Genistein

Overview

An isoflavonoid derived from soy products. It inhibits protein-tyrosine kinase and topoisomerase-II (DNA topoisomerases, type II) activity and is used as an antineoplastic and antitumor agent. Experimentally, it has been shown to induce G2 phase arrest in human and murine cell lines. Additionally, genistein has antihelmintic activity. It has been determined to be the active ingredient in Felmingia vestita, which is a plant traditionally used against worms. It has shown to be effective in the treatment of common liver fluke, pork trematode and poultry cestode. Further, genistein is a phytoestrogen which has selective estrogen receptor modulator properties. It has been investigated in clinical trials as an alternative to classical hormone therapy to help prevent cardiovascular disease in postmenopausal women . Natural sources of genistein include tofu, fava beans, soybeans, kudzu, and lupin.

Indication

Currently Genistein is being studied in clinical trials as a treatment for prostate cancer.

Associated Conditions

Calcium Deficiency
Deficiency, Vitamin D
Osteodystrophy
Osteomalacia
Osteoporosis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Exploring a Natural Solution for Childhood Obesity	2025/06/24	NCT07033767	Phase 1	Not yet recruiting	Western University
Genistein in trAnSthyretin recePtor Amyloid caRdiomyopathy	2024/10/09	NCT06634108	Phase 1	Recruiting	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Cardiovascular Genistein Therapy for Heart Failure Inflammation	2024/07/15	NCT06501768	Phase 1	Recruiting	University Medical Centre Ljubljana
Genistein Supplementation to Mitigate Cardiometabolic Dysfunction in Patients Undergoing Androgen Deprivation Therapy for Prostate Cancer	2016/05/09	NCT02766478	Phase 2	Terminated	Emory University
Study of Genistein in Pediatric Oncology Patients (UVA-Gen001)	2015/12/08	NCT02624388	Phase 2	Terminated	University of Virginia
Genistein in Treatment of Metastatic Colorectal Cancer	2013/11/15	NCT01985763	Phase 1	Completed	Sofya Pintova
Study of Genistein in Reducing Side Effects of Superficial Bladder Cancer Treatment	2011/12/12	NCT01489813	Phase 2	Completed	Emory University
Cholecalciferol and Genistein Before Surgery in Treating Patients With Early Stage Prostate Cancer	2011/03/29	NCT01325311	Phase 2	Completed	National Cancer Institute (NCI)
Phenylbutyrate/Genistein Duotherapy in Delta F508-Heterozygotes (for Cystic Fibrosis)	2008/01/10	NCT00590538	Phase 1	Terminated	Children's Hospital of Philadelphia
Synthetic Genistein (BONISTEIN™) in Patients Who Are Undergoing Surgery for Prostate Cancer	2007/10/18	NCT00546039	Phase 2	UNKNOWN	University Hospital, Aker

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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