MSD has announced in its Q1 2026 report that it has submitted a marketing authorisation application to the European Medicines Agency (EMA) for its oral PCSK9 inhibitor, enlicitide, for the treatment of primary hypercholesterolaemia or mixed dyslipidaemia. Enlicitide is an oral cyclic peptide designed to inhibit PCSK9, a protein that increases levels of low-density lipoprotein cholesterol (LDL-C) in the blood. The submission aims to provide a convenient, non-injectable alternative to existing PCSK9-targeting therapies.

The application is supported by positive data from three Phase III trials. The CORALreef Lipids study demonstrated a 57.1% reduction in LDL-C levels compared to a 3.0% increase for placebo. The CORALreef AddOn study showed enlicitide was superior to other oral non-statin treatments, and the CORALreef HeFH study confirmed efficacy in patients with heterozygous familial hypercholesterolaemia. The drug was well-tolerated across the program, with a safety profile comparable to placebo.

According to PharmCube's NextBiopharm® database, MSD could place the first PCSK9 inhibitor on the market ahead of 16 other active projects. Click here to request a free trial for NextBiopharm®.