Leqvio (inclisiran) / Alnylam, Novartis - LARVOL DELTA

Imaging-based demonstration of plaque regression and stabilization under inclisiran therapy using non-obstructive general angioscopy. (PubMed, Eur Heart J) - No abstract available

Journal

Cost-effectiveness of theoretical benefit of PCSK9 inhibitor use in patients with stroke due to severe intracranial atherosclerosis: A post hoc analysis of the SAMMPRIS trial (ISC 2026) - "At current out-of-pocket prices, the probability of cost-effectiveness of alirocumab, evolocumab, and inclisiran were 30.7%, 24.1%, and 19.2%, respectively, at a WTP threshold of <$100,000 over a 5-year horizon. With higher costs of recurrent stroke (150% of base), there is a 59.1% probability of cost-effectiveness for agents priced at $5,000/year; with higher treatment effectiveness (50%), the probability of cost-effectiveness increases to 74.3%.Conclusion : This theoretical framework does not demonstrate cost-effectiveness of currently available PCSK9i for the prevention of recurrent ischemic stroke in patients with severe intracranial atherosclerosis. The added benefits of PCSK9i in reducing coronary events and disability associated with lower rates of stroke or myocardial infarction may render these agents cost-effective for all atherosclerotic outcomes; however, this warrants further study."

Clinical • Cost effectiveness • HEOR • Retrospective data • Atherosclerosis • Cardiovascular • Dyslipidemia • Ischemic stroke • Myocardial Infarction

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

EFFECTIVENESS OF INCLISIRAN COMPARED TO ALIROCUMAB/EVOLOCUMAB IN PATIENTS WITH FAMILIAL OR SEVERE HYPERCHOLESTEROLEMIA (ACC 2026) - "Abstract is embargoed at this time."

Clinical • Dyslipidemia • Metabolic Disorders

Sustainable and Effective Lipid-Lowering Management: Prevention Strategies from the BRING-UP Prevention Study. (PubMed, Eur Heart J Qual Care Clin Outcomes) - "BRING-UP Prevention achieved its primary goal to increase the percentage of patients at LDL-C goal, demonstrating that, in many patients, this goal can be achieved increasing the use of low-cost therapies."

Clinical • Journal • Cardiovascular

Efficacy and safety of inclisiran in adolescents with heterozygous familial hypercholesterolaemia (ORION-16): a two-part, randomised, multicentre clinical trial. (PubMed, Lancet Diabetes Endocrinol) - P3 | "In adolescents with HeFH, inclisiran was effective in lowering LDL cholesterol, with sustained efficacy over 2 years, and was well tolerated. These results support inclisiran as a potentially useful addition for the treatment of adolescents with HeFH, providing an infrequent dosing regimen."

Journal • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Heterozygous Familial Hypercholesterolemia • Pediatrics

INCLISIRAN VS PCSK9 MONOCLONAL ANTIBODIES IN CORONARY ARTERY DISEASE: COMPARATIVE EFFECTIVENESS STUDY (ACC 2026) - "Abstract is embargoed at this time."

HEOR • Cardiovascular • Coronary Artery Disease

Inclisiran for children: is it worth it? (PubMed, Lancet Diabetes Endocrinol) - No abstract available

Journal

Inclisiran Attenuates Alzheimer's Disease-like Changes by Suppressing Microvascular Endothelial Ferroptosis to Preserve Blood-Brain Barrier Integrity. (PubMed, Free Radic Biol Med) - "Third, in vitro studies employing the HCMEC/D3 BBB model with integrated assessments of lipid peroxidation, mitochondrial function, and transwell-based barrier integrity demonstrated that Inclisiran significantly reduced ferroptosis and restored BBB integrity via PCSK9 suppression. Our findings not only establish a novel PCSK9-ferroptosis-BBB regulatory axis in AD pathogenesis but also posit the clinically approved lipid-lowering drug, Inclisiran, as a promising therapeutic candidate for AD, providing new targets and mechanisms for the prevention and treatment of AD."

