Delving into the Latest Updates on HSK-31858 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

CHF10196, HSK 31858, HSK-31858

+ [1]

Target

DPP-1

Action

inhibitors

Mechanism

DPP-1 inhibitors(Cathepsin C inhibitors)

Therapeutic Areas

Respiratory DiseasesImmune System DiseasesInfectious Diseases+ [1]

Active Indication

BronchiectasisNon-cystic fibrosis bronchiectasisairway disease+ [5]

Inactive Indication-

Originator Organization

Haisco Pharmaceutical Group Co., Ltd.

Active Organization

Haisco Pharmaceutical Group Co., Ltd.

CHIESI Farmaceutici SpA

Inactive Organization-

License Organization

Haisco Pharmaceutical Group Co., Ltd.

CHIESI Farmaceutici SpA

Drug Highest PhasePhase 3

First Approval Date-

RegulationBreakthrough Therapy (China)

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Structure/Sequence

Molecular FormulaC23H23FN4O4

InChIKeyONJDRXNRBKHINH-UWJYYQICSA-N

CAS Registry2762114-61-2

This study aims to find out whether the tablet CHF10196 is safe and effective for people with non-cystic fibrosis bronchiectasis, a long-term lung disease that causes widened airways, mucus buildup, infections, and flare ups of symptoms. The main goal is to see whether CHF10196 can reduce the number of lung flareups each year compared with placebo. The study will also assess whether it can improve lung function, quality of life, and overall safety.
The study has two phases. In the first phase, participants receive either CHF10196 tablets or placebo without knowing which one they are taking. In the second phase, all participants receive CHF10196 so its long-term safety can be further studied. Adults aged 18 to 85 years and adolescents aged 12 to under 18 years can take part, while continuing their usual stable bronchiectasis treatment.
Up to about 2.5 years of participation are planned. Around 904 participants will be enrolled, with regular clinic visits and phone check ins. In the first phase, participants take either CHF10196 or inactive tablets once daily; in the second phase, everyone takes CHF10196 once daily. Temporary treatment interruptions are allowed if needed, and participants who stop treatment early may still continue study visits, depending on the study phase.

Start Date01 Nov 2026

Sponsor / Collaborator

CHIESI Farmaceutici SpA

NCT07744386

/ Not yet recruitingPhase 1

An Open-label, Fixed-sequence, Non-randomized, Drug-drug Interaction Study to Evaluate the Effect of CHF10196 on the Pharmacokinetics of Dabigatran (P-gp Substrate) and Rosuvastatin (BCRP Substrate) in Healthy Male Participants.

The purpose of this study is to assess the potential drug-drug interaction of CHF10196 (a dipeptidyl peptidase 1 inhibitor) and its metabolite on the pharmacokinetics of dabigatran (a P-glycoprotein substrate) and Rosuvastatin (a breast cancer resistant protein substrate) in healthy male participants.

Start Date27 Oct 2026

Sponsor / Collaborator

CHIESI Farmaceutici SpA

NCT07683793

/ Not yet recruitingPhase 1

An Open-label, Fixed-sequence, Non-randomised, Drug-drug Interaction Study to Evaluate the Effect of Pantoprazole (Proton Pump Inhibitor) on the Pharmacokinetics of CHF10196 in Healthy Male Participants.

This Phase 1 study evaluates the effect of pantoprazole (a proton pump inhibitor) on the pharmacokinetics (PK) of CHF10196 (Florensocatib) in healthy male participants. Participants receive CHF10196 alone and in combination with pantoprazole to assess potential drug-drug interaction (DDI) effects on systemic exposure.

Start Date14 Oct 2026

Sponsor / Collaborator

CHIESI Farmaceutici SpA

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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8

Literatures (Medical) associated with HSK-31858

01 Oct 2026·European Respiratory Review

The dipeptidyl peptidase 1 inhibition landscape in bronchiectasis and its future direction

Review

Author: Jain, Raksha ; Chalmers, James D ; Mall, Marcus A ; Flume, Patrick A ; O'Donnell, Anne E

