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 and […]
Aculys Pharma Announces Positive Results in Japan Phase III Clinical Trial of Pitolisant inPatients with Obstructive Sleep Apnea Syndrome (OSAS)
Aculys has completed the double-blind portion of a Phase 3 trial evaluating the use of pitolisant in Japanese OSAS patients experiencing excessive daytime sleepiness (EDS) currently on Continuous Positive Airway Pressure (CPAP) therapy. In the study, the primary efficacy endpoint was statistically superior to placebo (p=0.007). Further the study confirmed that the safety and tolerability […]
Aculys Pharma: Pitolisant,a Histamine H3 Receptor Antagonist/Inverse Agonist for Narcolepsy,Receives Orphan Drug Designation
Tokyo, Japan, December 26, 2024 — Aculys Pharma, Inc. (“Aculys”), a clinical stage biopharmaceutical company focused on commercializing innovative treatments for neurological and psychiatry conditions, has announced that pitolisant (“this drug”), a histamine H3 receptor antagonist/inverse agonist for narcolepsy, which is currently under development, has received orphan drug designation from the Ministry of Health, Labour and […]
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. […]
Aculys Pharma Delivers Positive Results in Domestic Phase III Clinical Trial of Pitolisant for Narcolepsy Patients
Aculys completed the double-blind portion of a Phase 3 trial in Japan for the use of pitolisant in narcolepsy patients. In the study, the primary efficacy endpoint was achieved, and the study confirmed that the safety and tolerability of pitolisant were comparable to those observed in overseas clinical trials. Based on the study results, Aculys […]
Aculys Pharma Files New Drug Application for Diazepam Nasal Spray in Japan: An Antiepileptic Drug for the Treatment of Epileptic Seizures
Tokyo, Japan, September 2, 2024 – Aculys Pharma, Inc. (“Aculys”), a clinical stage biopharmaceutical company focused on commercializing innovative treatments for neurological conditions, announced that it has submitted a New Drug Application to the Ministry of Health, Labour and Welfare (MHLW) for diazepam nasal spray, an antiepileptic drug being developed in Japan for the treatment of […]
Inventiva secures a new patent in Japan, expanding the IP protection of its lead product candidate lanifibranor
Aculys Pharma Completes Patient Enrollment for Phase 3 Clinical Trial on Pitolisant in Patients with Narcolepsy
Tokyo, Japan, July 22, 2024 — Aculys Pharma, Inc. (“Aculys”), a clinical-stage biopharmaceutical company focused on commercializing innovative treatments for neurological conditions, today announced that it has finished enrolling patients for the domestic Phase 3 clinical trial on the histamine H3 receptor antagonist/inverse agonist pitolisant in patients with narcolepsy. Hidemasa Tanigaki, Chief Executive Officer of […]
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 Pharmaceuticals and Medical […]
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 SR One, along with […]