Overview
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Indication
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Associated Conditions
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Research Report
HSK-31858 Medication Report
Name: HSK-31858 Name (English): HSK-31858
Mechanism of Action: HSK-31858 is a novel, oral, potent, and highly selective small molecule inhibitor of dipeptidyl peptidase 1 (DPP1). DPP1 is an enzyme responsible for activating neutrophil serine proteases (NSPs), including neutrophil elastase (NE), proteinase 3, and cathepsin G, during neutrophil maturation in the bone marrow. By inhibiting DPP1, HSK-31858 reduces the activation of these NSPs, which are implicated in the damaging inflammation and progression of neutrophil-mediated inflammatory diseases.
Uses: HSK-31858 is being investigated for the treatment of respiratory diseases characterized by neutrophilic inflammation. Clinical trials are ongoing for the following indications:
- Bronchiectasis: Phase 2 trials have shown that HSK-31858 significantly reduces the frequency of exacerbations and prolongs the time to the first exacerbation in adults with bronchiectasis. A Phase 3 trial is currently recruiting participants with non-cystic fibrosis bronchiectasis.
- Cystic Fibrosis: A Phase 3 trial is recruiting participants with cystic fibrosis and bronchiectasis.
- Asthma: A Phase 2 trial is enrolling participants with asthma.
- Chronic Obstructive Pulmonary Disease (COPD): A Phase 2 trial is enrolling participants with COPD and bronchiectasis.
- Airway Mucus Hypersecretion in Chronic Airway Inflammatory Diseases: A Phase 2 trial is enrolling participants.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/02/11 | Phase 2 | ENROLLING_BY_INVITATION | Haisco Pharmaceutical Group Co., Ltd. | ||
2024/10/15 | Phase 2 | ENROLLING_BY_INVITATION | Haisco Pharmaceutical Group Co., Ltd. | ||
2022/11/01 | Phase 2 | Recruiting | Haisco Pharmaceutical Group Co., Ltd. |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
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| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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| No UK EMC drug information found for this drug. | |||||
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