Renalys Pharma to be Acquired by Chugai Pharmaceutical
TOKYO, JAPAN, October 24, 2025 — Renalys Pharma, Inc. (Headquarters: Tokyo; Representative Director Chaiman & CEO; BT Slingsby; “Renalys”) and Chugai Pharmaceutical Co., Ltd. (Headquarters: Tokyo; President & CEO: Osamu Okuda; “Chugai”) today announced a definitive stock purchase agreement, under which Chugai will acquire Renalys (the “Transaction”). Renalys is advancing sparsentan in Japan; the medicine […]
Renalys Pharma Announces Support for Alport Syndrome Registry Study Organized by Japanese Society for Pediatric Nephrology
TOKYO, JAPAN, October 22, 2025 — Renalys Pharma, Inc. (Headquarters: Chuo-ku, Tokyo; “Renalys”) is pleased to announce the company is providing financial support for the Alport Syndrome Registry Study organized by the Japanese Society for Pediatric Nephrology (Head Office: Chiyoda-ku, Tokyo). The study is headed by Professor Kandai Nozu, Department of Pediatrics, Graduate School of […]
Renalys Pharma Reaches Japan PMDA Agreement on Phase III Clinical Trials of Sparsentan for Focal Segmental Glomerulosclerosis (FSGS) and Alport Syndrome (AS)
TOKYO, JAPAN, October 17, 2025 — Renalys Pharma, Inc. (Headquarters: Chuo-ku, Tokyo; “Renalys”) today announced that it has reached an agreement with the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan regarding development plans for two Phase III clinical trials of sparsentan in Japan(development code: RE-021) — one investigating the use of sparsentan in focal […]
Renalys Announces Completion of Primary Endpoint Data Collection for Phase III Clinical Trial of Sparsentan for IgA Nephropathy in Japan
TOKYO, JAPAN, October 10, 2025 — Renalys Pharma, Inc. (Headquarters: Chuo-ku, Tokyo; “Renalys”) announced today that it has completed data collection for the primary endpoint in the Phase III clinical trial of sparsentan (development code: RE-021) for IgA nephropathy in Japan. The primary endpoint being evaluated is the urine protein creatinine ratio (24-hour urine collection) […]
Renalys Pharma announces completion of patient enrollment in registrational Phase III clinical trial of sparsentan for IgA nephropathy in Japan
TOKYO, JAPAN, January 30, 2025 — Renalys Pharma, Inc. (Headquarters: Chuo-ku, Tokyo; “Renalys Pharma”) announced today that it has completed patient enrollment for its registrational Phase III clinical trial of sparsentan for the treatment of IgA nephropathy in Japan. In April 2024 Renalys submitted an Investigational New Drug (IND) Application for sparsentan to the Pharmaceuticals […]
Sparsentan receives Orphan Drug Designation for primary IgA nephropathy in Japan
TOKYO, JAPAN, December 2, 2024 — Renalys Pharma, Inc., a late-stage clinical biopharmaceutical company announces that sparsentan, in-licensed from Travere Therapeutics, Inc. (“Travere”) and currently in phase III clinical trials in Japan, has received Orphan Drug Designation from the Japanese Ministry of Health, Labour and Welfare for the indication of primary IgA nephropathy as of November 27, 2024. […]
Travere Therapeutics Announces Full FDA Approval of FILSPARI® (sparsentan), the Only Non-Immunosuppressive Treatment that Significantly Slows Kidney Function Decline in IgA Nephropathy
FDA approves expanded indication making FILSPARI available to patients with IgA nephropathy (IgAN) at risk of progression; updated label includes data showing long-term durable benefit on proteinuria and kidney function preservation that accrued over two years Conversion to full approval based on results from the PROTECT Study, where FILSPARI delivered superior long-term kidney function preservation […]
Renalys Pharma announces first patient dosed in registrational Phase III clinical trial of sparsentan for IgA nephropathy in Japan
TOKYO, JAPAN, July 18, 2024 — Renalys Pharma, Inc. (Headquarters: Chuo-ku, Tokyo; “Renalys Pharma”) announced today that the first person was dosed in its registrational Phase III clinical trial of sparsentan for the treatment of IgA nephropathy in Japan. In April this year Renalys submitted an Investigational New Drug (IND) Application for sparsentan to the […]
Renalys Pharma Closes ¥6.0Bn Series A Financing to Advance Kidney Disease Treatments Across Asia
Financing Round Co-led by Catalys Pacific and SR One, Investment to Drive the Development of Sparsentan for IgA Nephropathy in Japan and Other Asian Countries TOKYO, JAPAN, July 17, 2024 — Renalys Pharma, Inc., a late-stage clinical biopharmaceutical company has completed a ¥6.0Bn Series A financing. The financing was led by Catalys Pacific and […]
Travere Therapeutics Reports First Quarter 2024 Financial Results
FDA grants Priority Review for sNDA to convert FILSPARI® (sparsentan) from accelerated approval to full approval for the treatment of IgAN in the U.S.; PDUFA target action date of September 5, 2024 Received 511 new patient start forms (PSFs) for FILSPARI in Q1 2024; Total of 1,963 PSFs received since launch Net product sales of FILSPARI totaled $19.8 million for the […]