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Last update 16 May 2025
HSK-31858
Last update 16 May 2025
Overview
Basic Info
Drug Type Small molecule drug |
Synonyms HSK 31858, HSK-31858, HSK31858 |
Target |
Action inhibitors |
Mechanism DPP-1 inhibitors(Cathepsin C inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Inactive Organization- |
License Organization |
Drug Highest PhasePhase 3 |
First Approval Date- |
RegulationBreakthrough Therapy (China) |
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Related
12
Clinical Trials associated with HSK-31858NCT06820749
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of HSK31858 Tablets in Patients with Airway Mucus Hypersecretion in Chronic Airway Inflammatory Diseases
CTR20243919
在健康受试者中评价利福平对HSK31858药代动力学影响的单中心、开放、两周期、固定序列临床研究
[Translation] A single-center, open-label, two-period, fixed-sequence clinical study to evaluate the effect of rifampicin on the pharmacokinetics of HSK31858 in healthy subjects
NCT06637254
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of HSK31858 Tablets in Patients with Bronchial Asthma
100 Clinical Results associated with HSK-31858
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100 Translational Medicine associated with HSK-31858
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100 Patents (Medical) associated with HSK-31858
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2
Literatures (Medical) associated with HSK-3185801 May 2025Lancet Respiratory Medicine
Effects of the DPP-1 inhibitor HSK31858 in adults with bronchiectasis in China (SAVE-BE): a phase 2, multicentre, double-blind, randomised, placebo-controlled trial
Article
Author: Huang, Zeng-yu ; Xu, Xing-xiang ; Li, Fang-qiong ; Xie, Shi-guang ; Ye, Huan ; Wu, Xiao-fei ; Xie, Shi-Guang ; Lin, Ying-xiang ; Xu, Xing-Xiang ; Liu, Han-mo ; Zhong, Nan-shan ; Zhang, Xian-ming ; Zhong, Nan-Shan ; Zhang, Xiao-ju ; Lin, Dian-Jie ; Qiu, Rong ; Xiong, Hao ; Chalmers, James D ; Zhang, Xian-Ming ; Zheng, Yao ; Lin, Dian-jie ; Huang, Yan-ming ; Guan, Wei-jie ; Yang, Zhi-Ren ; Li, Fang-Qiong ; Xu, Jin-fu ; Huang, Yan-Ming ; Shen, Yao ; Xiao, Zu-ke ; Xu, Jin-Fu ; Guan, Wei-Jie ; Zhao, Li ; Zhang, Guo-jun ; Li, Yuan-yuan ; Song, Yuan-lin ; Gao, Ling-yun ; Cao, Jie ; Gao, Ling-Yun ; Li, Ya-ming ; Yang, Zhi-ren ; Zhou, Hua ; Wen, Fu-qiang ; Qu, Jie-ming ; Chalmers, James Duncan ; Xiao, Zu-Ke ; Wang, Ling-wei
BACKGROUND:
Airway neutrophil inflammation with excessive neutrophil serine proteases is implicated in frequent exacerbations of bronchiectasis. HSK31858 is a novel reversible inhibitor of DPP-1. We aimed to assess the efficacy and safety of HSK31858 in decreasing the frequency of bronchiectasis exacerbations among adults with bronchiectasis.
METHODS:
SAVE-BE was a phase 2, double-blind, randomised, placebo-controlled trial in 25 tertiary centres in China. Participants were aged 18 years or older with a physician diagnosis of bronchiectasis, according to chest high-resolution CT showing bronchial dilatation and compatible respiratory symptoms, and at least two exacerbations within 12 months before screening. Participants were randomly assigned (1:1:1) via a central interactive web-response system to receive 20 mg HSK31858, 40 mg HSK31858, or placebo, orally, once daily for 24 weeks. Randomisation was stratified by exacerbation frequency in the previous year (less than three vs three or more annually) and study investigators and participants were masked to group assignment for analysis of study outcomes. The primary endpoint was the annualised exacerbation frequency over 24 weeks, assessed in the full analysis set. Safety was monitored throughout the study. This trial is registered with ClinicalTrials.gov, NCT05601778.
FINDINGS:
Between Dec 6, 2022, and March 31, 2024, 292 patients were screened, 226 of whom were enrolled and randomly assigned (75 to the 20 mg HSK31858 group, 76 to the 40 mg HSK31858 group, and 75 to the placebo group. 74 patients received 20 mg HSK31858, 75 received 40 mg HSK31858, and 75 received placebo and were included in the full analysis set. In the full analysis set, 136 (61%) participants were female and 88 (39%) were male. The mean annualised frequency of exacerbations was 1·00 per person-year (SD 1·44) in the 20 mg HSK31858 group, 0·75 per person-year (1·37) in the 40 mg HSK31858 group, and 1·88 per person-year (1·97) in the placebo group. The least-squares mean frequency of exacerbations was 1·05 per person-year (95% CI 0·73-1·51) in the 20 mg HSK31858 group, 0·83 per person-year (0·55-1·25) in the 40 mg HSK31858 group, and 2·01 per person-year (1·53-2·63) in the placebo group. The incidence rate ratio compared with placebo was 0·52 (95% CI 0·34-0·80; p=0·0031) for the 20 mg HSK31858 group and 0·41 (0·26-0·66; p=0·0002) for the 40 mg HSK31858 group. The incidence of adverse events was similar across the three groups. Neither HSK31858 dose was associated with an increased incidence of adverse events of special interest (eg, hyperkeratosis, gingivitis, or life-threatening infections).
