Lerochol (lerodalcibep-liga) / LIB Therap, Hasten Biopharma - LARVOL DELTA

Comparative LDL-C Reduction and Cardiovascular Outcomes With PCSK9-Pathway Therapies: A Systemic Review and Network Meta-Analysis (ESC 2026) - "Injection-site reactions were lowest with lerodalcibep and highest with inclisiran. SUCRA rankings for injection-site reactions favored lerodalcibep, followed by alirocumab/evolocumab, with inclisiran ranking lowest.ConclusionPCSK9-pathway therapies significantly reduce LDL-C, with lerodalcibep demonstrating the greatest lipid-lowering effect, while only evolocumab and alirocumab show definitive MACE reduction; overall safety profiles were comparable across agents."

Retrospective data • Review • Cardiovascular • Dyslipidemia

Enlicitide (Lipfendra) - an oral PCSK9 inhibitor for LDL-cholesterol lowering. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Dyslipidemia • Metabolic Disorders

Open Label Phase 3b Study to Evaluate the Long-Term Efficacy and Safety of Lerodalcibep in Children and Adolescents, 6 to 17 Years of Age, With Heterozygous Familial Hypercholesterolemia on Stable Diet and Oral Lipid-Lowering Therapy (clinicaltrials.gov) - P3 | N=150 | Not yet recruiting | Sponsor: LIB Therapeutics LLC

New P3 trial • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Heterozygous Familial Hypercholesterolemia • Metabolic Disorders

LIB Therapeutics…announced the U.S. Food and Drug Administration (FDA) has approved an autoinjector for LEROCHOL (lerodalcibep-liga) Injection 300 mg/1.2 mL, a third-generation Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitor that combines robust and sustained efficacy with once-monthly, single injection self-administration to support long-term adherence (Businesswire) - "The FDA also approved an update to the LEROCHOL indication statement in its prescribing information reflecting the reduction of risk for major adverse cardiovascular events (MACE) achieved in adults via LDL-C lowering with statins or with monoclonal antibody PCSK9 inhibitors used as an add-on to statin therapy....LIB plans to make the LEROCHOL autoinjector available in the United States by January 2027. Insurance coverage of LEROCHOL is expected to expand gradually over the course of 2027....The FDA approval of LEROCHOL was based on data from the comprehensive global Phase 3 LIBerate Clinical Trial Program..."

FDA approval • Launch US • US reimbursement • Cardiovascular • Heterozygous Familial Hypercholesterolemia

LIBerate Kids: Study to Evaluate the Efficacy and Safety of Lerodalcibep in Children 6 to 17 Years, With Heterozygous FH (clinicaltrials.gov) - P3 | N=150 | Enrolling by invitation | Sponsor: LIB Therapeutics LLC | Not yet recruiting ➔ Enrolling by invitation | Trial completion date: Jun 2027 ➔ Nov 2028 | Trial primary completion date: Dec 2026 ➔ Jul 2028

Enrollment open • Trial completion date • Trial primary completion date • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Heterozygous Familial Hypercholesterolemia • Metabolic Disorders

On 23 July 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Lyrokaul, intended for the treatment of adult patients with hypercholesterolaemia and mixed dyslipidaemia. (European Medicines Agency) - "Lyrokaul will be available as 300 mg solution for injection pre-filled syringes."

CHMP • Dyslipidemia • Heterozygous Familial Hypercholesterolemia

Everest Medicines Announces China NMPA Acceptance of the Biologics License Application for LEROCHOL in Adults with Hypercholesterolemia (PRNewswire) - "Everest Medicines...announced that China's National Medical Products Administration (NMPA) accepted the Biologics License Application (BLA) for LEROCHOL (lerodalcibep), a third-generation PCSK9 inhibitor, 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...The application is based on results from multiple global clinical trials as well as Phase 3 clinical trial in China."

China filing • Heterozygous Familial Hypercholesterolemia

Efficacy, Safety, and Dosing Durability of PCSK9-Targeting Therapies for Hypercholesterolemia: A Systematic Review and Network Meta-Analysis (ENDO 2026) - "Evolocumab accounted for 27,564 patients, alirocumab for 18,924 patients, inclisiran for 3,178 patients, and lerodalcibep for 1,400 patients. Lerodalcibep was associated with the highest rate of injection-site reactions (6.9%; SUCRA = 0.22), although events were predominantly mild and rarely led to treatment discontinuation. Conclusion PCSK9-targeting therapies provide substantial and durable LDL-C reduction, with lerodalcibep ranking highest for efficacy and evolocumab for injection-site tolerability, and overall risk of bias across included trials was low."

Retrospective data • Review • Dyslipidemia • Metabolic Disorders

Comparison chart: Some non-statin lipid-lowering drugs. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal

Drugs for hypercholesterolemia. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Dyslipidemia • Metabolic Disorders

LIB003-008: Study to Evaluate the Efficacy and Safety of Lerodalcibep for the Reduction of Cholesterol in Children and Adolescents with Heterozygous Familial Hypercholesterolemia (clinicaltrialsregister.eu) - P2/3 | N=5 | Not yet recruiting | Sponsor: LIB Therapeutics Inc.

