Calliditas Therapeutics AB has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its drug setanaxib for the treatment of Alport syndrome. Alport syndrome is a genetic disorder that affects the kidneys, eyes, and cochlea due to mutations in genes coding for type 4 collagen. The condition leads to kidney disease, hearing loss, and eye abnormalities and can progress to proteinuria, hypertension, kidney function decline, and end-stage renal disease (ESRD). Calliditas plans to initiate a phase 2 clinical study for Alport syndrome with setanaxib in the fourth quarter of 2023, focusing on this orphan indication where there are currently no approved treatments. The study is expected to include around 20 patients.