Who makes lerodalcibep?

LIB Therapeutics makes Lerochol, a third-generation PCSK9 inhibitor. It uses a smaller, engineered binding protein rather than a full antibody, which helps allow once-monthly dosing at a small injection volume.

How does lerodalcibep work?

Like other PCSK9 inhibitors, it blocks the PCSK9 protein so the liver keeps more LDL receptors active, clearing more LDL cholesterol from the blood. Its binding protein is designed to stay active in the body longer, which supports a once-monthly rather than every-two-weeks injection schedule.

What are the side effects of lerodalcibep?

The most common side effects in trials were cold-like symptoms (nasopharyngitis, 15% vs 14% with placebo), injection-site reactions (more common than with placebo, and mild to moderate) and mild swelling of the legs or ankles (2% vs under 1%), according to LIB Therapeutics. Its long-term side-effect profile is less established than Repatha's or Praluent's, which have been on the market for years.

Is the Lerochol autoinjector available?

Not yet. The FDA approved a Lerochol autoinjector pen on August 17, 2026, and LIB Therapeutics expects it to be available in the US by January 2027, at the same $199 a month cash price. Until then, Lerochol comes as a prefilled syringe.

What drugs reduce lipoprotein(a)?

PCSK9 inhibitors lower Lp(a) modestly as a side effect: lerodalcibep lowered it by about 33% in its main trial. No medicine is FDA-approved to target Lp(a) directly. The first dedicated Lp(a) drug to finish an outcomes trial, pelacarsen, missed its primary endpoint in September 2026, and others are still in trials.

How much does Lerochol cost without insurance?

LIB Therapeutics launched Lerochol in May 2026 with a direct-to-patient cash price of $199 a month. Manufacturer cash programs can change, so confirm current pricing before you fill. If you have insurance, compare that price with your plan's PCSK9 inhibitor copay before paying cash.

Lerochol (Lerodalcibep): Monthly PCSK9 Shot

Creator: Preval Health
Published: 2026-09-17

What is Lerochol?

Lerochol (lerodalcibep) is a once-monthly PCSK9 inhibitor shot you give yourself at home, made by LIB Therapeutics. It lowers LDL cholesterol (LDL-C) by about 56% compared with placebo and is FDA-approved, alongside diet and exercise, for adults with high LDL, including heterozygous familial hypercholesterolemia.

The FDA approved it in December 2025 (TCTMD), and it launched in the US on May 11, 2026 as a prefilled syringe, with a direct-to-patient cash price of $199 a month alongside standard insurance coverage (LIB Therapeutics).

What makes Lerochol different?

Lerochol was built around once-a-month dosing: a single 300 mg dose in a small 1.2 mL injection, which can be stored at room temperature for up to three months. Repatha and Praluent are most often injected every two weeks, with higher-dose monthly options. The other choices are a clinic shot twice a year (Leqvio) or a daily pill (Lipfendra).

Key Takeaway

Lerochol lowers LDL about as much as the injectable PCSK9 inhibitors already available. It makes dosing easier: one small injection a month, kept at room temperature, which simplifies travel and storage.

Lerochol is a third-generation PCSK9 inhibitor. Instead of a full monoclonal antibody like evolocumab or alirocumab, it uses a smaller, engineered binding protein built to stay active in circulation longer, which allows monthly dosing.

How much does Lerochol lower LDL?

About 56 to 59% compared with 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 on top of their usual treatment. 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% (TCTMD).

Source

Klug EQ, Llerena S, Burgess LJ, et al. “Efficacy and Safety of Lerodalcibep in Patients With or at High Risk of Cardiovascular Disease: A Randomized Clinical Trial.” JAMA Cardiology (2024).

View paper

In LIBerate-HeFH, 478 people with heterozygous familial hypercholesterolemia saw LDL fall 59% more than with placebo at week 24, and 68% reached both a 50% LDL drop and European LDL targets.

Source

Raal F, Fourie N, Scott R, et al. “Long-term efficacy and safety of lerodalcibep in heterozygous familial hypercholesterolaemia: the LIBerate-HeFH trial.” European Heart Journal (2023).

View paper

Does Lerochol prevent heart attacks?

We don't know yet. No Lerochol-specific cardiovascular outcomes trial has reported, so its approval rests on how much it lowers LDL.

In August 2026, the FDA updated the label to note that outcomes trials of statins and antibody PCSK9 inhibitors have shown that lowering LDL reduces major cardiovascular events (LIB Therapeutics). That statement describes the evidence for LDL lowering in general; Lerochol itself has no outcomes trial results yet.

What are the side effects?

The most common side effects in trials were cold-like symptoms, injection-site reactions and mild ankle or leg swelling. Per LIB Therapeutics, nasopharyngitis occurred in 15% of people vs 14% with placebo, and peripheral edema in 2% vs under 1%.

In LIBerate-HR, injection-site reactions were more common than with placebo (6.9% vs 0.3%) and were mild to moderate. Because Lerochol is newer, its long-term safety record is shorter than Repatha's or Praluent's.

When will the Lerochol autoinjector be available?

LIB Therapeutics expects the autoinjector to be available in the US by January 2027. The FDA approved it on August 17, 2026: a single-motion, pressure-activated pen that delivers the monthly 300 mg dose in seconds and can be kept at room temperature for up to 90 days. LIB plans to offer it through the same $199 a month cash program, alongside the current prefilled syringe (LIB Therapeutics).

Who might benefit most from Lerochol?

Lerochol suits people who want a once-a-month PCSK9 inhibitor they can keep out of the fridge:

People already considering a PCSK9 inhibitor who want one small injection a month
People who travel often or find strict refrigeration hard to manage, given the room-temperature stability
People with familial hypercholesterolemia not yet at target on a statin and ezetimibe
People who can't take statins and need a large LDL drop (see statin intolerance)

How do you get Lerochol?

Through insurance with prior authorization, or by paying cash. Like other PCSK9 inhibitors, Lerochol faces step-therapy requirements in many plans.

Through Preval Health, licensed clinicians in our partner network prescribe it the same way as every other advanced lipid therapy, through direct cash-pay access with no prior authorization wait. LIB Therapeutics' own $199 a month cash program fits that route. For the full list of options, see PCSK9 inhibitors explained or how to get a PCSK9 inhibitor prescription.

Summary

Lerochol makes treatment more convenient for anyone starting PCSK9 inhibitor therapy, or anyone whose treatment stalled on the every-two-weeks schedule of Repatha or Praluent. If an injectable PCSK9 inhibitor already works for you, you can stay on it.