Drugs / Genistein
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Genistein

also known as BIO 300 · AXP107-11 · G-2535 · Soy isoflavone

Other / unclassified targets TTR

Developed for
non-small cell lung carcinoma · acute radiation syndrome · cancer · coronary artery disorder · adenocarcinoma · amyloidosis · breast cancer · colon carcinoma
+16 more · cutaneous melanoma · head and neck cancer · heart failure · hypolipoproteinemia · kidney cancer · long COVID-19 · muscular atrophy · obesity disorder · osteoporosis · prostate adenocarcinoma · prostate cancer · rectal carcinoma · urinary bladder cancer · urinary bladder carcinoma · cardiovascular disorder · cystic fibrosis
Investigated by
National Cancer Institute (NCI) · Humanetics Corporation · Emory University · dsm-firmenich Switzerland AG · Greenstone Biosciences · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
+29 more · United States Department of Defense · American Medical Academy, Serbia · Axcentua Pharmaceuticals AB · Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. · Federal University of São Paulo · Henry Ford Health System · INRS-Institut Armand Frappier , Université du Québec · Imperial College London · Joint Warfighter Medical Research Program · MDEIE Ministry, Québec Government · Medical College of Wisconsin · Memorial Sloan Kettering Cancer Center · Milwaukee VA Medical Center · NYU Langone Health · National Heart, Lung, and Blood Institute (NHLBI) · National Institute of Allergy and Infectious Diseases (NIAID) · National Institutes of Health (NIH) · Northwestern University · Radiation Therapy Oncology Group · Sofya Pintova · St. Justine's Hospital · Stanford University · Uman Pharma · University Medical Centre Ljubljana · University of Maryland, Baltimore · University of Messina · University of Virginia · Western University · Western University, Canada

Trials 27 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT00276835 Nov 2005 → Jul 2007 cutaneous melanoma, kidney cancer Northwestern University Completed No outcome recorded
Phase 15 trials
Phase 1 NCT06741345 Dec 2024 → Aug 2025 Humanetics Corporation Completed No outcome recorded
Phase 1 NCT04650555 Dec 2020 → Jul 2021 acute radiation syndrome Humanetics Corporation Completed No outcome recorded
Phase 1 NCT02075112 Nov 2013 → Sep 2019 head and neck cancer Emory University Completed No outcome recorded
Phase 1 NCT00504335 Jun → Sep 2007 acute radiation syndrome Humanetics Corporation Completed No outcome recorded
Phase 1 NCT00001696 Apr 1998 → Mar 2001 cancer National Cancer Institute (NCI) Completed No outcome recorded
Phase 1/28 trials
Phase 1/2 NCT07033767 Aug 2025 → Aug 2026 overdue obesity disorder Western University Not yet recruiting No outcome recorded
Phase 1/2 NCT06634108 Sep 2024 → Sep 2025 overdue amyloidosis London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Recruiting No outcome recorded
Phase 1/2 NCT06501768 Jul 2024 → Jul 2026 overdue heart failure University Medical Centre Ljubljana Recruiting No outcome recorded
Phase 1/2 NCT02567799 Nov 2015 → Apr 2019 non-small cell lung carcinoma Humanetics Corporation Completed No outcome recorded
Phase 1/2 NCT02499861 Jul 2015 → Oct 2017 cancer St. Justine's Hospital Completed No outcome recorded
Phase 1/2 NCT01985763 Nov 2013 → Jan 2017 colon carcinoma, rectal carcinoma Sofya Pintova Completed No outcome recorded
Phase 1/2 NCT01628471 Nov 2012 → May 2015 non-small cell lung carcinoma Uman Pharma Completed No outcome recorded
Phase 1/2 NCT01182246 Nov 2010 → Mar 2016 adenocarcinoma Axcentua Pharmaceuticals AB Unknown No outcome recorded
Phase 210 trials
Phase 2 NCT07323732 Jan 2026 → Jan 2029 expected interstitial lung disease, non-small cell lung carcinoma Memorial Sloan Kettering Cancer Center Recruiting No outcome recorded
Phase 2 NCT04482595 Nov 2020 → Jul 2024 COVID-19, long COVID-19, pulmonary fibrosis Humanetics Corporation Unknown No outcome recorded
Phase 2 NCT02766478 Oct 2017 → Jul 2021 prostate cancer Emory University Terminated No outcome recorded
Phase 2 NCT01489813 May 2017 → Aug 2023 urinary bladder cancer Emory University Completed No outcome recorded
Phase 2 NCT02624388 Aug 2016 → Sep 2021 Ewing sarcoma, Hodgkins lymphoma, Wilms tumor, childhood medulloblastoma +5 University of Virginia Terminated No outcome recorded
Phase 2 NCT01325311 Dec 2011 → Jul 2014 prostate adenocarcinoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 2 NCT00290758 Jan 2006 → Mar 2009 breast cancer National Cancer Institute (NCI) Completed No outcome recorded
Phase 2 NCT00118040 Jun 2005 → Aug 2010 urinary bladder carcinoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 2 NCT01553773 Jul 2004 → Mar 2005 muscular atrophy Federal University of São Paulo Completed No outcome recorded
Phase 2 NCT00000613 Apr 1997 → Dec 2004 coronary artery disorder, depressive disorder, myocardial ischemia, osteoporosis National Heart, Lung, and Blood Institute (NHLBI) Completed No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT00355953 Jan 2003 → Jun 2005 University of Messina Completed No outcome recorded
Phase 2/3 NCT00287690 Oct 1999 → Aug 2003 coronary artery disorder Imperial College London Completed No outcome recorded
Phase 41 trial
Phase 4 NCT01497977 Sep 2008 → Jun 2010 hypolipoproteinemia American Medical Academy, Serbia Completed No outcome recorded
Also used as a comparator or background therapy in 3 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/22 trials
Phase 1/2 NCT00590538 Comparator Feb 2003 → Dec 2008 cystic fibrosis Children's Hospital of Philadelphia Terminated No outcome recorded
Phase 1/2 NCT00016744 Comparator Sep 2001 → Oct 2005 cystic fibrosis Children's Hospital of Philadelphia Completed No outcome recorded
Phase 21 trial
Phase 2 NCT00546039 Comparator Apr 2007 → Aug 2008 prostate cancer University Hospital, Aker Unknown No outcome recorded

