Lerodalcibep

Lerodalcibep-liga is a recombinant fusion protein that binds PCSK9 with picomolar affinity. PCSK9 binds to low-density lipoprotein receptor (LDLR) on the surface of hepatocytes to promote LDLR degradation within the liver.

• LEROCHOL TM is indicated 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 proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor indicated as an adjunct to diet and exercise: to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).ICD-10: E78.00

• None. None.contraindicated

The recommended dosage of LEROCHOL is 300 mg administered subcutaneously once monthly. ( 2.1 ) Inject LEROCHOL subcutaneously into the abdomen or thigh. A caregiver or healthcare professional can administer into the upper arm. ( 2.2 ) Refer to the Instructions for Use for administration of prefilled syringe. ( 2.2 ) 2.1 Recommended Dosage The recommended dosage of LEROCHOL is 300 mg once monthly administered subcutaneously. Assess LDL-C when clinically indicated. The LDL-lowering effect of LEROCHOL may be measured as early as 4 weeks after initiation and, provided monthly dosing is continued, anytime thereafter without regard to timing of the dose. 2.2 Recommendations Regarding Missed Dose(s) If a dose is missed by: Less than 7 days, instruct the patient to administer LEROCHOL as soon as possible and resume the patient's original monthly dosage schedule. Seven (7) or more days, instruct the patient to administer LEROCHOL as soon as possible and start a new monthly dosage schedule based on this date. 2.3 Important Administration Instructions Train patients and/or their caregivers on how to prepare and administer LEROCHOL, according to the Instructions for Use, and instruct them to read and follow the Instructions for Use each time they use LEROCHOL. Prior to use, allow LEROCHOL to warm to room temperature up to 25°C (77°F) for at least 30 minutes if LEROCHOL has been refrigerated [see How Supplied/Storage and Handling ( 16 )] . Visually inspect LEROCHOL prior to administration. LEROCHOL is a clear to slightly opalescent, brownish-yellow to amber solution.

Common adverse reactions occurring in ≥1% of patients treated with LEROCHOL were injection site reactions, nasopharyngitis, diarrhea, nausea and peripheral edema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LIB Therapeutics, Inc. at 1-877-2-LEROCHOL or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adults with Primary Hypercholesterolemia Adverse Reactions in Two Pooled 52-week Controlled Trials In two pooled 52-week, double-blind, randomized, placebo-controlled trials (Trials 1 and 2), 1,229 patients received 300 mg of LEROCHOL subcutaneously every 4 weeks [see Clinical Studies ( 14 )] . The mean age was 64 years (range 25 to 90 years), 52% were 65 years of age or older, 37% female, 79% White, 18% Black or African American, 4% Asian; 7% identified as Hispanic or Latino ethnicity. At baseline, 9% of patients had a diagnosis of HeFH, 74% had established atherosclerotic cardiovascular disease (ASCVD), and 26% were at increased risk for ASCVD. Adverse reactions reported in at least 2% of LEROCHOL-treated patients and more frequently than in placebo-treated patients are shown in Table 1 . Adverse reactions led to treatment discontinuation in 4% of LEROCHOL-treated patients and placebo-treated patients.

8.1 Pregnancy Risk Summary Discontinue LEROCHOL when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. LEROCHOL increases LDL-C uptake and lowers LDL-C levels in the circulation, thus decreasing cholesterol and possibly other biologically active substances derived from cholesterol; therefore, LEROCHOL may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology ( 12.1 )]. In addition, treatment of hypercholesterolemia is not generally necessary during pregnancy. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia for most patients. Available data from clinical trials on LEROCHOL use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, there were no adverse developmental effects observed when pregnant monkeys were administered lerodalcibep-liga subcutaneously during organogenesis and through to parturition at doses up to 100 mg/kg/week [up to 119-fold the exposure at the maximum recommended human dose (MRHD) of 300 mg every month].

Metabolism

Following a single subcutaneous administration, exposure to lerodalcibep-liga increased in a dose proportional manner over the dose range 75 to 300 mg of lerodalcibep-liga. Lerodalcibep-liga pharmacokinetics were observed at steady state in patients at the approved recommended dosage and are presented as mean (SD), unless otherwise specified.

• Dec 12, 2025BLABLA761427Lib Therapeutics, Inc.

The 10 most recently updated of 12 ClinicalTrials.gov registrations naming Lerodalcibep as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Randomized, Placebo-Controlled, Double-Blind, Phase 3b Study to Evaluate the Efficacy and Safety of Lerodalcibep in Children 6 to 17 Years, With Heterozygous FH
  Not yet recruiting · Phase 3 · Interventional · 150 enrolled · LIB Therapeutics LLC
  NCT07102511updated 2025-08-03
• A Study on Evaluating the Safety of HST101 in Healthy Chinese Participants
  Enrolling by invitation · Phase 1 · Interventional · 30 enrolled · Hasten Biopharmaceutical Co., Ltd.
  NCT06504043updated 2025-03-14
• A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia
  Recruiting · Phase 3 · Interventional · 210 enrolled · Hasten Biopharmaceutical Co., Ltd.
  NCT06568471updated 2025-02-06
• Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients
  Completed · Phase 3 · Interventional · 166 enrolled · LIB Therapeutics LLC
  NCT05004675updated 2024-10-23
• Long-term Efficacy and Safety of OLE LIB003 in HoFH, HeFH, and High-risk CVD Patients Requiring Further LDL-C Reduction
  Enrolling by invitation · Phase 3 · Interventional · 2,000 enrolled · LIB Therapeutics LLC
  NCT04798430updated 2024-10-22
• Study of Long-Term Efficacy and Safety of LIB003 in CVD or High Risk for CVD Patients Needing Further LDL-C Reduction
  Unknown · Phase 3 · Interventional · 900 enrolled · LIB Therapeutics LLC
  NCT04806893updated 2023-12-11
• Study to Assess the Efficacy and Safety of LIB003 in HeFH Patients on Oral Lipid Therapy Needing Further LDL-C Reduction
  Completed · Phase 3 · Interventional · 478 enrolled · LIB Therapeutics LLC
  NCT04797104updated 2023-12-11
• Study of Efficacy and Safety of LIB003 in Patient With CVD on Statins Requiring Additional LDL-C Reduction
  Unknown · Phase 3 · Interventional · 900 enrolled · LIB Therapeutics LLC
  NCT04797247updated 2023-12-11
• Trial to Evaluate Efficacy and Safety of LIB003, Evolocumab and Alirocumab in High-risk CVD Patients
  Completed · Phase 3 · Interventional · 204 enrolled · LIB Therapeutics LLC
  NCT04790513updated 2023-03-29
• Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in HoFH
  Completed · Phase 3 · Interventional · 65 enrolled · LIB Therapeutics LLC
  NCT04034485updated 2023-03-29

Frequently asked questions

How does Lerodalcibep work?

Lerodalcibep-liga is a recombinant fusion protein that binds PCSK9 with picomolar affinity. PCSK9 binds to low-density lipoprotein receptor (LDLR) on the surface of hepatocytes to promote LDLR degradation within the liver.

What is Lerodalcibep used for?

According to FDA labeling, Lerodalcibep carries indications including: LEROCHOL TM is indicated 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 proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor indicated as an adjunct to diet and exercise: to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Lerodalcibep?

Lerodalcibep is classified as Other lipid modifying agents, PCSK9 Inhibitors, Increased Cholesterol Elimination.

What are the brand names for Lerodalcibep?

Lerodalcibep is marketed under brand names including Lerochol.

What are the contraindications for Lerodalcibep?

Lerodalcibep labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.