    Phase
    Phase 2 / Phase 3
    Registry status
    Withdrawn
    Start
    2025-11
    Completion
    2027-09
    Enrolment
    0

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

    ConditionClear Cell Renal Cell Carcinoma
    Interventionpiflufolastat F 18
    PhasePhase 2 / Phase 3
    Registry statusWithdrawn
  • PSMA Therapy and Immunotherapy in Kidney Cancer

    NCT06361810 · start 2025-10-01

    Registered record
    Registry ID
    NCT06361810
    Conditions
    Metastatic Renal Cell Carcinoma; Metastatic Clear Cell Renal Cell Carcinoma
    Interventions
    Pembrolizumab; 177Lu-PNT2002; (F-18)-DCFPyL
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Withdrawn
    Start
    2025-10-01
    Completion
    2032-01
    Enrolment
    0

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

    ConditionMetastatic Renal Cell Carcinoma; Metastatic Clear Cell Renal Cell Carcinoma
    InterventionPembrolizumab; 177Lu-PNT2002; (F-18)-DCFPyL
    PhasePhase 1 / Phase 2
    Registry statusWithdrawn
  • PSMA PET for Treatment Response evaLuation of systemIC Therapies in prostAte caNcer (PELICAN)

    NCT07089550 · start 2025-04-02

    Registered record
    Registry ID
    NCT07089550
    Conditions
    PSMA Positive Tumors or Tumor Tissues; Prostate Cancer Metastatic
    Interventions
    PSMA PET/CT scan
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Recruiting
    Start
    2025-04-02
    Completion
    2034-04-26
    Enrolment
    1,300

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

    ConditionPSMA Positive Tumors or Tumor Tissues; Prostate Cancer Metastatic
    InterventionPSMA PET/CT scan
    PhaseNot recorded
    Registry statusRecruiting
  • Prostate MRI and Pylarify PSMA PET/CT

    NCT05568537 · start 2024-10

    Registered record
    Registry ID
    NCT05568537
    Conditions
    Prostate Cancer
    Interventions
    Pylarify Piflufolastat Flourine-18 (18F-DCFPyL)
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Withdrawn
    Start
    2024-10
    Completion
    2026-10
    Enrolment
    0

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

    ConditionProstate Cancer
    InterventionPylarify Piflufolastat Flourine-18 (18F-DCFPyL)
    PhasePhase 4
    Registry statusWithdrawn
  • Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial

    NCT06499870 · start 2024-09-06

    Registered record
    Registry ID
    NCT06499870
    Conditions
    Prostate Adenocarcinoma
    Interventions
    Biopsy; Biospecimen Collection; Computed Tomography; Enzalutamide; Fluorine F 18 Piflufolastat; Image Guided Radiation Therapy; Magnetic Resonance Imaging; Positron Emission Tomography; Questionnaire Administration; Relugolix
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2024-09-06
    Completion
    2032-11-19
    Enrolment
    50

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

    ConditionProstate Adenocarcinoma
    InterventionBiopsy; Biospecimen Collection; Computed Tomography; Enzalutamide +6 more
    PhasePhase 2
    Registry statusRecruiting
  • Evaluation of the Change in PSMA Expression in Prostate Cancer in Response to Hormonal Therapy

    NCT05919329 · start 2024-06-25

    Registered record
    Registry ID
    NCT05919329
    Conditions
    Castration Resistant Prostate Cancer; Castration Sensitive Prostate Cancer; Prostate Adenocarcinoma
    Interventions
    Piflufolastat; PSMA PET/CT Scan; PSMA PET/MRI scan; Biospecimen Collection; Electronic Health Record Review
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Recruiting
    Start
    2024-06-25
    Completion
    2030-09-01
    Enrolment
    80

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

    ConditionCastration Resistant Prostate Cancer; Castration Sensitive Prostate Cancer; Prostate Adenocarcinoma
    InterventionPiflufolastat; PSMA PET/CT Scan; PSMA PET/MRI scan; Biospecimen Collection +1 more
    PhasePhase 4
    Registry statusRecruiting
  • Pilot of 18F-DCFPyL-PSMA PET in mCRPC Patients Receiving 117Lu-Vipivotide Tetraxetan

    NCT06099093 · start 2024-04-01

    Registered record
    Registry ID
    NCT06099093
    Conditions
    Prostate Cancer; Metastatic Castration-resistant Prostate Cancer; Metastatic Castration-resistant Prostate Carcinoma
    Interventions
    18F-DCFPyl
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Recruiting
    Start
    2024-04-01
    Completion
    2026-12-01
    Enrolment
    30

