Pharmaceutical development company Nuformix plc (LSE:NFX) declared on Monday that it has submitted an application to the US Food and Drug Administration for Orphan Drug Designation (ODD) for tranilast, the active ingredient in its inhaled NXP002 programme targeting Idiopathic Pulmonary Fibrosis (IPF).

This move follows the European Medicines Agency's grant of ODD for the same indication in May 2025.

The FDA will review the application within 90 days and may grant designation, request additional information or deny the request. If approved, Nuformix could gain benefits including tax credits for clinical trials, a waiver of the Prescription Drug User Fee Act application fee, and seven years of marketing exclusivity upon product approval.

IPF is a progressive and fatal lung disease affecting fewer than 200,000 people in the US, with no cure and limited treatment options. Nuformix is in discussions with potential partners regarding an out-licence or option agreement for NXP002 as part of its drug repurposing strategy in fibrosis and oncology.