NDASUBCUTANEOUSSOLUTION
Approved
Dec 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LEQVIO (inclisiran) is an oligonucleotide therapeutic that uses RNA interference to reduce PCSK9 production, thereby lowering LDL cholesterol. It is administered as a subcutaneous injection for patients with elevated cholesterol who require additional lipid-lowering therapy. The drug represents a novel mechanism within cardiovascular disease management.
$11MPart D
Peak10.2 years to LOEEarly-stage adoption with modest Medicare spending indicates growth phase; commercial teams are likely focused on clinician education and payer access strategies rather than large-scale peak-phase operations.
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)
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 Jun 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
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
Evaluation of 1-Year Clinical Outcomes With Early Inclisiran Initiation in Post-MI Patients
Started Sep 2025
300 enrolled
Myocardial Infarction
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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.