The designation marks an important milestone for the OXC-201 program and underscores the significant medical need in IPF, a serious, progressive lung disease for which current treatments only slow progression rather than cure it. The US, which accounts for roughly 80 percent of the global IPF market, offers ODD holders benefits including regulatory support, fee reductions, tax credits, and up to seven years of market exclusivity.

“Having OXC-201 now also granted Orphan Drug Designation by the FDA is a highly important recognition of the program’s potential,” says Ulrika Warpman Berglund, CEO of Oxcia. “The ODD status strengthens our ability to develop OXC-201 efficiently and positions the candidate as a potentially differentiated treatment in an area of substantial medical need.”

OXC-201 is a first-in-class oral OGG1 inhibitor targeting core mechanisms behind inflammation and fibrosis. Preclinical studies have shown effects on inflammatory and fibrotic disease markers, improved lung function in disease models, and potential to reduce cough. Clinical studies are set to begin in 2027.