Journal • Alzheimer's Disease • CNS Disorders • Dyslipidemia • APOE

Inclisiran in Chronic Kidney Disease patients: a real world experience. (PubMed, Cardiorenal Med) - "Inclisiran should be considered as a viable therapeutic alternative for the management of pure hypercholesterolemia in patients with chronic kidney disease who are intolerant to statin treatment because it achieves the optimal LDL-cholesterol targets required by actual guidelines without side effects."

Journal • Real-world evidence • Cardiovascular • Chronic Kidney Disease • Coronary Artery Disease • Diabetes • Dyslipidemia • Heart Failure • Metabolic Disorders • Myocardial Infarction • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

PCSK9 INHIBITOR INCLISIRAN ATTENUATES CARDIOTOXICITY INDUCED BY SEQUENTIAL ANTHRACYCLINE AND TRASTUZUMAB EXPOSURE VIA NLRP3 AND MYD88 PATHWAY INHIBITION (ACC 2026) - "Abstract is embargoed at this time."

Cardiovascular • MYD88 • NLRP3

EFFECTIVENESS OF LDL-C LOWERING WITH ALIROCUMAB AND INCLISIRAN IN A CLINICAL PRACTICE SETTING (ACC 2026) - "Abstract is embargoed at this time."

Clinical

Inclisiran in Patients with CKD: Post Hoc Pooled Analysis of Three Phase 3 Trials. (PubMed, J Am Soc Nephrol) - "Inclisiran demonstrated sustained and effective LDL cholesterol reduction in patients with or at risk of atherosclerotic cardiovascular disease, regardless of baseline eGFR as low as 15 mL/min/1.73m2, without new safety findings."

Journal • P3 data • Retrospective data • Atherosclerosis • Cardiovascular • Chronic Kidney Disease • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Heterozygous Familial Hypercholesterolemia • Metabolic Disorders • Nephrology • Renal Disease • APOB

V-ACCELERATE: Intravascular Imaging Study of the Effect of Inclisiran on Plaque in Patients With Acute Myocardial Infarction (clinicaltrials.gov) - P4 | N=318 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Atherosclerosis • Cardiovascular • Dyslipidemia • Myocardial Infarction • APOB

Clinician-level variation in lipid management for secondary prevention of atherosclerotic cardiovascular disease: Opportunities for practice improvement. (PubMed, Am J Prev Cardiol) - "Among 9098 patients with ASCVD (median age 71.0 years, 61.6% male, 70.5% White) seen across 77 cardiology clinicians (56 physicians, 21 APPs), 52.8% were on a high-intensity statin, 17.1% were on ezetimibe, 7.8% were on novel LLT (proprotein convertase subtilisin/kexin type 9 monoclonal antibody, inclisiran, or bempedoic acid). Even among cardiology clinicians at the same academic medical center, practice patterns varied widely in using LLT and achieving LDL-C goals for secondary prevention. Understanding the reasons for this variability and standardizing lipid management across the specialty may improve quality of care for patients with ASCVD."

Journal • Atherosclerosis • Cardiovascular • CNS Disorders • Coronary Artery Disease • Diabetes • Dyslipidemia • Metabolic Disorders • Peripheral Arterial Disease • Vascular Neurology

LACK OF RESPONSE TO INCLISIRAN IN HIGH-RISK PATIENTS WITH ADVERSE EFFECTS TO TRADITIONAL LIPID-LOWERING THERAPIES (ACC 2026) - "Abstract is embargoed at this time."

Adverse events • Clinical • Cardiovascular

Inclisiran in Dyslipidemia with High Residual Platelet Reactivity. (PubMed, Diseases) - "Assessment of platelet function using the VerifyNow assay may improve identification of residual thrombotic risk in patients with advanced atherosclerotic disease. Inclisiran appears to be a promising adjunctive therapy for dyslipidemic patients with persistently elevated cardiovascular risk and HRPR despite standard treatment. Further prospective studies are warranted to clarify the relationship between intensive LDL-C lowering, platelet reactivity, and clinical outcomes, and to optimize integrated lipid-lowering and antiplatelet strategies."

