Japan-based late-stage clinical biopharmaceutical company Renalys Pharma, Inc. announced on Monday that sparsentan, licensed from Travere Therapeutics, Inc., has received Orphan Drug Designation in Japan for primary IgA nephropathy.

Designation by the Japanese Ministry of Health, Labour and Welfare applies to conditions affecting fewer than 50,000 patients with high unmet medical needs, offering benefits such as priority review and a potentially faster approval timeline.

Sparsentan, already approved in Europe and the United States, is undergoing phase III clinical trials in Japan using data from the global PROTECT study. Renalys Pharma holds exclusive development and commercialization rights for sparsentan across Japan and multiple Asian markets. Efforts will focus on addressing the critical need for effective treatment options for IgA nephropathy, a leading cause of kidney failure.

Travere Therapeutics received FDA approval in September 2024 for sparsentan under the US brand name FILSPARI. The drug is designed to slow kidney function decline in patients with high-risk IgA nephropathy progression. Renalys Pharma remains committed to expediting sparsentan's availability to patients in Japan.