Affiliation: Natural Radiation Response Mechanisms Group, Division of Radiation Biosciences, Institute of Nuclear Medicine & Allied Sciences (INMAS), Brig. S.K. Mazumdar Road, Delhi- 110054, India.
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.