Journal • Review • Atherosclerosis • Cardiovascular • Coronary Artery Disease • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Metabolic Disorders

CARDIOVASCULAR OUTCOMES OF INCLISIRAN USE IN PATIENTS WITH CLINICAL ATHEROSCLEROTIC CARDIOVASCULAR DISEASE (ASCVD) ON MAXIMALLY TOLERATED STATINS: A PROPENSITY-MATCHED ANALYSIS (ACC 2026) - "Abstract is embargoed at this time."

Clinical • Atherosclerosis • Cardiovascular

CHOLINET: Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy (clinicaltrials.gov) - P=N/A | N=3000 | Recruiting | Sponsor: Federico II University | N=1000 ➔ 3000 | Trial completion date: Nov 2024 ➔ Nov 2030

Enrollment change • Trial completion date • Dyslipidemia • Metabolic Disorders

Clinical Efficacy of Inclisiran in Preventing Postoperative Complications in Patients Undergoing Coronary Artery Bypass Grafting (ChiCTR) - P4 | N=100 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Nanjing Medical University; The First Affiliated Hospital of Nanjing Medical University

New P4 trial • Atherosclerosis • Cardiovascular • Coronary Artery Disease • Heart Failure

EARLY AND SUSTAINED LOW-DENSITY LIPOPROTEIN CHOLESTEROL GOAL ATTAINMENT WITH “INCLISIRAN FIRST” IN VICTORION-INITIATE (ACC 2026) - "Abstract is embargoed at this time."

Dyslipidemia

ROBUST LP(A) REDUCTION WITH COMBINED TOCILIZUMAB AND INCLISIRAN IN A HIGH-RISK INFLAMMATORY PATIENT (ACC 2026) - "Abstract is embargoed at this time."

Clinical • Cardiovascular

Net sales grew +8% (cc1, +8% USD) with core operating income up +14% (cc, +12% USD) (GlobeNewswire) - "Sales growth driven by continued strong performance from priority brands including...Kesimpta (+36% cc)...Cosentyx (+8% cc)...Kesimpta (USD 1 228 million, +27% cc) sales grew across all regions driven by increased demand and strong access...Cosentyx (USD 1 807 million, +11% cc) sales grew across all regions, driven by volume, with continued demand for recent launches (including HS and IV in the US) and steady performance in core indications (PsO, PsA, AS and nr-AxSpA)...Leqvio (USD 335 million, +46% cc) continued steady growth across all regions...Fabhalta (USD 155 million, +167% cc) sales grew, reflecting continued launch execution in PNH as well as renal indications IgAN and C3G."

Sales • Ankylosing Spondylitis • Familial Hypercholesterolemia • Heterozygous Familial Hypercholesterolemia • Hidradenitis Suppurativa • Multiple Sclerosis • Paroxysmal Nocturnal Hemoglobinuria • Psoriasis • Psoriatic Arthritis

V-INVINCIBLE: Inclisiran Effectiveness in China: a Pragmatic Randomized Trial (clinicaltrials.gov) - P4 | N=1590 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Coronary Artery Disease • Heart Failure • APOB

Seventeen years to change practice: will the 2025 ESC/EAS dyslipidaemia guidelines finally break the Sisyphean cycle? (PubMed, Atherosclerosis) - "The extension of the pharmacological arsenal of lipid-lowering therapies with bempedoic acid, evinacumab, inclisiran, icosapent ethyl (and not mixtures with of eicosapentaenoic acid and docosahexaenoic acid) have enriched the arsenal of LDL-cholesterol and triglyceride-lowering drugs...Therefore, the guidelines recommend immediate initiation of high-intensity statin with ezetimibe for most patients with acute coronary syndrome or the immediate intensification of the therapy in those who are already on lipid-lowering drugs at the acute event...This update also has weaknesses, including missed opportunities to promote a more courageous approach for combination therapies, limitations in the diabetes risk classification, and discrepancies across ESC guideline papers which hopefully will be overcome in the next full update. Since real-world clinical adoption is far slower than evidence creation, implementation lags remain a Sisyphean obstacle, highlighting the ongoing need..."

Journal • Review • Acute Coronary Syndrome • Cardiovascular • Diabetes • Dyslipidemia • Metabolic Disorders