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 21h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PYLARIFY (piflufolastat F-18) is a positron-emitting radioactive diagnostic agent administered intravenously as a solution. It is used for diagnostic imaging in nuclear medicine to detect and localize disease. The drug works by emitting positron radiation that is detected by PET imaging equipment to visualize metabolic activity.
Peak11.1 years to LOE
Product is at peak commercial stage with no biosimilar or direct generic competition, suggesting stable team size and focused optimization work.
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 Feb 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
36 enrolled
Pancreatic CancerBreast CancerHepatocellular Carcinoma
Career Relevance
PYLARIFY is a specialized diagnostic agent with limited linked job visibility, reflecting its niche position in nuclear medicine. Career opportunities are concentrated in medical affairs, clinical support, and specialized commercial roles focused on healthcare provider education and imaging center partnerships.
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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.