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Peflutren Lipid Microsphere Injectable

Phase 2

Liver Disease | Small molecule | Gastrointestinal |Lantheus Holdings, Inc.|Last Updated: Aug 18, 2011

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
UNCONTROLLED
Total Trials1
Total Enrollment80
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00162058A Phase II Study of DMP 115 to Assess Focal Liver LesionsPHASE2 COMPLETED 80Mar 1, 2004Apr 1, 2006Aug 18, 20111 United Kingdom
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Study Endpoints
Primary Endpoints
The ratio of signal intensities obtained from unenhanced vs. contrast-enhanced ultrasound imaging of liver tissue and liver lesions will be calculated at the end of the study.
Secondary Endpoints
The determination of the presence or absence of focal liver lesions during the Blinded Read and the Institutional Read of ultrasound images.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
Interventions
NameTypeDescription
Peflutren Lipid Microsphere Injectable SuspensionDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Diagnosed with 1 but \<7 focal liver lesions * Scheduled for liver biopsy within 30 days of study * Scheduled for CT or MR within 30 days of study Exclusion Criteria: * Critically ill subjects * Subjects with right-to-left shunts

Countries:United Kingdom
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