Bronchiectasis (BE) is a heterogeneous lung disease characterised by chronic neutrophilic inflammation. A “vicious vortex” develops through the interactions between neutrophilic inflammation, infection and impaired mucociliary clearance, leading to progressive structural lung damage and worsening lung function. As part of this neutrophilic inflammation, neutrophil serine proteases (NSPs) overwhelm their natural inhibitors, with high NSP levels being associated with pulmonary exacerbations in people with BE. NSPs, activated by dipeptidyl peptidase 1 (DPP1) during neutrophil maturation in the bone marrow, are released from neutrophils at sites of inflammation. Pharmacological inhibition of DPP1 is a compelling approach to reduce neutrophilic inflammation in BE. Three DPP1 inhibitors have had favourable results in clinical studies for BE, namely brensocatib, florensocatib and verducatib, with recent approval of brensocatib, a first-in-class DPP1 inhibitor, in the US and Europe, providing a promising treatment option for people with BE. Many questions about DPP1 inhibition remain, including long-term efficacy and safety, and efficacy in people with cystic fibrosis, primary COPD and immunodeficiencies, who were generally excluded from prior large studies. Despite the availability of cystic fibrosis transmembrane conductance regulator modulator therapy, many people with cystic fibrosis continue to have pulmonary exacerbations. The inclusion of a broad population with a range of aetiologies is key in the development of DPP1 inhibitors to support access to treatment for all those who could benefit. This review explores the current DPP1 inhibition landscape, discussing the clinical studies to date for these three novel DPP1 inhibitors and the evolution of DPP1 studies in BE.

01 Sep 2026·Cell Reports Medicine

Symptoms and treatment response to florensocatib and inhaled tobramycin in bronchiectasis: Post hoc analysis of two randomized trials

Article

Author: Sun, Lu-Yin ; Li, Fang-Qiong ; Sun, Xiao-Li ; Gao, Yong-Hua ; Li, Xue-Shan ; Guan, Wei-Jie ; Liu, Han-Mo

Inhaled antibiotics and DPP-1 inhibitors improve clinical outcomes in bronchiectasis, but whether baseline symptom burden predicts differential treatment responses remains unclear. In this post hoc analysis of two multicenter randomized trials (SAVE-BE, n = 224; TORNASOL, n = 357), we evaluate the association between baseline Quality of Life-Bronchiectasis Respiratory Symptom Scale (QoL-B-RSS) and treatment effects of florensocatib and inhaled tobramycin. In SAVE-BE, florensocatib reduces exacerbation rates versus placebo (relative risk [RR], 0.47; 95% confidence interval [CI], 0.33-0.67; p < 0.0001), with RRs of 0.53 and 0.40 observed in patients with high and low symptom burdens, respectively, but no significant symptomatic improvement. In TORNASOL, tobramycin produces clinically meaningful QoL-B-RSS improvements (exceeding the 8-point cutoff in high-symptom patients) and ameliorates bronchitic symptoms, with greater benefits in those with higher baseline symptom burden. These hypothesis-generating findings suggest that baseline symptom burden may identify differential responses to anti-inflammatory versus anti-infective therapies in bronchiectasis and support its potential as a simple, practical stratification tool to guide personalized treatment.

01 Jul 2026·ERJ Open Research

Florensocatib in adults with bronchiectasis: the HOPE-BE trial protocol and baseline demographic characteristics

Article

Author: Feng, Yan ; Dong, Li-Min ; Huang, Yan-Ming ; Zhang, Guo-Jun ; Guan, Wei-Jie ; Liu, Jin-Li ; Ye, Huan ; Sun, Lu-Yin ; Wang, Jin-Xiang ; Li, Fang-Qiong ; Min, Ling-Feng ; Zhong, Nan-Shan ; Liu, Xun-Chao ; Qiu, Rong ; Liang, Zhi-Jun ; Shen, Hui ; Song, Xin-Yu ; Jiang, Hui ; Liang, Jian-Ping ; Yang, Zhi-Ren ; Cao, Jie ; Liu, Han-Mo ; Bao, Zhang

Background:

Florensocatib (formerly known as HSK31858) is a novel reversible inhibitor of dipeptidyl peptidase 1. We sought to determine the efficacy and safety of florensocatib in decreasing exacerbation frequency in Chinese adults with bronchiectasis.

