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NCE-1 Intelligence & Market Opportunity

Pylarify

Piflufolastat F 18
Diagnostic agent
Intravenous Solution

Accurately staging prostate cancer changes treatment decisions, and conventional imaging often misses small metastatic deposits. Pylarify (piflufolastat F 18) brought PSMA-targeted PET into wider practice.

It binds PSMA, which is heavily overexpressed on prostate cancer cells, making suspected metastasis or biochemical recurrence visible on PET imaging. The intravenous fluorine-18 agent is approved to identify prostate-specific membrane antigen-positive lesions in men with prostate cancer.

Pylarify became one of the most widely adopted PSMA PET agents in the U.S., helped by fluorine-18’s longer half-life, which suits centralized manufacturing and distribution. It faces direct competition from other PSMA tracers, making reimbursement and radiopharmacy logistics the decisive factors to track.

Approval Date
26-May-21
NCE-1 Date
26-May-25
NCE Date
26-May-26
Commercial snapshot

Market performance & projections

Revenue ($M)
NA
CAGR (%)
NA
Projected sales, 2026–2032 ($M)
Analyst projection, $M per year
2026
NA
2027
NA
2028
NA
2029
NA
2030
NA
2031
NA
2032
NA
Molecule profile

Details & specifications

Molecule
Piflufolastat F 18
Innovator
PROGENICS PHARMACEUTICALS, INC.
Dosage Form
Intravenous Solution
Strength
50 mL (1-80 mCi/mL)
Therapeutic Category
Diagnostic agent
Usage
To identify prostate-specific membrane antigen-positive lesions in prostate cancer
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Intelligence you can file on

Verified regulatory data
Milestones tracked against primary FDA sources and refreshed continuously.
Analyst-built projections
Seven-year sales outlooks modeled by our pharma intelligence team.
First-to-file focus
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