# Piflufolastat F-18 / Pylarify TruVu

Source: https://nuclide.cc/drugs/pylarify/  
Nuclide record `pylarify` (Agent). Data CC BY-NC 4.0, attribute "Data from Nuclide (nuclide.cc)"; commercial use needs a licence.

## TL;DR

Piflufolastat F-18 (Pylarify) is the leading PSMA PET tracer for prostate cancer, with a new formulation approved in March 2026.

## Summary

Piflufolastat F-18 is a PET tracer: an 18F-labelled urea that binds prostate-specific membrane antigen (PSMA), lighting up prostate cancer deposits that conventional CT and bone scan miss. It was approved in 2021 for PSMA PET in initial staging and biochemical recurrence, and Lantheus' Pylarify TruVu formulation, approved on 9 March 2026, offers an improved formulation and distribution profile. A single 333 MBq dose is injected and imaging follows 60 to 120 minutes later; adverse effects are minor. The 18F label allows central manufacture and shipping, unlike generator-produced 68Ga agents, and it competes with Illuccix/Gozellix (68Ga, Telix), Locametz (Novartis) and Posluma. The open question is whether the management changes PSMA PET triggers translate into longer survival. For a newcomer: the leading tracer for seeing where prostate cancer actually is.

## Fields

- Kind: Agent
- Status: approved
- Last checked: 2026-09-04
- Brand: Pylarify
- Code: 18F-DCFPyL
- Modality: PET imaging agent
- Mechanism: 18F-labelled PSMA-binding urea.
- Approvals: US 2021: PSMA PET imaging in prostate cancer; US 2026: Pylarify TruVu formulation; EU 2023: EU brand Pylclari (Curium)
- Dosing: IV injection (diagnostic); 333 MBq (9 mCi) single dose; imaging 60-120 minutes later

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Piflufolastat_F-18
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Piflufolastat%20F-18

## Connected records

- isotopes: [Fluorine-18](https://nuclide.cc/isotopes/f-18/), [Gallium-68](https://nuclide.cc/isotopes/ga-68/)
- indications: [Prostate cancer](https://nuclide.cc/indications/prostate/)
- technologies: [PSMA PET](https://nuclide.cc/technologies/psma-pet/)
- targets: [PSMA](https://nuclide.cc/targets/psma/)
- companies: [Lantheus](https://nuclide.cc/companies/lantheus/), [Nihon Medi-Physics](https://nuclide.cc/companies/nihon-medi-physics/)
- drugs: [Illuccix (kit for Ga-68 gozetotide)](https://nuclide.cc/drugs/illuccix/)
- institutions: [Society of Nuclear Medicine and Molecular Imaging](https://nuclide.cc/institutions/snmmi/)
- pairings: [PSMA PET → PSMA radioligand therapy](https://nuclide.cc/pairings/psma-pet-to-rlt/)
- roadmaps: [Molecular imaging roadmap: FDG → PSMA → FAP → antigen and immune PET](https://nuclide.cc/roadmaps/molecular-imaging-roadmap/), [PSMA theranostics roadmap: antigen discovery → PSMA PET → 177Lu-PSMA-617 → earlier lines and alpha](https://nuclide.cc/roadmaps/psma-theranostics-roadmap/), [Radiopharmaceutical roadmap: iodine → lutetium → actinium](https://nuclide.cc/roadmaps/radiopharma-roadmap/)
- bottlenecks: [Reimbursement and coding for radiopharmaceuticals](https://nuclide.cc/bottlenecks/b-reimbursement-coding/)
- fronts: [Molecular imaging](https://nuclide.cc/fronts/f-molecular-imaging/)
- key papers: [Appropriate use criteria for prostate-specific membrane antigen (PSMA) PET imaging](https://nuclide.cc/key-papers/paper-jadvar-snmmi-psma-auc-jnm-2022/)
- terms: [PSMA-RADS (PSMA reporting and data system)](https://nuclide.cc/terms/psma-rads/)
- trials: [CONDOR](https://nuclide.cc/trials/condor/), [OSPREY](https://nuclide.cc/trials/osprey/)

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