Overview
Isoflavone is a soy phytoestrogen and a biologically active component of several agriculturally important legumes such as soy, peanut, green peas, chick peas and alfalfa . Soybean is an exceptionally rich source of dietary isoflavones, where the average isoflavone content is 1-2 mg/gram . The main soy isoflavones are mostly present in glycosylated forms and include Genistein, Daidzein, and glycitein, which accounts for approximately 50%, 40%, and 10%, respectively, of the total soybean isoflavone content . The clinical benefits of soy proteins have been studied and demonstrated for many years, with some evidence of soy products associated with a reduced incidences of coronary heart disease, atherosclerosis, type II diabetes mellitus, and breast and prostate cancer . While existing data are consistent or inadequate in supporting most of the suggested health benefits of consuming soy proteins and isoflavones , the trials investigating isoflavone as a potential treatment for atrophy, menopause, and postmenopausal symptoms are ongoing. Isoflavone is found as one of constituents in oral over-the-counter dietary supplements indicated for improved bone mass density and body fat regulation.
Indication
Indicated for over-the-counter use as a dietary supplement for increasing bone density and regulating blood fat.
Associated Conditions
No associated conditions information available.
Research Report
Isoflavone (DB12007): A Comprehensive Pharmacological, Clinical, and Regulatory Review
Executive Summary and Compound Identification
Executive Summary
Isoflavone (DB12007) is the parent compound of a class of biologically active phytoestrogens, predominantly found in soybeans and other leguminous plants. Chemically classified as a small molecule, it serves as the structural backbone for key dietary isoflavones such as genistein, daidzein, and glycitein. These compounds are also categorized as Selective Estrogen Receptor Modulators (SERMs) due to their tissue-specific estrogenic and antiestrogenic activities, which are mediated by a preferential binding affinity for estrogen receptor beta ($ER\beta$) over estrogen receptor alpha ($ER\alpha$). The bioavailability and ultimate physiological effect of dietary isoflavones are critically dependent on biotransformation by the gut microbiome, which converts inactive glycosides into absorbable, active aglycones. This metabolic step, particularly the conversion of daidzein to the more potent metabolite equol, is highly variable among individuals and represents a major determinant of clinical response.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/12/29 | Phase 2 | Recruiting | Rajesh Kumar | ||
2014/03/03 | Phase 1 | Completed | |||
2012/03/14 | Phase 2 | Completed | Federal University of São Paulo | ||
2010/01/20 | Phase 4 | Completed | American Lung Association Asthma Clinical Research Centers | ||
2009/06/22 | Phase 3 | UNKNOWN | Federal University of São Paulo | ||
2009/05/20 | Phase 3 | UNKNOWN | Federal University of São Paulo | ||
2005/12/06 | Not Applicable | UNKNOWN | National Health Research Institutes, Taiwan | ||
2005/10/28 | Phase 4 | Completed | |||
2005/10/12 | Phase 3 | UNKNOWN | |||
2005/09/20 | 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
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| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
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| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
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| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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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 |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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