U.S. Food and Drug Administration Approves LIB Therapeutics’ LEROCHOL™ (lerodalcibep-liga) for Adults with Elevated LDL Cholesterol

CINCINNATI, Ohio – December 15, 2025 – LIB Therapeutics Inc. (LIB), a privately held biopharmaceutical company with a singular focus on helping high-risk patients achieve their cholesterol goals, today announced the U.S. Food and Drug Administration (FDA) has approved LEROCHOL™ (lerodalcibep-liga) injection for subcutaneous use as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).

LEROCHOL is a novel, third-generation PCSK9 inhibitor designed to help patients achieve and maintain their LDL-C targets. It is self-administered as a once-monthly, single small-volume subcutaneous injection with extended room-temperature stability (up to 3 months), giving patients the freedom to administer it where and when they choose.

“We founded LIB Therapeutics with a mission to bring an effective and more patient-friendly treatment option to the millions of patients who still need additional LDL-C reduction in order to achieve the lower targets recommended in recent guidelines. Today’s FDA approval validates that mission and the focus of my medical career,” said Evan Stein, M.D., Ph.D., Founder, CEO and Chief Scientific Officer of LIB Therapeutics. “LEROCHOL was designed for patients who need life-long treatment to achieve and maintain the new lower LDL-C goals especially those with cardiovascular disease and the millions with inherited high cholesterol (familial hypercholesterolemia or FH). We look forward to bringing LEROCHOL to patients in the coming months. I wish to thank the more than 2,500 patients throughout the world who participated in our clinical trials and our small team of very dedicated colleagues at LIB who believed in the drug and worked tirelessly for nearly 10 years, including during the COVID-19 pandemic, to achieve this milestone. I would also like to express our thanks to the FDA Division of Diabetes, Lipid Disorders, and Obesity for their thoroughness, guidance and flexibility during the development and review process and during the government shutdown.”

Cardiovascular disease (CVD) remains the leading cause of death globally and in the United States, and lower LDL-C levels have been demonstrated to lead to better outcomes. Despite the availability of statins and other lipid-lowering therapies, millions of patients with or at risk of CVD, including those with FH, fail to achieve updated guideline-recommended LDL-C targets. Approximately 1 in 200 individuals worldwide have FH, a genetic condition characterized by severely elevated LDL-C levels from birth that requires lifelong management. PCSK9 inhibitors as a class offer the most effective and safe LDL-C lowering. However widespread adoption has been limited by inconvenience and access barriers, leaving millions of patients with a need for additional treatment options.

“The primary challenge in lipid management today is helping patients achieve and maintain the increasingly stringent LDL-C targets in current guidelines,” said Dean J. Kereiakes, M.D., FACC, MSCAI, Chairman of The Christ Hospital Heart and Vascular Institute and Professor of Medicine at the University of Cincinnati. “While PCSK9 inhibitors as a class deliver powerful cholesterol lowering potential, LEROCHOL was designed to address the barriers that have limited their use, including ease of use features like a single small monthly injection, self-administered at home with extended room-temperature stability for home storage and travel. For patients with cardiovascular disease who require lifelong cholesterol management, LEROCHOL offers an important addition to our treatment options.”

To read the full press release, please CLICK HERE.