Diabetes and Vascular Disease

MON-651 - High-Dose Crisugabalin Significantly Improving the Pain Symptoms in Patients with Diabetic Peripheral Neuropathic Pain (DPNP)

Monday, June 15, 2026

9:00 AM - 2:00 PM CT

Location: ENDOExpo; Poster Floor

Abstract Poster Presenter(s)

YG

Yun Gao, MD

West China Hospital, Sichuan University
Chengdu, China (People's Republic)

Co-Author(s)

JY

Jixiang Ying, MD

West China Longquan Hospital Sichuan University, Chengdu, China
Chengdu, China (People's Republic)
CT

Cuixia Tan, MD

Chengdu First People's Hospital
Chengdu, China (People's Republic)
YY

Yi Yang, MD

Sichuan Provincial People's Hospital
Chengdu, China (People's Republic)
CD

Chunying Deng, MD

Fourth People's Hospital of Zigong City
Zigong, China (People's Republic)
YL

Yaming Li, M.M.

Haisco Pharmaceutical Group Co, Ltd.
Chengdu, China (People's Republic)
SY

Shiyu Yan, Ph.D.

Haisco Pharmaceutical Group Co, Ltd.
Chengdu, China (People's Republic)
WC

Wentao Chen, Master

Haisco Pharmaceutical Group Co, Ltd.
Chengdu, China (People's Republic)

Senior Author/Primary Investigator(s)

XR

Xingwu Ran, MD

West China Hospital, Sichuan University
Chengdu, China (People's Republic)

Introduction &

Objective: Dose titration challenges associated with conventional medications hinder the attainment and maintenance of optimal therapeutic doses in patients with diabetic peripheral neuropathic pain(DPNP), leading to suboptimal analgesia. Crisugabalin, an oral third-generation GABA analog and calcium channel modulator that has received National Medical Products Administration (NMPA) approval for the treatment of DPNP. This study explores the efficacy and safety of Crisugabalin (40/80/120/160 mg/d) in patients with DPNP, aiming to identify high-dose responsive subgroups and broaden the high-dose safety window through subgroup analysis.

Methods: This study utilized a multicenter, single-arm clinical design. Eligible patients were aged between 18 and 75 years, had been diagnosed with DPNP, and had a NRS pain score of 4 or higher. Starting from Day 1, participants were administered Crisugabalin at an initial dose of 40 mg/d. Based on efficacy and tolerability, the dose was gradually increased to 80 mg/d within 1 week. Participants were required to visit the hospital for follow-up at the end of each treatment week, during which pain relief was assessed. If pain relief was inadequate but the current dose was well-tolerated, dose escalation was initiated on the day of follow-up: the dose was increased from 80 mg/d to 120 mg/d, with a maximum escalation to 160 mg/d for maintenance treatment. The entire treatment course lasts for 4 weeks.

Results: The study plan was designed to recruit 120 participants, and 14 of them completed the study. At week 4, the mean change from baseline in the ADPS was -3.983 ± 1.556. Notably, the dosage of 9 participants was increased to the high-dose groups (120 or 160 mg/d). Crisugabalin also showed more significant improvements in the ADSIS scores and the weekly relative changes in ADPS compared with the baseline. These participants presented a superior response rate of NRS reduction ≥30% and ≥50% from the baseline compared with Phase III clinical studies, without an increase in the incidence or severity of TEAEs. These TEAEs were generally self-limiting, resolved without intervention.

Conclusion: Interim data suggest significant efficacy and a favorable safety profile of high-dose Crisugabalin in Chinese patients with DPNP.

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