Recent Updates
Recently added Catalysts

CP-526,555

Phase 2

Smoking Cessation | Small molecule | Other |Pfizer, Inc.|Last Updated: Oct 19, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials4
Total Enrollment2,150
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT0013975012 Week Evaluation of the Safety and Efficacy of 3 Doses of CP-526,555 and Placebo for Smoking CessationPHASE2 COMPLETED 600 — — Dec 1, 2004Feb 1, 2006Jun 4, 200715 Japan
NCT0015022812 Week Evaluation of the Safety and Efficacy of a Flexible Dose of CP-526,555 and Placebo for Smoking CessationPHASE2 COMPLETED 300 — — Dec 1, 2001Sep 1, 2002Jun 4, 20077 United States
NCT0015025412 Week Evaluation of the Safety and Efficacy of 4 Dosing Strategies of CP-526,555 and Placebo for Smoking Cessation.PHASE2 COMPLETED 625 — — Sep 1, 2001Oct 1, 2002Jun 4, 200713 United States
NCT00150241A Seven-Week Dose-Ranging Study of CP-526,555 Compared With Placebo and Zyban for Smoking CessationPHASE2 COMPLETED 625 — — Feb 1, 2000Jan 1, 2002Oct 19, 20157 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
4-week continuous quit rate (CQR) for Weeks 9-12
4-week continuous quit rate (CQR) at Weeks 4-7 and 9-12 .
4 week continuous quit rate (CQR) at Weeks 9-12 and Weeks 4-7
The primary efficacy outcome is smoking abstinence for any continuous 4-week period (4-week CQR) during the study treatment phase.
Secondary Endpoints
Continuous abstinence for Weeks 9-52 and Weeks 9-24
Long-term quit rate at Week 52
4-week CQR for Weeks 4-7
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
CP-526,555 (varenicline)DRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range20 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * Cigarette smokers who are motivated to stop smoking and have smoked an average of at least 10 cigarettes per day Exclusion Criteria: * Subjects who have used a nicotine replacement product within 30 days of the study screening visit or intend to use it during the study.

Countries:JapanUnited States
Unlock Eligibility Criteria