Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
nicotine lozenge · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 2 mg nicotine prototype | EXPERIMENTAL | 2 mg nicotine prototype |
| 2 mg nicotine lozenge | ACTIVE_COMPARATOR | marketed formulation |
| 4 mg nicotine prototype | EXPERIMENTAL | 4 mg |
| 4 mg nicotine lozenge | ACTIVE_COMPARATOR | 4 mg |
| Name | Type | Description |
|---|---|---|
| 4 mg nicotine lozenge | DRUG | marketed formulation |
| 2 mg nicotine lozenge | DRUG | marketed formulation |
| 2 mg nicotine prototype | DRUG | 2 mg |
| 4 mg nicotine prototype | DRUG | 4 mg |
Inclusion Criteria: * Subject is either male or female between 18 - 55 years of age inclusive. * Subject has a BMI within the range 19-27 kg/m². \[BMI = Weight (kg) ÷ Height (m)²\]. * Subject admits to having smoked commercially-available cigarettes daily for the preceding 12 months and to routinel...
Nicotine lozenge is used for healthy volunteer smokers in clinical research settings. It is an investigational small molecule being studied as a nicotine replacement product. The drug is currently in Phase 1 clinical development, with one completed trial involving 32 participants.
Nicotine lozenge targets nicotine receptors in the body. It delivers nicotine to help manage smoking cessation by replacing the nicotine obtained from cigarettes. The drug is designed to reduce withdrawal symptoms and cravings associated with quitting smoking.
Nicotine lozenge is developed by GSK plc, a global pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical research to evaluate the bioequivalence of different formulations of the nicotine lozenge product.
Nicotine lozenge is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical testing.
Nicotine lozenge has one completed clinical trial registered as NCT00651352, titled 'A Single Dose Bioequivalence Study Of Two Formulations Of Nicotine Lozenges.' This Phase 1 study enrolled 32 healthy volunteer smokers and was active-controlled, comparing different formulations of the lozenge.
Nicotine lozenge is not the same as nicotine gum. While both are nicotine replacement therapies, they are distinct dosage forms. The lozenge is designed to dissolve slowly in the mouth, whereas gum is chewed to release nicotine. They are separate products with different delivery mechanisms.