Dipeptidyl peptidase 1 inhibitors for inflammatory respiratory diseases: mechanisms, clinical trials, and therapeutic prospects

Dipeptidyl peptidase 1 (DPP1) inhibitors constitute a major advance in respiratory disease therapeutics. Through selective blockade of neutrophil serine protease (NSP) activation, these agents establish novel treatment paradigms for inflammatory respiratory conditions characterized by neutrophil-dri...

Full description

Saved in:
Bibliographic Details
Main Authors: Dandan Zhang, Wenwen Zhang, Ping Hu, Wei Zhang
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-08-01
Series:Frontiers in Pharmacology
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fphar.2025.1656316/full
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1849229184376766464
author Dandan Zhang
Wenwen Zhang
Ping Hu
Wei Zhang
author_facet Dandan Zhang
Wenwen Zhang
Ping Hu
Wei Zhang
author_sort Dandan Zhang
collection DOAJ
description Dipeptidyl peptidase 1 (DPP1) inhibitors constitute a major advance in respiratory disease therapeutics. Through selective blockade of neutrophil serine protease (NSP) activation, these agents establish novel treatment paradigms for inflammatory respiratory conditions characterized by neutrophil-driven pathology. This comprehensive review examines the development status, clinical efficacy, and safety profile of DPP1 inhibitors in neutrophil-driven diseases, particularly non-cystic fibrosis bronchiectasis (NCFBE) and chronic obstructive pulmonary disease (COPD). Leading compounds including brensocatib, BI 1291583, and HSK31858 have demonstrated substantial clinical efficacy. In the pivotal WILLOW Phase II trial, brensocatib significantly extended time to first exacerbation (hazard ratio 0.58–0.62, p < 0.05) in bronchiectasis patients. The subsequent ASPEN Phase III trial confirmed these findings, with brensocatib reducing annualized exacerbation rates by 21% (10 mg) and 19% (25 mg) compared to placebo (adjusted p = 0.004 and p = 0.005, respectively). Similarly, HSK31858 demonstrated comparable efficacy in Chinese patients, reducing exacerbation risk by 48%–59% in the SAVE-BE trial. While the clinical phenotype observed in Papillon-Lefèvre syndrome (PLS) necessitates careful monitoring of skin and periodontal health during DPP1 inhibition therapy, clinical trials have shown these adverse events occur at low frequencies (1%–4%) and are predominantly mild to moderate in severity. Future research priorities include establishing standardized monitoring protocols for dermatological and periodontal health, developing biomarkers for patient stratification, validating long-term safety profiles, and optimizing combination treatment strategies. With brensocatib potentially becoming the first approved mechanism-specific therapy for bronchiectasis by mid-2025, DPP1 inhibitors represent a paradigm shift in managing neutrophil-mediated respiratory diseases.
format Article
id doaj-art-a6ae6618ae7a46d6acc77680bfe72503
institution Kabale University
issn 1663-9812
language English
publishDate 2025-08-01
publisher Frontiers Media S.A.
record_format Article
series Frontiers in Pharmacology
spelling doaj-art-a6ae6618ae7a46d6acc77680bfe725032025-08-22T05:26:57ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122025-08-011610.3389/fphar.2025.16563161656316Dipeptidyl peptidase 1 inhibitors for inflammatory respiratory diseases: mechanisms, clinical trials, and therapeutic prospectsDandan ZhangWenwen ZhangPing HuWei ZhangDipeptidyl peptidase 1 (DPP1) inhibitors constitute a major advance in respiratory disease therapeutics. Through selective blockade of neutrophil serine protease (NSP) activation, these agents establish novel treatment paradigms for inflammatory respiratory conditions characterized by neutrophil-driven pathology. This comprehensive