Overview
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Indication
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Associated Conditions
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Research Report
AST-120 (Kremezin): A Comprehensive Monograph on the Oral Carbon Adsorbent for Chronic Kidney Disease and Beyond
Introduction and Drug Profile
Overview of AST-120
AST-120 is an orally administered intestinal sorbent developed and innovated by Kureha Corporation in Japan.[1] Marketed under the brand name Kremezin®, it represents a unique therapeutic approach within the field of nephrology.[4] Its primary approved indication in several Asian countries is to slow the progression of chronic kidney disease (CKD), delay the initiation of maintenance dialysis, and ameliorate the systemic symptoms of uremia in patients with progressive CKD.[4] Pharmacologically, it is classified as an adsorbent for chronic kidney disease, functioning not through systemic absorption but by sequestering specific molecules within the gastrointestinal lumen.[9]
The development of AST-120 was driven by the understanding that the accumulation of certain gut-derived uremic toxins plays a direct role in the pathophysiology of CKD progression and its associated cardiovascular complications. By targeting the precursors of these toxins at their source within the intestine, AST-120 aims to interrupt a key pathological feedback loop where the consequences of renal failure (toxin accumulation) actively contribute to further renal and systemic damage. This upstream intervention distinguishes it from renal replacement therapies like dialysis, which attempt to clear toxins after they have entered the systemic circulation.
Physicochemical Properties
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2020/11/20 | Phase 4 | Completed | |||
2019/01/14 | Phase 1 | Completed | |||
2013/05/29 | Phase 3 | Completed | |||
2012/09/07 | Phase 4 | Completed | Chang Gung Memorial Hospital | ||
2011/10/25 | Phase 4 | Completed | Tungs' Taichung Metroharbour Hospital | ||
2010/07/07 | Phase 4 | UNKNOWN | |||
2009/03/24 | Phase 2 | Completed | Ocera Therapeutics | ||
2009/03/12 | Phase 4 | Completed | |||
2008/01/07 | Phase 2 | Terminated | Ocera Therapeutics | ||
2007/12/31 | Phase 2 | Terminated | Ocera Therapeutics |
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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