A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients for Postoperative Pain Treatment

Phase 3 Completed 387 enrolled Haisco Pharmaceutical Group Co., Ltd.

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a multi-center, randomized, double-blind, placebo/active-controlled study. About 387 subjects undergoing elective abdominal operation under general anesthesia are planned to be enrolled and randomized into the HSK21542 group (129 subjects), tramadol group (129 subjects), and placebo group (129 subjects).

Timeline

Start: 2022-06-08
Primary completion: 2022-12-16
Completion: 2023-03-28

Outcome

Met primary endpoint

paper HSK21542-303 (-64.0 [2.25] vs -45.9 [2.25]; P < 0.001) demonstrated superiority of HSK21542 over placebo in terms of SPID0-24 h PMID 40413233 ↗

Publications

Zhong Y, Xu Y, Lei Q, Yang M, Wang S, Hu X, Xie H, Li Y, Qin Z, Gu Z, Zhang J, Wang Y, Wu J, Wang H, Ming Y, Xia Z, Zhai H, Jiang K, Zhang P, Wang Z, Wang L, Li L, Cheng Z, Jiang H, Wang G, Chen J, Zhao Z, Chen X, Yan M. HSK21542 in patients with postoperative pain: two phase 3, multicentre, double-blind, randomized, controlled trials. Nat Commun. 2025 May 24;16(1):4830. doi: 10.1038/s41467-025-60013-y.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	HSK21542	Peptide	1 ug/kg	Intravenous
Subject	Tramadol	Other / unclassified	50 mg	Intravenous

Indications

No indication recorded.