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piflufolastat (18F)
Piflufolastat (18F) is a fluorine-18 labeled small molecule that binds to prostate-specific membrane antigen (PSMA) for positron emission tomography (PET) imaging of PSMA-expressing tumors.
Piflufolastat (18F) is a fluorine-18 labeled small molecule that binds to prostate-specific membrane antigen (PSMA) for positron emission tomography (PET) imaging of PSMA-expressing tumors. Used for PET imaging of PSMA-positive lesions in men with prostate cancer, Detection and localization of metastatic prostate cancer.
At a glance
| Generic name | piflufolastat (18F) |
|---|---|
| Also known as | Pylarify, Pylclari |
| Sponsor | Blue Earth Diagnostics |
| Drug class | PSMA-targeting PET imaging agent |
| Target | PSMA (prostate-specific membrane antigen) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
Piflufolastat is a PSMA-targeting PET imaging agent that localizes to cells expressing prostate-specific membrane antigen, a transmembrane protein highly expressed in prostate cancer and certain other malignancies. The fluorine-18 radiolabel enables detection via PET imaging, allowing visualization and localization of PSMA-positive lesions for diagnostic and staging purposes. This facilitates improved detection of metastatic disease and guides treatment planning in oncology.
Approved indications
- PET imaging of PSMA-positive lesions in men with prostate cancer
- Detection and localization of metastatic prostate cancer
Common side effects
- Radiation exposure (inherent to PET imaging)
- Injection site reactions
Key clinical trials
- An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC. (PHASE3)
- Pilot of 18F-DCFPyL-PSMA PET in mCRPC Patients Receiving 117Lu-Vipivotide Tetraxetan (PHASE4)
- Study to Assess [177Lu]Lu-PSMA-R2 (AAA602) and [225Ac]Ac-PSMA-R2 (AAA802) in Participants With PSMA-positive HRLPC (PHASE1, PHASE2)
- RefleXion PET/CT Imaging Performance in Patients With Prostate Cancer (NA)
- Piflufolastat F 18 PET/CT in Patients With Suspected, or at High Risk for Metastatic ccRCC (PHASE2, PHASE3)
- Evaluation of the Change in PSMA Expression in Prostate Cancer in Response to Hormonal Therapy (PHASE4)
- Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial (PHASE2)
- Intrapatient Comparison of Urinary Radioactivity Following Piflufolastat (18F) and Flotufolastat (18F) PET in Men With Low PSA Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- piflufolastat (18F) CI brief — competitive landscape report
- piflufolastat (18F) updates RSS · CI watch RSS
- Blue Earth Diagnostics portfolio CI