Swedish clinical-stage biotech company Oxcia AB, which develops therapies targeting oxidative stress and DNA damage response pathways, announced on Thursday that the European Medicines Agency has made the decision to grant Orphan Drug Designation for OXC-201 in idiopathic pulmonary fibrosis.

The designation provides regulatory and financial incentives, including 10 years of market exclusivity, scientific advice, support for clinical-trial design, substantial fee reductions and access to the Centralised Authorisation Procedure. It also increases eligibility for grants and accelerated regulatory pathways.

OXC-201 is being developed for idiopathic pulmonary fibrosis, a progressive disease characterised by lung scarring that restricts breathing and reduces oxygen supply, with median survival of three to five years. Preclinical data show effects on inflammatory and fibrotic markers, improved lung function and indications of reduced coughing, alongside evidence of good tolerability.

Clinical trials are scheduled to begin in 2027.