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Research Report
Zastaprazan: A Comprehensive Clinical and Pharmacological Profile
I. Introduction to Zastaprazan
A. Overview of Zastaprazan as a Novel Acid-Suppressive Agent
Zastaprazan is a novel, orally administered potassium-competitive acid blocker (P-CAB) developed for the treatment and prevention of acid-related gastrointestinal disorders. It represents a new generation of acid-suppressive therapy, aiming to address limitations of existing treatments such as proton pump inhibitors (PPIs).[1] The development focus on characteristics like faster onset of action and food-independent dosing directly targets known drawbacks of PPIs, suggesting a strategic approach to capture market share by offering enhanced convenience and potentially more consistent acid control.[5] This approach is particularly relevant as the P-CAB class is positioned to offer tangible improvements in a mature acid-suppression market. By demonstrating non-inferiority to standard PPIs, with trends towards faster action, Zastaprazan aims to establish itself as a significant therapeutic option. The emphasis on food-independent dosing and rapid onset addresses patient convenience and adherence, critical factors in managing chronic acid-related conditions.
B. Developer and Originator Information
Zastaprazan was developed by Onconic Therapeutics Inc., a clinical-stage biopharmaceutical company based in South Korea.[1] Onconic Therapeutics is a subsidiary of Jeil Pharmaceutical Co., Ltd..[12] Notably, Onconic Therapeutics is distinguished as the only biotech firm in Korea to have secured regulatory approval and commercialized a new drug prior to its public listing, highlighting its research and development capabilities.[21]
C. Chemical Identity and Alternative Names
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
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2020/02/25 | Phase 2 | Completed |
FDA Drug Approvals
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No FDA approvals found for this drug. |
EMA Drug Approvals
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No EMA approvals found for this drug. |
HSA Drug Approvals
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No HSA approvals found for this drug. |
NMPA Drug Approvals
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No NMPA approvals found for this drug. |
PPB Drug Approvals
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No PPB approvals found for this drug. |
TGA Drug Approvals
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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 |
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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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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