Ionizing radiation-induced Acute Radiation Syndrome (ARS) can be prevented/treated using radioprotective
agents including; radioprotectors, radiomitigators and radio-therapeutics. Most of the radioprotective molecules currently
being developed have emerged from classical drug discovery approaches and have certain shortcomings related to efficacy
and toxicity. In order to overcome these issues, adoption of new target-based drug development approaches is required.
Like other pharmaceutical drug development programs, patents are being used to protect the new radioprotective
compounds that provide right of exclusivity to the inventors. In addition to patents, the FDA approval for safety and efficacy
is required for the development of radioprotective drugs that is often being done under FDA’s animal rule and requires
huge amount of funding. However, radiation countermeasure agents considered emergency medicines and not carrying
attractive revenue generation opportunities and are often granted ‘orphan drug status’. Thus, pharma giants do not
take much interest in such molecules that limit the funding options only to the government agencies, which in turn reduces
the interest of researchers in this particular area. In addition to their emergency use, these agents could also be employed
for clinical radiotherapy purposes and may provide reasonable incentive to the inventor. Thus, encouraging the development
of new radioprotective agent with cutting-edge drug discovery approaches needs more public-private partnership ensuring
affordable access; that may stimulate researchers to engage in the area of radioprotector development. This article
attempts to cover information available so far on the products/patents/major compounds, known in this critical area of development,
along with most relevant regulatory issues and future perspectives.
Acute radiation syndrome, radiation protection, radiation mitigation, radiation countermeasure.
Natural Radiation Response Mechanisms Group, Division of Radiation Biosciences, Institute of Nuclear Medicine & Allied Sciences (INMAS), Brig. S.K. Mazumdar Road, Delhi- 110054, India.