Rainier Clinical Research Center Helps to Advance Cholesterol Medicine
Lipfendra hits the market as a new LDL cholesterol drug.
Rainier Clinical Research Center is proud to celebrate a major milestone: on July 16, 2026, the FDA approved Lipfendra (enlicitide), a first-of-its-kind oral medication to lower LDL cholesterol, and RCRC helped make it happen.
RCRC participated in four unique clinical trials with Merck supporting the development of Lipfendra, contributing clinical data that helped bring this breakthrough therapy from the research site to the pharmacy shelf.
"Enlicitide delivers substantial reductions in LDL cholesterol, which helps address one of the most important modifiable risk factors for atherosclerotic cardiovascular disease," said Dr. Sheryl Marks, RCRC Medical Director and Principal Investigator.
A new kind of cholesterol drug
Lipfendra is the first oral PCSK9 inhibitor on the market. Until now, drugs in this class, including Repatha (evolocumab) and Praluent (alirocumab), were available only by injection. Now patients can take a single daily pill.
The FDA approved a 20-mg once-daily dose to lower LDL cholesterol in adults with hypercholesterolemia.
The results speak for themselves
Approval followed two positive phase 3 trials, in which Lipfendra cut LDL-C by:
56% in patients with high cholesterol
59% in patients with HeFH (Heterozygous Familial Hypercholesterolemia)
at 24 weeks compared with placebo.
Convenient and affordable
Lipfendra pills store at room temperature. Per a Merck spokesperson, the drug will carry a list price of $315 per month before discounts, roughly half the cost of injectable PCSK9 products inhibitors, and will be offered through the federal government's direct-to-patient prescription drug discount program. The medication requires an eight-hour fast before dosing and a 30-minute wait before eating afterward.
Fast-tracked as a national priority
The FDA approved Lipfendra under the Commissioner's National Priority Voucher (CNPV) program, which shortens review times from 6–12 months to 1–2 months for drugs aligned with national health priorities i.e. those offering innovative breakthroughs, addressing significant unmet needs, or strengthening domestic pharmaceutical manufacturing.
A thank you to the RCRC team
Dr. Marks credited the entire RCRC team for the Center's role in the Merck studies behind this approval:
"I am proud of our team's role in helping bring an important new therapy to patients. The submission of data from RCRC and the FDA approval reflects the dedication, professionalism, and hard work that each of you has contributed to supporting these studies. Congratulations, and thank you for everything you do."