PYLARIFY

Peak

piflufolastat f-18

NDAINTRAVENOUSSOLUTIONPriority Review
Approved
May 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
3

Mechanism of Action

Positron Emitting Activity

Pharmacologic Class:

Radioactive Diagnostic Agent

Clinical Trials (3)

NCT06074510Phase 4Active Not Recruiting

PYLARIFY® PET/CT or PET/MRI in Men With Favorable Intermediate Risk (FIR) Prostate Cancer

Started Feb 2024
274 enrolled
Prostate Cancer
NCT05712473N/ANot Yet Recruiting

An Observational Registry Assessing the Impact of PYLARIFY® (Piflufolastat F18) PET in Patients With Prostate Cancer

Started Feb 2023
500 enrolled
Prostate Cancer
NCT05394259Phase 1Recruiting

A Pilot Study to Assess the Clinical Utility of PYLARIFY PET-CT for Detecting Metastasis in Pancreatic Cancer, Hepatocellular Carcinoma and Breast Cancer

Started Oct 2022
36 enrolled
Pancreatic CancerBreast CancerHepatocellular Carcinoma

Loss of Exclusivity

LOE Date
Jun 9, 2037
137 months away
Patent Expiry
Jun 9, 2037
Exclusivity Expiry
May 26, 2026

Patent Records (5)

Patent #ExpiryTypeUse Code
8487129
Nov 7, 2027
SubstanceProduct
12070513
Jul 31, 2029
SubstanceProduct
U-3130
9861713
Jul 31, 2029
SubstanceProduct
U-3130
8778305
Sep 21, 2030
SubstanceProduct
U-3130
10947197
Jun 9, 2037
SubstanceProduct
U-3130