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

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 Ming, Zhongyuan Xia, Haoyu Zhai, Ke Jiang, Peng Zhang, Zhiping Wang, Liangrong Wang, Lin Li, Zhigang Cheng, Huayong Jiang, Guonian Wang, Jingli Chen, Zhibin Zhao, Xiangdong Chen () and Min Yan ()
Additional contact information
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

Nature Communications, 2025, vol. 16, issue 1, 1-13

Abstract: 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

Date: 2025
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DOI: 10.1038/s41467-025-60013-y

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