INTERPRETATION:
Both HSK31858 doses improved clinical outcomes in adults with bronchiectasis, significantly reducing the exacerbation frequency compared with placebo. The development of new drugs targeted at amelioration of neutrophilic inflammation (eg, via suppression of DPP-1 activity) might lead to new options for hindering the progression of bronchiectasis.
FUNDING:
Haisco.
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
Safety, tolerability, pharmacokinetics and pharmacodynamics of HSK31858, a novel oral dipeptidyl peptidase‐1 inhibitor, in healthy volunteers: An integrated phase 1, randomized, double‐blind, placebo‐controlled, single‐ and multiple‐ascending dose study
Article
Author: Hou, Jie ; Wu, Nan ; Wang, Lu ; Wang, Yuhao ; Chen, Meixia ; Liu, Hanmo ; Yu, Chao ; Hu, Mengyue
Abstract:
Aim:
Dipeptidyl peptidase‐1 (DPP‐1) inhibitors have been studied for the treatment of neutrophil‐mediated inflammatory diseases including bronchiectasis, bronchial asthma and cystic fibrosis. This study evaluated the pharmacokinetics, pharmacodynamics, safety and tolerability of DPP‐1 inhibitor HSK31858 in healthy Chinese volunteers.
Methods:
Volunteers in Part A randomly received single doses of HSK31858 (15, 40, 60 and 80 mg) or placebo in fasted states. The 40‐mg cohort also received HSK31858 40 mg or placebo in fed states. In Part B, volunteers randomly received HSK31858 10, 20 and 40 mg or placebo once daily for 28 days in fasted states. The primary endpoints were safety and tolerability of HSK31858.
Results:
Among 38 volunteers in Part A and 36 in Part B, HSK31858 was well tolerated; no deaths, serious adverse events, or discontinuations due to adverse events occurred. The median Tmax was 0.75 to 1.0 h and the mean terminal t1/2 was 16.5 to 21.0 h in the fasted state with single doses of HSK31858. Both Cmax and AUC0‐t exhibited a dose‐dependent rise. Food had no effect on AUC. Multiple doses of HSK31858 demonstrated a similar pharmacokinetics profile, with about 2‐fold accumulation in AUC. HSK31858 dose‐dependently inhibited neutrophil count‐normalized neutrophil elastase (NEnorm) activity. The maximal percentage decrease in NEnorm activity relative to baseline during 28 days of HSK31858 treatments was 13.6% and 76.4% with HSK31858 10 and 40 mg once‐daily, respectively.
Conclusion:
HSK31858 was safe and well tolerated. The pharmacokinetics and pharmacodynamics profile of HSK31858 supports further clinical development for the treatment of neutrophil‐mediated inflammatory diseases.
Trial Registration:
NCT05663593.
2
News (Medical) associated with HSK-3185821 Nov 2023
License out/inPhase 2
100 Deals associated with HSK-31858
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R&D Status
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Non-cystic fibrosis bronchiectasis | Phase 3 | China | 26 Sep 2024 | |
| airway disease | Phase 2 | China | 10 Dec 2024 | |
| Pulmonary Disease, Chronic Obstructive | Phase 2 | China | 10 Dec 2024 | |
| Asthma | Phase 2 | China | 22 Oct 2024 | |
| Acute Lung Injury | Phase 1 | China | 28 Oct 2024 | |
| Respiratory Distress Syndrome, Acute | Phase 1 | China | 28 Oct 2024 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
Phase 1 | - | - | HSK31858 15 mg | wljvdtjmed(jdrdwqnpiw) = fwlnsdmyys gkvvupzngo (xlvcgzgidq ) View more | - | 02 Apr 2025 | |
HSK31858 40 mg | swblymgtyu(ucnckqinxv) = dnhrsopovk rvipsoyxvr (bbowlczbtm ) View more | ||||||
Phase 2 | 136 | HSK31858 20 mg | uatkxanwdu(pzzfrpyojf) = bijstwzfll xfqewkzyfm (glmfgiarfk, 1.44) | Positive | 25 Mar 2025 | ||
HSK31858 40 mg | uatkxanwdu(pzzfrpyojf) = eohxoiklyu xfqewkzyfm (glmfgiarfk, 1.37) | ||||||
NCT05663593 (ERS2023) Manual  | Phase 1 | - | ysdmiqlufl(zezcpzhgtl) = HSK31858 was absorbed rapidly, with no significant accumulation of Cmax, while AUC accumulation was more pronounced. There was dose-dependent inhibitory effect in whole blood NE activity, with maximum inhibition of 13.6%, 44.1%,and 76.4% in the 10mg,20mg, and 40mg groups, repectively. mlhgijueiy (ktptaierdf ) | Positive | 09 Sep 2023 |
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