Pharmacokinetics and pharmacodynamics of inclisiran, a small interfering RNA therapy, in patients with hepatic impairment
Open accessAbstract
BACKGROUND: Inclisiran, a small interfering RNA molecule, reduces low-density lipoprotein cholesterol (LDL-C) by inhibiting production of proprotein convertase subtilisin/kexin type 9 (PCSK9) in the liver. OBJECTIVE: To investigate the pharmacokinetics, pharmacodynamics, and safety of inclisiran in patients with mild or moderate hepatic impairment (HI) vs participants with normal hepatic function (NHF). METHODS: In this single-center, open-label, parallel-group study, patients with mild (Child-Pugh A) or moderate (Child-Pugh B) HI and with NHF, matched by age, body mass index, sex, and race (if possible), received a single subcutaneous therapeutic dose of inclisiran (300 mg). Pharmacokinetic profiles, pharmacodynamic endpoints (PCSK9 and LDL-C), and safety were assessed. RESULTS: Twenty-eight participants completed the study (mild HI: n = 10; moderate HI: n = 6; NHF: n = 12). Inclisiran achieved maximum plasma concentration at 4-6 h and was undetectable in plasma at 48 h in most participants, irrespective of liver function. Inclisiran exposure was 1.24-fold higher in the mild HI vs NHF groups (90% confidence interval [CI] 1.01-1.53) and 2.03-fold higher in the moderate HI vs NHF groups (90% CI 1.60-2.58). LDL-C and PCSK9 plasma levels decreased from baseline up to the last assessment on Day 60 in all groups, with a similar response in NHF and mild HI groups but a less pronounced and more varied decrease in the moderate HI group. Inclisiran was generally safe and well tolerated. CONCLUSION: The pharmacokinetic exposure of inclisiran increased by up to two fold in patients with moderate HI compared with those with NHF, while pharmacodynamic effects remained relatively unchanged. Inclisiran is generally safe and well tolerated in patients with mild or moderate HI, with no dose adjustment needed. However, a larger, long-term clinical trial would help to further evaluate the long-term safety profile of inclisiran in patients with liver disease.
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Inclisiran rapidly starts working because PCSK9 levels decrease substantially during the initial days after administration.
“Pharmacokinetic analysis shows Inclisiran rapidly starts working because PCSK9 levels decrease substantially during the initial days after administration [22, 23].”
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 [22]
The PD section and Table 4 (page unavailable) report substantial PCSK9 reductions by Day 30 after inclisiran administration. Although the Assessments section lists PCSK9 measurements at 48 hours and Days 5 and 7, the retrieved passages do not report substantial reductions during those initial days, so the claimed rapid onset is not established by the available text. (LLM, conf=0.84)
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Badri, P. S., Kolachana, K., Duong, A., Lasko, M. J., Nandi, T., Mehrotra, N., & Robbie, G. J. (2025) · Clinical Pharmacokinetics · doi:10.1007/s40262-025-01606-0 · Cited by 2 · see citing works
Zadeh, S. S. T., Toth, P. P., & Banach, M. (2026) · Frontiers in Pharmacology · doi:10.3389/fphar.2026.1789019 · Cited by 2 · see citing works
Eficacia, beneficio y seguridad de inclisiran
López‐Miranda, J. (2024) · Clínica e Investigación en Arteriosclerosis · doi:10.1016/j.arteri.2024.07.003 · Cited by 1 · see citing works
Accelerating drug discovery with mass spectrometry-driven bioanalytical innovations and beyond
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Inclisiran: Small Interfering Ribonucleic Acid Injectable for the Treatment of Hyperlipidemia
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Research Progress of Inclisiran
王, 玉. (2022) · Advances in Clinical Medicine · doi:10.12677/acm.2022.1281061
Inclisiran — lipid-lowering drug using RNA therapy. Hypolipidemic potential
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Inclisiran - hope in the fight against dyslipidemia
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New drugs for treating dyslipidemias. From small molecules to small interfering RNAs
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3) SiRNA Drug Inclisiran for Lowering Serum LDL-cholesterol Levels
Yamashita, S. (2024) · Nihon Naika Gakkai Zasshi · doi:10.2169/naika.113.1572
Inclisiran for children: is it worth it?
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Inclisiran—will it fulfill its promise?
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- Authors
- Kallend, D., Stoekenbroek, R., He, Y., Smith, P. F., & Wijngaard, P.
- Affiliations
- Certara (United States) (US)
- Corresponding author
- He, YanLing
- Venue
- Journal of Clinical Lipidology
- Publisher
- Elsevier BV
- Published
- 2022-03
- Volume
- 16
- Issue
- 2
- Pages
- 208-219
- ISSN
- 1876-4789 (ISSN-L)
- 1933-2874
- OpenAlex
- W4205949466
- Cited by
- 73
- References
- 26
- Citations by year
- 2026: 8 · 2025: 13 · 2024: 21 · 2023: 20 · 2022: 11
- FWCI
- 15.60
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Journal of clinical lipidology (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Funders
- Novartis Pharmaceuticals Corporation
- Medicines Company
- Novartis Institutes for BioMedical Research
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipid metabolism and disorders
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmacogenetics and Drug Metabolism
- Keywords
- inclisiran, siRNA, liver dysfunction, pharmacokinetics, pharmacodynamics, PCSK9 inhibition, LDL cholesterol lowering, liver function, drug exposure, safety and tolerability, dose adjustment
- MeSH terms
- Proprotein Convertase 9, Humans, Cholesterol, LDL, Liver Diseases, RNA, Small Interfering
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