Renalys Pharma Announces Positive Topline Results from Phase III Study of Sparsentan in Japanese Patients with IgA Nephropathy
– In a Phase 3 clinical study evaluating the efficacy and safety of sparsentan in Japanese patients with IgA nephropathy (N=35), the percent change from baseline in the 24-hour urine protein-to-creatinine ratio at Week 36, which was the study’s primary endpoint, was -58.54%. Sparsentan was well-tolerated with a profile consistent with other global trials and […]
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 was […]
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 Medicine, Kobe […]
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 segmental glomerulosclerosis […]
Aculys Pharma Acquired by Viatris
Tokyo, Japan, October 16, 2025 – Aculys Pharma, Inc. (“Aculys”), a clinical stage biopharmaceutical company focused on commercializing innovative treatments for neurological conditions, today announced that Viatris Inc. (Nasdaq: VTRS) has completed its acquisition of Aculys. Guided by a core philosophy of “Catalyst to Access” and a core mission to address the challenges of drug lag […]
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 evaluated was the urine protein creatinine ratio (24-hour urine collection) at 36 weeks […]
Aculys Pharma Receives Marketing Approval for Spydia® Nasal Spray in Japan, an Immediate-Use Medication for Epileptic Seizures
Tokyo, Japan, June 24, 2025 – Aculys Pharma, Inc. (“Aculys”), a clinical stage biopharmaceutical company focused on commercializing innovative treatments for neurological conditions, announced that it has received marketing approval from the Ministry of Health, Labour and Welfare (MHLW) of Japan for “Spydia® Nasal Spray 5 mg, 7.5 mg, and 10 mg” (generic name: diazepam) for […]
Inventiva announces completion of enrollment in the Phase 3 NATiV3 clinical trial of lanifibranor in patients with MASH and advanced fibrosis
Aculys Pharma Signs 4.4 Billion Yen Series C Funding Round Agreement
The additional funding will be used to prepare for regulatory approval and commercialization of diazepam nasal spray and pitolisant Tokyo, Japan, March 24, 2025 – Aculys Pharma, Inc. (“Aculys”), a clinical stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics in the fields of neurological and psychiatry, announced that it has entered […]
Inventiva and Hepalys Pharma, Inc. announce the initiation of the clinical development program of lanifibranor in Japan with the dosing of the first participant in Phase 1 trial