NDAINTRAVENOUSSOLUTIONPriority Review
Approved
May 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
3
Data completeness
4/8 — Partial
Priority Review
PYLARIFY (piflufolastat f-18) by Progenicyte Therapeutics is positron emitting activity [moa]. First approved in 2021.
Drug data last refreshed 26m ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PYLARIFY is a positron-emitting radioactive diagnostic agent (F-18 labeled piflufolastat) administered intravenously as a solution for PET imaging. It functions as a molecular imaging tracer that localizes to target tissues, enabling non-invasive visualization and detection of disease. The mechanism relies on positron emission activity to generate diagnostic signals during PET scanning.
Peak10.6 years to LOE
Product is at peak lifecycle stage with no current competitive pressure, suggesting stable team size and established commercial operations.
Mechanism of Action
Positron Emitting Activity
Pharmacologic Class:
Radioactive Diagnostic Agent
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
PYLARIFY® PET/CT or PET/MRI in Men With Favorable Intermediate Risk (FIR) Prostate Cancer
Started Feb 2024
274 enrolled
Prostate Cancer
An Observational Registry Assessing the Impact of PYLARIFY® (Piflufolastat F18) PET in Patients With Prostate Cancer
Started May 2023
500 enrolled
Prostate Cancer
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
20 enrolled
Pancreatic CancerBreast CancerHepatocellular Carcinoma
Career Relevance
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.