NEW ORLEANS, LA – The U.S. Food and Drug Administration (FDA) has approved NEXLETOL™ (bempedoic acid), a once-daily, oral, non-statin LDL-cholesterol (LDL-C) lowering therapy developed by Esperion Therapeutics. The treatment is indicated as an adjunct to diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who require additional LDL-C reduction. Dr. Patrick Dennis, Principal Investigator at Touro Medical Center in New Orleans, LA, contributed to the pivotal clinical trial through his collaboration with DelRicht Research.

This approval marks the first oral, non-statin LDL-C lowering therapy approved in nearly 20 years and introduces a novel mechanism for targeting cholesterol biosynthesis.

DelRicht Research on a New Option for Patients Who Need More Than Statins

Despite widespread use of statin therapy, millions of adults in the U.S. are unable to achieve their target LDL-C levels, whether due to statin intolerance, insufficient response, or additional cardiovascular risk factors. NEXLETOL works by inhibiting ATP citrate lyase (ACL), an enzyme upstream of HMG-CoA reductase, the target of statins. This unique approach allows for complementary LDL-C reduction when added to existing regimens.

In Phase 3 trials, NEXLETOL lowered LDL-C by an average of 18 percent compared to placebo when used alongside moderate- or high-intensity statins. The therapy was generally well tolerated, with the most common adverse events being mild to moderate and including muscle spasms, back pain, and increased uric acid levels.

“The approval of NEXLETOL represents an important milestone for patients with ASCVD or HeFH who haven’t been able to reach their cholesterol goals with statins alone,” said Rachel Hastings, Managing Partner at DelRicht Research. “We are proud of the work our investigators and teams contributed to this trial and the impact it could have on reducing cardiovascular risk.”

“We are proud of the work our investigators and teams contributed to this trial and the impact it could have on reducing cardiovascular risk.”

— Rachel Hastings, Managing Partner at DelRicht Research

Local Leadership Supporting Global Progress

Dr. Patrick Dennis, who has served as PI for numerous lipid and cardiovascular studies, played a key role in the evaluation of NEXLETOL’s safety and efficacy. His collaboration with DelRicht Research continues to position New Orleans as a strong hub for impactful cardiovascular research.

“For patients who have tried everything and still can’t get their cholesterol down, NEXLETOL offers a new, much-needed option,” said Dr. Patrick Dennis, Principal Investigator. “Being part of this study and seeing its approval reinforces how important continued innovation is in cardiovascular care.”

“For patients who have tried everything and still can’t get their cholesterol down, NEXLETOL offers a new, much-needed option. Being part of this study and seeing its approval reinforces how important continued innovation is in cardiovascular care.”

— Dr. Patrick Dennis, Principal Investigator at DelRicht Research

Esperion has also launched NEXLIZET™, a combination of bempedoic acid and ezetimibe, providing even greater LDL-C reduction for eligible patients. Both products aim to support the nearly 15 million patients in the U.S. who are not meeting their LDL-C targets despite treatment.

A Future-Focused Approach to Cholesterol Management

As cardiovascular disease remains the leading cause of death worldwide, the approval of NEXLETOL reflects a significant advancement in lipid management. With accessible, once-daily oral dosing and a growing body of evidence behind its use, NEXLETOL offers a promising new path forward for patients, and DelRicht Research is proud to have played a role in bringing it to market.

Read the full press release from Esperion Therapeutics.