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Also known as GW501516 oral tablets, GW590735
GW501516 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Arm 1 | PLACEBO_COMPARATOR | Placebo |
| Arm 2 | ACTIVE_COMPARATOR | Fenofibrate |
| Name | Type | Description |
|---|---|---|
| GW501516 oral tablets | DRUG | - |
| GW590735 | DRUG | 1µg to 20µg daily doses of GW590735 |
| fenofibrate | DRUG | Marketed Drug |
Inclusion criteria: * Have a fasting plasma HDLc concentration \<=45mg/dL (\<=1.16mmol/L), plasma LDLc levels that do not require treatment according to the National Cholesterol Education Program/Adult Treatment Panel III (NCEP/ATPÂ III) guidelines. * Have a fasting plasma TG concentration =500mg/d...
GW501516 is an investigational small molecule developed by GSK plc (ticker: GSK) for dyslipidaemias, a group of lipid disorders. It is a Phase 2 drug candidate in the cardiovascular therapeutic area. It has been studied in a completed Phase 2 trial in subjects with low levels of high-density lipoprotein cholesterol.
GW501516 is being developed for dyslipidaemias, conditions involving abnormal lipid levels in the blood. Its completed Phase 2 trial enrolled subjects who had low levels of high-density lipoprotein cholesterol. It is an investigational agent and is not an approved treatment.
GW501516 targets PPARD, also known as the peroxisome proliferator-activated receptor delta. It acts as an agonist at this receptor, meaning it activates PPARD. PPARD is a nuclear receptor involved in regulating lipid metabolism and energy homeostasis, which is relevant to its development in dyslipidaemias.
GW501516 is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical development program for this small molecule in dyslipidaemias.
GW501516 is in Phase 2 development. It is an investigational drug and has not been approved by the FDA. One Phase 2 trial has been completed, and no trials are currently active.
GW501516 has been studied in one completed Phase 2 trial, NCT00158899, titled "GW501516 In Subjects Who Have Low Level Of High-Density Lipoprotein Cholesterol." The trial enrolled 424 participants across Belgium, Denmark, Estonia, Finland, France, Germany, Lithuania, Netherlands, Norway, Portugal, and Sweden.
Yes, GW501516 oral tablets refers to the same drug candidate as GW501516. The oral tablet form is the formulation studied in its clinical development program for dyslipidaemias.