Renalys Pharma, Inc, a Japan-based biopharmaceutical firm, announced on Thursday that it has dosed its first patient in Japan for its registrational Phase III clinical trial of sparsentan for the treatment of IgA nephropathy.

In April this year, the company submitted an Investigational New Drug (IND) Application for sparsentan to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.

The registrational Phase III study is a multicentre, open-label, single arm study in Japanese patients with IgA nephropathy, and is planned to confirm the efficacy and safety of sparsentan in approximately 30 Japanese patients. Results from the urine protein/creatinine ratio (UP/C) endpoint in the study are expected in the second half of 2025 to support a submission for approval to PMDA.

Sparsentan was developed by California-based Travere Therapeutics, Inc. Renalys Pharma has an exclusive license for development and commercialisation of the product in Japan, South Korea, Taiwan, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam.