LEQVIO

Peak

inclisiran

NDASUBCUTANEOUSSOLUTION
Approved
Dec 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
45

Mechanism of Action

double-stranded small interfering ribonucleic acid (siRNA), conjugated on the sense strand with triantennary N-Acetylgalactosamine (GalNAc) to facilitate uptake by hepatocytes. In hepatocytes, inclisiran utilizes the RNA interference mechanism and directs catalytic breakdown of mRNA for PCSK9. This…

Clinical Trials (5)

NCT07102628Phase 3Recruiting

Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes

Started Oct 2025
300 enrolled
Acute Coronary Syndrome
NCT07142265N/ARecruiting

Evaluation of 1-Year Clinical Outcomes With Early Inclisiran Initiation in Post-MI Patients

Started Sep 2025
300 enrolled
Myocardial Infarction
NCT06770543N/ARecruiting

Leqvio rPMS (Regulatory Post-Marketing Surveillance in Korea)

Started Aug 2025
1,500 enrolled
Primary Hypercholesterolemia or Mixed Dyslipidemia
NCT06909565Phase 4Recruiting

Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention

Started Jul 2025
6,000 enrolled
Percutaneous Coronary InterventionPeripheral Endovascular Intervention
NCT06941792Phase 4Active Not Recruiting

Inclisiran Effectiveness in China: a Pragmatic Randomized Trial

Started Jun 2025
1,590 enrolled
Coronary Heart Disease

Loss of Exclusivity

LOE Date
Aug 25, 2036
127 months away
Patent Expiry
Aug 25, 2036
Exclusivity Expiry
Feb 12, 2029

Patent Records (5)

Patent #ExpiryTypeUse Code
8809292
May 10, 2027
SubstanceProduct
U-4249
8222222
Dec 29, 2027
U-4414
10131907
Aug 24, 2028
SubstanceProduct
U-4414
10806791
Dec 4, 2028
Substance
9370582
Dec 4, 2028
SubstanceProduct
U-4249