NDASUBCUTANEOUSSOLUTION
Approved
Dec 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LEQVIO (inclisiran) is an oligonucleotide (RNA-based) therapeutic that lowers LDL cholesterol by inhibiting PCSK9 protein production in the liver. It is administered as a subcutaneous injection for patients with elevated LDL cholesterol, particularly those with familial hypercholesterolemia or established cardiovascular disease. The drug represents a novel non-statin mechanism for cholesterol management.
$11MPart D
Peak9.9 years to LOEProduct is at peak commercial stage with modest uptake; commercial team is likely mature but focused on market expansion and reimbursement optimization.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Early Intensive Lipid-Lowering With Inclisiran for Plaque Stabilization in Acute Coronary Syndrome
Started Sep 2026
294 enrolled
Acute Coronary Syndromes (ACS)
Comparative Assessment of Inclisiran on Top of Standard of Care Versus Standard of Care Alone for LDL-C Evaluation in Acute Coronary Syndrome Patients in Saudi Arabia
Started Jun 2026
300 enrolled
Acute Coronary Syndrome
Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Formulation of Inclisiran Containing Polysorbate 80 Compared to the Currently Marketed Formulation
Started Jun 2026
120 enrolled
Inclisiran Formulation
A Study to Evaluate the Pharmacodynamics of a Combination of QCZ484 and Inclisiran in Participants With Hypertension and Concomitant Hypercholesterolemia
Started May 2026
120 enrolled
Hypercholesterolaemia
A Real-World Study of Long-Term Adherence and Persistence to Inclisiran, Evolocumab, and Alirocumab
Started Apr 2026
5,995 enrolled
Cardiovascular DiseasesAtherosclerotic Cardiovascular DiseaseHypercholesterolemia, Familial
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.