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 31 sources stand behind the page.

FieldValueCited text
Known as Genistein “Starting on day 10 and continuing through day 19, genistein will be administered orally at a dose of 600mg/day in two divided doses (i.e. 300mg po bid x 10 days)” NCT00276835
25

“A Pilot Study of Soy Isoflavone, Genistein, in Combination With Radiation Therapy and Cisplatin in Locally Advanced Squamous Cell Carcinoma of the Head and Neck” NCT02075112

Genistein HME was evaluated in a phase 1, open-label, single ascending dose (SAD) and multiple single dose (MSD) study enrolling 34 healthy volunteers.” PMID 36301689 Oct 2022

“BIO 300 Oral Suspension (genistein 1500 mg) will be self-administered daily for 7 days each week for 12 weeks.” NCT04482595

“The soya daily dose contained 2 isoflavones: genistein (39mg) and daidzein (1mg).” NCT01497977

“a gel with isoflavones (genistein 4%)” NCT01553773

GenisteinNCT02075112

NCT06501768

NCT00016744

NCT02624388

NCT00290758

NCT00287690

NCT00355953

NCT07033767

NCT00546039

NCT01489813

NCT00118040

NCT00590538

NCT01325311

NCT01628471

NCT00000613

NCT06634108

NCT02766478

NCT00001696

NCT02499861

NCT01985763

Known as AXP107-11 ClinicalTrials.gov intervention name — accepted as the source's own label NCT01182246
Known as BIO 300 ClinicalTrials.gov intervention name — accepted as the source's own label NCT00504335
3

NCT06741345

NCT02567799

NCT07323732

Known as G-2535 “A phase 2 cancer chemoprevention biomarker trial of isoflavone G-2535 (genistein) in presurgical bladder cancer patients.” PMID 22293631 Jan 2012
Known as Soy isoflavone “A Pilot Study of Soy Isoflavone, Genistein, in Combination With Radiation Therapy and Cisplatin in Locally Advanced Squamous Cell Carcinoma of the Head and Neck” NCT02075112
Action Inhibit “Genistein is a known protein-tyrosine kinase inhibitor” NCT00001696
Modality Other / unclassified “Genistein is a phytoestrogen of the isoflavone family which has been shown to have beneficial effects on endothelial function and bone metabolism.” NCT00355953
Route Topical topical application of genistein to the nasal mucosa during the NPD procedure on study days 1 and 7.” NCT00016744
Target TTR “genistein has been shown to bind and stabilize TTR, potentially inhibiting its misfolding and subsequent fibril formation.” NCT06634108