New P2/3 trial • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Heterozygous Familial Hypercholesterolemia • Metabolic Disorders

Lerodalcibep (Lerochol) for hypercholesterolemia. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Dyslipidemia • Metabolic Disorders

Lipoprotein(a) reduction with inclisiran, alirocumab, evolocumab, enlicitide, and lerodalcibep: A systematic review and meta-analysis of randomized controlled trials. (PubMed, J Clin Lipidol) - "No statistically significant differences in Lp(a) reduction were observed between currently available PCSK9-targeting medications. Agent selection may reasonably be based on non-efficacy factors, including administration frequency, cost, and patient preference."

Journal • Retrospective data • Review • Atherosclerosis • Cardiovascular

Response to PCSK9 Inhibition Based on LDL Receptor Function in Familial Hypercholesterolemia: A Nonrandomized Clinical Trial. (PubMed, JAMA Cardiol) - P3 | "This nonrandomized clinical trial reports on a predefined, pooled subanalysis of participants with HeFH requiring additional lipid-lowering therapy in the open-label worldwide phase 3 study of the PSCK9 inhibitor lerodalcibep...Despite most participants receiving treatment with statins or ezetimibe, the mean (SD) baseline LDL-C was 144.9 (61.9) mg/dL...These findings support that LDL-C reductions in patients with HeFH with PCSK9 inhibition are predominantly mediated by upregulation of the unaffected wild-type LDLR. ClinicalTrials.gov Identifier: NCT04798430."

Clinical • Journal • Atherosclerosis • Cardiovascular • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Heterozygous Familial Hypercholesterolemia • Metabolic Disorders

Cardiovascular pharmacotherapy in year in 2025. (PubMed, Eur Heart J Cardiovasc Pharmacother) - "Here, we summarize the most relevant advances in cardiovascular pharmacotherapy in 2025, including the approval of four new drugs (aficamten, etripamil, lerodalcibep, and plozasiran), the label expansions for five already approved drugs, and the results of major randomized clinical trials with already approved drugs, including those that met the prespecified primary endpoints (positive trials) representing new pharmacological options for cardiovascular diseases, those with neutral or negative results which did not confirm the primary endpoints and the withdrawal from the U.S. market of Andexanet-alfa for safety concerns. Finally, we present the most promising experimental cardiovascular drugs currently being investigated in ongoing phase 2 and 3 clinical trials."

Clinical • Journal • Cardiovascular

Lerodalcibep: First Approval. (PubMed, Drugs) - "Lerodalcibep is administered as a once-monthly subcutaneous injection. This article summarizes the milestones in the development of lerodalcibep leading to this first approval for the treatment of adults with hypercholesterolaemia."

Journal • Dyslipidemia • Familial Hypercholesterolemia

EFFICACY AND SAFETY OF LERODALCIBEP IN CHINESE PATIENTS WITH HYPERCHOLESTEROLEMIA:A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 TRIAL (ACC 2026) - "Lerodalcibep/HST101, 300mg QM reduced mean PBO adjusted LDL-C >65% in Chinese patients with a favorable tolerability and safety profile. These results support the use of lerodalcibep in Chinese patients not achieving adequate LDL-C reduction with statins alone."

Clinical • P3 data • Dyslipidemia • Metabolic Disorders

LONG-TERM EFFICACY AND SAFETY OF LERODALCIBEP, A NOVEL THIRD GENERATION PCSK9 INHIBITOR, IN THE OPEN-LABEL 72-WEEK EXTENSION STUDY OF SUBJECTS COMPLETING THE PHASE 3 STUDIES (ACC 2026) - "Mean age (range) was 61.1 (11-90) yrs, 40% females, 80% white, 20% black/Asian, 70% with CVD, 31% diabetic, 31% FH, 88% on statin and 29% ezetimibe, with mean baseline LDL-C 125 mg/dL. Treatment with lerodalcibep for 72 weeks demonstrated consistent long-term efficacy and a reassuring safety profile, consistent with the data for the 1776 subjects previously treated with lerodalcibep in the base trials."

Clinical • P3 data

Novel drugs approved by the EMA, the FDA and the MHRA in 2025: A year in review. (PubMed, Br J Pharmacol) - "Among the FIC drugs, it is worth mentioning the Nav1.8 channel inhibitor suzetrigine, the first non-opioid approved to palliate acute pain; the first positive allosteric modulator of transient receptor potential melastatin 8 (TRPM8), acoltremon, that increases basal tear production in dry eye disease, a globally common disorder; lerodalcibep, a 'third generation' adnectin inhibitor of the protease Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) to treat elevated LDL-c; and zoliflodacin and gepotidacin, both innovatively targeting bacterial topoisomerases to treat uncomplicated urinary tract infections. These approaches include: the combination of two FIC drugs, the RAF/MEK clamp avutometinib paired with the FAK/Pyk2 inhibitor defactinib, to block more efficiently the RAS-RAF-MEK-ERK/FAK oncogenic pathway in low-grade serous ovarian cancer; fitusiran, the first RNAi therapy for haemophilia, targeting for the first time the production of the natural..."

