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Piflufolastat F18 - Curium Pharma/Progenics Pharmaceuticals

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Drug Profile

Piflufolastat F18 - Curium Pharma/Progenics Pharmaceuticals

Alternative Names: 18FDCFPyL (PyL-PSMA) PET/CT; [18F]-DCFPyL; DCFPyL-18F; Fluorine-18 DCFPyL; Fluorine-18 piflufolastat; Piflufolastat F 18 injection; PyL; PYLARIFY; PYLCLARI

Latest Information Update: 02 Jan 2026

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At a glance

  • Originator Johns Hopkins University School of Medicine
  • Developer Curium Pharma; Progenics Pharmaceuticals
  • Class Amides; Carboxylic acids; Fluorinated hydrocarbons; Imaging agents; Pyridines; Radiopharmaceutical diagnostics; Radiopharmaceuticals; Small molecules; Urea compounds
  • Mechanism of Action Positron-emission tomography enhancers
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Prostate cancer
  • Phase II/III Renal cell carcinoma

Most Recent Events

  • 23 Dec 2025 Launched for Prostate cancer (Diagnosis) in Poland (IV)
  • 10 Dec 2025 Lantheus Medical Imaging withdraws phase II/II trial in Renal cell carcinoma (Diagnosis) in USA (IV) prior to enrollment due to challenges in patient enrollment (NCT07084909)
  • 20 Oct 2025 Phase-II/III clinical trials in Renal cell carcinoma (Diagnosis) in USA (IV) (NCT07084909)

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