Novartis Launches New Phase III Trial of Inclisiran in Acute Coronary Syndrome Patients

August 4,ClinicalTrials.gov official website showsNovartis registered a Phase III clinical trial for inclisiran sodium, aiming to evaluateAcute Coronary Syndrome（ACS）Early hospitalization of the patientInclisiran SodiumEfficacy and Safety of Treatment.

Screenshot source:ClinicalTrials.gov Official Website

This is a multicenter, randomized, double-blind, placebo-controlled study, with subjects being those who recently experiencedAcute Coronary Syndrome（ACS）Patients, includingST-Segment Elevation Myocardial Infarction（STEMI）AndNon-ST-Segment Elevation Myocardial Infarction（NSTEMI）of patients. The study includes:

Screenshot source:ClinicalTrials.gov Official Website

This study plans to enroll 300 people, with the primary endpoint beingFrom baseline to Day 150,Low-Density Lipoprotein（LDL-C）Percentage change.

Inclisiran Sodium isThe World's FirstApproved PCSK9 siRNA Drug,Approved for marketing by the EU and FDA in 2020 and 2021, respectively, for the treatment of adultsHypercholesterolemia and Mixed Dyslipidemia, demonstrating the therapeutic potential of small nucleic acid drugs in the field of chronic diseases.

To date, the drug has been approved for 4 indications in the EU, 3 indications in the US, and 4 indications in China.

By virtue of"Two Shots a Year" for Long-Lasting ReductionLDL-C Characteristics，Sales of Inclisiran sodium from 2021$12 millionSurged to 2024$7.54 billionAccording to the half-year report released by Novartis in 2025, the sales of the drug reached$5.55 billion，Up 66% Year-on-Year。

Screenshot source: Insight database