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 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PYLARIFY (piflufolastat F-18) is a radioactive diagnostic agent that emits positron activity for medical imaging. It is administered intravenously as a solution to detect disease at the molecular level. The mechanism relies on positron emission tomography (PET) imaging technology to visualize and localize pathological processes.
Peak10.8 years to LOE
Product is in peak commercial phase with no direct competitors, suggesting stable team size and established market 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 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
Working on PYLARIFY offers stability in a niche, specialized market with minimal competitive pressure and strong patent protection through 2037. Career growth may be constrained by lower commercial team scaling compared to large-market pharmaceuticals, but specialization in nuclear diagnostics offers unique technical expertise.
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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.