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Piflufolastat F18

Phase 1

Pancreatic Cancer | Small molecule | Oncology |Lantheus Holdings, Inc.|Last Updated: Apr 15, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05394259A Pilot Study to Assess the Clinical Utility of PYLARIFY PET-CT for Detecting Metastasis in Pancreatic Cancer, Hepatocellular Carcinoma and Breast CancerPHASE1 RECRUITING 36Oct 28, 2022Feb 2, 2027Apr 15, 20261 United States
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Study Endpoints
Primary Endpoints
Accuracy is defined as the number of concordant cases between PYLARIFY PET-CT and the gold standard truth divided by the total sample size.
through study completion, an average of 1 year
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
Piflufolastat F18EXPERIMENTALPiflufolastat F18 will first be given by vein over about 5 seconds.
Interventions
NameTypeDescription
Piflufolastat F18DRUGGiven by vein (IV)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Age ≥18 years. Because no dosing or adverse event data are currently available on the use of PYLARIFY in patients \<18 years of age, children are excluded from this study. 2. ECOG performance status ≤2 (Karnofsky ≥60%,). 3. Subject or subject's Legally Authorized Representati...

Countries:United States
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Competitive Landscape -Pancreatic Cancer 186 trials
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT05394259studyFirstPostDate: changed