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HSK21542 in patients with postoperative pain: two phase 3, multicentre, double-blind, randomized, controlled trials

Author

Listed:
  • Yinbo Zhong

    (Second Affiliated Hospital of Zhejiang University School of Medicine)

  • Younian Xu

    (Huazhong University of Science and Technology)

  • Qian Lei

    (University of Electronic Science and Technology of China)

  • Mengchang Yang

    (The Third People’s Hospital of Chengdu)

  • Saiying Wang

    (The Third Xiangya Hospital of Central South University)

  • Xiaoling Hu

    (The First Affiliated Hospital of University of South China)

  • Haihui Xie

    (Dongguan People’s Hospital (The Tenth Affiliated Hospital of Southern Medical University))

  • Yalan Li

    (The First Clinical Medical College of Jinan University))

  • Zhong Qin

    (Wuxi People’s Hospital)

  • Zhengfeng Gu

    (Wuxi People’s Hospital)

  • Jiaqiang Zhang

    (Henan Provincial People’s Hospital)

  • Yuexin Wang

    (Cangzhou People’s Hospital)

  • Jinglei Wu

    (Liuzhou People’s Hospital Affiliated to Guangxi Medical University)

  • Haiying Wang

    (Second Affiliated Hospital of Zhejiang University School of Medicine)

  • Yue Ming

    (Second Affiliated Hospital of Zhejiang University School of Medicine)

  • Zhongyuan Xia

    (Renmin Hospital of Wuhan University)

  • Haoyu Zhai

    (The First People’s Hospital of Guangyuan)

  • Ke Jiang

    (The Affiliated Hospital of Guizhou Medical University)

  • Peng Zhang

    (Yibin Second People’s Hospital)

  • Zhiping Wang

    (Affiliated Hospital of Xuzhou Medical University)

  • Liangrong Wang

    (The First Affiliated Hospital of Wenzhou Medical University)

  • Lin Li

    (General Hospital of the Northern Theater Command of Chinese PLA)

  • Zhigang Cheng

    (Xiangya Hospital Central South University)

  • Huayong Jiang

    (Shaoxing People’s Hospital)

  • Guonian Wang

    (The Fourth Hospital of Harbin Medical University)

  • Jingli Chen

    (Huazhong University of Science and Technology)

  • Zhibin Zhao

    (The First People’s Hospital of Lianyungang)

  • Xiangdong Chen

    (Huazhong University of Science and Technology)

  • Min Yan

    (Second Affiliated Hospital of Zhejiang University School of Medicine)

Abstract

HSK21542, a peripherally restricted kappa opioid receptor agonist, was evaluated for efficacy and safety in patients with postoperative pain following abdominal surgery. This was assessed in two phase 3, multicentre, randomized, double-blind, controlled trials (HSK21542-301 [ClinicalTrials.gov identifier, NCT04738357] and HSK21542-303 [ClinicalTrials.gov identifier, NCT05390905]) in China. HSK21542-301 was a dual-arm study comparing HSK21542 1.0 μg/kg with placebo, while HSK21542-303 involved three arms comparing HSK21542 1.0 μg/kg with tramadol 50 mg/dose and placebo. All treatments were administered intravenously. The primary endpoint was the time-weighted summed pain intensity differences over 24 h (SPID0-24 h). Both HSK21542-301 (least squares [LS] mean [± standard error], −39.1 [1.88] vs −27.4 [1.89]; P

Suggested Citation

  • Yinbo Zhong & Younian Xu & Qian Lei & Mengchang Yang & Saiying Wang & Xiaoling Hu & Haihui Xie & Yalan Li & Zhong Qin & Zhengfeng Gu & Jiaqiang Zhang & Yuexin Wang & Jinglei Wu & Haiying Wang & Yue Mi, 2025. "HSK21542 in patients with postoperative pain: two phase 3, multicentre, double-blind, randomized, controlled trials," Nature Communications, Nature, vol. 16(1), pages 1-13, December.
    • Handle: RePEc:nat:natcom:v:16:y:2025:i:1:d:10.1038_s41467-025-60013-y
    DOI: 10.1038/s41467-025-60013-y
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