Lerochol (Lerodalcibep): Monthly PCSK9 Shot

Lerochol is a once-monthly PCSK9 inhibitor shot made by LIB Therapeutics. The FDA approved it in December 2025, alongside diet and exercise, for adults with high LDL, including heterozygous familial hypercholesterolemia. It launched in the US on May 11, 2026 as a prefilled syringe.

Instead of a full antibody like evolocumab or alirocumab, it uses a smaller engineered binding protein built to stay active longer, which allows monthly dosing.

Lerochol is a single 300 mg dose in a small 1.2 mL injection each month. It can sit at room temperature for up to three months. Repatha and Praluent are most often injected every two weeks, with higher-dose monthly options.

About 56 to 59% versus placebo, in the same range as Repatha and Praluent. In LIBerate-HR, 922 people with or at high risk of cardiovascular disease took monthly lerodalcibep or placebo for a year.

LDL fell 56% more than with placebo at week 52, more than 90% of people on lerodalcibep reached their LDL target, and Lp(a) fell by about 33%.

In LIBerate-HeFH, 478 people with heterozygous familial hypercholesterolemia saw LDL fall 59% more than with placebo at week 24.

Researchers do not know yet. No Lerochol-specific cardiovascular outcomes trial has reported, so approval rests on LDL lowering.

In August 2026 the FDA updated the label to note that outcomes trials of statins and antibody PCSK9 inhibitors showed lower LDL reduces major cardiovascular events. That statement covers LDL lowering in general. Lerochol has no outcomes results of its own.

The most common ones in trials were cold-like symptoms, injection-site reactions and mild ankle or leg swelling. Nasopharyngitis occurred in 15% versus 14% on placebo, and peripheral edema in 2% versus under 1%.

In LIBerate-HR, injection-site reactions ran 6.9% versus 0.3% on placebo, mild to moderate. Lerochol is newer, so its long-term safety record is shorter than Repatha's or Praluent's.

LIB Therapeutics launched a direct-to-patient cash price of $199 a month. Cash programs can change, so confirm current pricing before you fill. Insurance often applies prior authorization or step therapy to PCSK9 inhibitors.

The FDA approved an autoinjector pen on August 17, 2026. It delivers the monthly 300 mg dose and can stay at room temperature for up to 90 days. LIB expects it by January 2027 at the same $199 cash price.