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CP-526, 555

Phase 2

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

Target and mechanism

ModalitySmall molecule

Also known as CP-526,555 (varenicline)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials4
Total Enrollment2,150

FDA Designations

No designations recorded

Clinical trial landscape

CP-526, 555 · 4 trials · 1 indication

Phase 2 4
NCT0013975012 Week Evaluation of the Safety and Efficacy of 3 Doses of CP-526,555 and Placebo for Smoking CessationSmoking Cessation
COMPLETED600 Analytics
NCT0015022812 Week Evaluation of the Safety and Efficacy of a Flexible Dose of CP-526,555 and Placebo for Smoking CessationSmoking Cessation
COMPLETED300 Analytics
NCT0015025412 Week Evaluation of the Safety and Efficacy of 4 Dosing Strategies of CP-526,555 and Placebo for Smoking Cessation.Smoking Cessation
COMPLETED625 Analytics
NCT00150241A Seven-Week Dose-Ranging Study of CP-526,555 Compared With Placebo and Zyban for Smoking CessationSmoking Cessation
COMPLETED625 Analytics
PHASE2COMPLETED
12 Week Evaluation of the Safety and Efficacy of 3 Doses of CP-526,555 and Placebo for Smoking Cessation
Smoking Cessation
NCT00139750600
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PHASE2COMPLETED
12 Week Evaluation of the Safety and Efficacy of a Flexible Dose of CP-526,555 and Placebo for Smoking Cessation
Smoking Cessation
NCT00150228300
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PHASE2COMPLETED
12 Week Evaluation of the Safety and Efficacy of 4 Dosing Strategies of CP-526,555 and Placebo for Smoking Cessation.
Smoking Cessation
NCT00150254625
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PHASE2COMPLETED
A Seven-Week Dose-Ranging Study of CP-526,555 Compared With Placebo and Zyban for Smoking Cessation
Smoking Cessation
NCT00150241625
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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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
CP-526,555 (varenicline)DRUG -
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Eligibility Criteria

Age Range20 Years to 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
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Frequently asked questions about CP-526, 555

What is CP-526,555 used for?

CP-526,555 is being studied for smoking cessation, meaning it is intended to help people stop smoking. It is a small molecule developed by Pfizer, Inc. and has been tested in Phase 2 clinical trials in adults aged 18 and older in the United States and adults aged 20 and older in Japan.

Who makes CP-526,555?

CP-526,555 is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer sponsored the Phase 2 clinical program evaluating the drug for smoking cessation, including dose-ranging and flexible-dose studies conducted in the United States and Japan.

What phase is CP-526,555 in?

CP-526,555 is in Phase 2 development. All four of its listed clinical trials are Phase 2 studies, and all four are completed, with no active trials currently listed. It is an investigational drug and has not been approved by the FDA for smoking cessation.

What clinical trials is CP-526,555 in?

CP-526,555 has been studied in four completed Phase 2 trials: NCT00150254, NCT00150241, NCT00150228, and NCT00139750. These trials evaluated multiple dosing strategies and flexible dosing of CP-526,555 versus placebo for smoking cessation, with NCT00150241 also comparing it with Zyban. Total enrollment across the program was 2,150 participants.

Is CP-526,555 the same as varenicline?

Yes, CP-526,555 is also known as varenicline. CP-526,555 was the development code used for varenicline, the small molecule Pfizer studied in Phase 2 trials for smoking cessation. Readers searching for either name are referring to the same drug asset.

How many patients were enrolled in CP-526,555 trials?

The CP-526,555 Phase 2 program enrolled 2,150 participants in total across four completed trials. Enrollment ranged from 300 participants in NCT00150228 to 625 participants each in NCT00150254 and NCT00150241, with NCT00139750 enrolling 600 participants in Japan.