review examines the development status, clinical efficacy, and safety profile of DPP1 inhibitors in neutrophil-driven diseases, particularly non-cystic fibrosis bronchiectasis (NCFBE) and chronic obstructive pulmonary disease (COPD). Leading compounds including brensocatib, BI 1291583, and HSK31858 have demonstrated substantial clinical efficacy. In the pivotal WILLOW Phase II trial, brensocatib significantly extended time to first exacerbation (hazard ratio 0.58–0.62, p < 0.05) in bronchiectasis patients. The subsequent ASPEN Phase III trial confirmed these findings, with brensocatib reducing annualized exacerbation rates by 21% (10 mg) and 19% (25 mg) compared to placebo (adjusted p = 0.004 and p = 0.005, respectively). Similarly, HSK31858 demonstrated comparable efficacy in Chinese patients, reducing exacerbation risk by 48%–59% in the SAVE-BE trial. While the clinical phenotype observed in Papillon-Lefèvre syndrome (PLS) necessitates careful monitoring of skin and periodontal health during DPP1 inhibition therapy, clinical trials have shown these adverse events occur at low frequencies (1%–4%) and are predominantly mild to moderate in severity. Future research priorities include establishing standardized monitoring protocols for dermatological and periodontal health, developing biomarkers for patient stratification, validating long-term safety profiles, and optimizing combination treatment strategies. With brensocatib potentially becoming the first approved mechanism-specific therapy for bronchiectasis by mid-2025, DPP1 inhibitors represent a paradigm shift in managing neutrophil-mediated respiratory diseases.https://www.frontiersin.org/articles/10.3389/fphar.2025.1656316/fulldipeptidyl peptidase 1 inhibitorsneutrophil serine proteasesnon-cystic fibrosis bronchiectasischronic obstructive pulmonary diseasebrensocatibBI 1291583
spellingShingle Dandan Zhang
Wenwen Zhang
Ping Hu
Wei Zhang
Dipeptidyl peptidase 1 inhibitors for inflammatory respiratory diseases: mechanisms, clinical trials, and therapeutic prospects
Frontiers in Pharmacology
dipeptidyl peptidase 1 inhibitors
neutrophil serine proteases
non-cystic fibrosis bronchiectasis
chronic obstructive pulmonary disease
brensocatib
BI 1291583
title Dipeptidyl peptidase 1 inhibitors for inflammatory respiratory diseases: mechanisms, clinical trials, and therapeutic prospects
title_full Dipeptidyl peptidase 1 inhibitors for inflammatory respiratory diseases: mechanisms, clinical trials, and therapeutic prospects
title_fullStr Dipeptidyl peptidase 1 inhibitors for inflammatory respiratory diseases: mechanisms, clinical trials, and therapeutic prospects
title_full_unstemmed Dipeptidyl peptidase 1 inhibitors for inflammatory respiratory diseases: mechanisms, clinical trials, and therapeutic prospects
title_short Dipeptidyl peptidase 1 inhibitors for inflammatory respiratory diseases: mechanisms, clinical trials, and therapeutic prospects
title_sort dipeptidyl peptidase 1 inhibitors for inflammatory respiratory diseases mechanisms clinical trials and therapeutic prospects
topic dipeptidyl peptidase 1 inhibitors
neutrophil serine proteases
non-cystic fibrosis bronchiectasis
chronic obstructive pulmonary disease
brensocatib
BI 1291583
url https://www.frontiersin.org/articles/10.3389/fphar.2025.1656316/full
work_keys_str_mv AT dandanzhang dipeptidylpeptidase1inhibitorsforinflammatoryrespiratorydiseasesmechanismsclinicaltrialsandtherapeuticprospects
AT wenwenzhang dipeptidylpeptidase1inhibitorsforinflammatoryrespiratorydiseasesmechanismsclinicaltrialsandtherapeuticprospects
AT pinghu dipeptidylpeptidase1inhibitorsforinflammatoryrespiratorydiseasesmechanismsclinicaltrialsandtherapeuticprospects
AT weizhang dipeptidylpeptidase1inhibitorsforinflammatoryrespiratorydiseasesmechanismsclinicaltrialsandtherapeuticprospects