Also known as: Leqvio
Inclisiran is a small interfering RNA (siRNA) therapy targeting PCSK9 mRNA to lower LDL cholesterol. It is marketed under the brand name Leqvio and used as an adjunct to diet and exercise in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia. The FDA first approved Leqvio on December 22, 2021.
Alnylam Pharmaceuticals entered a $1.23 billion discovery collaboration with Tenaya Therapeutics to identify up to 15 novel genetic targets for heart disease. The agreement includes $10 million upfront and up to $1.13 billion in milestone payments.
The cardiovascular biologics market is projected to reach $4.23 billion by 2033, while the cell therapy market is expected to reach $5.38 billion by 2032, driven by RNA-based therapies and regulatory approvals.
A review in The Lancet highlights emerging long-acting injectable therapies for hypertension that could reduce treatment to two doses annually instead of daily pills, with several candidates now in late-stage clinical trials.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07581808 |
Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Secondary Prevention |
NOT_YET_RECRUITING | PHASE4 |
| NCT07102628 |
Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes |
RECRUITING | PHASE3 |
| NCT06858332 |
Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia |
RECRUITING | |
| NCT06813911 |
Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD |
RECRUITING | PHASE3 |
| NCT06597019 |
Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia |
RECRUITING | PHASE3 |
| NCT06597006 |
Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia |
RECRUITING | PHASE3 |
| NCT06586684 |
Effect of Small Interfering RNA Inclisiran on Carotid Plaques As Assessed by Carotid Ultrasound |
NOT_YET_RECRUITING | PHASE4 |
| NCT06494501 |
The Prevent Coronary Artery Disease Trial |
RECRUITING | PHASE3 |
| NCT06421363 |
Continuity of Care Between Primary Care Cardiology and Specialty Services for Patients With Chronic Ischemic Heart Disease |
NOT_YET_RECRUITING | PHASE4 |
| NCT06386419 |
A Clinical Study to Evaluate the Safety and Effectiveness of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia |
COMPLETED | PHASE4 |
