Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Varenicline Tartarate · 1 trial · 1 indication
Number of subjects who reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory \[NUI\]) and with end-expiratory exhaled carbon monoxide (CO) measurement less than or equal to 10 parts per million (ppm) for weeks 9 through 12 (inclusive).
| Arm | Type | Description |
|---|---|---|
| placebo | PLACEBO_COMPARATOR | - |
| varenicline | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| placebo | DRUG | 1mg (placebo) by mouth twice daily for 12 weeks (first week is up titration schedule---0.5mg once daily for 3 days, 0.5mg twice daily for 4 days) |
| Varenicline Tartarate | DRUG | 1 mg by mouth twice daily for 12 weeks (first week is up titration schedule---0.5mg once daily for 3 days, 0.5mg twice daily for 4 days) |
Inclusion Criteria: * Subjects will be current cigarette smokers who have smoked an average of at least 10 cigarettes per day during the past year and during the month prior to the screening visit. * mild to moderate COPD confirmed by spirometry * Subjects must have a clinical diagnosis of COPD. E...
Varenicline Tartarate is used for smoking cessation. It is being developed by Pfizer, Inc. as a treatment to help people stop smoking, and it has been studied in adults with mild-to-moderate chronic obstructive pulmonary disease as part of a Phase 3 clinical program.
Varenicline Tartarate targets CHRNB2 and CHRNA4, which are nicotinic acetylcholine receptor subunits. It acts as an agonist at these targets. By binding to these receptors, the drug is designed to interact with the same receptor system that nicotine acts on, which is the basis for its use in smoking cessation.
Varenicline Tartarate is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the company responsible for the clinical development of this small molecule in the smoking cessation indication.
Varenicline Tartarate is in Phase 3 clinical development for smoking cessation. The program includes one completed Phase 3 trial. It is an investigational asset in this dataset and is not described here as approved by the FDA.
Varenicline Tartarate has been studied in the Phase 3 trial NCT00285012, titled Smoking Cessation in Subjects With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD). That trial is completed, enrolled 504 participants, was randomized, double-blind, and placebo-controlled, and ran in the United States, France, Italy, and Spain.
Varenicline Tartarate is used for smoking cessation, helping people stop smoking. The completed Phase 3 trial NCT00285012 evaluated it in adults aged 35 years and older with mild-to-moderate COPD, a population in which quitting smoking is a key clinical goal.