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Prototype

Phase 1

Dental Plaque | Small molecule | ENT |Pfizer, Inc.|Last Updated: Jun 5, 2019

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
PLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00762151A Study to Investigate the Anti-Plaque Effect of AN0128 ToothpastePHASE1 COMPLETED 18Nov 1, 2007Jan 1, 2008Jun 5, 20191 United States
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Study Endpoints
Primary Endpoints
Reduction in the gingival margin plaque index in a 24-hour post-treatment (no brushing)
Baseline (time zero), 24 hour time point
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Study Design & Arms
MaskingNONE
ModelCROSSOVER
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Negative ControlPLACEBO_COMPARATORRegular Toothpaste
Positive ControlACTIVE_COMPARATORStandard anti-plaque and anti-bacterial toothpaste.
PrototypeACTIVE_COMPARATORAN0128 Toothpaste
Interventions
NameTypeDescription
Negative Control (Regular Toothpaste)OTHERRegular Toothpaste
Positive Control (anti-plaque/anti-bacterial toothpaste)OTHERStandard anti-plaque and anti-bacterial toothpaste
Prototype (AN0128 Toothpaste)DRUGAN0128 Toothpaste
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Must be between ages 18 to 65 years inclusive * Have a minimum of 16 natural uncrowned teeth (excluding 3rd molars) present * Must give written informed consent * Be in good general health * Must discontinue oral hygiene for 24-hours after initial appointment * No known histor...

Countries:United States
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