Overview
Epigallocatechin gallate has been investigated for the treatment of Hypertension and Diabetic Nephropathy.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
Epigallocatechin Gallate (EGCG): A Comprehensive Monograph on its Pharmacology, Clinical Utility, and Safety Profile
Executive Summary
Epigallocatechin gallate (EGCG) stands as the most abundant and biologically active catechin within green tea (Camellia sinensis), a natural product that has garnered immense scientific and public interest for its potential health benefits. Preclinical research has extensively documented its potent antioxidant, anti-inflammatory, antineoplastic, and neuroprotective properties, positioning it as a highly promising therapeutic agent for a wide spectrum of chronic and infectious diseases. However, the trajectory from promising preclinical compound to effective clinical therapeutic is fraught with significant challenges, and EGCG serves as a paradigmatic example of this difficult transition. The central obstacle that defines and complicates its clinical development is its exceptionally poor oral bioavailability. This pharmacokinetic limitation necessitates the administration of high oral doses to achieve potentially therapeutic systemic concentrations. This requirement, in turn, creates a profound efficacy-safety dilemma, as these high doses—particularly those at or above 800 mg per day—are directly associated with a statistically significant risk of dose-dependent hepatotoxicity.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/04/11 | Phase 2 | Completed | Shandong Cancer Hospital and Institute | ||
2024/07/29 | Phase 1 | Recruiting | Han Xi Zhao | ||
2024/02/20 | Phase 1 | Recruiting | Hal Chapman | ||
2023/10/05 | Phase 2 | Recruiting | |||
2023/03/07 | Phase 1 | Recruiting | Shandong Cancer Hospital and Institute | ||
2020/09/17 | Phase 2 | Completed | |||
2020/03/09 | Phase 2 | Active, not recruiting | |||
2019/04/26 | Early Phase 1 | Completed | Hal Chapman | ||
2016/07/14 | Phase 2 | Completed | |||
2015/10/20 | Phase 2 | UNKNOWN | Shandong Cancer Hospital and Institute |
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
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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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