Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GW590735 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1 | PLACEBO_COMPARATOR | Placebo |
| Arm 2 | ACTIVE_COMPARATOR | Fenofibrate |
| Name | Type | Description |
|---|---|---|
| GW590735 | DRUG | 1µg to 20µg daily doses of GW590735 |
| fenofibrate | DRUG | Marketed Drug |
Inclusion criteria: * High-density lipoprotein cholesterol less than or equal to 45 mg/dL. * Triglycerides greater than or equal to 120 mg/dL and less than or equal to 500 mg/dL. * Women must be surgically sterile or postmenopausal. Exclusion criteria: * Heart disease * Diabetes
GW590735 is an investigational small molecule being developed for dyslipidaemias, a group of lipid disorders involving abnormal cholesterol or triglyceride levels in the blood. It was studied in a Phase 2 trial titled Dyslipidemia Study Investigating The Increase In "Good Cholesterol" in adults with dyslipidaemias in the United States and Canada.
GW590735 targets PPARA, also known as peroxisome proliferator-activated receptor alpha. It acts as an agonist at this receptor, meaning it activates PPARA. PPARA is a nuclear receptor involved in regulating lipid metabolism, which is the biological rationale for studying the drug in dyslipidaemias.
GW590735 is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor behind the clinical program evaluating the compound in dyslipidaemias within the cardiovascular therapeutic area.
GW590735 is in Phase 2 development. It has completed one Phase 2 clinical trial in dyslipidaemias. The compound is investigational and has not been approved for any indication. No active trials are currently listed for GW590735.
GW590735 has been evaluated in one completed Phase 2 trial, NCT00169559, titled Dyslipidemia Study Investigating The Increase In "Good Cholesterol". The trial enrolled 250 adults aged 18 years and older of all sexes in the United States and Canada. It was randomized, double-blind, and placebo-controlled.