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Research Report
Ocedurenone (KBP-5074): A Comprehensive Report on its Development, Clinical Profile, and Discontinuation
I. Introduction to Ocedurenone
A. Overview of Ocedurenone (KBP-5074)
Ocedurenone, identified by the investigational name KBP-5074, is a novel, orally administered small molecule pharmaceutical agent.[1] It was engineered as a third-generation non-steroidal mineralocorticoid receptor antagonist (nsMRA).[3] This classification is significant, as it positions Ocedurenone in a therapeutic class aiming to improve upon older, steroidal MRAs, such as spironolactone and eplerenone, and to compete with other contemporary nsMRAs like finerenone. The development of third-generation nsMRAs generally seeks to optimize the balance of efficacy and safety, particularly concerning side effects common to earlier MRAs.
B. Initial Therapeutic Promise and Targeted Indications
Ocedurenone was primarily developed and investigated for the treatment of uncontrolled hypertension. A particular focus was placed on patients with advanced chronic kidney disease (CKD), specifically those with stage 3b or stage 4 CKD.[5] This patient demographic represents a substantial unmet medical need, as managing hypertension in the presence of advanced CKD is challenging due to the high risk of cardiovascular complications and the limitations of existing antihypertensive treatments, especially concerning the risk of hyperkalemia.[7]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2021/07/20 | Phase 3 | Terminated | KBP Biosciences | ||
2020/11/18 | Phase 1 | Completed | KBP Biosciences | ||
2020/10/28 | Phase 1 | Completed | KBP Biosciences | ||
2020/09/01 | Phase 1 | Completed | KBP Biosciences | ||
2016/07/19 | Phase 1 | Completed | KBP Biosciences | ||
2016/01/12 | Phase 1 | Completed | KBP Biosciences | ||
2014/08/29 | Phase 1 | Completed | KBP Biosciences |
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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