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Potential mechanisms include improvements in blood pressure, lipid profiles, body weight, inflammation, and endothelial function as well as direct cardioprotective effects on the cardiac muscle and vasculature [41]

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Pharmacodynamic profile of a novel inhibitor of the hepatic glucose-6-phosphatase system

A plausible scenario, then, looks like this: Phase 3 primary completion in late 2025, NDA submission in the second half of 2025, FDA filing acceptance and review initiation in early 2026, and a PDUFA (Prescription Drug User Fee Act) action date likely in mid to late 2026