Methods:

The HOPE-BE trial was a phase 3, randomised, placebo-controlled trial which determines the efficacy and safety of high-dose florensocatib (40 mg once daily) versus placebo in Chinese adults with bronchiectasis who had two or more exacerbations within the past year. Patients were randomly assigned in a 2:1 ratio to receive florensocatib 40 mg or matching placebo once daily for 52 weeks. We recorded demographics, medical history, bacterial infection status and quality-of-life and performed spirometry at baseline.

Results:

We randomised 700 patients who were enrolled from 67 sites in mainland China between September 2024 and November 2025. 60.4% of patients were female. 559 (79.9%) and 141 (20.1%) of patients, respectively, had two and three or more exacerbations in the past year. The median (interquartile range) of 24-h sputum weight was 14.8 (29.3) g, and the median (interquartile range) of sputum purulence score was 5.0 (2.0). 192 (27.4%) patients were culture positive to Pseudomonas aeruginosa , and demonstrated significantly higher 24-h sputum volume and purulence score, and lower lung function and quality-of-life scores. Significant geographical variations were seen regarding comorbidity, blood eosinophil counts and sputum bacteriology.

Conclusion:

The baseline demographic characteristics of the HOPE-BE trial may provide important clues to future therapeutic efficacy assessment in adults with bronchiectasis.

2

News (Medical) associated with HSK-31858

21 Nov 2023

·www.pharmaindustrial-india.com

Chiesi and Haisco Announce Licensing Agreement

Chiesi Farmaceutici and Haisco Pharmaceutical Group Co.Ltd have announced the execution of a Licensing Agreement to develop, manufacture, and commercialise outside China and adjacent territories (Hong Kong SAR, Macau SAR and Taiwan District) HSK31858, a novel, reversible dipeptidyl peptidase 1 (DPP1) inhibitor for respiratory diseases. HSK31858 is an oral, potent, and highly selective small molecule DPP1 inhibitor currently in Phase 2 trials in China with the potential to be an anti-inflammatory agent in bronchiectasis. With this agreement Chiesi will expand its product portfolio in its strategic respiratory field, aiming to further increase its impact in this area and contribute to developing treatments for severe respiratory diseases with high unmet medical needs. “This collaboration demonstrates our commitment to develop new medicines aimed at improving the lives of patients who suffer from severe respiratory diseases with limited treatment options,” commented Thomas Eichholtz, Head of Global Research and Development at Chiesi Group. “HSK31858 is an important addition to our pipeline, and it offers a great opportunity to combine the two partners’ strong experience in this field.” “This collaboration with Chiesi is an important milestone in our globalisation strategy, we are pleased that HSK31858 will benefit patients worldwide in the future” said Xiulian Fan, General Manager at Haisco Pharmaceutical. “We acknowledge and appreciate Chiesi’s significant commitment and expertise in the development of drugs in the respiratory field and believe that this partnership will help maximise the value of HSK31858”. Under the terms of the agreement, Chiesi will make an upfront payment and additional contingent milestone payments to Haisco, including royalties on product sales.

License out/inPhase 2

20 Nov 2023

·www.prnewswire.com

Chiesi Group signed a License Agreement with Haisco Pharmaceutical to develop, manufacture, and commercialise a novel, reversible dipeptidyl peptidase 1 inhibitor for bronchiectasis

