Inclisiran is a Antisense RNAi Oligonucleotide owned by Novartis, and is involved in 33 clinical trials, of which 13 were completed, 15 are ongoing, and 5 are planned.

Inclisiran is a RNAi therapeutic and acts by targeting PCSK9. It lowers tissue and circulating PCSK9 levels resulting in higher LDL receptor levels in the liver, and subsequently lower LDLc levels. The drug candidate by lowering LDLc levels aids in the treatment of disease.

The revenue for Inclisiran is expected to reach a total of $48.9bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Inclisiran NPV Report.

Inclisiran was originated by Alnylam Pharmaceuticals and is currently owned by Novartis.

Inclisiran Overview

Inclisiran (Leqvio, Sibrava) is a cholesterol-lowering agent. It is formulated as solution for subcutaneous route of administration. Leqvio is indicated in adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, as an adjunct to diet: in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. Leqvio is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of low-density lipoprotein cholesterol.

Inclisiran (ALN-PCSK9sc) is under development for the treatment of atherosclerotic cardiovascular disease, heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia, hyperlipidemia, atherosclerotic cardiovascular disease (ASCVD), acute coronary syndrome and elevated low-density lipoprotein-cholesterol (LDL-C). The drug candidate is administered through subcutaneous route. ALN-PCS is a RNAi therapeutic targeting intracellular and extracellular PCSK9. ALN-PCS incorporates RNA interference with LNP technology.

Novartis Overview

Novartis is a healthcare company that focuses on the discovery, development, manufacture and marketing of prescription and generic pharmaceutical products and eye care products. It provides drugs for the treatment of cancer, cardiovascular diseases, dermatological conditions, neurological disorders, ophthalmic and respiratory diseases, immune disorders, and infections, among others. The company offers generic medicines and biosimilars through Sandoz. Novartis conducts research in various disease areas through The Novartis Institutes for BioMedical Research (NIBR). The company operates through a network of subsidiaries and offices across the Americas, Europe, the Middle East, Africa, and Asia-Pacific. Novartis is headquartered in Basel, Switzerland.

The company reported revenues of (US Dollars) US$52,877 million for the fiscal year ended December 2021 (FY2021), an increase of 6% over FY2020. In FY2021, the company’s operating margin was 22.1%, compared to an operating margin of 20.3% in FY2020. In FY2021, the company recorded a net margin of 45.4%, compared to a net margin of 16.2% in FY2020. The company reported revenues of US$12,842 million for the third quarter ended September 2022, a decrease of 1.9% over the previous quarter.

Quick View – Inclisiran

Report Segments
  • Innovator (NME)
Drug Name
  • Inclisiran
Administration Pathway
  • Subcutaneous
Therapeutic Areas
  • Cardiovascular
  • Metabolic Disorders
Key Companies
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.