Merck's MK-0616 looks set to become first oral PCSK9 inhibitor in dyslipidemia market

New clinical data from US pharma giant Merck & Co (NYSE: MRK) for MK-0616, an investigational oral cholesterol-lowering drug, revealed that it significantly reduced low-density lipoprotein (LDL) cholesterol in adults by 41.2% at the lowest dose of 6mg and 60.9% at the highest dose of 30mg at week 8 in patients with hypercholesterolemia and atherosclerotic cardiovascular disease (ASCVD), with no reports of serious adverse events.

Assuming the drug gains regulatory approval, MK-0616 is expected to be launched in 2026 and reach $70 million in sales by 2028, according to data and analytics company GlobalData.

“MK-0616 could potentially be the first oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to effectively lower LDL cholesterol. Merck has designed a powerful pill that could become a major player and even beat competitors in the dyslipidemia space, as all other PCSK9 inhibitors on the market are injectable,” commented GlobalData’ cardiovascular and metabolic disorders analyst Dr Shireen Mohammad.