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. 2025 Aug;14(4):1311-1329.
doi: 10.1007/s40122-025-00745-3. Epub 2025 May 16.

Rapid Onset of Pain Relief with Crisugabalin in Patients with Diabetic Peripheral Neuropathic Pain: Findings from a Multicenter, Randomized, Double-Blind, Controlled Study

Tianrong Pan  1 , Jianhua Ma  2 , Yukun Li  3 , Kailiang Wang  4 , Chengxia Jiang  5 , Yawei Zhang  6 , Jie Liu  7 , Ruiqin Du  8 , Wei Zhang  9 , Fang Bian  10 , Fang Zhang  11 , Lijun Wang  12 , Shuguang Pang  13 , Tao Ning  14 , Bangqiong Wang  15 , Ya Li  16 , Xiaohong Wu  17 , Keqin Zhang  18 , Xulei Tang  19 , Honglin Hu  20 , Xin Sun  21 , Ping Li  22 , Zhifeng Cheng  23 , Jia Sun  24 , Jing Yang  25 , Yanjun Wang  26 , Jialin Gao  27 , Hong Mao  28 , Fangqiong Li  29 , Qin Huang  29 , Yaming Li  29 , Zhixin Peng  29 , Xiaohui Guo  30
Affiliations

Rapid Onset of Pain Relief with Crisugabalin in Patients with Diabetic Peripheral Neuropathic Pain: Findings from a Multicenter, Randomized, Double-Blind, Controlled Study

Tianrong Pan et al. Pain Ther. 2025 Aug.

Abstract

Introduction: This study aims to evaluate the efficacy and safety of Crisugabalin in patients with diabetic peripheral neuropathic pain (DPNP), with a focus on its rapid onset of action.

Methods: All the analyses in this study were based on data from a phase 2/3 adaptive randomized clinical trial that enrolled 596 patients. Participants were categorized into four treatment groups according to the intervention received: Crisugabalin 40 mg/day, Crisugabalin 80 mg/day, placebo, and Pregabalin 300 mg/day. The primary endpoint was the change in the average daily pain score (ADPS) over a 13-week treatment period. Secondary endpoints included changes in the Numeric Rating Scale (NRS) and the daily sleep interference score (DSIS) during the first two weeks of treatment.

Results: Both Crisugabalin treatment groups (40 mg/day and 80 mg/day) demonstrated statistically significant reductions in ADPS compared to the placebo group starting from week 1 and continuing through week 13 (P < 0.05). Significant differences in pain relief for the Pregabalin group were observed only from week 6. Improvements in NRS and DSIS scores were also noted in both Crisugabalin groups, with statistically significant enhancements evident as early as day 2 of administration. Safety assessments indicated that Crisugabalin was well-tolerated, with a low incidence of serious adverse events and no significant increase in dropout rates among participants.

Conclusion: The findings suggest that Crisugabalin offers effective pain relief with an acceptable safety profile, highlighting its rapid onset in patients with DPNP.

Clinical trial registration: Clinical trial registration number derived from our parent project, we have retained the original registration identifier: NCT04647773.

Keywords: Crisugabalin; Diabetic peripheral neuropathic pain (DPNP); Pain relief; Pregabalin; Rapid onset.

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Conflict of interest statement

Declarations. Conflict of interest: Fangqiong Li, Qin Huang, Yaming Li, and Zhixin Peng are full-time employees of Haisco Pharmaceutical Group Co., Ltd., the sponsor of this study. All other co-authors (Tianrong Pan, Jianhua Ma, Yukun Li, Kailiang Wang, Chengxia Jiang, Yawei Zhang, Jie Liu, Ruiqin Du, Wei Zhang, Fang Bian, Fang Zhang, Lijun Wang, Shuguang Pang, Tao Ning, Bangqiong Wang, Ya Li, Xiaohong Wu, Keqin Zhang, Xulei Tang, Honglin Hu, Xin Sun, Ping Li, Zhifeng Cheng, Jia Sun, Jing Yang, Yanjun Wang, Jialin Gao, Hong Mao, and Xiaohui Guo) declare no conflicts of interest relevant to this manuscript. Ethical Approval: The study was approved by the ethics committees or institutional review boards of the leading unit (the First Hospital of Peking University, Beijing, China) and other subcenters. This study was performed in accordance with the Helsinki Declaration of 1964 and its later amendments. Participants provided their consent by signing a written informed consent form.

Figures

Fig.1
Fig.1
Average daily pain score (ADPS) change from baseline, Weeks 1–13: a statistically significant difference between Crisugabalin 40 mg/day and placebo; b statistically significant difference between Crisugabalin 80 mg/day and placebo; c statistically significant difference between Pregabalin and placebo. A P value of < 0.05 is considered statistically significant
Fig.2
Fig.2
Numeric Rating Scale (NRS; A) and daily sleep interference score (DSIS; B) change from baseline, Days 1–14. a statistically significant difference between Crisugabalin 40 mg/day and placebo; b statistically significant difference between Crisugabalin 80 mg/day and placebo; c statistically significant difference between Pregabalin and placebo. A P value of < 0.05 is considered statistically significant
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