The FDA has approved the first cholesterol-lowering pill that works by the same powerful mechanism as the leading injectable drugs, and clinical trial results show it works just as well. On July 16, 2026, Merck announced that the FDA approved Lipfendra (enlicitide) tablets 20 mg as a once-daily oral treatment for adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). The drug belongs to the PCSK9 inhibitor class, which had until now been available only as subcutaneous injections administered every two to four weeks.
In Phase 3 trials, Lipfendra cut LDL cholesterol by 56% in one trial and 59% in another at 24 weeks, both placebo-adjusted figures. That puts the pill's efficacy squarely in the same range as the injectable PCSK9 inhibitors already on the market.
