Drugs / Genistein
Trials 27
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 · 2 met primary · 2 missed | ||||||
| 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 Stop: Enrollment |
| 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 Stop: Enrollment |
| Phase 2 | NCT01325311 | Dec 2011 → Jul 2014 | prostate adenocarcinoma | National Cancer Institute (NCI) | Completed | Missed primary |
| Phase 2 | NCT00290758 | Jan 2006 → Mar 2009 | breast cancer | National Cancer Institute (NCI) | Completed | Missed primary |
| Phase 2 | NCT00118040 | Jun 2005 → Aug 2010 | urinary bladder carcinoma | National Cancer Institute (NCI) | Completed | Met primary |
| Phase 2 | NCT01553773 | Jul 2004 → Mar 2005 | muscular atrophy | Federal University of São Paulo | Completed | Met primary |
| 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 · 1 met primary | ||||||
| Phase 2/3 | NCT00355953 | Jan 2003 → Jun 2005 | — | University of Messina | Completed | Met primary |
| 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 |
| Comparator or background therapy3 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 2 | NCT00546039 Comparator | Apr 2007 → Aug 2008 | prostate cancer | University Hospital, Aker | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2025-01-22 | Humanetics Corporation | Results Humanetics Corporation Announces Positive Phase 2 Clinical Trial Results in COVID-19 Study Aimed at Improving Pulmonary Function humaneticscorp.com ↗
Participants who received BIO 300 demonstrated a statistically significant improvement in pulmonary function at 12 weeks, which was maintained at 12 months, as measured by forced expiratory volume in one second (FEV1). |
| 2024-10-30 | Humanetics Corporation | Results Humanetics Corporation Advances Development of Novel Radiation Protection Drug with New Study Results humaneticscorp.com ↗
The results showed that BIO 300 mediated improved survival, led to fewer fevers, maintenance of body weight, and quicker recovery of red blood cell counts. |
| 2023-09-19 | Humanetics Corporation | Results Humanetics Corporation Publishes Clinical Trial Results of BIO 300 in Patients with NSCLC humaneticscorp.com ↗ |
| 2023-08-22 | Humanetics Corporation | Results BIO 300 Featured at the 2023 Military Health System Research Symposium humaneticscorp.com ↗
Data presented at this meeting demonstrated the protective effects of oral and injectable formulations of BIO 300 from ARS when administered prior to exposure to radiation. |
| 2023-05-24 | Humanetics Corporation | Results BIO 300 Enhances Radiotherapy Efficacy Against Lung Tumors in a NonClinical Model humaneticscorp.com ↗
The researchers concluded that BIO 300 was radioprotective of normal lung tissue without compromising the efficacy of radiotherapy on lung tumors. |
| 2023-02-15 | Humanetics Corporation | Results Humanetics Announces Positive Results from Independent Data Monitoring Committee humaneticscorp.com ↗
The DSMB conducted an interim analysis of the unblinded trial data and determined that the study is not futile, and that it is reasonable to continue with the trial. |
| 2023-02-07 | Humanetics Corporation | Results BIO 300 Demonstrates Protection Against Radiation-Induced Lung Injury humaneticscorp.com ↗
The researchers concluded that both BIO 300 formulations, as well as the combination of BIO 300 with PEGfilgrastim, demonstrated significant efficacy in preventing radiation-induced lung inflammation and fibrosis, whereas PEGfilgrastim administered alone had minimal impact on such delayed lung injuries. |
| 2022-11-15 | Humanetics Corporation | Results Humanetics Corporation Publishes Results of Phase 1 Study of BIO 300 Oral Powder humaneticscorp.com ↗
Humanetics Corporation (Humanetics) announced the publication of results from their recently completed phase 1 trial of BIO 300 Oral Powder in healthy volunteers in the journal Clinical Pharmacology in Drug Development ( NCT04650555 ). |
| 2022-10-25 | Humanetics Corporation | Results Humanetics Corporation Presents at the 2022 Annual Radiation Research Society Meeting humaneticscorp.com ↗
Data presented included the protective effects of BIO 300 Oral Powder for both acute hematological and long-term pulmonary effects of acute radiation exposure when administered prophylactically. |
| 2022-10-05 | Humanetics Corporation | Regulatory FDA Clears BIO 300 Studies in Second Oncology Indication humaneticscorp.com ↗
Humanetics Corporation (Humanetics) announced today that it has received FDA clearance of its Investigational New Drug (IND) application for BIO 300 to mitigate erectile dysfunction in men undergoing radiation treatment for prostate cancer. |
| 2022-07-27 | Humanetics Corporation | Results BIO 300 Pharmacokinetics Studies Published humaneticscorp.com ↗
The researchers concluded that the effect of irradiation on the PK of BIO 300 is minimal, an important finding for use of the drug during radiation emergencies or during cancer radiotherapy treatments. |
| 2022-04-26 | Humanetics Corporation | Results New Data Published Comparing BIO 300 with Neulasta humaneticscorp.com ↗
This nonclinical research showed that giving BIO 300 prior to exposure to lethal levels of radiation improved survival equal to Neulasta®, which is given after exposure. |
| 2021-09-22 | Humanetics Corporation | Results Humanetics Corporation Completes Phase 1 Trial humaneticscorp.com ↗
BIO 300 Oral Powder was found to be safe and well-tolerated at daily doses up to 3000mg. |
| 2021-08-24 | Humanetics Corporation | Regulatory Humanetics Corporation's BIO 300 Receives FDA Fast Track Designation humaneticscorp.com ↗
Humanetics Corporation (Humanetics) announced today that BIO 300, a drug under development to increase survival in persons exposed to high levels of radiation, has been granted Fast Track status by the U.S. Food and Drug Administration (FDA). |
| 2020-10-20 | Humanetics Corporation | Results Humanetics Presents New Data at Radiation Research Society Meeting humaneticscorp.com ↗
The data describe the development of this novel solid-dosage formulation and the ability of BIO 300 Oral Powder to protect against radiation injury when administered prophylactically. |
| 2018-01-30 | Humanetics Corporation | Results Humanetics Corporation Presents Data on Drug to Protect Cardiac Cells Against Toxicity from Space-like Radiation humaneticscorp.com ↗
BIO 300 protected the microHeart ® cells from various doses of the mixed-field radiation, enhancing their survival following mission-relevant doses of radiation. |
| 2017-10-31 | Humanetics Corporation | Results Humanetics Presents Data on BIO 300 humaneticscorp.com ↗
Presented data support the development of BIO 300 as an adjunct therapy in combination with radiation therapy for the prevention of radiation-induced erectile dysfunction in prostate cancer patients. |
| 2015-06-02 | Humanetics Corporation | Regulatory Humanetics Corporation Granted FDA Clearance To Proceed With Cancer Treatment Study humaneticscorp.com ↗
Humanetics, along with research partners at Henry Ford Hospital, will proceed with a phase I/II clinical trial to evaluate the safety of BIO 300 and its ability to lessen the damage to normal lung tissue resulting from chemoradiation lung cancer treatment. |
All press releases naming this drug 22 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 31 sources stand behind the page.
| Field | Value | Cited 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 ↗ “Genistein” NCT02075112 ↗ |
| 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 ↗ |
| 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 ↗ |