To Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Diabetic Peripheral Neuropathic Pain

Summary

Investigate the efficacy and safety of HSK16149 capsules in Chinese diabetic peripheral neuropathic pain (DPNP) following 13 weeks treatment in comparison to placebo.

Timeline

Start

2020-12-02

Primary completion

2022-11-09

Completion

2022-11-16

Outcome

Met primary endpoint

paper showing statistical significance for both HSK16149 doses vs placebo (both P < .001). PMID 39158916 ↗

paper The efficacy of HSK16149 capsules was superior to placebo in all groups for relieving DPNP PMID 39158916 ↗

Publications

• Pan T, Ma J, Li Y, Wang K, Jiang C, Zhang Y, Liu J, Du R, Zhang W, Bian F, Zhang F, Wang L, Pang S, Ning T, Wang B, Li Y, Wu X, Zhang K, Tang X, Hu H, Sun X, Li P, Cheng Z, Sun J, Yang J, Wang Y, Gao J, Mao H, Li F, Huang Q, Li Y, Peng Z, Guo X. Rapid Onset of Pain Relief with Crisugabalin in Patients with Diabetic Peripheral Neuropathic Pain: Findings from a Multicenter, Randomized, Double-Blind, Controlled Study. Pain Ther. 2025 Aug;14(4):1311-1329. doi: 10.1007/s40122-025-00745-3. Epub 2025 May 16.
• Guo X, Zhang T, Yuan G, Zeng W, Hu Q, Ma J, Li Y, Li H, Zhang Y, Liu J, Bian F, Zhang W, Zhang F, Pang S, Li Y, Wu X, Tang X, Zhang K, Pan T, Hu H, Cheng Z, Wang Y, Gao J, Sun J. GABA Analogue HSK16149 in Chinese Patients With Diabetic Peripheral Neuropathic Pain: A Phase 3 Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2425614. doi: 10.1001/jamanetworkopen.2024.25614.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	HSK16149	Unknown	20 mg	Oral
Subject	HSK16149	Unknown	40 mg	Oral
Subject	HSK16149	Unknown	60 mg	Oral
Subject	HSK16149	Unknown	80 mg	Oral
Comparator	Pregabalin	Small molecule	150 mg	Oral

Indications