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

    ConditionProstate Cancer; Metastatic Castration-resistant Prostate Cancer; Metastatic Castration-resistant Prostate Carcinoma
    Intervention18F-DCFPyl
    PhasePhase 4
    Registry statusRecruiting
  • A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC

    NCT05849298 · start 2024-01-03

    Registered record
    Registry ID
    NCT05849298
    Conditions
    Prostatic Neoplasm
    Interventions
    AAA617; AAA517; Piflufolastat F 18; ARPI; ADT; Best supportive care
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Active not recruiting
    Start
    2024-01-03
    Completion
    2026-12-23
    Enrolment
    49

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

    ConditionProstatic Neoplasm
    InterventionAAA617; AAA517; Piflufolastat F 18; ARPI +2 more
    PhasePhase 2
    Registry statusActive not recruiting
  • A Pilot Presurgical Trial of REGN5678 (Anti-PSMA x CD28) in Patients With High-risk, Localized Prostate Cancer Followed by Radical Prostatectomy

    NCT06085664 · start 2023-12-04

    Registered record
    Registry ID
    NCT06085664
    Conditions
    Prostate Cancer; Radical Prostatectomy
    Interventions
    REGN5678; Piflufolastat F18
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Recruiting
    Start
    2023-12-04
    Completion
    2028-06-30
    Enrolment
    42

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

    ConditionProstate Cancer; Radical Prostatectomy
    InterventionREGN5678; Piflufolastat F18
    PhasePhase 1 / Phase 2
    Registry statusRecruiting
  • Focal Therapy With Stereotactic Body Radiation Therapy (SBRT) for Patients With a Single Prostate Tumor

    NCT05616650 · start 2023-10-19

    Registered record
    Registry ID
    NCT05616650
    Conditions
    Prostatic Neoplasms; Prostate Cancer; Prostate Adenocarcinoma
    Interventions
    18F-DCFPyL; Stereotactic Body Radiation Therapy
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2023-10-19
    Completion
    2031-12-01
    Enrolment
    42

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

    ConditionProstatic Neoplasms; Prostate Cancer; Prostate Adenocarcinoma
    Intervention18F-DCFPyL; Stereotactic Body Radiation Therapy
    PhasePhase 2
    Registry statusRecruiting
  • PSMA-Targeted 18F-DCFPyL PET/MRI for the Detection of Prostate Cancer

    NCT04910425 · start 2023-06-17

    Registered record
    Registry ID
    NCT04910425
    Conditions
    Prostate Carcinoma
    Interventions
    Fluorine F 18 DCFPyL; Gadobenate Dimeglumine; Gadobutrol; Magnetic Resonance Imaging; Multiparametric Magnetic Resonance Imaging; Positron Emission Tomography; Transrectal Ultrasonography Guided Biopsy
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Withdrawn
    Start
    2023-06-17
    Completion
    2028-07
    Enrolment
    0

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

    ConditionProstate Carcinoma
    InterventionFluorine F 18 DCFPyL; Gadobenate Dimeglumine; Gadobutrol; Magnetic Resonance Imaging +3 more
    PhasePhase 2
    Registry statusWithdrawn
  • An Observational Registry Assessing the Impact of PYLARIFY® (Piflufolastat F18) PET in Patients With Prostate Cancer

    NCT05712473 · start 2023-05-22

    Registered record
    Registry ID
    NCT05712473
    Conditions
    Prostate Cancer
    Interventions
    PYLARIFY
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Active not recruiting
    Start
    2023-05-22
    Completion
    2031-05
    Enrolment
    500

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

    ConditionProstate Cancer
    InterventionPYLARIFY
    PhaseNot recorded
    Registry statusActive not recruiting
  • 18F-DCFPyL PET/CT in Hepatocellular Carcinoma

    NCT05009979 · start 2023-01-18

    Registered record
    Registry ID
    NCT05009979
    Conditions
    Hepatocellular Carcinoma
    Interventions
    F18-FDG; MRI; CT; F18-DCFPyL; Tumor biopsy
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Terminated
    Start
    2023-01-18
    Completion
    2024-11-20
    Enrolment
    8

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

    ConditionHepatocellular Carcinoma
    InterventionF18-FDG; MRI; CT; F18-DCFPyL +1 more
    PhasePhase 2
    Registry statusTerminated