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
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