Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Clemastine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Clemastine Fumarate Tablets, 2.68 mg (Cord Laboratories) |
| 2 | EXPERIMENTAL | Tavist Tablets, 2.68 mg (Sandoz Pharmaceutical Corp.) |
| Name | Type | Description |
|---|---|---|
| Clemastine Fumarate Tablets, 2.68 mg (Cord Laboratories) | DRUG | - |
| Tavist Tablets, 2.68 mg (Sandoz Pharmaceutical Corp.) | 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.
Clemastine is used for allergy. It is a small molecule antihistamine developed by Novartis AG, which trades under the ticker NVS. The clinical program recorded for Clemastine lists allergy as the condition studied, and the drug is in Phase 1 development.
Clemastine targets HRH1, the histamine H1 receptor. It acts as an antagonist at that receptor, meaning it blocks the receptor rather than activating it. This target class places Clemastine among antihistamine small molecules directed at histamine signaling in allergic conditions.
Novartis AG is the developer of Clemastine. Novartis trades under the ticker NVS. The drug is also known as Clemastine Fumarate Tablets, 2.68 mg (Cord Laboratories), so readers searching under that name are looking at the same clemastine product.
Clemastine is in Phase 1 development. It is an investigational small molecule and is not described as approved. The recorded program includes one completed Phase 1 trial, with no active trials currently listed, so the clinical work captured here has finished.
Clemastine has been studied in one completed Phase 1 trial, NCT00913549. That trial was titled to demonstrate the relative bioequivalency of dosage forms of Clemastine 2.68 mg tablets. It enrolled 36 participants, was randomized and controlled, and used healthy male volunteers aged 19 years and older.