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
Existing / approved use
Documented · FDA, WHO, ChEMBLApproved 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 evidenceClinical
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 measuredDihydrofolate 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 measuredOther 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.
- Mefloquine HydrochlorideExisting use: Malaria, Plasmodium falciparum malaria, Plasmodium vivax malaria81.8% AI-predicted activityagainst M. tuberculosisLab records exist8 registered studies
- KetoconazoleExisting use: Adrenal gland disease, Blastomycosis, Cushing syndrome and 3 more81.2% AI-predicted activityagainst M. tuberculosisLab records exist50+ registered studies
- LevoketoconazoleExisting use: Adrenal gland disease, Adrenal gland hyperfunction, Cushing syndrome81.2% AI-predicted activityagainst M. tuberculosis6 registered studies
- Fluphenazine DecanoateExisting use: Mental or behavioural disorder, Psychosis80.7% AI-predicted activityagainst M. tuberculosis4 registered studies
- Fluphenazine EnanthateExisting use: Mental or behavioural disorder, Psychosis80.7% AI-predicted activityagainst M. tuberculosisNo documented evidence found
- NifurtimoxExisting use: American trypanosomiasis, Chagas disease, Leishmaniasis and 1 more78.4% AI-predicted activityagainst M. tuberculosis19 registered studies
- Fluphenazine HydrochlorideExisting use: Mental or behavioural disorder, Psychosis77.8% AI-predicted activityagainst M. tuberculosis5 registered studies
- NitazoxanideExisting use: Amebiasis, Diarrhea77.8% AI-predicted activityagainst M. tuberculosisLab records exist50+ registered studies
- TopiramateExisting use: Epilepsy, Lennox-Gastaut syndrome, Migraine disorder and 1 more77.4% AI-predicted activityagainst M. tuberculosisLab records exist50+ registered studies
- TrabectedinExisting use: Cancer, Dedifferentiated liposarcoma, Leiomyosarcoma and 7 more76.8% AI-predicted activityagainst M. tuberculosis50+ registered studies
- Chlorpromazine HydrochlorideExisting use: Conduct disorder, Mental or behavioural disorder, Nausea and vomiting and 3 more75.0% AI-predicted activityagainst M. tuberculosis33 registered studies
- ProchlorperazineExisting use: Anxiety disorder, Nausea and vomiting, Psychosis and 1 more74.1% AI-predicted activityagainst M. tuberculosis50+ registered studies
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 CancerInterventionN-803; ETBX-71 Vaccine; 18F-DCFPyLPhasePhase 2Registry statusRecruitingStudy 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 CancerInterventionAAA602; AAA802; Gallium (68Ga) gozetotide; Piflufolastat (18F) +2 morePhasePhase 1 / Phase 2Registry statusWithdrawnPiflufolastat 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 CarcinomaInterventionpiflufolastat F 18PhasePhase 2 / Phase 3Registry statusWithdrawnPSMA 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 CarcinomaInterventionPembrolizumab; 177Lu-PNT2002; (F-18)-DCFPyLPhasePhase 1 / Phase 2Registry statusWithdrawnPSMA 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 MetastaticInterventionPSMA PET/CT scanPhaseNot recordedRegistry statusRecruitingProstate 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 CancerInterventionPylarify Piflufolastat Flourine-18 (18F-DCFPyL)PhasePhase 4Registry statusWithdrawnRelugolix 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 AdenocarcinomaInterventionBiopsy; Biospecimen Collection; Computed Tomography; Enzalutamide +6 morePhasePhase 2Registry statusRecruitingEvaluation 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 AdenocarcinomaInterventionPiflufolastat; PSMA PET/CT Scan; PSMA PET/MRI scan; Biospecimen Collection +1 morePhasePhase 4Registry statusRecruitingPilot 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 CarcinomaIntervention18F-DCFPylPhasePhase 4Registry statusRecruitingA 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 NeoplasmInterventionAAA617; AAA517; Piflufolastat F 18; ARPI +2 morePhasePhase 2Registry statusActive not recruitingA 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 ProstatectomyInterventionREGN5678; Piflufolastat F18PhasePhase 1 / Phase 2Registry statusRecruitingFocal 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 AdenocarcinomaIntervention18F-DCFPyL; Stereotactic Body Radiation TherapyPhasePhase 2Registry statusRecruitingPSMA-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 CarcinomaInterventionFluorine F 18 DCFPyL; Gadobenate Dimeglumine; Gadobutrol; Magnetic Resonance Imaging +3 morePhasePhase 2Registry statusWithdrawnAn 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 CancerInterventionPYLARIFYPhaseNot recordedRegistry statusActive not recruiting18F-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 CarcinomaInterventionF18-FDG; MRI; CT; F18-DCFPyL +1 morePhasePhase 2Registry statusTerminated