Chiesi Group and Haisco Pharmaceutical will collaborate closely to develop HSK31858, a novel reversible dipeptidyl peptidase 1 (DPP1) inhibitor for respiratory diseases. This agreement expands Chiesi's comprehensive R&D program in bronchiectasis, a respiratory disease with high unmet medical needs, for which no approved treatment is available to date. Haisco Pharmaceutical will receive an upfront payment and future milestone payments, including royalties on product sales. PARMA, Italy and CHENGDU, China, Nov. 20, 2023 /PRNewswire/ -- Chiesi Farmaceutici S.p.A ("Chiesi Group"), an international, research-focused biopharmaceuticals and healthcare group, and Haisco Pharmaceutical Group Co.Ltd (Haisco Pharmaceutical) today announced the execution of a Licensing Agreement to develop, manufacture, and commercialise outside China and adjacent territories (Hong Kong SAR, Macau SAR and Taiwan District) HSK31858, a novel, reversible dipeptidyl peptidase 1 (DPP1) inhibitor for respiratory diseases. HSK31858 is an oral, potent, and highly selective small molecule DPP1 inhibitor currently in Phase 2 trials in China with the potential to be an anti-inflammatory agent in bronchiectasis. With this agreement Chiesi will expand its product portfolio in its strategic respiratory field, aiming to further increase its impact in this area and contribute to developing treatments for severe respiratory diseases with high unmet medical needs. "This collaboration demonstrates our commitment to develop new medicines aimed at improving the lives of patients who suffer from severe respiratory diseases with limited treatment options," commented Thomas Eichholtz, Head of Global Research and Development at Chiesi Group. "HSK31858 is an important addition to our pipeline, and it offers a great opportunity to combine the two partners' strong experience in this field." "This collaboration with Chiesi is an important milestone in our globalisation strategy, we are pleased that HSK31858 will benefit patients worldwide in the future" said Xiulian Fan, General Manager at Haisco Pharmaceutical. "We acknowledge and appreciate Chiesi's significant commitment and expertise in the development of drugs in the respiratory field and believe that this partnership will help maximise the value of HSK31858". Under the terms of the agreement, Chiesi will make an upfront payment and additional contingent milestone payments to Haisco, including royalties on product sales. SOURCE Chiesi

License out/inPhase 2Phase 1

100 Deals associated with HSK-31858

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External Link

KEGG	Wiki	ATC	Drug Bank
D13278	-	-	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bronchiectasis	Phase 3	-	CHIESI Farmaceutici SpA	01 Nov 2026
Non-cystic fibrosis bronchiectasis	Phase 3	China	Haisco Pharmaceutical Group Co., Ltd.	26 Sep 2024
airway disease	Phase 2	China	Haisco Pharmaceutical Group Co., Ltd.	01 Dec 2024
Catarrhal bronchitis	Phase 2	China	Haisco Pharmaceutical Group Co., Ltd.	01 Dec 2024
Pulmonary Disease, Chronic Obstructive	Phase 2	China	Haisco Pharmaceutical Group Co., Ltd.	01 Dec 2024
Asthma	Phase 2	China	Haisco Pharmaceutical Group Co., Ltd.	22 Oct 2024
Acute Lung Injury	Phase 1	China	Haisco Pharmaceutical Group Co., Ltd.	28 Oct 2024
Respiratory Distress Syndrome, Acute	Phase 1	China	Haisco Pharmaceutical Group Co., Ltd.	28 Oct 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05663593 (Pubmed \| Br J Clin Pharmacol)	Phase 1	-	-	HSK31858 15 mg	njuvlpdbwj(lufvbqovso) = ipcykontnf vswbxvasvc (czknloaacw ) View more	-	01 Aug 2025
				HSK31858 40 mg	cubdptcmqa(hdjjzxwkmt) = xzalywteyk srpcrszjik (duevbanveu ) View more
NCT05601778 (SAVE-BE, Pubmed \| Lancet Respir Med) Manual	Phase 2	Bronchiectasis	136	HSK31858 20 mg	blhasvqwha(xsralbvqpo) = vidpbhzwbf wjffzxzxig (vavqvetwfo, 1.44)	Positive	25 Mar 2025
				HSK31858 40 mg	blhasvqwha(xsralbvqpo) = ensplzdrum wjffzxzxig (vavqvetwfo, 1.37)
ERS2024	Phase 2	Bronchiectasis sputum purulence score	226	HSK31858 20mg	bgqstbjmxj(cumyihuoag) = btjinpjyum iwenbooiko (vwwmlrqxnx ) View more	Positive	07 Sep 2024
				HSK31858 40mg	bgqstbjmxj(cumyihuoag) = wfuxbzejme iwenbooiko (vwwmlrqxnx ) View more
NCT05663593 (ERS2023) Manual	Phase 1	Bronchiectasis	-	HSK31858	sphhqmwqbq(qxjsbkycdv) = 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. pbmakbxqqc (xodhvtqdbg )	Positive	09 Sep 2023
ERS2023	Phase 1	-	75	HSK31858	ibcxcmualg(zbxdteetyg) = HSK31858 was absorbed rapidly, with no significant accumulation of Cmax, while AUC accumulation was more pronounced. qrkrhmkkjc (jjmyqvftvz ) View more	Positive	09 Sep 2023
				Placebo