Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nisoldipine · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Test: | EXPERIMENTAL | Nisoldipine ER Tablets, 30 mg |
| Reference | ACTIVE_COMPARATOR | Sular Extended-release Tablets, 30 mg |
| Test: Nisoldipine ER Tablets, 40 mg | EXPERIMENTAL | Nisoldipine Extended-release Tablets, 40 mg |
| Reference: Sular Tablets 40 mg | ACTIVE_COMPARATOR | Sular Tablets, 40 mg |
| Name | Type | Description |
|---|---|---|
| Nisoldipine Extended-release Tablets, 30 mg | DRUG | 1 x 30 mg Tablet under fasting conditions |
| Sular® Extended Release Tablets, 30 mg | DRUG | 1 x 30 mg Tablet under fasting conditions |
| Nisoldipine Extended-release Tablets, 40 mg | DRUG | - |
| Sular Tablets, 40 mg | DRUG | - |
Inclusion Criteria: * Age: 18 years and older. * Sex: Male and/or non-pregnant, non-lactating female. * Women of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 21 days prior to the start of the study and on the evening ...
Nisoldipine is a small molecule drug developed by Viatris Inc. (ticker VTRS). It is an extended-release tablet formulation studied in Phase 1 clinical trials. The specific medical conditions it is intended to treat have not been disclosed.
Nisoldipine targets the calcium channel subunits CACNA1C, CACNA1S, CACNA1D, and CACNA1F. It acts as a blocker of these targets. This mechanism is characteristic of calcium channel blockers, which modulate calcium ion flow.
Nisoldipine is developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the company responsible for the development of the nisoldipine extended-release tablet formulations.
Nisoldipine is in Phase 1 clinical development. The two completed trials were Phase 1 studies. It is an investigational drug and has not been approved by the FDA for any indication.
Nisoldipine has been studied in two completed Phase 1 clinical trials: NCT00985660, a bioequivalence study of the 30 mg extended-release tablets, and NCT00979537, a single-dose fed bioequivalence study of the 40 mg extended-release tablets. Both enrolled healthy volunteers in the United States.
Yes, nisoldipine is also known as nisoldipine extended-release tablets, 30 mg and 40 mg. These alternative names refer to the same active drug in extended-release tablet form.