Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as varenicline free base patch, Varenicline free base solution
varenicline free base · 3 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | - |
| Cohort 2 | EXPERIMENTAL | - |
| Cohort 3 | EXPERIMENTAL | - |
| Cohort 4 | EXPERIMENTAL | - |
| Varenicline transdermal delivery system | EXPERIMENTAL | - |
| Varenicline free base solution | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| varenicline free base patch | DRUG | varenicline transdermal delivery system (12.0 mg payload \[drug amount loaded in each patch\]) will be applied to the skin once daily for 14 days |
| placebo patch | DRUG | Matched placebo transdermal delivery system will be applied to the skin once daily for 14 days |
| Varenicline free base solution | DRUG | A single application of a 4.8 mg varenicline solution will be applied to the upper back over a 24 hour period |
Inclusion Criteria: * Healthy * male or female * adult cigarette smokers of any race Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including d...
Varenicline free base is being studied for smoking cessation. It is an investigational small molecule developed by Pfizer, Inc. (ticker: PFE) and is in Phase 1 clinical development. The completed trials enrolled healthy adult volunteers rather than patients actively seeking to quit smoking.
Varenicline free base targets CHRNB2 and CHRNA4, which are nicotinic acetylcholine receptor subunits. It acts as an agonist at these receptors. This target profile is the basis for its investigation in smoking cessation.
Varenicline free base is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer conducted the Phase 1 studies of the patch and solution formulations of this compound.
Varenicline free base is in Phase 1 clinical development. It is investigational and has not been approved. All three of its recorded trials are Phase 1 studies, and all three are completed, with no active trials currently listed.
Three completed Phase 1 trials studied varenicline free base: NCT01234142, a 45-participant patch absorption study in the United States; NCT01013454, a 12-participant patch study in Belgium; and NCT00774605, a 12-participant study comparing a solution and a patch in the United States.
Yes. Varenicline free base patch and varenicline free base solution are alternative names for the same investigational compound. The patch and solution refer to the transdermal and liquid formulations tested in the Phase 1 absorption studies.