> ## 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.

# Orphan Drug Status for Soligenix’s Dusquetide
- URL: https://www.fdaweb.com/orphan-drug-status-for-soligenixs-dusquetide/
- Published: 2016-08-18T12:00:00.000Z
- Updated: 2026-09-14T21:25:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136547

FDA has granted Soligenix an orphan drug designation for dusquetide and its use in treating macrophage activation syndrome (MAS). Dusquetide has previously received an orphan designation for treating acute radiation syndrome. Dusquetide is an innate defense regulator, a new class of short, synthetic peptides that accelerates bacterial clearance and resolution of tissue damage while modulating inflammation following exposure to a variety of agents including bacterial pathogens, trauma, radiation or chemotherapy, according to the company. “Dusquetide's activity in preclinical models has demonstrated the potential to enhance mechanisms of the innate immune system to clear infection and modulate the inflammatory response, the critical attributes of this syndrome,” it says.

MAS is a life-threatening complication of rheumatic disease that seems to occur in individuals with systemic juvenile idiopathic arthritis, systemic lupus erythematosus and Kawasaki disease more frequently than in other diseases. It is characterized by pancytopenia, liver insufficiency, coagulopathy and neurologic symptoms and is thought to be caused by the activation and uncontrolled proliferation of T lymphocytes and well-differentiated macrophages, leading to widespread hemophagocytosis and cytokine overproduction, Soligenix says.