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Zyvox / Linezolid

Phase 3

Bacterial Infections | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Aug 14, 2009

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
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment13
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00035854New Antibiotic to Treat Pediatric Patients With Infections Due to a Specific Bacteria (Vancomycin-Resistant Enterococcus)PHASE3 COMPLETED 13Feb 1, 2002May 1, 2004Aug 14, 200921 United States
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Study Endpoints
Primary Endpoints
Investigator's and sponsor's evaluation of patient clinical outcome.
Secondary Endpoints
Pathogen eradication rates, changes in clinical signs and symptoms, body temperature, WBC count, lesion size (for SSSIs) and chest radiograph findings(for HAP).
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
Zyvox® / LinezolidDRUG -
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Eligibility Criteria
Age RangeN/A — 17 Years
SexALL
Healthy VolunteersNo
Study Sites21

Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary. Inclusion Criteria: * Hospitalized/chronic care pediatric patients (birth through 17 years) * Known infections due to vancomycin-resistant enterococcus sp...

Countries:United States
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