FDA Approves Lerodalcibep for Adults With Hypercholesterolemia

The US Food and Drug Administration has approved the use of lerodalcibep (Lerochol) to reduce LDL cholesterol alongside changes in diet and exercise among adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Drugmaker LIB Therapeutics announced the news Monday.

Lerodalcibep is a third-generation, subcutaneous injectable PCSK9 inhibitor that patients self-administer monthly. Unlike other drugs in this class, it can be kept at room temperature for up to 3 months.

The agency’s approval is based on the phase III LIBerate-HR clinical trial, which showed that lerodalcibep reduced LDL cholesterol by an absolute 56% compared with placebo over the course of a year among more than 900 global patients with or at high risk for CVD. More than 2,900 patients have been included in the LIBerate clinical trial program, including upwards of 2,400 in the 72-week open-label extension trial, with consistent results observed.

Across the board, lerodalcibep reduced LDL cholesterol by at least 60% in patients with or at high risk for CVD and at least 50% in those with HeFH, who typically have higher baseline levels. No treatment-related serious adverse events were reported in the long-term extension studies.

The drug was developed especially for patients with familial hypercholesterolemia, who often fail to meet LDL targets despite several available drug options, according to the manufacturer.

“The primary challenge in lipid management today is helping patients achieve and maintain the increasingly stringent LDL cholesterol targets in current guidelines,” said Dean J. Kereiakes, MD (The Christ Hospital Heart and Vascular Institute, Cincinnati, OH), in a press release. “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.”

Lerodalcibep is slated to be available in the US as a prefilled syringe next spring, with an autoinjector device coming later in 2026. The price has not yet been announced, but LIB Therapeutics says it will provide patient assistance program information when the drug launches.

The manufacturer also expects the European Medicines Agency to approve lerodalcibep in June 2026.