Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Desipramine Cord Laboratories · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Desipramine HCL 100 mg Tablets Cord Laboratories |
| 2 | ACTIVE_COMPARATOR | Norpramin 100 mg Tablets Merrell Dow Pharmaceuticals, Inc |
| Name | Type | Description |
|---|---|---|
| Desipramine HCL 100 mg Tablets Cord Laboratories | DRUG | - |
| Norpramin 100 mg Tablets Merrell Dow Pharmaceuticals, Inc | DRUG | - |
| Desipramine HCl 50 mg Tablets Cord Laboratories | DRUG | - |
| Norpramin 50 mg Tablets Merrell Dow Pharmaceuticals, Inc | 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.
Desipramine Cord Laboratories is a small molecule antidepressant developed by Novartis AG (ticker NVS) for depression. It is a Phase 1 investigational product studied in bioequivalence trials comparing Cord Laboratories desipramine HCl tablets against Merrell Dow's Norpramin tablets. The drug is also known as Desipramine HCL 100 mg Tablets Cord Laboratories and Desipramine HCl 50 mg Tablets Cord Laboratories.
Desipramine Cord Laboratories is being studied for depression, which falls within the psychiatry therapeutic area. The clinical program has focused on demonstrating relative bioequivalence of Cord Laboratories desipramine HCl tablets to Merrell Dow's Norpramin tablets in healthy adult male volunteers. It remains an investigational product rather than an approved therapy in this development program.
Desipramine Cord Laboratories targets SLC6A2, the norepinephrine transporter, and acts as an inhibitor of this target. By inhibiting SLC6A2, the drug affects norepinephrine reuptake. This target class and mechanism are consistent with its study in depression, the indication pursued in its clinical development program.
Desipramine Cord Laboratories is developed by Novartis AG, which trades under the ticker NVS. The product is manufactured under the Cord Laboratories name, and its bioequivalence trials compared Cord's desipramine HCl tablets against Merrell Dow's Norpramin tablets as the reference product.
Desipramine Cord Laboratories is in Phase 1 development. Both of its recorded trials are Phase 1 bioequivalence studies, and both are completed, with no active trials currently listed. It is an investigational product and has not been established as approved for any indication based on this development program.
Desipramine Cord Laboratories has been evaluated in two completed Phase 1 bioequivalence trials. NCT00914004 compared single 100 mg doses of Cord's 50 mg desipramine HCl tablets to Merrell Dow's 50 mg Norpramin tablets, and NCT00913809 compared Cord's 100 mg desipramine HCl tablets to Merrell Dow's 100 mg Norpramin tablets. Each trial enrolled 36 healthy male volunteers.