Medical Countermeasures for Radiation Exposure and Related Injuries: Characterization of Medicines, FDA-Approval Status and Inclusion into the Strategic National Stockpile

Abstract

World events over the past decade have highlighted the threat of nuclear terrorism as well as an urgent need to develop radiation countermeasures for acute radiation exposures and subsequent bodily injuries. An increased probability of radiological or nuclear incidents due to detonation of nuclear weapons by terrorists, sabotage of nuclear facilities, dispersal and exposure to radioactive materials, and accidents provides the basis for such enhanced radiation exposure risks for civilian populations. Although the search for suitable radiation countermeasures for radiation-associated injuries was initiated more than half a century ago, no safe and effective radiation countermeasure for the most severe of these injuries, namely acute radiation syndrome (ARS), has been approved by the United States Food and Drug Administration (FDA). The dearth of FDA-approved radiation countermeasures has prompted intensified research for a new generation of radiation countermeasures. In this communication, the authors have listed and reviewed the status of radiation countermeasures that are currently available for use, or those that might be used for exceptional nuclear/radiological contingencies, plus a limited few medicines that show early promise but still remain experimental in nature and unauthorized for human use by the FDA.

Fig. 1

Promising radiation countermeasures under development. Currently there are seven radiation countermeasures having FDA-IND status: Entolimod/CBLB502, Ex-RAD, BIO 300, OrbeShield, HemaMax, 5‐Androstenediol (5‐AED), and Neupogen. G-CSF and GM-CSF are available in the SNS. Other countermeasures are under different stages of development. Among the promising countermeasures being developed are myeloid progenitors (CLT‐008), GT3, AEOL 10150, and amifostine. There are three countermeasures against internally deposited radionuclides: potassium iodide, Prussian blue, and Ca-/Zn-DTPA.