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cefazolin

Phase 1

Sepsis | Small molecule | Infectious Disease |Smith & Nephew SNATS, Inc.|Last Updated: Sep 4, 2018

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 Enrollment9
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00850122An Open Label Study to Describe the Pharmacokinetics of Cefazolin in Preterm NeonatesPHASE1 COMPLETED 9Jul 1, 2013Jul 1, 2018Sep 4, 20181 Brazil
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Study Endpoints
Primary Endpoints
Cefazolin pharmacokinetics including half life, clearance, and volume of distribution
Dose 1 and Dose 4
Secondary Endpoints
Safety
7 days following last dose of cefazolin
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CefazolinEXPERIMENTALDosage Number of Infants ≤28 days of age 25 mg/kg IV q12 6 29-120 days of age 25 mg/kg IV q8 6
Interventions
NameTypeDescription
cefazolinDRUGCefazolin dosing - administered for 48 hours Dosage ≤28 days of age 25 mg/kg IV q12 29-120 days of age 25 mg/kg IV q8
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Eligibility Criteria
Age Range48 Hours — 120 Days
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * \< 28 weeks gestation at birth * \> 48 hours and \<121 days of age at the time of study drug administration * One of the following: * Suspected systemic infection * Receiving cefazolin for prophylaxis * Receiving cefazolin treatment of a systemic infection Exclusion Cr...

Countries:Brazil
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