Approval Probability
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Adjusted LOA
ML Risk
Also known as TAP311 capsules
TAP311 · 2 trials · 3 indications
Summary statistics on number of patients with total adverse events, serious adverse events and death will be reported.
Number of patients with adverse events and changes from baseline in vital signs, ECG and clinical labs (blood chemistry, hematology and urinalysis).
| Arm | Type | Description |
|---|---|---|
| TAP311 capsules | EXPERIMENTAL | Patients will receive TAP311 capsule orally once daily for 14 days. |
| Placebo of TAP311 capsules | PLACEBO_COMPARATOR | Matching placebo to TAP311 capsule, once daily for 14 days |
| TAP311 in Healthy Volunteers | EXPERIMENTAL | - |
| Matching Placebo | PLACEBO_COMPARATOR | Healthy Volunteers and Patients will be treated in Placebo group. |
| TAP311 and Simvastatin | EXPERIMENTAL | - |
| TAP311 in Patients | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| TAP311 capsules | DRUG | - |
| Placebo | DRUG | - |
| TAP311 | DRUG | - |
Inclusion Criteria: * Male and female patients 18 to 80 years (inclusive) of age. * Patients are not treated for dyslipidemia with medications other than HMG-CoA reductase inhibitors (statins) for at least 4 weeks prior to Day 1. Patients should be on stable doses of current medications, if any, fo...
TAP311 is an investigational small molecule developed by Novartis AG for dyslipidemia, a condition marked by abnormal lipid levels in the blood. It has been studied in Phase 1 clinical trials and is not approved. TAP311 is also known as TAP311 capsules.
TAP311 was studied for the treatment of dyslipidemia, a cardiovascular condition involving abnormal lipid levels in the blood. Its clinical development has been limited to Phase 1 trials evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy subjects and dyslipidemic patients.
TAP311 is developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the Phase 1 clinical trials of TAP311 in dyslipidemia.
TAP311 is in Phase 1 development. It is investigational and has not been approved by the FDA. The Phase 1 program has been completed, with no active trials currently listed.
TAP311 has been evaluated in two completed Phase 1 trials. NCT01632358 studied safety and pharmacokinetics in 279 dyslipidemic patients across the United States, Jordan, and Taiwan. NCT01487460 studied safety, tolerability, pharmacokinetics, and pharmacodynamics in 137 healthy subjects and dyslipidemic patients in the United States.
Yes, TAP311 capsules is an alternative name for TAP311, the investigational small molecule developed by Novartis AG for dyslipidemia. Both names refer to the same Phase 1 drug candidate.