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Considerations on the clinical pharmacology of small interfering RNA drugs
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Jiang-shuo LI1, 2, Jian-xiong ZHANG1, 2, Hang YIN1, 2, Rui-hua DONG1, 2, Jing-yi MA3, Shu-jie LIU3, Chun-min WEI3, Rui-rui HE3
Chinese Journal of Clinical Pharmacology | 2025, 41(9) : 1329 - 1334
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Chinese Journal of Clinical Pharmacology | 2025, 41(9): 1329-1334
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Considerations on the clinical pharmacology of small interfering RNA drugs
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Jiang-shuo LI1, 2, Jian-xiong ZHANG1, 2, Hang YIN1, 2, Rui-hua DONG1, 2, Jing-yi MA3, Shu-jie LIU3, Chun-min WEI3, Rui-rui HE3
Affiliations
  • 1.Department of Research Ward, Beijing Friendship Hospital Affiliated to Capital Medical University, Beijing 100050, China
  • 2.Beijing Key Laboratory of Early Clinical Evaluation of Nucleic Acid Products and Cell Therapy, Beijing 100050, China
  • 3.Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
Published: 2025-05-17 doi: 10.13699/j.cnki.1001-6821.2025.09.023
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Small interference RNA (siRNA) drugs have unique characteristics in molecular structure, mechanism of action and pharmacokinetic characteristics, presenting numerous challenges during the clinical research phase. This paper mainly presents the clinical pharmacology study of six siRNA drugs, that have been approved by the U.S. Food and Drug Administration, from the pharmacokinetic characteristics, drug-drug interactions, the special population with liver or kidney dysfunction, immunogenicity and cardiac safety etc. By the comprehensive overview of the early clinical pharmacology evaluation method of siRNA drugs, we hope to provide references for the design of early clinical trials and the translation of clinical research of siRNA drugs.

small interference RNA  /  N-acetylgalactosamine  /  pharmacokinetics  /  clinical pharmacology
Jiang-shuo LI, Jian-xiong ZHANG, Hang YIN, Rui-hua DONG, Jing-yi MA, Shu-jie LIU, Chun-min WEI, Rui-rui HE. Considerations on the clinical pharmacology of small interfering RNA drugs[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (9) : 1329 -1334 . DOI: 10.13699/j.cnki.1001-6821.2025.09.023
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Article Info
doi: 10.13699/j.cnki.1001-6821.2025.09.023
  • Receive Date：2024-11-10
  • Online Date：2026-08-04
  • Published：2025-05-17
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History
  • Received：2024-11-10
Funding
Affiliations
    1.Department of Research Ward, Beijing Friendship Hospital Affiliated to Capital Medical University, Beijing 100050, China
    2.Beijing Key Laboratory of Early Clinical Evaluation of Nucleic Acid Products and Cell Therapy, Beijing 100050, China
    3.Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
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小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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