> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Lifts Hold on Radiation Countermeasure
- URL: https://www.fdaweb.com/fda-lifts-hold-on-radiation-countermeasure/
- Published: 2016-02-22T12:00:00.000Z
- Updated: 2026-09-15T02:37:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134844

> FDA has removed a clinical hold against Aeolus Pharmaceuticals’ AEOL 10150, allowing the company to move forward with a Phase 1 safety study in healthy normal volunteers in the second quarter. The agency placed the hold in 2014, asking for more information on the product’s toxicology data that supported a new formulation, genotoxicity data, and discoloration of the skin at injection sites. The therapy is being developed as a medical countermeasure for radiation-induced lung fibrosis in cancer patients receiving radiation therapy, and for use in an undisclosed second indication. Its co-development partner is HHS’ Biomedical Advanced Research and Development Authority.  
>  
> The company says AEOL 10150 is a broad-spectrum catalytic antioxidant designed to neutralize reactive oxygen and nitrogen species. “The neutralization of these species reduces oxidative stress, inflammation, and subsequent tissue damage-signaling cascades resulting from radiation exposure,” it says.  
>