Renalys Pharma Concludes Patient Enrollment for Phase III Trial

Renalys Pharma, Inc., a privately owned late-stage clinical biopharmaceutical firm located in Japan, declared that it has finalized patient enrollment and achieved the target case number for its registrational phase III clinical trial of sparsentan aimed at treating IgA nephropathy in Japan.

In April of this year, Renalys filed an Investigational New Drug (IND) Application for sparsentan with the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. The phase III registrational study is an open-label, single-arm, multicenter clinical trial involving Japanese patients with IgA nephropathy, aimed at verifying the efficacy and safety of sparsentan in about 30 Japanese patients. Results from the urine protein/creatinine ratio (UP/C) endpoint in the study are anticipated in the latter half of 2025 to aid in a submission for approval to PMDA.

"We are profoundly thankful to the collaborating medical institutions for their outstanding contributions, allowing Renalys to finish patient enrollment sooner than planned," stated BT Slingsby, MD, PhD, MPH, CEO and executive chairman of Renalys Pharma, Inc. "By maintaining our ongoing partnership and dedication, we aim to provide this novel treatment of sparsentan to patients as swiftly as possible."

Sparsentan was created by Travere Therapeutics, Inc. (Travere). Renalys Pharma holds an exclusive license for the development and marketing of sparsentan in Japan, South Korea, Taiwan, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam.