Inclisiran—Safety and Effectiveness of Small Interfering RNA in Inhibition of PCSK-9
Open accessAbstract
Dyslipidemia is listed among important cardiovascular disease risk factors. Treating lipid disorders is difficult, and achieving desirable levels of LDL-cholesterol (LDL-C) is essential in both the secondary and primary prevention of cardiovascular disease. For many years, statins became the basis of lipid-lowering therapy. Nevertheless, these drugs are often insufficient due to their side effects and restrictive criteria for achieving the recommended LDL-C values. Even the addition of other drugs, i.e., ezetimibe, does not help one achieve the target LDL-C. The discovery of proprotein convertase subtilisin/kexin type 9 (PCSK9) discovery has triggered intensive research on a new class of protein-based drugs. The protein PCSK9 is located mainly in hepatocytes and is involved in the metabolism of LDL-C. In the beginning, antibodies against the PCSK9 protein, such as evolocumab, were invented. The next step was inclisiran. Inclisiran is a small interfering RNA (siRNA) that inhibits the expression of PCSK9 by binding specifically to the mRNA precursor of PCSK9 protein and causing its degradation. It has been noticed in recent years that siRNA is a powerful tool for biomedical research and drug discovery. The purpose of this work is to summarize the molecular mechanisms, pharmacokinetics, pharmacodynamics of inclisiran and to review the latest research.
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RISC stability within cells enables inclisiran to deliver a long-lasting pharmacodynamic response through infrequent dosing.
“The RNA-Induced Silencing Complex (RISC) maintains stability within cells which enables Inclisiran to deliver a long-lasting pharmacodynamic response through infrequent dosing [20].”
From Inclisiran SiRNA therapy for durable LDL-C reduction: a systematic review and meta-analysis highlighting a breakthrough in long-term cardiovascular risk management (2026) · cites this paper as [20]
Section 5 describes RISC’s role in RNA silencing and says inclisiran uses that mechanism, but does not state that RISC remains stable within cells. Sections 7 and 13 report sustained effects and dosing every six months; they do not attribute those effects to RISC stability. Page numbers were not provided in our copy. (LLM, conf=0.85)
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High on-treatment platelet reactivity to aspirin in patients after myocardial infarction
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Inclisiran, the billion-dollar drug, to lower LDL cholesterol – is it worth it?
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- Authors
- Wołowiec, Ł., Osiak, J., Wołowiec, A., Wijata, A., Grześk, E., Kozakiewicz, M., Banach, J., Nowaczyk, A., Nowaczyk, J., & Grześk, G.
- Affiliations
- Nicolaus Copernicus University (PL)
- Corresponding author
- Nowaczyk, Alicja
- ORCID
- Venue
- Pharmaceutics
- Publisher
- MDPI AG
- Published
- 2023-01-18
- Volume
- 15
- Issue
- 2
- Pages
- 323
- ISSN
- 1999-4923 (ISSN-L)
- PMC
- PMC9965021
- OpenAlex
- W4317425638
- Cited by
- 43
- References
- 112
- Citations by year
- 2026: 11 · 2025: 15 · 2024: 12 · 2023: 5
- FWCI
- 2.78
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Pharmaceutics (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › RNA Interference and Gene Delivery
- Health Sciences › Medicine › Surgery › Cholesterol and Lipid Metabolism
- Keywords
- inclisiran, siRNA, PCSK9 inhibition, LDL cholesterol lowering, dyslipidemia, cardiovascular disease prevention, ezetimibe, evolocumab
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