Drug intelligence / Profile preview

piflufolastat f 18

Development stage
Approved
Lead developer
Lantheus
Modality
Small Molecules, Antibody-Radionuclide Conjugates → Antibody Conjugates → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

Piflufolastat f 18 is a radiopharmaceutical diagnostic agent used in positron emission tomography (PET) imaging to detect prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer. It is indicated for patients with suspected metastasis who are candidates for initial definitive therapy or those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) levels. The drug consists of a urea-based molecule labeled with the radioactive isotope fluorine-18 (^18F), which binds specifically to PSMA—a transmembrane glycoprotein highly overexpressed in prostate cancer cells compared to normal tissues. Upon intravenous administration, piflufolastat f 18 accumulates in PSMA-expressing tissues and enables visualization of cancerous lesions via PET imaging. It was first approved by the FDA in May 2021 under the brand name Pylarify and later by the EMA as PYLCLARI[1][2][3][4][5].

Brand names
PylarifyPYLCLARI
Other names
piflufolastat F 18[F-18]-DCFPyL
02

Targets

PSMA (Prostate-specific membrane antigen)

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