Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Imipramine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Imipramine Hydrochloride 50 mg Tablets (Sandoz Inc.) |
| 2 | ACTIVE_COMPARATOR | Tofranil Imipramine Hydrochloride 50 mg Tablets (Tyco Healthcare) |
| Name | Type | Description |
|---|---|---|
| Imipramine Hydrochloride 50 mg Tablets (Sandoz Inc.) | DRUG | - |
| Tofranil Imipramine Hydrochloride 50 mg Tablets (Tyco Healthcare) | 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.
Imipramine is a small molecule drug in the psychiatry therapeutic area, studied for depression. It is also known as Imipramine Hydrochloride 50 mg Tablets (Sandoz Inc.). It is being developed by Novartis AG, which trades under the ticker NVS. It is an investigational therapy in clinical development.
Imipramine targets SLC6A2 and SLC6A4. It acts as an inhibitor of these targets. SLC6A2 and SLC6A4 are transporter proteins involved in neurotransmitter handling, and inhibition of these targets is the basis of its pharmacological activity in depression research.
Imipramine is developed by Novartis AG, which trades under the ticker NVS. The drug is also known as Imipramine Hydrochloride 50 mg Tablets (Sandoz Inc.), reflecting the Sandoz product name associated with this formulation.
Imipramine is in Phase 1 clinical development. It is investigational and has not been established as an approved therapy based on the available development information. The Phase 1 program includes one completed trial, and no trials are currently active.
Imipramine has been studied in one completed Phase 1 trial, NCT00946764. That trial enrolled 48 healthy adult volunteers under fasting conditions and was randomized and active controlled, without double blinding. It compared the relative bioavailability of Sandoz Inc. and Tyco Healthcare (Tofranil) 50 mg imipramine hydrochloride tablets.