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PIFLUFOLASTAT
Piflufolastat F 18 binds to PSMA-expressing cells, including prostate cancer cells, and emits positrons for imaging.
At a glance
| Generic name | PIFLUFOLASTAT |
|---|---|
| Drug class | Radioactive Diagnostic Agent [EPC] |
| Target | PSMA |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2021 |
Mechanism of action
Piflufolastat F 18 targets cells that express PSMA, a protein often overexpressed in prostate cancer. The fluorine-18 emits positrons, allowing for detection via positron emission tomography (PET).
Approved indications
Common side effects
- Headache
- Dysgeusia
- Fatigue
Key clinical trials
- An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC. (PHASE3)
- A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC (PHASE2)
- Pilot of 18F-DCFPyL-PSMA PET in mCRPC Patients Receiving 117Lu-Vipivotide Tetraxetan (PHASE4)
- A Pilot Presurgical Trial of REGN5678 (Anti-PSMA x CD28) in Patients With High-risk, Localized Prostate Cancer Followed by Radical Prostatectomy (PHASE1, PHASE2)
- 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)
- A Pilot Study to Assess the Clinical Utility of PYLARIFY PET-CT for Detecting Metastasis in Pancreatic Cancer, Hepatocellular Carcinoma and Breast Cancer (PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- PIFLUFOLASTAT CI brief — competitive landscape report
- PIFLUFOLASTAT updates RSS · CI watch RSS