Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being developed for the treatment of dyslipidemia, also spelled dyslipidaemia, a condition characterized by abnormal levels of lipids in the blood. It is being studied in the cardiovascular therapeutic area. As of now, TAP311 is in Phase 1 clinical development and has not been approved by regulatory authorities.
The specific molecular target of TAP311 has not been disclosed in available information. The drug is being investigated for its effects on lipid levels in patients with dyslipidemia, but its mechanism of action is not publicly detailed. Further research and clinical trials may reveal how TAP311 works at the molecular level.
TAP311 is being developed by Novartis AG, a multinational pharmaceutical company headquartered in Switzerland. Novartis is publicly traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the safety and efficacy of TAP311 in patients with dyslipidemia.
TAP311 is currently in Phase 1 clinical development. It has completed two Phase 1 trials, with no active trials ongoing at this time. The drug is investigational and has not received approval from the U.S. Food and Drug Administration or any other regulatory agency for the treatment of dyslipidemia.
TAP311 has been studied in two completed Phase 1 clinical trials. The first, NCT01487460, evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy subjects and dyslipidemic patients in the United States. The second, NCT01632358, assessed safety and pharmacokinetics in dyslipidemic patients across the United States, Jordan, and Taiwan.
No alternative names for TAP311 have been identified in available information. The drug is referred to solely as TAP311 in clinical trial registries and related documentation. It is a distinct investigational compound developed by Novartis AG for the potential treatment of dyslipidemia.