Overview
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Indication
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Associated Conditions
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Research Report
CKD-385: An Investigative Report on its Profile, Clinical Development, and Current Status
1. Executive Summary
CKD-385 is identified as a small molecule drug developed by Chong Kun Dang Pharmaceutical Corp..[1] Its primary therapeutic focus has been cardiovascular diseases, with investigations into angina pectoris, heart failure, and hypertension.[1] The clinical development program for CKD-385 involved a series of Phase 1 trials initiated in South Korea around 2020-2021. These studies were designed to evaluate the pharmacokinetic (PK) properties and safety of CKD-385, including high-dose formulations, in healthy volunteers under both fed and fasting conditions.[1] Older information also suggests a potential, likely discontinued, Phase 2 study for hypertension in the United States.[1]
Despite this early-phase clinical activity, a significant uncertainty surrounds CKD-385's current development trajectory. The compound is notably absent from Chong Kun Dang Pharmaceutical Corp.'s recent official R&D pipeline disclosures.[4] This omission, coupled with reports from pharmaceutical databases indicating an "Unknown status" for its clinical trials or "No recent reports of development" as of early 2024 [1], strongly suggests that the development of CKD-385 may have been deprioritized, paused, or discontinued. Furthermore, critical details such as its specific molecular target, a comprehensive mechanism of action, definitive chemical structure (including CAS Number), and any published results from its clinical trials are largely unavailable in the public domain based on the provided information.
2. CKD-385: Profile and Developer
2.1. Chemical Nature and Identification
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2021/05/28 | Phase 1 | UNKNOWN | |||
2021/05/28 | Phase 1 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
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No FDA approvals found for this drug. |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
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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 |
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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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