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RGN-457 is an inhaled peptide biologic formulation of thymosin beta 4 (Tβ4), a naturally occurring 43-amino acid peptide, developed by RegeneRx Biopharmaceuticals. It is designed for the treatment of cystic fibrosis (CF) and other pulmonary indications. The drug works by reducing the cohesivity and viscosity of CF sputum, which is often thickened by high concentrations of extracellular actin, thereby facilitating airway clearance. Additionally, RGN-457 exhibits anti-inflammatory properties that may help mitigate lung damage. RegeneRx holds the development rights under an exclusive worldwide license from the National Institutes of Health (NIH). As of 2008, the company had completed preclinical work necessary for an IND application and was seeking a strategic partner for further clinical development.
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