Renalys Pharma Inc, a privately held late-stage clinical biopharmaceutical company based in Japan, announced on Thursday that it has completed patient enrolment for its registrational Phase III clinical trial of sparsentan for the treatment of IgA nephropathy in Japan.

The company submitted an Investigational New Drug (IND) Application for sparsentan to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan in April 2024.

The registrational Phase III study, a multicentre, open-label, single arm study in Japanese patients with IgA nephropathy, is intended 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 to be released in the second half of 2025 to support a submission for approval to PMDA.

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

In 2024, Travere received full FDA approval for sparsentan (US brand name: FILSPARI) to slow kidney function decline in adults with primary IgA nephropathy who are at risk of disease progression.