Genistein is under clinical development by Humanetics and currently in the Phase I and Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Genistein’s likelihood of approval (LoA) and phase transition for Radiation Toxicity (Radiation Sickness, Acute Radiation Syndrome) took place on 26 Aug 2021, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Genistein Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Genistein overview

Genistein (BIO-300) is under development as a medical radiation countermeasure for the prevention or treatment of erectile dysfunction in prostate cancer, acute radiation syndrome (ARS), radiation-induced pneumonitis, COVID-19-related acute respiratory distress syndrome, pulmonary fibrosis, decrease the incidence of mucositis, oral lesions, and salivary gland dysfunction in head and neck cancer patients and to protect healthy tissues against the damaging effects of routine CT scans and x-rays and acute respiratory distress syndrome, pulmonary fibrosis patients with coronavirus infection. The drug candidate is administered by oral route. BIO-300 is a non-synthetic single molecular agent. BIO 300 is suspension of genistein nanoparticles. Genistein is a naturally occurring chemical known as an isoflavone, derived from soy products, that has been investigated as an anticancer agent and which behaves as an antioxidant.

Humanetics overview

Humanetics, a subsidiary of Golden Gate Capital, is a clinical stage pharmaceutical company that develops and discovers proprietary products. The company provides medical foods, prescription drugs, and consumer products. It offers radiomodulator development program that include BIO 300, which is used in cancer patients to reduce the side-effects of radiation treatments. Humanetics also undertakes clinical trial for INDs for BIO 300. The company discovers and develops products in the areas of medical imaging, oncology, and medical countermeasures. It collaborates with private and public research institutions for its research activities. Humanetics is headquartered in Edina, Minnesota, the US.

Quick View Genistein LOA Data

Report Segments
  • Innovator
Drug Name
  • Genistein
Administration Pathway
  • Oral
Therapeutic Areas
  • Infectious Disease
  • Male Health
  • Mouth and Dental Disorders
  • Oncology
  • Respiratory
  • Toxicology
Key Developers
  • Sponsor Company: Humanetics
  • Originator: Armed Forces Radiobiology Research Institute and U.S. National Institutes of Health
Highest Development Stage
  • Phase II

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.