FDAnews
www.fdanews.com/articles/210427-algernons-ifenprodil-gets-orphan-drug-nod-for-idiopathic-pulmonary-fibrosis

Algernon’s Ifenprodil Gets Orphan Drug Nod for Idiopathic Pulmonary Fibrosis

December 8, 2022

The FDA has granted Orphan Drug status to Algernon Pharmaceuticals’ Ifenprodil for treating idiopathic pulmonary fibrosis (IPF), a chronic, progressive disease that causes scarring of the lungs.

Ifenprodil is an N-methyl-D-aspartate (NMDA) receptor antagonist, which blocks the thickening, stiffening and scarring of lung tissue.

The drug was evaluated in a phase 2a clinical trial, which showed significant reduction in the frequency of IPF-associated coughs.

Orphan Drug status is only available for rare diseases, which affect fewer than 200,000 patients in the U.S. If approved, the drug would receive seven years of market exclusivity.

View today's stories