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AFQ065

Phase 1

Smoking Abstinence | Small molecule | Other |Novartis AG|Last Updated: Jun 22, 2007

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
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00414752Effects of AFQ056 and Nicotine in Reducing Cigarette SmokingPHASE1 COMPLETED 36Sep 1, 2006 -Jun 22, 20071 Germany
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Study Endpoints
Primary Endpoints
Reduction of craving by self-report questionnaires during 3 days of voluntary smoking stoppage
Secondary Endpoints
Reduction in symptoms of withdrawal during 3 days of voluntary smoking stoppage
Reduction in nicotine consumption during 6 days of free smoking
Reduction in impulsivity during 3 days of free smoking and during 3 days of voluntary smoking stoppage
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
AFQ065DRUG -
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy, male \& female subjects at least 18 years and ≤60 years of age * In good health * Female subjects must be surgically sterilized or postmenopausal. * Current smokers not intending to quit * Smoke on average 15 cigarettes or more and less than 60 cigarettes a day for th...

Countries:Germany
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