Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Promethazine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Promethazine HCl 50 mg Tablets (Sandoz, Inc) |
| 2 | ACTIVE_COMPARATOR | Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories) |
| Name | Type | Description |
|---|---|---|
| Promethazine HCl 50 mg Tablets (Sandoz, Inc) | DRUG | - |
| Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories) | DRUG | - |
Inclusion Criteria: * No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: * Positive test results for HIV or hepatitis B or C. * Treatment for drug or alcohol dependence.
Promethazine is a small molecule drug developed by Novartis AG (ticker NVS) and is used in allergy, part of the immunology therapeutic area. It is also known as Promethazine HCl 50 mg Tablets (Sandoz, Inc). It is currently in Phase 1 clinical development.
Promethazine is used for allergy, which falls within the immunology therapeutic area. Its clinical development has focused on this indication, including a bioavailability study conducted in healthy adult volunteers under fasting conditions. It remains an investigational agent in Phase 1 development.
Promethazine targets HRH1, the histamine H1 receptor, and acts as an antagonist at this receptor. This target class is consistent with its development for allergy. The drug is a small molecule being developed by Novartis AG under ticker NVS.
Promethazine is developed by Novartis AG, which trades under the ticker NVS. The product is also known as Promethazine HCl 50 mg Tablets (Sandoz, Inc), reflecting the Sandoz naming associated with the drug.
Promethazine is in Phase 1 clinical development. It is investigational and has not been established as approved. One Phase 1 trial has been completed, and no active trials are currently listed for the drug.
Promethazine has been studied in one completed Phase 1 trial, NCT00947063, titled a relative bioavailability study of Promethazine HCl 50 mg tablets under fasting conditions. The trial enrolled 36 healthy adult volunteers, was randomized, and used an active-controlled design.