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Peer-reviewedCC BY-NC-ND 4.0Diabetes, Obesity & Metabolism

Efficacy and Safety of Crisugabalin for Inadequately Controlled Diabetic Peripheral Neuropathic Pain: A Randomized, Active‐Controlled, Phase 2 Trial

  • Yaming Li1
  • Fang Zhang2
  • Wei Liu3
  • Xiuhai Su4
  • Bin Zhou5
  • Na Xu6
  • Junjie Shang7
  • Chen Fang8
  • Liujun Fu9
  • Fangqiong Li10
  • Chao Zheng11
  • Jinyou Duan1
11 affiliations
  1. 1Shaanxi Key Laboratory of Natural Products & Chemical Biology College of Chemistry & Pharmacy, Northwest A&F University Xianyang Shaanxi Province China
  2. 2Department of Endocrinology Kaifeng Hospital of Traditional Chinese Medicine Kaifeng Henan Province China
  3. 3Department of Endocrinology Yongzhou Central Hospital Yongzhou Hunan Province China
  4. 4Department of Endocrinology Cangzhou Integrated Traditional Chinese and Western Medicine Hospital Cangzhou Hebei Province China
  5. 5Department of Endocrinology Shaoyang Central Hospital Shaoyang Hunan Province China
  6. 6Department of Endocrinology Nanyang Central Hospital Nanyang Henan Province China
  7. 7Department of Endocrinology Nanyang Second People's Hospital Nanyang Henan Province China
  8. 8Department of Endocrinology Suzhou Ninth People's Hospital Suzhou Jiangsu Province China
  9. 9Department of Endocrinology The First Affiliated Hospital of Henan University of Science and Technology Luoyang Henan Province China
  10. 10Haisco Pharmaceutical Group Co., Ltd. Chengdu Sichuan Province China
  11. 11Department of Endocrinology The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang Province China
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Abstract

Aims: Crisugabalin (HSK16149), a selective γ‐aminobutyric acid (GABA) analog, has shown preliminary efficacy in controlling diabetic peripheral neuropathic pain (DPNP), but efficacy in patients with inadequate response to prior pregabalin treatment remains unknown.

Materials and Methods: This multicentre randomized controlled trial was conducted from April 18, 2024 to July 18, 2024. Adults patients with DPNP and inadequate response to pregabalin were randomized at a 1:1 ratio to receive crisugabalin (40 mg/day) or pregabalin (300 mg/day) for 4 weeks. The primary endpoint was the mean change of SF‐MPQ pain score from baseline to 4 weeks of treatment.

Results: Ninety‐three patients were randomized: 47 and 46 in the crisugabalin and pregabalin groups, respectively. The efficacy analysis included 90 patients (mean age, 58.9 years; 49 men). The least square mean (LSM) difference in the mean change of SF‐MPQ pain score was −7.2 (95% CI: −12.4, −2.0; ANCOVA p = 0.007) between the two groups. The rate of treatment‐emergent adverse events was 29.5% (13/44) and 47.8% (22/46) in the crisugabalin and pregabalin groups, respectively.

Conclusions: Treatment with crisugabalin 40 mg/day resulted in greater pain reduction in comparison to pregabalin 300 mg/day over a period of 4 weeks in DPNP patients with inadequate response to prior pregabalin treatment.

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Cite

BibTeXRIS
BibTeX
@article{li2026efficacy,
  title = {{Efficacy and Safety of Crisugabalin for Inadequately Controlled Diabetic Peripheral Neuropathic Pain: A Randomized, Active‐Controlled, Phase 2 Trial}},
  author = {Yaming Li and Fang Zhang and Wei Liu and Xiuhai Su and Bin Zhou and Na Xu and Junjie Shang and Chen Fang and Liujun Fu and Fangqiong Li and Chao Zheng and Jinyou Duan},
  journal = {Diabetes, Obesity \& Metabolism},
  year = {2026},
  month = oct,
  doi = {10.1111/dom.71401},
  url = {https://doi.org/10.1111/dom.71401},
  note = {CC BY-NC-ND 4.0},
}
RIS
TY  - JOUR
TI  - Efficacy and Safety of Crisugabalin for Inadequately Controlled Diabetic Peripheral Neuropathic Pain: A Randomized, Active‐Controlled, Phase 2 Trial
AU  - Yaming Li
AU  - Fang Zhang
AU  - Wei Liu
AU  - Xiuhai Su
AU  - Bin Zhou
AU  - Na Xu
AU  - Junjie Shang
AU  - Chen Fang
AU  - Liujun Fu
AU  - Fangqiong Li
AU  - Chao Zheng
AU  - Jinyou Duan
PY  - 2026
DA  - 2026/10/02
JO  - Diabetes, Obesity & Metabolism
DO  - 10.1111/dom.71401
UR  - https://doi.org/10.1111/dom.71401
AB  - Aims: Crisugabalin (HSK16149), a selective γ‐aminobutyric acid (GABA) analog, has shown preliminary efficacy in controlling diabetic peripheral neuropathic pain (DPNP), but efficacy in patients with inadequate response to prior pregabalin treatment remains unknown.  Materials and Methods: This multicentre randomized controlled trial was conducted from April 18, 2024 to July 18, 2024. Adults patients with DPNP and inadequate response to pregabalin were randomized at a 1:1 ratio to receive crisugabalin (40 mg/day) or pregabalin (300 mg/day) for 4 weeks. The primary endpoint was the mean change of SF‐MPQ pain score from baseline to 4 weeks of treatment.  Results: Ninety‐three patients were randomized: 47 and 46 in the crisugabalin and pregabalin groups, respectively. The efficacy analysis included 90 patients (mean age, 58.9 years; 49 men). The least square mean (LSM) difference in the mean change of SF‐MPQ pain score was −7.2 (95% CI: −12.4, −2.0; ANCOVA p = 0.007) between the two groups. The rate of treatment‐emergent adverse events was 29.5% (13/44) and 47.8% (22/46) in the crisugabalin and pregabalin groups, respectively.  Conclusions: Treatment with crisugabalin 40 mg/day resulted in greater pain reduction in comparison to pregabalin 300 mg/day over a period of 4 weeks in DPNP patients with inadequate response to prior pregabalin treatment.
SN  - 1462-8902
SN  - 1463-1326
ER  -