Oral PCSK9 Inhibitor Enlicitide Reduces LDL Cholesterol by Approximately 60% in Phase 3 Trial A phase 3 clinical trial published in The New England Journal of Medicine demonstrated that enlicitide, an experimental oral PCSK9 inhibitor developed by Merck, significantly lowered low-density lipoprotein (LDL) cholesterol—commonly known as 'bad' cholesterol—by about 60% compared to placebo. The study, led by researchers at UT Southwestern Medical Center and involving 2,909 participants with atherosclerotic cardiovascular disease (ASCVD) or at high risk for it, showed a mean LDL reduction of around 57% at 24 weeks (adjusted difference of -55.8 percentage points versus placebo) and sustained benefits at 52 weeks. Most participants were already on statins but had baseline LDL levels averaging 96 mg/dL, above guideline targets of 70 mg/dL or lower for high-risk groups. Enlicitide also reduced other markers like non-HDL cholesterol, apolipoprotein B, and lipoprotein(a). Unlike existing injectable PCSK9 inhibitors (such as evolocumab or alirocumab), which achieve similar reductions but face underuse due to injection requirements, enlicitide is a once-daily pill, potentially improving adherence and access. The drug targets the PCSK9 protein to increase LDL receptor activity in the liver, building on decades of research from UT Southwestern, including Nobel Prize-winning work on LDL receptors and genetic insights from the Dallas Heart Study. Safety profiles were comparable to placebo, with no notable differences in adverse events. An ongoing outcomes trial is evaluating whether these lipid reductions translate to fewer heart attacks and strokes. If approved by the FDA, enlicitide could represent a major advance in preventing cardiovascular events for millions, addressing gaps where statins alone fail to achieve optimal cholesterol control.

Oral PCSK9 Inhibitor Enlicitide Reduces LDL Cholesterol by Approximately 60% in Phase 3 Trial

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LIB takes aim at cholesterol market with new PCSK9 option LIB Therapeutics has won FDA approval for a once-monthly cholesterol drug, Lerochol, that it says offers ease-of-use advantages over rivals.

Privately-held drug developer #LIBTherapeutics has claimed #FDA approval for a new once-monthly #PCSK9inhibitor – Lerochol – that can be used to reduce #cholesterol levels.

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Approval of Ongericimab Injection by China NMPA

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#NMPAApproval #OngericimabInjection #JunshiBiosciences #PCSK9Inhibitor #CholesterolTreatment #Hyperlipidemia #InnovativeMedicine #ChinaBiopharma

China NMPA Approves Ebronucimab Injection for Hypercholesterolemia Treatment

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#Ebronucimab #PCSK9Inhibitor #CholesterolTreatment #NMPAApproval #ChineseBiologics #Hypercholesterolemia #CardiovascularHealth #KangrongDongfang

ACC25: AZ stakes its claim to the oral PCSK9 category AstraZeneca has revealed phase 2b results with its oral PCSK9 inhibitor AZD0780 as it tries to narrow a lead held by MSD with its rival cholesterol drug.

NEWS: #AstraZeneca has revealed phase 2b results with its oral #PCSK9inhibitor AZD0780, including a more than 50% reduction in #LDLcholesterol when added to standard therapy, as it tries to narrow a lead held by MSD with its rival drug.