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Chlorhexidine gluconate

Phase 3

Topical Antisepsis | Small molecule | Infectious Disease |Becton, Dickinson and Company|Last Updated: Nov 26, 2025

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
RandomizedPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00636480Preoperative Skin Preparation EvaluationPHASE3 COMPLETED 60Oct 1, 2007Mar 1, 2008Nov 26, 20251 United States
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Study Endpoints
Primary Endpoints
3.0 log10 reduction in CFU/cm2 on inguinal sites, and 2.0 log10 reduction in CFU/cm2 on abdominal sites
10 minutes and 6 hours after application of test solutions
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
CHG 2%-26 mlEXPERIMENTALChlorhexidine gluconate in an aqueous base, 26 ml applicator
ChloraPrep 26 mlACTIVE_COMPARATORChloraPrep One-Step 26 ml Active drug contains chlorhexidine gluconate and alcohol
Sterile SalinePLACEBO_COMPARATORSterile salt water administered topically.
Interventions
NameTypeDescription
Chlorhexidine gluconateDRUGChlorhexidine gluconate (2% w/v) in an aqueous base, 26 ml applicator. Active drug contains alcohol and the placebo contains no drug. Administered topically.
ChloraPrep One StepDRUGAdminister topically
Sterile salineDRUG0.9% NaCl solution
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Eligibility Criteria
Age Range16 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Free of dermatoses, cuts, lesions, or other skin disorders on or around the test sites; no exposure to topical or systemic antimicrobials, antibiotics, or steroids (other than contraceptives, for the fourteen (14) day pre-test conditioning period and must agree to abstain from...

Countries:United States
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