European regulatory • FDA event • Journal • Review • Bronchiectasis • Dry Eye Disease • Hematological Disorders • Hemophilia • Infectious Disease • Nephrology • Oncology • Ophthalmology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pain • Pulmonary Disease • Rare Diseases • Respiratory Diseases • Solid Tumor • NAV1 • TRPM8

From physiopathology to treatment of familial hypercholesterolemia: Existing and emerging pharmacotherapies. (PubMed, Pharmacol Rev) - "This includes established drugs such as proprotein convertase subtilisin/kexin type 9 inhibitors, inclisiran, lomitapide, and bempedoic acid. Emerging therapies include evinacumab, lerodalcibep, antisense oligonucleotide-based drugs, certain cholesteryl ester transfer protein inhibitors like obicetrapib, AZD8233, gemcabene, diacylglycerol O-acyltransferase-2 inhibitors, acyl-CoA:cholesterol acyltransferase-2 inhibitors, vupanorsen, volanesorsen, olezarsen, pelacarsen (TQJ230), olpasiran (AMG890), zerlasiran (SLN360), lepodisiran (LY3819469), and muvalaplin...Recent pharmacological advancements provide significant opportunities for successful low-density lipoprotein cholesterol management and control of FH. Although some of these agents are already used, several highly effective compounds are in development, heralding a promising future for FH treatment."

Journal • Review • Atherosclerosis • Cardiovascular • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Metabolic Disorders • APOB

Efficacy and safety of proprotein convertase subtilisin/kexin type 9 inhibitors for adults with familial hypercholesterolemia: A network meta-analysis. (PubMed, Int J Cardiol Cardiovasc Risk Prev) - "In heterozygous FH (HeFH) populations, ongericimab showed the greatest reductions in LDL-C (mean difference [MD]: -74.98 %), ApoB (MD: -64.64 %), and Lp(a) (MD: -59.66 %), with SUCRA rankings of 68.7 %, 63.6 %, and 95.0 %, respectively...In terms of safety, lerodalcibep showed the most favorable profile for injection-site reactions and ALT >3 × ULN, with SUCRA values of 98.5 % and 96.7 %, respectively...Inclisiran's efficacy may be underestimated due to short-term follow-up. Monotherapy with PCSK9 inhibitors has limited efficacy in HoFH patients, highlighting the need for combination therapies."

Clinical • Journal • Retrospective data • Review • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Heterozygous Familial Hypercholesterolemia • Homozygous Familial Hypercholesterolemia • Metabolic Disorders • APOB

U.S. Food and Drug Administration Approves LIB Therapeutics’ LEROCHOL (lerodalcibep-liga) for Adults with Elevated LDL Cholesterol (Businesswire) - "Approved for adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia. LEROCHOL expected to be available in the U.S. in spring 2026....The FDA approval of LEROCHOL was based on data from the comprehensive global Phase 3 LIBerate Clinical Trial Program, which enrolled a diverse population of over 2,900 patients with CVD, without CVD at very high and high risk for CVD...."

FDA approval • Launch US • Cardiovascular • Heterozygous Familial Hypercholesterolemia

LIB Therapeutics Announces Results from Late Breaking Science Presentation at 2025 American Heart Association Meeting in New Orleans November 9, 2025 (Businesswire) - "Lerodalcibep demonstrated consistent long-term efficacy in those continued on the drug and was well tolerated, with no treatment related serious adverse events; 72-week primary endpoint; mean & absolute LDL-C reductions of 59.2% & 66.6 mg/dL respectively....LIB submitted a Biologic License Application (BLA) to the U.S. Food and Drug Administration (FDA) in December 2024, and received formal filing by FDA in February with an anticipated PDUFA date on target for mid December this year...Marketing Authorization Application was submitted to, and accepted by the European Medicines Agency in May with anticipated approval in June 2026."

EMA approval • FDA approval • Late-breaking abstract • P3 data • Cardiovascular • Dyslipidemia

Long-term Efficacy and Safety of Lerodalcibep in the Open-label 72-week Extension Study of Subjects Previously on Inclisiran or Lerodalcibep in the LIBerate-VI Trial (AHA 2025) - "Treatment with lerodalcibep demonstrated consistent long-term efficacy in those previously treated with the drug. Subjects switched from inclisiran to lerodalcibep had prolonged substantial additional LDL-C reductions and goal achievement, consistent with added inhibition of circulating free PCSK from non-hepatic synthesis."

Clinical • Metabolic Disorders • APOB

Lerodalcibep: Another Crucial Addition to the Dyslipidaemia Arsenal. (PubMed, Rev Cardiovasc Med) - No abstract available

Journal • Dyslipidemia